cyrilzakka/clinical-trials huggingface dataset:
Dorsal Root Ganglion Stimulation for Hand and Upper Limb Pain

There are no studies as yet specifically investigating the application of DRG stimulation in the treatment of chronic pain affecting the upper limbs. The investigators propose to investigate the effect of dorsal root stimulation in patients with chronic hand or upper limb pain.

Dorsal Root Ganglion (DRG) stimulation is a form of Spinal Cord Stimulation (SCS), which has been available and used for the treatment of chronic pain in Europe since late 2011. Clinical practice and pre/post market studies have shown that stimulation of the DRG can significantly reduce chronic intractable pain of various aetiologies. However, there are no studies as yet specifically investigating the application of DRG stimulation in the treatment of chronic pain affecting the upper limbs. Furthermore, there are very few studies of SCS generally, in an upper limb pain population, despite this being a group often referred for and treated with SCS in tertiary, interventional pain practices. Due to several limitations of traditional SCS systems, chiefly concerning the stability of stimulation induced paraesthesia, DRG stimulation is being increasingly utilised in its place for this condition.

Eligibility Criteria:
* Subject is appropriate for SCS implantation according to standard criteria from the Dutch Neuromodulation Society
* Subject is \>18 to \<75 years old.
* Subject is able and willing to comply with the follow-up schedule and protocol
* Subject has chronic (\> 6 months) uni/bi-lateral pain, primarily in the upper limb(s)
* (Arm and/or Hand)
* Minimum baseline pain rating of 60 mm on the VAS in the primary region of pain
* Documented, successful paraesthesia mapping of transient stimulation over painful anatomy
* Subject is able to provide written informed consent

Exclusion criteria

* Subject has no other exclusion criteria for SCS implantation according to standard criteria from the Dutch Neuromodulation Society
* Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
* Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
* Subject has participated in another clinical study within 30 days
* Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy
* Subject has had a complete or partial amputation of the painful upper limb(s) and is experiencing phantom and/or stump pain post amputation
Analyzing Clinical Trial Experiences of Prostate Cancer Patients

Participation in clinical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the participation or completion of these specific demographic groups.

This study will admit a wide range of data on the clinical trial experience of Prostate Cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might shed insights for the sake of future Prostate Cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with Prostate Cancer as identified by imaging
* Patient has self-identified as planning to enroll in an interventional clinical trial for Prostate Cancer
* Patient is at least 18 years of age

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Inability to perform regular electronic reporting
* Patient has a ECOG score of 4
Immune and Viral Outcomes of HIV-1 Therapy Interruption

The purpose of this study is to determine if stopping anti-HIV drugs for a period of time is safe and effective for enhancing the immune function of patients with HIV.

Our preliminary studies have shown that structured treatment interruption of highly active antiretroviral therapy (HAART) may boost patients' immune responses to HIV-1. In this study, we will test the hypothesis that repeated structured treatment interruptions will increase HIV-1 immunity and result in better control of viral replication than in controls. We will test this hypothesis by determining time to viral rebound after withdrawal of antiretroviral therapy in a randomized, non-blinded study of a well-characterized subject population from a single center. Patients in this study will be randomized to either treatment interruption or control groups. Patients will be monitored for adherence to therapy and changes in immune status following HAART interruption. CD4 percentage, CD 4 and CD8 mediated anti-HIV-1 responses, cell surface T-cell antigen expression, and thymic function will be assessed.

Eligibility Criteria:
Inclusion Criteria

* HIV-1 positive
* HIV RNA \< 500 copies/ml on a regimen of two nucleoside reverse transcriptase inhibitors (NRTIs) and either one protease inhibitor (PI) or one nonnucleoside reverse transcriptase inhibitor (NNRTI) for 6 months prior to study entry - HIV RNA \< 50 copies/ml at study screening
* CD4 \> 400 cells/mm3 with CD4 nadir of \> 100 cells/mm3
* Agree to Medication Event Monitoring System monitoring of one component of antiretroviral regimen
* HIV-1 viral load \>10,000 copies/ml at any time prior to initiating the current uninterrupted HAART regimen
* Willing to abstain from all immunomodulatory drugs during the study
Development of Computer-aided Detection and Diagnosis From Imaging Techniques

This study will develop and evaluate new techniques for computer-aided detection and diagnosis (CAD) of medical problems using images from diagnostic tests such as computed tomography (CT), ultrasound, nuclear medicine and x-ray images. The Food and Drug Administration has approved CAD techniques for detecting masses and calcifications on mammography and lung nodules using chest x-rays. Many other applications of CAD would potentially benefit patients. This study will explore additional uses of CAD.

The study will use imaging data, demographic information, and other medical information from the medical charts of Clinical Center patients to test and evaluate new CAD applications. Such applications include detection of subcutaneous (under the skin) lesions in melanoma patients, bone lesions in patients with advanced cancer, and pulmonary emboli (blood clot lodged in a lung artery) in patients who are known to have pulmonary emboli, and other uses.

Radiologic images are becoming more and more complex, and utilization of radiologic techniques is accelerating. Radiologists and other clinicians are being inundated with radiologic data. Computer aided detection and diagnosis (CAD) have the potential to improve patient care by increasing sensitivity of diagnostic tests, reducing false positives and improving physician efficiency. Computer aided detection and diagnosis have been under development for many years yet there is still much work to be done to move it from the bench to the bedside. The purpose of this project is to develop and evaluate techniques for CAD using the existing radiologic data available in the Clinical Center's Department of Diagnostic Radiology. Such techniques include but are not limited to automated detection of melanoma, bone metastases and pulmonary emboli. The outcome of this study will be algorithms and software that accurately detect lesions on radiologic studies.

Eligibility Criteria:
* INCLUSION CRITERIA:

Inclusion criteria are the availability of radiologic examinations in the clinical PACS (picture archiving system) in the Clinical Center. Existing Patient scans with and without the target lesion will be included. Examples of target lesions include subcutaneous and bone lesions and pulmonary emboli, although patient scans with other disorders depicted on radiologic studies may be included when appropriate. Patient scans without the target lesion may be included to determine the specificity of the computer aided detection or diagnosis algorithm.

EXCLUSION CRITERIA:

There are no exclusion criteria.
Evaluating Primary Suicide Prevention in Adolescents With Risk Factors

Suicide is one of the main causes of death among teenagers. Because it is preventable, primary prevention of suicide has become a public health priority, with encouraging results in promoting suicide awareness and reducing suicidal thoughts among adolescents. However, the lack of studies conducted among vulnerable populations (i.e., marginalised, disengaged and disadvantaged) is a major gap, even though these populations present an increased risk of suicidal behaviour.

The aim of this project is to test the effectiveness of a brief primary suicide prevention intervention for vulnerable adolescents, using a randomised controlled trial. Vulnerable adolescents include those 1) detained in juvenile detention centres, 2) at risk of dropping out of school, 3) undergoing treatment for psychiatric disorders, and 4) belonging to a sexual or gender minority. The main aim is to test the effectiveness of the intervention on a composite measure of suicide awareness, psychological distress and suicidal thoughts. The project will also explore other issues that present challenges for vulnerable populations: access to primary suicide prevention and non-response bias. The study will provide relevant results to address the current lack of high-quality evidence for primary suicide prevention in adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Vulnerable adolescents defined as being: 1) detained in juvenile detention centers, 2) disconnected from school, 3) in treatment for psychiatric disorders, or 4) belonging to a sexual or gender minority.
* Age 14 to 18 years old.
* Good knowledge of French.
* Accepting to sign the informed consent.

Exclusion Criteria:

* The medical/educational staff considers that the intervention will interfere with appropriate management of acute psychiatric disorder or may cause harm to self or other.
* Being enrolled in another suicide prevention intervention during the study period.
COVID-19 Simulation Education on Nursing Students

This study aims to determine the effect of simulation education as an approach to patients with COVID-19 on nursing students' perception and fear of the COVID-19 disease. This study was conducted in a randomized controlled trials with 86 nursing students from a university between November 10 and December 10, 2021.


Eligibility Criteria:
Inclusion Criteria:

* Nursing student and
* Agreeing to participate in the study

Exclusion Criteria:

* Refusing to participate in the study or quitting the study
Clinical Study of Approved Contact Lenses

Evaluation of Johnson \& Johnson Acuvue Vita (senofilcon C) soft contact lenses to the Bausch + Lomb Ultra (samfilcon A) soft contact lenses

to compare the performance of currently marketed Johnson \& Johnson Acuvue Vita (senofilcon C) soft contact lenses to the currently marketed Bausch + Lomb Ultra (samfilcon A) soft contact lenses among adapted wearers of Acuvue Oasys soft contact lenses.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be between the ages of 18 and 40 years old, inclusive, on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent.
2. Subjects must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
3. Subjects must be willing and able to comply with all treatment and follow-up/study procedures.
4. Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
5. Subjects must have clear central corneas and be free of any anterior segment disorders.
6. Subjects must be myopic and require contact lens sphere power correction from -0.50 diopter (D) to -6.00 D (considering vertex distance adjustments in both eyes).
7. Subjects must be habitual wearers of Johnson \& Johnson Acuvue Oasys single vision spherical soft contact lenses in each eye.
8. Subjects must use a contact lens care regimen on a routine basis.
9. Subjects must agree to wear their study lenses on a daily wear basis for the duration

Exclusion Criteria:

1. Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation
2. Subjects who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions:

   * she is currently pregnant
   * she plans to become pregnant during the study
   * she is breastfeeding
3. Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
4. Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
Making Data Count Intervention Evaluation

Hospitals collect copious amounts of data to share with their board for quality assurance and improvement purposes. The way these data are presented can influence board members' decisions. For example, time-series charts highlight the highest and lowest data but do not clarify whether those data lie outside expected or 'common cause' variation. Statistical process control charts make this clarification and, in so doing, guide quality assurance and improvements in a more targeted fashion.

A previous study showed that data suitable for presentation as a control chart are seldom presented in that format. A training intervention called 'Making Data Count' was created to improve the uptake of statistical process control charts by hospitals in England. The current study will use a randomized design to evaluate whether the intervention increases control charts in hospitals that were not early adopters of the training intervention.

This study is a parallel cluster randomized trial (with baseline-line measurements) across 20 National Health Service (NHS) hospitals in England. The hospitals will be randomly split into two groups. One group will be scheduled to experience the training intervention, and the other group will be placed on a waiting list to experience the training later. The primary analysis will compare the difference in the use of control charts between waitlist and intervention hospitals (adjusting for pre-intervention use) reported with 95% confidence intervals. A qualitative thematic analysis of feedback forms will be conducted.

The present research will evaluate the impact of the training intervention on the use of control charts. The results will apply to institutions that are not early adopters of this training intervention.


Eligibility Criteria:
Inclusion Criteria:

* NHS Hospital
* Placed on a red-list for predominantly using R-A-G or two-point data presentations in their board papers.
Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).

The design of this study is to conduct a comprehensive safety evaluation of the pulmonary hemodynamic effects of Optison. The study is being conducted in subjects referred for cardiac catheterization for clinical reasons.


Eligibility Criteria:
Inclusion Criteria:

* Must be already scheduled for left and/or right heart catheterization for clinical reasons.
* Must be in sinus rhythm, without an arrhythmia likely to affect the ability to assess pulmonary hemodynamics by catheterization, as determined by the investigator.
* Women of childbearing potential must be using adequate birth control and have a negative pregnancy test.

Exclusion Criteria:

* History of right-to-left, bi-directional, or transient right-to-left cardiac shunts or diagnosed by color flow Doppler echocardiography during screening.
* Hypersensitivity to Optison, perflutren, blood, blood products, or albumin.
* Female subjects who are nursing mothers.
Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel

This study aims to evaluate the utility of long-acting liposomal bupivacaine (Exparel®) in improving pain scores and reducing narcotic pain requirements in pediatric patients following minor urologic procedures.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients 6 years and older undergoing minor pediatric urologic surgery
* Patients who are otherwise eligible to receive routine care following minor urologic surgery

Exclusion Criteria:

* Contraindication to receiving local anesthetics (i.e. pre-existing cardiac, renal, hepatic dysfunction)
* Pediatric patients younger than 6 years of age
* Pediatric patients with a history of pain syndromes or are unable to tolerate opiate medication
* Unwilling to participate in 48 hours and 10-14 day follow-up phone calls
Effectiveness and Safety of Nivolumab in Participants That Have Head and Neck Cancer That Has Come Back or Has Spread

Non-interventional study in Japan of participants with HNC recurring or that has spread and who are treated with nivolumab


Eligibility Criteria:
Inclusion Criteria:

* Recurrent/metastatic HNC patients with disease progression on or after a platinum-based therapy treated with nivolumab at least once from 01-Jul-2017 through 31-Dec-2017

Exclusion Criteria:

* History of participation in any clinical trials prior- or post-nivolumab treatment

Other protocol defined inclusion/exclusion criteria could apply
Gefitinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of glioblastoma multiforme. Phase II trial to study the effectiveness of gefitinib in treating patients who have newly diagnosed glioblastoma multiforme.

OBJECTIVES:

I. Determine treatment effectiveness of gefitinib, in terms of response rate, time to progression, survival at 52 weeks, progression-free survival at 6 months, and overall survival, in patients with newly diagnosed glioblastoma multiforme.

II. Determine the toxic effects of this drug in these patients. III. Assess fatigue, depression, excessive daytime somnolence, and quality of life in patients treated with this drug.

IV. Assess individual variation in responses, pharmacokinetic parameters, and/or biological correlates due to genetic differences in enzymes involved in transport, metabolism, and/or mechanism of action of this drug in these patients.

V. Determine if the type of epidermal growth factor receptor affects tumor response and outcome in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral gefitinib daily. Courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each treatment course, every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years.

Patients are followed every 8 weeks until tumor progression and then every 3 months for 5 years and annually for up to 10 years. Patients removed from study treatment for reasons other than disease progression are followed every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study within 14 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed newly diagnosed WHO grade IV astrocytoma (glioblastoma multiforme) or gliosarcoma

  * No WHO grade III anaplastic astrocytoma, oligodendroglioma, or mixed oligoastrocytoma
* Completed standard external beam radiotherapy within the past 2-5 weeks

  * No evidence of tumor progression during radiotherapy
* Performance status - ECOG 0-2
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10.0 g/dL
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST no greater than 3 times ULN
* Creatinine no greater than 1.5 times ULN
* No other active malignancy
* No uncontrolled infection
* No other severe concurrent disease that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior chemotherapy (including polifeprosan 20 with carmustine implant) for this tumor
* See Disease Characteristics
* No prior stereotactic radiosurgery or interstitial brachytherapy
* No more than 15 weeks since prior surgery
Impact of Preoperative Oral Branched-chain Amino Acids on Reducing Postoperative Insulin Resistance.

Postoperative insulin resistance refers to the phenomenon that the body's glucose uptake stimulated by insulin is reduced due to stress effects such as trauma or the inhibitory effect of insulin on liver glucose output is weakened after surgery.

There is a clear link between postoperative insulin resistance and poor perioperative prognosis. Therefore, exploring interventions to reduce postoperative stress insulin resistance, stabilize postoperative blood glucose, and reduce postoperative complications are clinical problems that need to be solved urgently. In recent years, research on branched-chain amino acids and metabolic diseases has become a hot spot. Studies have found that in the rat model, preoperatively given a high branched-chain amino acid diet can inhibit postoperative insulin resistance and stabilize blood glucose levels. This research plan is to try to add branched-chain amino acids before surgery to observe the occurrence of postoperative insulin resistance in patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age 50-80 years old ;
2. Clinical diagnosis of colorectal cancer;
3. Planned elective laparoscopic radical resection of colorectal cancer;
4. Preoperative American Society of Anesthesiologists（ASA）score grade I-III ;
5. Informed consent was obtained from patients.

Exclusion Criteria:

1. Clinical diagnosis of Diabetes mellitus;
2. Preoperative insulin resistance ;
3. Renal insufficiency requires dialysis, hepatic insufficiency (Child - Pugh grade B and above);
4. Eating disorders caused by gastrointestinal obstruction;
5. Pregnant or lactating women;
6. Patients with severe mental illness.
Impact of Anti-inflammatory and Antibiotic Therapy on the Emergence of Peri-tonsillar Abscess

Analyze in children and adults, risk factors in the onset of the APA. The main hypothesis focuses on the use of anti-inflammatory in the context of pharyngitis or sore throat before the symptoms of ABS. Secondary objectives:

1. - Analyze the implementation of a rapid diagnostic test and its result on the occurrence of an ABS
2. - Measure the frequency of prescription and describe the reasons for not prescribing an antibiotic for patients who consulted for a sore throat and having developed a PLA
3. - Describe the microbial flora could puncture of patients hospitalized for APA


Eligibility Criteria:
Inclusion Criteria:

* clinical existence of a PLA (phlegmon), validated by a senior ENT, usually (but not necessarily) following a request by an emergency. The visible appearance to the merits throat must justify puncture. Cases will be included whether or not they had consulted for a "sore throat" in the 10 days preceding the date of diagnosis

Exclusion Criteria:

* Neoplastic disease of the throat, scalable Hematologic with tonsillar localization History of tonsillectomy