cyrilzakka/clinical-trials huggingface dataset:
Identification of a MOLecuLar Signature in Locally Advanced Cervical Cancer Patients

The importance of radioresistance in cervical cancer treatment failure indicates that certain biomarkers may be useful for cervical cancer treatment individualization. However, to date, no study has analyzed the role of the gene expression signature of the three RNA species (ANXA2-NDRG1-STAT1) to predict radiosensitivity/resistance in cervical cancer patients undergoing exclusive CTRT. The previously validated three-gene signature may enable stratification in LACC patients treated with the current standard of care, represented by exclusive CTRT.

The importance of radioresistance in cervical cancer treatment failure indicates that certain biomarkers may be useful for cervical cancer treatment individualization. Several biomarkers of cervical cancer radioresistance have been previously studied and proposed; however, none of these has been the subject to further clinical studies and implemented into clinical practice. Recently, a panel of three protein coding genes (ANXA2-NDRG1-STAT1) differently expressed in radiosensitive LACC patients compared with the radioresistant ones, has been proposed by our institution. The population of LACC patients included in a previous study was treated with neo-adjuvant CTRT followed by radical surgery. However, to date, no study has analyzed the role of the gene expression signature of the three RNA species (ANXA2-NDRG1-STAT1) to predict radiosensitivity/resistance in cervical cancer patients undergoing exclusive CTRT. The previously validated three-gene signature may enable stratification in LACC patients treated with the current standard of care, represented by exclusive CTRT.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
* FIGO 2018 stage IIB and IIIC1\[38\]
* Treatment with exclusive chemoradiation including brachytherapy
* Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer
* Has radiographically evaluable disease, measurable per RECIST 1.1
* Negative pregnancy test
* Adequate hematologic, renal, and hepatic functions, with following blood tests:

Neutrophils \> 1500/μL Platelets \> 100.000/ μL Hemoglobin \> 9 g/dL Serum creatinine \< 1.8 mg/dL Total bilirubin \< 3 mg/ dL LDH \< 3x normal value GOT \< 3x normal value GPT \< 3x normal value ALP \< 3 x normal value

Exclusion Criteria:

* Rare cervical cancer histologies (neuroendocrine, glassy cells, serous, endometrioid etc)
* Neo-adjuvant treatment
* Patients included in other clinical trials
* Patients refusing to sign informed consent
* Contraindications to radiotherapy
* Contraindications to pelvic radiotherapy: ulcerative colitis, diverticulitis, chronic pelvic inflammatory disease, previous pelvic radiotherapy
Postoperative Delirium: Brain Vulnerability and Recovery

In this study, we propose to use EEG and a brain imaging technique known as diffuse optical tomography (DOT) to study when people are in delirium and when they recovery. We plan to also compare brain function of patients who recovered from delirium to patients who did not have delirium using DOT and fMRI. We will also continually monitor the participant's EMR to help coordinate timing of study procedures, as well as to collect information pertaining to their surgery, recovery progress, and indicators of mental status including delirium.

Postoperative delirium - a mental state of confusion, inattention, and impaired thought - is a potentially life-threatening condition. As many as half of patients that have heart and non heart-related surgery will experience postoperative delirium. Patients diagnosed with postoperative delirium have poorer outcomes and longer hospitalizations. Unfortunately, it is an under-diagnosed condition with a variable delay in when it appears. Additionally, there are no objective tools or tests that can be before or after surgery to anticipate and identify those patients who are at risk. Electroencephalography \[EEG\] and functional magnetic resonance imaging \[fMRI\] have helped us understand the changes in the brain during delirium. These suggest that a weakening in correlated activity within a group of brain regions, known as the default mode network (DMN), may be related to delirium.

Eligibility Criteria:
Common inclusion criteria:

1. Age ≥ 60
2. Surgery requiring cardiopulmonary bypass (CPB) for coronary artery bypass grafting, septal myectomy and/or heart valve repair/replacement
3. English speaking.

Common exclusion criteria:

1. Implanted pacemaker
2. Automatic internal cardiac defibrillator or other implant for which non-contrast magnetic resonance imaging (MRI) is contraindicated
3. Concomitant aortic or cerebrovascular procedure
4. Inability to lay flat or still for MRI
5. Legal blindness or severe deafness
6. Seizure history
7. Known focal brain lesion larger than 3 cm.

Delirium Case Arm:

1. Delirious as diagnosed by the Confusion Assessment Method (CAM)/ Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) at some point during postoperative day 1-5.

Postoperative Control Arm:

1. Not delirious as diagnosed by the CAM/CAM-ICU on postoperative day 1-5.
Quality of Life in Binge Eating Disorder.

Binge Eating Disorder (BED) patients tend to report low quality of life (Qol). However, research is limited. Most research on Qol in BED include generic measures, rather than disease specific. Obesity is prevalent in BED, but contradicting evidence exists on the influence of obesity in BED.

Eating disorders (ED's) are a group of disorders characterized by abnormal eating behaviors ranging from insufficient to excessive food intake, with concurrent disturbances in thoughts and emotions. Binge Eating Disorder (BED) is the most prevalent ED in both men and women, yet was only recently included in the Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) as a diagnostic entity.

In general, ED's have been associated with significantly worse health related quality of life (HRQoL) compared to healthy population.

High rates of overweight (BMI ≥ 25) and obesity (BMI ≥ 30) are found in BED patients and obesity in itself is associated with lower QoL. The most widely used tools to measure Qol in ED's are the Medical Outcome Studies Short Form (SF) Scale, e.g. SF-36 and SF-12, which are generic in nature. Generic QoL measures have shown lack of sensitivity for some ED diagnoses and might not be suitable enough to pick up unique features that might characterize each disorder.

The objective of this study is to evaluate quality of life in Danish BED patients before treatment by using disease specific Qol measure. Furthermore, we want to assess the impact of obesity and depression on disease specific Qol in BED patients. The hypothesis are that obesity and depression will be associated with an impaired level of disease specific Qol.

Eligibility Criteria:
Inclusion Criteria:

1. Patients referred to treatment for BED at Center f. Eating Disorders, OUH.

Exclusion Criteria:

1. Extremely severe BED.
2. Severe psychiatric comorbidity.
Study of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy (Violet Study)

A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in female children and young adults with genetically confirmed PCDH19 gene mutation.

The Violet Study is a global, double-blind, placebo-controlled, Phase 2 clinical trial that plans to enroll approximately 25 female patients between the ages of 1 and 17 with a confirmed disease-related PCDH19 gene variant. Patients will undergo a baseline period before being randomized to receive, in addition to their existing anti-seizure treatment, either ganaxolone or placebo for 17 weeks. Following the treatment period, all patients that meet certain eligibility requirements will have the opportunity to receive ganaxolone in the open label phase of the study. The study's primary efficacy endpoint is percent reduction in seizures. Secondary outcome measures will include non-seizure-related endpoints to capture certain behavioral and sleep disturbances that have been seen in previous clinical studies with ganaxolone.

Eligibility Criteria:
Inclusion Criteria:

* Molecular confirmation of a pathogenic or likely pathogenic PCDH19 variant
* Failure to control seizures despite 2 or more anti-seizure medications
* 12 seizures over a 12-week period of primary seizure types prior to screening
* On a stable regimen of concomitant AEDs, Ketogenic diets, and modified Atkins diet should be unchanged for 3 months prior to screening)

Exclusion Criteria:

* Previous exposure to ganaxolone
* \> 8 consecutive weeks of seizure freedom during the 12 weeks prior to screening
* Concurrent use of strong inducers or inhibitors of CYP3A4/5/7 is not permitted
* Use of tetrahydrocannabinol (THC) or non-approved cannabidiol (CBD) is prohibited during the double-blind phase
* Exposure to any other investigational drug within 30 days or fewer than 5 half-lives prior to screening
HINTEGRA Total Ankle Prosthesis Follow-up

The Hintegra® Total Ankle Prosthesis is a non constrained, three-component prosthesis that consists of a flat tibial component, an anatomically-shaped talar component, and a high-density polyethylene inlay. The Hintegra ankle was specifically developed as an attempt to address the needs of minimal bone resection, extended bone support, proper ligament balancing, and minimal contact stressed within and around the prosthesis.

The objective of this study is to evaluate the safety and efficacy of the HINTEGRA® Total Ankle prosthesis at short and mid term follow up.


Eligibility Criteria:
Inclusion Criteria:

* Patient implanted with an Hintegra® Total Ankle Prosthesis (only prosthesis designed with pegs) in primary ankle surgery since a minimum of 2 years
* Age ≥ 18 years
* Have willingness to give his/her data transfer authorisation

Exclusion Criteria:

* History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
Clinical and Dosimetric Study of Patients Treated With 177Lu-PSMA-617 for Prostate Cancer.

Single-centre, retrospective and prospective observational study. This study aims to evaluate the dose delivered by radiation to the tumour and organs at risk, as a factor predicting response and the appearance of toxicities. Dosimetric calculations are made for each treatment using scintigraphic images acquired following injection of 177Lu-PSMA-617.

The management of patients and the administration of treatment with 177Lu-PSMA are carried out in the usual way in the nuclear medicine department of the Institut Bergonié, and are not modified in any way.

The treatment regimen is standard, with 6 cycles spaced 6 weeks apart at a fixed dose of 7.4 GBq. Patients are selected on the basis of a 68Ga-PSMA-11 PET/CT scan to assess whether PSMA is properly expressed.

Only data are collected for the study and they are derived from the usual management of patients treated with 177Lu-PSMA at the Institut Bergonié: information on the treatment, anatomical data and 177Lu-PSMA fixation in lesions and tissues, scintigraphic images acquired post-treatment, data on monitoring the effects of the treatment, 68Ga-PSMA PET/CT images.

Eligibility Criteria:
Inclusion Criteria:

1. Patient aged 18 and over.
2. Patient with indication for or having started or completed treatment with 177Lu-PSMA-617 since 01/11/2023:

   1. Progressive, metastatic, castration-resistant prostate cancer,
   2. overexpressing prostate specific membrane antigen (PSMA)
   3. treated with taxane chemotherapy and at least one 2nd generation hormone therapy (apalutamide, enzalutamide, darolutamide, abiraterone-prednisone).
3. Patient able to lie still for 1 hour for image acquisition.
4. Patient's place of residence \< 2 hours' drive from the Institut Bergonié.
5. Patient has not expressed any opposition to the use of his/her medical data for research purposes.

Exclusion Criteria:

None
Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy

Several studies have been showed that rifaximin can improve cognitive functions, driving simulator performance and health-related quality of life in patients with minimal hepatic encephalopathy. The aim of this prospective randomized open controlled study was to evaluate the efficacy and safety of rifaximin at different doses for the treatment of covert hepatic encephalopathy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients agreed to sign the informed consents
2. Patients aged 18-70 years，males or females
3. Patients who were diagnosed with occult hepatic encephalopathy by PHES and Stroop tests

Exclusion Criteria:

1. Allergy to rifamycin/rifamutin/rifampin/rifapentine
2. Current or recent (\<3 month) use of alcohol or can't stop drinking during the study period
3. Use of antibiotics within last 6 weeks
4. Use of lactulose/lactitol, probiotics, L-ornithine-L-aspart，zinc，metronidazole, neomycin, or rifaximin within last 6 weeks
5. Infection or gastrointestinal hemorrhage within last 6 weeks
6. Use of psychoactive drugs within last 6 weeks
7. Occurred overt hepatic encephalopathy within last 3 months
8. history of portosystemic shunt surgery or transjugular intrahepatic portosystemic shunt
9. Poor vision, color blindness or motor defects that interfere with the performance of psychometric tests
10. Other non-controllable neurological or psychiatric problems which may affect cognitive function such as Alzheimer's disease, Parkinson's disease or schizophrenia
11. Conformed or highly suspicious diagnosis of liver malignant tumors
12. Human immunodeficiency virus (HIV) infection
13. Uncontrolled hypertension, diabetes or other serious cardiac and pulmonary diseases
14. White blood cell count\<1×10\^9/L
15. Pregnancy and breastfeeding
16. Participated in other drug clinical trials within 3 months
17. The researchers thought it was not suitable for this clinical trial
Patient Centered Methods to Collect Sexual Orientation and Gender Identity Status in the ED

This trial is the final phase of a three phase PCORI-funded study to develop and test patient-centered approaches to collect sexual orientation and gender identity (SO/GI) information in the ED. From the results of Phase 1 qualitative interviews and national quantitative survey and Phase 2 Delphi rounds with the Stakeholder Advisory Board, we have determined two methods of collection favored by patients and providers to implement in the trial. The first method, nurse verbal collection, is in alignment with Partners recommended clinical practice and is therefore a quality improvement (QI) evaluation. The second method, non-verbal registrar form collection with nurse verbal confirmation, is a research intervention to evaluate and compare a new patient-centered approach to SO/GI collection. To compare the patient-centeredness of the two different approaches, satisfaction surveys will be administered to ED patients and staff members involved in collection.

In summary, the study design (1) evaluates recommended current practice (QI), (2) evaluates a quality improvement project to increase recommended current practice, and (3) evaluates a new method of collecting SO/GI (research intervention).


Eligibility Criteria:
Inclusion Criteria:

* Adult ED patients who are cognitively and physically capable of informed consent
* Adult ED nurses and registrars who are cognitively and physically capable of informed consent

Exclusion Criteria:

* Children
* Any person not cognitively and physically capable of informed consent
A Study of CA-170 (Oral PD-L1, PD-L2 and VISTA Checkpoint Antagonist) in Patients With Advanced Tumors and Lymphomas

CA-170 is a rationally designed and orally available, small molecule that directly targets the Programmed death-ligands 1 and 2 (PD-L1/PD-L2), and V-domain Ig suppressor of T cell activation (VISTA) immune checkpoints and results in activation of T cell proliferation and cytokine production. This is a multi-center, open-label, Phase 1 trial of orally administered CA-170 in adult patients with advanced solid tumors or lymphomas who have progressed or are non-responsive to available therapies and for which no standard therapy exists.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 18 years of age;
2. Life expectancy of at least 3 months;
3. ECOG PS ≤ 1;
4. Acceptable bone marrow and organ function at screening;
5. Ability to swallow and retain oral medications;
6. Negative serum pregnancy test in women of childbearing potential;
7. Measurable disease;
8. Tumor for which standard therapy, including approved anti-PD-1 or anti-PD-L1 therapy, when applicable, does not exist or is no longer effective. For patients enrolling into backfill of dose levels at or below the MTD/RP2D, patients with tumor types known to have a high VISTA expression (such as metastatic malignant pleural mesothelioma of epithelioid histology).

Exclusion Criteria:

1. Prior treatment anti-cancer therapy or use of any investigational agent within the past 28 days or 5 half-lives, whichever is shorter;
2. Toxicity from prior chemotherapy that has not resolved to Grade ≤ 1;
3. Radiotherapy within the last 21 days;
4. Primary brain tumors or CNS metastases;
5. Major or minor surgery \< 28 and \<14 days from the start of treatment, respectively;
6. Active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications;
7. Endocrinopathies, unless on stable hormone replacement therapy;
8. Active infection requiring systemic therapy;
9. Receipt of live vaccines against infectious diseases within 28 days;
10. HIV positive or an AIDS-related illness;
11. Active/chronic HBV or HCV infection;
12. Uncontrolled CHF (NYHA Class 2-4), angina, MI, CVA, coronary/peripheral artery bypass graft surgery, TIA, or PE in prior 3 months;
13. Cardiac dysrhythmias;
14. Gastrointestinal disease that interferes with receipt of oral drugs;
15. Concomitant malignancy;
16. Pregnant or lactating female;
Do Emotions and Pain Combined Affect Mechanical Pain Thresholds and Other Pain-related Variables

The purpose of this study is to investigate if different emotional states could influence mechanical pain thresholds and other pain - related variables such as pain tolerance, pain intensity and pain - related negative affect.

Participants will be randomized into 4 different groups watching different short video-clips (2.20 min), while at the same time experience short-lasting, experimentally induced pain. The negative emotions group will watch an uncomfortable short video containing violence and blood, the positive emotions group will watch a video containing a stand-up comedy show, the neutral emotions group will watch a video about how to paint a house, and the control group will just wait for 2.20 min, without any instructions about what to think about. Pressure pain thresholds will be measured with an algometer before and after the video-clip combined with experimental pain interventions.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age
* Fluent in Swedish.

Exclusion Criteria:

* Pain anywhere in body during the test session
* Known neurological disease.
To Develop a Walking Exercise Program for Non-ambulatory Stroke Survivors

The goal of this clinical trial is to test a gait (walking) training program in non-ambulatory (unable to walk) chronic stroke survivors. The main question it aims to answer is:

• Will gait training improve the cardiovascular system in non-ambulatory chronic stroke survivors better than a sitting leg cycling exercise?

Participants will walk on a treadmill with a partial body-weight support system and the gait training device. Researchers will compare with a leg-cycling exercise to see if there are significant differences in resting heart rate, systolic blood pressure (SBP), and A1c levels in the blood.

Stroke is a leading cause of death and permanent disability. About 795,000 strokes occur in the US each year and more than seven million Americans are living with effects of stroke. Cardiovascular diseases are commonly presented and are primary causes of death in stroke survivors. Numerous studies have proven the benefits of walking or other forms of aerobic exercise for cardiovascular and pulmonary function in people after stroke. This proposed randomized controlled efficacy trial will primarily examine whether the investigators' gait training can improve the cardiovascular system in non-ambulatory chronic stroke survivors better than a sitting leg cycling exercise. The investigators have recently developed a novel gait training device and a training program. The experimental group in the proposed project will undergo an 8-week gait training program using a treadmill with body-weight support and the investigators' novel gait training device. The control group will receive an 8-week sitting leg cycling exercise program with similar exercise intensity, frequency, and duration. The proposed project will examine differences between the two groups using a set of comprehensive outcome assessments of cardiovascular, pulmonary, and sensorimotor functions.

Eligibility Criteria:
Inclusion Criteria:

* must be 18 to 80 years old
* male or female
* independent ambulation before stroke
* able to understand and follow verbal commands in English
* have physicians' approval for exercise
* be in a stable medical condition
* must be after the first stroke
* unable to walk independently
* in the chronic stage (at least 6 months after stroke onset)

Exclusion Criteria:

* musculoskeletal or other disorders that prevent the participant from participating in the exercise
* blood pressure higher than 200/110 mm Hg
* diagnosis of severe depression
* functionally restricted passive movement in the major joints of lower limbs
* unable to speak or understand English
* unable to travel to the Research Laboratory
* currently participate in other walking training using treadmill with or without a body-weight support system
* body weight greater than 400 lbs