cyrilzakka/clinical-trials huggingface dataset:
SPACE (SPS ADVANCED CAGE): SPS Spacer for Intervertebral Fusion, Longitudinal, Prospective Clinical Study

Space clinical study aims to evaluate the performance, in terms of efficacy and safety of an intervertebral spacer associated with a bioceramic bone substitute in the context of intervertebral surgery for degenerative diseases.

Specifically, it is intended to evaluate:

* the capacity for bone regeneration/fusion, defined as absence of loosening and presence of continuous trabecular bone bridge in the absence of radiolucency lines, verified by imaging (CT) and evaluated according to the Brantingan scale;
* the safety of the medical device, through the incidence of any adverse events, complications, unexpected reactions, accidents;
* the improvement of clinical outcome in terms of pain and disability, at 9/14 months follow-up compared with preoperative scores, by clinical indices such as ODI and VAS.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided hospital consent for surgical treatment;
* Male patients and non-pregnant female patients between the ages of 18 and 75 years;
* Patients requiring single-level interbody fusion in the L3-L4 and L4-L5 tract;
* Patients with degenerative diseases of the spine, such as lumbar canal stenosis, lumbar discopathy, degenerative spondylolisthesis grade I;
* Patients with a BMI \<= 30;
* Patients physically and mentally willing and able to comply with postoperative indications;
* Patient able to understand the Italian language;
* If the investigator decides to fuse an additional level for spinal stability during surgery, this is not an exclusion criterion; however, only one level will be measured to comply with the surgical indication.
* Female patients who are pregnant or planning to become pregnant during the course of the study;
* Obese patients with a BMI index \> 30.

Exclusion Criteria:

Patients with:

* systemic or localized infection;
* Inflammatory or autoimmune disease;
* hypercalcemia;
* coagulation disorders;
* metabolic disorders;
* insulin-dependent diabetes;
* alterations or complications of thyroid function;
* overt allergy to calcium phosphate salts;
* self-reported allergies to drugs and/or medical devices;
* tumor and/or infectious diseases of the spine;
* active neoplasms;

In addition, patients who:

* Abuse alcohol and drugs;
* Are affected by smoking (\> 20 cigarettes/day);
* Are on drug therapy that causes alteration of bone regeneration (e.g., chemotherapy);
* already had surgery (revision surgery).
Pelvic Cancer Registry for Online Adapted Radiotherapy

This prospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART scenario with two virtual (hypothetical) control scenarios.

Primary endpoint:

* 10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART

Secondary endpoints:

* Clinical endpoints: Tumor control, late toxicities compared to conventional irradiated patients, quality of life and patient-reported outcomes
* Technical endpoints: Target volume, target coverage, dose to organs at risk, anatomical variability score

Background: Conventional Radiotherapy (Image Guided Radiotherapy, IGRT) requires a CT-based treatment planning process a priori. During this process, a treatment plan is calculated, which then is applied to the patient with a linear accelerator on a daily basis, possibly using image guidance to account for variability in patient position. However, daily changes of the anatomy of targets and organs at risk (OARs) can only be addressed by applying additional safety margins, resulting in larger irradiated volumes and possibly higher toxicity.

A promising and innovative technique for margin and in consequence toxicity reduction is online Adaptive Radiotherapy (oART) using daily imaging to create a "plan of the day" aligned to the actual anatomy by means of artificial intelligence (AI) and with the patient on the treatment couch. This approach is especially promising in the pelvic region due to the high anatomic variability, e.g. caused by peristalsis or volume changes of bladder and rectum. Furthermore, the application of oART in the field of thoracic tumors is being evaluated. oART is an already established form of treatment which is used regulary everyday in clinical practice and is not a study-related intervention. A direct comparison of both techniques IGRT vs. oART is missing.

Methods: This prospective and retrospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART scenario with two virtual (hypothetical) control scenarios as follows:

* oART - Applied treatment: AI-based daily treatment plan creation, adapted to daily anatomy
* Virt 1 - Hypothetical dose distribution of initial treatment plan, based on the initial planning CT
* Virt 2 - Hypothetical dose distribution of initial treatment plan, applied to the anatomy of the day as depicted by cone-beam CT at the treatment machine

Eligibility Criteria:
INCLUSION CRITERIA

* Patients with pelvic or thoracic tumors with an indication for radiotherapy
* Patient information and declaration of consent
* Patients age ≥ 18 years

EXCLUSION CRITERIA

* Prior radiotherapy in affected site
Protein-Distinct Macronutrient-Equivalent Diet 2

The central hypothesis is that the addition of minimally processed lean pork to a healthy plant-forward low ultra-processed diet will enhance nutrient adequacy, promote muscular fitness, and maintain metabolic functions for improved healthspan. A well-designed, randomized, controlled, crossover, feeding study with clinical and molecular mechanistic endpoints is proposed to provide the most definitive level of evidence logistically possible in humans and to establish the role of minimally processed lean pork in healthspan promotion. Utilizing an all-food-provided (dine-in and take-out) design over 18 weeks (rolling recruitment, 8+8, 2w washout), a comprehensive assessment of metabolomics, system biology, physical, and physiological markers that indicate the risk of age-related comorbidities-critical micronutrient deficiency, frailty, metabolic dysfunctions, and cognitive decline, is proposed in upper Midwesterners 65 years and older. A minimally processed plant-forward diet with or without added pork will be compared for over 250 outcome measures using mixed-effects modeling adjusting for covariates in R. n=15/diet/arm i.e., a total starting sample size of n=30 is proposed for 90% power.


Eligibility Criteria:
Inclusion Criteria:

* Generally good health status based on one routine physical in the past 15 months
* Normal HbA1C, weigh 110 lb or more
* Age 65 years or more, generally healthy, all races and both sexes
* Generally practicing a meat-based dietary pattern, do not have any special dietary requirement
* Willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.
* Willing to consume pork as sole meat source during the feeding study.

Exclusion Criteria:

* Tobacco/drug/alcohol use
* Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight.
* Active history of cancer, diabetes, heart, liver, and kidney diseases
* major gastrointestinal disorders in the past 3 months
* history of heart attacks or stroke
* Unable to meet in-person visit requirements for dining, picking up meals, and tests
* Any mental health condition that would affect the ability to provide written informed consent.
* If they were unwilling to abstain from taking certain nutritional supplements, alcohol, or non-study foods during the study period.
A Phase 3 Randomized, Double-Blind Placebo Controlled, Multi-regional Trial to Evaluate the Efficacy and Safety of GT0918 for the Treatment of Mild to Moderate COVID-19 Male Patients

The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) in male outpatients with mild to moderate COVID-19 disease

The subjects in the experimental group will receive GT0918 (200mg oral once-daily (QD) for 14 consecutive days) in addition to supportive treatment. The subjects in the control group will receive placebo (200mg oral once-daily (QD) for 14 consecutive days) in addition to supportive treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Adult males age ≥18 years of age at the time of randomization
2. Are currently not hospitalized for acute respiratory symptoms (not applicable for subjects whose countries require mild to moderate COVID-19 patients to be hospitalised, such as COVID-19 patients in mainland China)
3. The subject's first positive SARS-CoV-2 viral infection test result (using an approved molecular test, or other approved commercial or public health assay on any approved specimen) must be ≤3 days prior to randomization
4. Subjects with adequate liver and renal function
5. Agree to the collection of nasopharyngeal swabs and venous blood
6. The participant or legally authorized representative signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria:

1. Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 \< 300, or a respiratory rate ≥30 per minute, or a heart rate ≥125 per minute
2. Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to COVID-19 or requires treatment with supplemental oxygen
3. Have known allergies to any of the components used in the formulation of the study drug or placebo
4. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) requiring systemic therapy and that in the opinion of the investigator could constitute a risk to the subject or study assessments when taking study drug or placebo
5. Have any co-morbidity anticipated to require surgery within \<7 days, or that is considered life threatening within 30 days
6. Have received treatment with the anti-androgen agents or 5-alpha reductase inhibitors within 3 months of the first dose
7. Prior, current, or planned future use of any of the following treatments at screening: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening
8. Are investigator site personnel directly affiliated with this study
9. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days prior to randomization
Study of How Low Blood Sugar Affects the Way Blood Vessels Work

Hypothesis: Low blood sugar (hypoglycemia) decreases function of the lining of the blood vessels in normal humans.

This study is designed to explore how hypoglycemia affects the function of the blood vessel lining. This will be determined by measuring blood flow to the arm before and after occlusion of flow. Blood vessel function will be measured before induction of hypoglycemia, during insulin induced hypoglycemia, and after recovery from hypoglycemia. A second study will be done but without hypoglycemia.

Purpose: The purpose of the research is to learn more about how low blood sugar (low blood glucose or hypoglycemia) affects the way the blood vessels work in healthy people. Subjects who participate in this research project must be in good health and taking no medications.

Methods: A screening visit to the Clinical Research Center of the Ohio State University will be used to assess eligibility to participate. The main study consists of two visits to the Clinical Research Center that occur two to four weeks apart. Each of these visits will involve a procedure known as an insulin clamp. This involves giving insulin and sugar water into a vein. The amount of sugar given varies to keep the blood sugar at a predetermined level. For one of the two visits the blood sugar will be low and the other it will be normal. The function of the blood vessels will be measured three times during each study by measuring blood flow before and after stopping blood flow to the arm for 5 min.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years
* BMI \<27 kg/m2

Exclusion Criteria:

* Pregnancy
* Systolic blood pressure \>140 mmHg
* Diastolic Blood pressure \>90 mg/dl
* Spot daytime urine microalbumin concentration \> 20 μg/mg creatinine
* Past or present history of chronic disease (e.g. cancer, hypertension, cardiovascular disease, chronic inflammatory disease) other than diabetes in type 1 diabetic subjects.
* Use of non prescription medications in the past 3 days
* Use of prescription medications in the past 2 weeks
Inflammatory Markers in Obstructive Sleep Apnea (OSA) Patients.

The aim of our study was to assess the levels of inflammatory biomarkers in a large sample of OSA patients and to investigate any correlation between these markers with clinical and polysomnographic (PSG) parameters.

Subjects undergone a PSG for OSA diagnosis were recruited. Patients with known comorbidities were excluded from the study. Included patients were grouped according to apnea-hypopnea index (AHI) as mild, moderate and severe. Patients with AHI \< 5 served as control group. Demographic, PSG data, serum levels of hs-C-reactive protein (hs-CRP), fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) were measured and compared between groups.

Systemic inflammation is important in obstructive sleep apnea (OSA) pathophysiology and its comorbidity. The objective of this study was to investigate how early biomarkers of inflammation may be altered in OSA patients. To complete this goal the investigators assessed the circulating levels of four inflammatory markers, hs-C-reactive protein (hs-CRP), Fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) in a representative population of consecutively enrolled, untreated and otherwise healthy subjects with a clinical suspicion of obstructive sleep apnea. A secondary objective was to investigate any correlation between these markers with clinical and polysomnographic (PSG) parameters of these subjects.Subjects who had undergone a PSG for OSA diagnosis were recruited. Patients with known comorbidities were excluded from the study. Included patients were grouped according to apnea-hypopnea index (AHI) as mild, moderate and severe. Patients with AHI \< 5 served as control group. Demographic, PSG data, serum levels of hs-CRP, fibrinogen, ESR and UA were measured and compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed, untreated, and otherwise healthy obstructive sleep apnea (OSA) patients
* healthy subjects (without OSA)

Exclusion Criteria:

* refusal to participate,
* previous OSA diagnosis and treatment
* known comorbidities,
* pregnancy,
* history of narcolepsy or restless leg syndrome.
* Subjects younger than 18 years,
* Central sleep apnea syndrome (CSAS) diagnosed with PSG,
A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases

To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734 in adult subjects with type I interferon-mediated autoimmune diseases.

MEDI7734 is a human monoclonal antibody that binds to and causes temporary depletion of plasmacytoid dendritic cells (pDCs), a type of white blood cell. The objectives of this study are to evaluate the safety, drug levels, and pDC levels in subjects who are given a single injection of MEDI7734 or a placebo.

The study will be conducted in subjects with at least one of the five following autoimmune diseases: dermatomyositis, polymyositis, Sjogren's syndrome, systemic lupus erythematosus, or systemic sclerosis.

After a screening period, subjects will be randomized in a 3:1 ratio to receive a single dose of MEDI7734 or matching placebo, administered as a subcutaneous (under the skin) injection. After that, subjects will be evaluated periodically at the study site over at least the next 85 days.

Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.

Eligibility Criteria:
Key Inclusion Criteria:

1. Age 18-65 years old
2. Diagnoses of dematomyositis, polymyositis, Sjogren's syndrome, systemic lupus erythematosus and/or systemic sclerosis based on standard criteria.
3. Weight 40-120kg
4. Stable disease such that in the opinion of the investigator it is unlikely that a change in subject's therapeutic regimen would be required during the subsequent 3 months.

Key Exclusion Criteria:

1. History of a hypersensitivity reaction or anaphylaxis to a previous mAb or human immunoglobulin therapy.
2. Chronic hepatitis B, chronic hepatitis C, or HIV infection.
3. History of latent or active tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening.
4. Herpes zoster infection within 3 months before randomization
5. Any of the following medications within 6 months of Day 1: cyclophosphamide, leflunomide \> 20 mg/day, abatacept.
6. Receipt of a mAb within 5 published half-lives prior to Day 1.
7. Receipt of rituximab or an experimental B-cell depleting mAb within 6 months of Day 1.
8. Receipt of rituximab or an experimental B-cell depleting mAb without return of CD19 or CD20 count to above the lower limit of normal.
9. Receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation, total lymphoid irradiation, or T-cell vaccination therapy -
Revisiting Parental Survey for Screening for Obstructive Sleep Apnea in Patients Undergoing Polysomnography

The investigators are proposing a study where the investigators would give a survey to the parents of patients having a sleep study. The survey would contain questions relating to symptoms of sleep apnea and then the investigators would correlate the parent answers to the results of the sleep study.


Eligibility Criteria:
Inclusion Criteria:

* Any patient coming for sleep study at Nationwide Children's Hospital and parent willing to fill out questionnaire.
* Children ages 3-18 years old regardless of sex or race.

Exclusion Criteria:

* Parental refusal.
The Specificity of Cervical Facet Medial Branch Blocks

Cervical facet arthropathy is a common cause of chronic neck pain. The "gold standard" for diagnosis is either blocking the facet joints, or more commonly blocking the medial branch nerves that innervate the joints. However, many studies have found a high false-positive rate when the nerves are blocked using 0.5 ml of local anesthetic. We will randomize patients to receive either cervical facet medial branch blocks with 0.25 ml of local anesthetic and contrast, or 0.5 ml. We will then do a CT scan to determine the accuracy and specificity of each block. Our hypothesis is that using the higher volume (0.5 ml) might be responsible for the high false-positive rate.

Inclusion criteria: Dept. of Defense beneficiaries \> 18 years of age; neck pain \> 3 months duration; cervical paraspinal tenderness Exclusion criteria: Radicular signs or symptoms; use of anticoagulants or bleeding disorder.

Outcome measures: The number of blocks whereby the contrast bathes the target nerve; the number of blocks whereby the contrast spreads to the medial branch nerve at the adjacent spinal level; the number of times the contrast diffuses into the intervertebral foramen or epidural space. We will also compare pain relief over 8 hours following the block between both volumes.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Chronic neck pain \> 3 months
* Paraspinal tenderness

Exclusion Criteria:

* Absence of radicular symptoms
* No bleeding diathesis
* Contrast allergy
Endovascular treatmenT for Acute Ischemic Stroke in China

This is a retrospective real world registry study, aiming to explore the effectiveness and safety of endovascular treatment of acute ischemic stroke in a Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18;
* Ischemic stroke confirmed by head CT or MRI;
* Patients receiving endovascular treatment;
* First ever stroke or mRS≤2 after previous disease;
* Complete and clear pre- and post-operative DSA images are available

Exclusion Criteria:

* Imaging data not qualified for evaluation;
* Absence of important clinical data;
* The first 50 patients receiving endovascular treatment in a single centerr.
Prospective Sample Collection for Cancer of Bladder

The goal of the Flemish Databank for Urothelial Cancer is to collect clinical and pathological data of patients treated for urothelial cancer (UC).

The goal of this study is to enable the prospective collection of demographic, clinical, pathological and follow-up data of UC patients after signing informed consent. The specific usage of these prospectively collected clinical data will be described in future trials.

Templates for data collection, which also include clinical outcome parameters and quality indicators, were developed in InfoPath™ as an electronic case report form (eCRF) and were implemented within our hospital's electronic patient file system (called Klinisch Werkstation (KWS), which runs in different Flemish hospitals). These eCRFs have been developed based on the recommendations of the European Association of Urology (EAU) guidelines and the Canadian Urological Association (CUA) white paper. Three separate eCRFs were developed for the management of non-muscle-invasive bladder cancer (NMIBC) patients: surgery report, bladder instillation form, and multidisciplinary team (MDT) form. With the scientific output parameters and quality indicators based on the current knowledge, patient flow-charts for the diagnosis of bladder cancer, and management of low-, intermediate- and high-risk NMIBCs have been developed.

This databank will be first used to externally validate the European Organization for Research and Treatment of Cancer (EORTC) and the Club Urologico Español de Tratamiento Oncologico (CUETO) nomograms for recurrence and progression in patients with NMIBC who have been treated according to the state of the art and prospectively followed up. In-depth analysis of the data generated in this registry will give us the opportunity to define improvements in patient follow-up protocol. Moreover, based on this dataset, we aim to develop a risk calculator for disease recurrence and progression, which will be readily available for Flemish hospitals to use.

Eligibility Criteria:
Inclusion Criteria:

* who are aged between 18-90,
* who are of male or female sex,
* who give their informed consent to collect their clinical and pathological data,
* who are planned to undergo TURBT for BC,
* who are planned to undergo (salvage) radical cystectomy with or without an extended pelvic lymph node dissection,
* who are planned to undergo tumor biopsy (from primary or metastatic tumor),
* who are planned to undergo radical nephroureterectomy ± partial cystectomy or segmental ureterectomy, with or without a lymph node dissection,
* who are planned to undergo endoscopic tumor biopsy or resection,
* from whom metastases will be surgically removed.

Exclusion Criteria:

* patients who do not give their informed consent to collect their clinical and pathological data,
* patients who withdraw their informed consent to use their clinical and pathological data,
* patients who refuse the planned treatment,
* women who are pregnant or have suspicion of pregnancy.