cyrilzakka/clinical-trials huggingface dataset:
Clinical Efficacy and Safety of Axiom Worldwide DRX9000 Axial Decompression System for Treatment of Low Back Pain

This study will document efficacy and safety of the Axiom Worldwide DRX9000™ for treatment of low back pain (LBP) in a prospective, randomized, crossover, multicenter trial utilizing a standardized clinical research multimodal protocol. During the first two weeks subjects are randomized to receive either conservative care or DRX treatment first and then cross over to receive either conservative care or DRX treatment the next 6 weeks. This study will test the hypothesis that standardized 6-week treatment regimen of spinal decompression using DRX9000™ will reduce chronic lower back pain more than conservative therapy (current baseline therapy).

This study will document efficacy and safety of the Axiom Worldwide DRX9000™ for treatment of low back pain (LBP) in a prospective, randomized, crossover, multicenter trial utilizing a standardized clinical research multimodal protocol. During the first two weeks subjects are randomized to receive either conservative care or DRX treatment first and then cross over to receive either conservative care or DRX treatment the next 6 weeks. This study will test the hypothesis that standardized 6-week treatment regimen of spinal decompression using DRX9000™ will reduce chronic lower back pain more than conservative therapy (current baseline therapy

Eligibility Criteria:
Inclusion Criteria:

* In addition to a diagnosis of LBP, ALL of the following criteria must be met:

  * Male or female, \>18 years of age
  * Able to provide written informed consent (ICF) to the IRB approved clinical multimodal protocol
  * Chronic (onset more than 12 weeks) low back pain with an intensity level of \> 4 on a verbal rating scale for pain (VRS) of 0-10 (with 0 = no pain and 10 = worst possible pain)
  * Completed necessary diagnostic medical history evaluation forms as described in the protocol to confirm the patient's diagnosis and eligibility for the study
  * Willing and able to complete the 6 week 20 session DRX9000 outpatient treatments and a minimum of 6 months follow-up

Exclusion Criteria:

* If ANY of the following exclusion criteria are present, the subject is NOT eligible:

  * Pregnancy
  * Evidence of neurologic motor deficits on clinical examination
  * Evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection or compression fracture
  * Severe spinal stenosis
  * Litigation for health-related claim (in process or pending), Worker's Compensation, or Personal Injury cases
  * Previous spine fusion surgery or instrumentation
  * Hemiplegia or paraplegia
  * Significant cardiovascular or metabolic disease, or abdominal aortic aneurysm
  * Unwillingness to postpone other types of therapy for LBP that are not listed as adjuncts in the research protocol
  * Known alcohol abuse or drug abuse
  * Height less than 4 feet 10 inches (147 cm) or greater than 6 feet 8 inches (203 cm)
  * Body weight greater than 300 pounds (136 kg)
Evaluating TESLA-G, a Gamified, Telegram-delivered, Quizzing Platform for Surgical Education in Medical Students

Telegram Education for Surgical Learning and Application Gamified (TESLA-G) is an online, gamified quizzing platform for surgical education in medical students.The main objective of this pilot study is to assess the feasibility and acceptability of carrying out a full randomised control trial involving TESLA-G.

A pilot randomised controlled trial involving 50 undergraduate medical students will be conducted. They will be randomised into an intervention group and an active control group.

Feasibility will be determined by participant enrollment, retention rate, and quiz completion. Acceptability will be measured quantitatively via a post-intervention learner satisfaction survey and qualitatively via semi-structured interviews. Additionally, participants' scores for pre- and post-intervention knowledge tests will be compared.

Online multiple-choice question (MCQ) quizzes are a well-established summative assessment tool in medical education. However, they suffer from high drop-out rates, attributed to waning user motivation over time. Various studies have shown that incorporation of gamified elements into learning can promote engagement and motivation.

In this pilot study, we will assess the feasibility and acceptability of a novel gamified quizzing platform, Telegram Education for Surgical Learning and Application Gamified (TESLA-G), to determine the possibility of a future larger-scale randomised controlled trial.

This study entails a randomised controlled trial with two arms, an intervention group (TESLA-G) and an active control group (conventional quizzing platform). 50 first to fifth year medical students from Lee Kong Chian School of Medicine, Nanyang Technological University will be randomised into the two arms with a 1:1 allocation ratio, stratified by year of study. Participants will use the assigned quizzing platform to attempt questions on a specific topic (endocrine surgery) over a period of two weeks.

At the end of the study period, several outcomes will be assessed. Feasibility will be determined by participant enrollment, retention rate, and quiz completion. Acceptability will be measured quantitatively via a post-intervention learner satisfaction survey and qualitatively via semi-structured interviews. Additionally, participants' scores for pre- and post-intervention knowledge tests will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled in a full-time 5-year undergraduate programme in the medical school that leads to the Bachelor of Medicine and Bachelor of Surgery (MBBS)
* Willing and able to provide consent for participating in the entire duration of the study including all pre- and post-study assessments

Exclusion Criteria:

* NIL
Differentiation of Malig. & Ben. Solitary Pulm. Nodules & Prediction of Clin. Outcome Using Perfus. Analysis of DCEMRI

The purpose of our study is to determine whether contrast-enhanced dynamic MRI (DCE MRI) analysis of tumor angiogenesis and perfusion can be used as a reliable modality to differentiate benign from malignant solitary pulmonary nodules (SPN) before surgical intervention, using kinetic model derived from DCE MRI, and further correlate if there is any positive correlation between angiogenesis factor (vascular endothelial growth factor VEGF, microvessel density MVD); and if the perfusion parameters from DCE MRI can predict patients' outcomes and survival.

The solitary pulmonary nodule (SPN) is a common finding in chest radiography. Pulmonary nodules larger than 1cm indicative of malignancy or with indeterminate finding according to morphology criteria have to be defined by invasive methods such as biopsy or surgical excision, and benign pathology makes up 20-50% of those resected pulmonary lesions. The lesions not receiving surgical intervention often need imaging follow-up on a regular basis for a long period of time to monitor the stability of the finding.

There are many reports regarding the MRI perfusion analysis of neoplasms from many organs, including bone marrow, liver, breast, cervix, and they stressed not only on comparison between benignity and malignancy, but also on monitoring the treatment outcomes after neoadjuvant chemotherapy, radiation therapy or anti-angiogenic agent therapy \[7-15\]. Dynamic contrast-enhanced MRI (DCE MRI) is not a standard examination for SPN, but there have been some data regarding the differentiation between malignant and benign SPN using DCE MRI, with MRI offering higher specificity compared to dynamic CT scan \[6, 7, 16\]. It was also reported that DCE MRI could delineate kinetic and morphologic differences in tumor angiogenesis and perfusion characteristics between malignant and benign pulmonary lesions with relatively high accuracy \[7, 16\]. The purpose of our study is to determine whether DCE MRI analysis of tumor angiogenesis and perfusion can be used as a reliable modality to differentiate benign from malignant SPN before surgical intervention, using kinetic model derived from DCE MRI, and further correlate if there is any positive correlation between angiogenesis factor (vascular endothelial growth factor VEGF, microvessel density MVD); and if the perfusion parameters from DCE MRI can predict patients' outcomes and survival.

Eligibility Criteria:
Inclusion Criteria:

* patients who have solitary pulmonary nodules in CT

Exclusion Criteria:

* patients who don't fit the above inclusion criteria
Effects of Adding Chickpeas to the American Diet (Long Term Study)

This prospective study will assess the effects of adding legumes, especially chick peas, to the diet of healthy adults on the commensal bacteria from feces of human subjects and resulting self-reported GI symptoms as well as markers of immune function.

Long-term observational study:

Subjects enrolled will participate in an observational setting for three months. During this time period, individuals will be encouraged, to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods. Fecal samples for microbiota analysis will be collected every month. Participants will record a weekly online questionnaire about legume intake and GI health as well as other health status updates. While participants will be encouraged to maintain regular intake of chickpeas throughout the long-term study, consumption of other legumes will be encouraged.

Eligibility Criteria:
Inclusion Criteria:

* Good Health
* No systemic antibiotics during the preceding two months
* No medication suppressing immune function
* Willingness to provide basic demographic as well as medical history data

Exclusion Criteria:

* Gastric Ulcers
* Inflammatory Bowel Disease (IBD) or Irritable Bowel Syndrome (IBS)
* Chronic constipation/diarrhea
* Body Mass Index (BMI) \> 30
* Dietary restrictions that prevent legume intake
* Currently on any medication that can affect GI transit time
* Consumption of \>3 servings/week of chickpeas or \>6 servings/week of legumes BEFORE study begins
Glycan Attachment Specificity, Toward ROtavirus Vaccine IMprovement GASTROVIMc (Clinical Investigation)

The GASTROVIM research explores the links between individual genetic susceptibility, genetic variability of rotavirus strains and effectiveness of immunization with the rotavirus vaccination: a clinical investigation to assess glycan attachment specificity, toward rotavirus vaccine improvement.

The work will be carried out in France and in a tropical area of population with diverse geographical origins: the Guyana populated with Native Americans, people of European descent, people of Asian (Hmong) and a large source population African.

The first aim of the project will be to characterize the specificity of the VP8 \* HBGA of RotaTeq and Rotarix vaccines in order to ensure their binding characteristics glycans are similar to those of recent P8 clinical strains circulating in France and were maintained in the culture passages.

The second objective will be to validate the impact of recently described polymorphisms HBGAs on susceptibility to infection by RVA through GASTROVIMc prospective clinical research.

The third objective will be to determine the relative role of recognition and HBGAs ganglioside in the initial attachment and viral entry.

The expression of HBGAs and ganglioside by permissive cell lines in culture human stem RVA be manipulated to define the role of glycans in attachment and infection.

Eligibility Criteria:
Inclusion Criteria:

* 0 to 16.
* giving consent to participate if applicable (\>6yo)
* Parents informed and written consent obtained
* admitted in paediatric emergency for wether an acute gastroenteritis (case group) or anything else than an infection or gastroenteritis (control group)

Exclusion Criteria:

* case group: rotavirus rapid screen test negative; viral gastroenteritis other than rotavirus; bacterial gastroenteritis
* control group: Family and / or patient unable to full informed consent to research; Infectious Pathology context in general.
A Trial to Evaluate Safety of Firmagon® (Degarelix) in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer

The purpose of this open-label, single-arm, multicenter, post-marketing trial is to evaluate long-term safety of Firmagon® in approximately 230 Indian patients diagnosed with advanced hormone-dependent prostate cancer requiring androgen deprivation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Has given written informed consent before any study-related activity is performed
* Advanced hormone-dependent prostate cancer for which androgen deprivation therapy is indicated, and independently from this trial, Firmagon® is intended to be used for treatment
* Age greater than or equal to 18 years and less than 80 years
* Advanced hormone-dependent prostate cancer without any other clinically significant disorder
* Easten Cooperative Oncology Group score ≤ 2
* PSA ≥ 2 ng/mL at screening
* Life expectancy of at least 12 months as per the investigator's judgement

Exclusion Criteria:

* Previous or concurrent hormonal management of prostate cancer
* Contraindication for prescription of Firmagon®
* Concurrent treatment with a 5-α-reductase inhibitor
* Considered as a candidate for curative therapy
* History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
* QTc interval over 450 msec or risk factors for torsades de pointes or on Class IA and Class III anti arrhythmic medications
* Cancer within the last 5 years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
* Known or suspected hepatic, symptomatic biliary disease (this includes moderate to severe chronic hepatic impairment)
* Patients with clinically significant laboratory abnormalities / disorders other than prostate cancer
* Patient with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) infections
A Study of the Safety and Pharmacokinetics of GDC-0152, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies

The study consists of two stages. In Stage 1, maximum tolerated dose (MTD) will be determined. In Stage 2, additional patients will be treated at the MTD of GDC-0152.


Eligibility Criteria:
Inclusion Criteria

* Histologically documented, incurable, locally advanced or metastatic solid malignancies, or non-Hodgkin's lymphoma (NHL) without leukemic phase
* Disease (either target or non-target lesions) that can be assessed by imaging studies and/or physical examination
* For patients with solid tumors or NHL without leukemic phase, disease progression on or after standard therapy, or a malignancy for which there is no standard therapy
* All prior therapy-related toxicities have recovered to baseline-grade toxicity with the exception of alopecia.
* Life expectancy of ≥ 60 days
* Resting oxygen saturation ≥ 92% on room air
* Agreement to use an effective form of contraception for the duration of the study

Exclusion Criteria

* History of central nervous system disease
* Chemotherapy, cancer hormonal therapy (except GnRH agonists), radiotherapy, or immunotherapy within 4 weeks prior to Day 1 (6 weeks for nitrosoureas or mitomycin)
* Use of any other investigational agent or device
* Major surgery or significant traumatic injury within 3 weeks prior to Day 1
* Pregnant or nursing
* Clinically significant cardiovascular disease, New York Heart Association (NYHA) Classification Grade 2 or greater congestive heart failure, a ventricular arrhythmia requiring medication within 1 year prior to Day 1, or NYHA Grade 2 or greater peripheral vascular disease on Day 1
* Known HIV infection
* Patients with ongoing inflammatory processes or a Grade ≥ 2 fever or Grade ≥ 2 fever-associated constitutional symptoms (including rigors/chills, sweating, and others determined by the investigator), or a clinically significant systemic infection within the last month
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications
* History of any chronic liver disease, active hepatic infection, or evidence of hepatic cirrhosis, or Grade ≥ 2 liver dysfunction.
* Baseline oxygen requirement or history of pulmonary fibrosis
* Any signs or symptoms Grade ≥ 2 by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0, at study entry except for alopecia, pain, asymptomatic Grade 2 diffusing capacity of the lung for carbon monoxide (at the discretion of the investigator) or where otherwise specified
* Patients who need to take a concomitant medication, dietary supplement, or food that is a known inhibitor/inducer of the CYP3A4/5 and/or the 2C8 metabolic pathway or that has a narrow therapeutic window and involves these enzymes for their metabolism
Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery

The aim of the present study is to evaluate changes in the morphology and function of the corneal endothelium before and after cataract surgery in patients with diabetes type II. Also to explain if determination of HgbA1c in diabetics is a predictor for the changes in morphology and function.

Thirty patients with Diabetes type II and thirty non-diabetes patients scheduled to cataract surgery (phacoemulsification with intraocular lens implantation) were invited to participate in the study. Preoperatively, all patients had a full eye examination and 3 endothelial cell photos were taken.

Three months postoperatively the patients were called for a re-examination including 3 endothelial cell photos. The function of the cornea is dependent of the number and morphology of the endothelial cells, and even small traumas like cataract surgery may disrupt the cornea integrity leading to corneal haze and blur. Diabetics may be more vulnerable to corneal stress.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cataract scheduled for surgery

Exclusion Criteria:

* Patients with corneal diseases, glaucoma or uveitis, previous intraocular surgery or eye traumas.
Prevalenc Of Lumbosacral Radiculopathy Among Physiotherapists Of Pediatric Rehabilitation OF PEDIATRIC REHABILITATION

Determine the prevalence of lumbosacral radiculopathy among pediatric physiotherapists in the ministry of health in Cairo, Egypt.

the aim of current study was to determine the prevalence of lumbosacral radiculopathy among pediatric physiotherapists in the ministry of health in Cairo, Egypt.

Eligibility Criteria:
Inclusion Criteria:

* a) The age of the subjects ranged from 25-40 years old; b) all subjects working in Ministry of Health in Cairo-Egypt; c) BMI \<30

Exclusion Criteria:

* they were with history of bone disease, renal, liver or endocrinal disorders; b) having lumbosacral radiculopathy before working as pediatric physiotherapists, c) having trauma in back or accident and pregnant pediatric physiotherapists
Multi-omics Analysis to Characterize the Invasive Evolution of Pulmonary Subsolid Nodules

Current clinical follow-up frequency and treatment timing for pulmonary subsolid nodules (SSNs) rely mostly on whether the nodules grow, which may not accurately reflect the pathological status, and may lead to unnecessary follow-ups. This study aims to use multi-omics techniques to dynamically observe the growth and invasiveness evolution process of SSNs and uncover its invasiveness mechanism. Radiological characteristics of SSNs in different invasiveness stages were also analyzed and summarized by analyzing preoperative CT. This can overcome the bottleneck of invasiveness assessment in the growth process of SSN and provide scientific evidence for the scientific management and clinical treatment timing choice of SSN patients, thus facilitating the rational allocation of medical resources and prolonging the expected survival of national health.

This prospective observational cohort study aims to recruit 120 patients with subsolid nodules (SSNs) and 100 healthy volunteers. Enroll 120 patients with SSNs planned for surgery and 100 healthy volunteers. Sequence blood and tissue samples from patients and compare the relevance of biomarkers between the two. Use blood from healthy volunteers as blank controls. Additionally, analyzes radiological characteristics of SSNs at different invasive stages using preoperative CT.

Eligibility Criteria:
Inclusion Criteria:

Patients with SSNs

1. Newly diagnosed patients with persistent SSNs confirmed by thin-section chest CT examination
2. Patient areilling to undergo surgery
3. Voluntarily sign a written informed consent form

Healthy Volunteers

1. Healthy volunteers aged 18-50 years, regardless of gender.
2. No lung nodules detected on chest thin-section CT.
3. No history of cancer.
4. Voluntary sign a written informed consent form.

Exclusion Criteria:

Patients with SSNs

1. Surgical contraindications
2. Inability to cooperate with CT/MR examination to obtain high-quality images
3. History of malignant tumors
4. Previous targeted, immune, or ablation therapy
5. Postoperative pathology of non-lung adenocarcinoma disease spectrum
6. Other situations deemed unsuitable for participation in this study by the researchers

Healthy Volunteers

1. Drug abuse
2. HIV infection or AIDS
3. History of syphilis, gonorrhea, or other infectious diseases
4. Hepatitis B or C virus carrier
Comparison of Biochemical Changes in Patients With Trochanteric Region Fracture Fixation With DHS Versus PFN

Hip fractures are one of the most frequent fractures in older adults. There is still controversy which surgical strategy is the best option for treatment of hip fractures especially trochanteric region fractures. Surgical intervention that follows hip fracture induces biochemical, physiological and fibrinolytic changes that are so-called "second hit phenomenon" which trigger systemic inflammatory response syndrome. The investigators are aiming to study this phenomenon after two different surgical procedures and help surgeons in everyday practice to choose the most suitable surgical treatment for patients with trochanteric region fracture and give the scientific community more evidence which methods is better since there is still controversy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with trochanteric region fractures AO/OTA 31.A1-31.A2
* Time from fracture till surgery up to 1 week
* American Society of Anesthesiologists Classification (ASA) I-III
* Willing to participate

Exclusion Criteria:

* Polytrauma patients
* Open fractures
* Existing local or systemic infection
* Pre-existing coagulatory disorder
* Existing malignancy
* Corticosteroid use
* Systemic inflammatory disease
* Voluntary withdraws of the patient