cyrilzakka/clinical-trials huggingface dataset:
Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L)

This is an expanded access protocol designed to make Lucanix® available to subjects with advanced non-small cell lung cancer (NSCLC) who are not eligible for the Phase III Protocol, NR001-03. A total of 45 patients will be enrolled into the study.

The primary objective of this study is to increase the overall survival of the study subjects by providing expanded access to Lucanix. Overall survival and progression-free survivals will be compared with historical controls.

The secondary objectives of this study are:

* Evaluate the best overall tumor response.
* Evaluate progression-free survival (PFS).
* Evaluate treatment toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* ≥ 18 years
* Histological confirmed non-curable stage III or IV NSCLC.
* Must have completed at least one (1) regimen of anti-cancer therapy.
* Following frontline therapy, subjects must observe the following wash- out periods:

  * Subjects with stable disease or better must have received the last anti-cancer therapy not less than five months prior to enrollment.
  * Subjects with progressive disease must have received the last anti-cancer therapy at least one (1) month prior to enrollment.
* All subjects who have received two (2) or more regimens of therapy must have received the last anti-cancer therapy at least one (1) month prior to enrollment.
* Performance status (ECOG) ≤ 2
* Absolute granulocyte count ≥ 1,500/mm3
* Platelet count ≥ 100,000/mm3
* Total Bilirubin ≤ 2× Upper Limit of Normal
* AST and ALT ≤ 2× Upper Limit of Normal
* Creatinine ≤ 2× Upper Limit of Normal
* Negative pregnancy test for women of childbearing potential.

Exclusion Criteria:

* Concurrent systemic steroids \> 2 mg prednisone/day
* Prior splenectomy
* Any chemotherapy, steroid therapy, or investigational anti-cancer agent within 4 weeks of study entry.
* Subjects who received prior monotherapy with Lucanix.
* Symptomatic brain metastases unless treated and stable for ≥ 2 months
* Known HIV positivity
* Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions which, in the opinion of the investigator would compromise protocol objectives.
* Prior malignancy (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years
* History of psychiatric disorder that would impede adherence to protocol
* Pregnant or nursing women or refusal to practice contraception if of reproductive potential
Electroencephalography Based Neurofeedback in Chronic Neuropathic Pain

Chronic neuropathic pain is a global health concern, affecting millions of patients worldwide. It is often extremely debilitating and poses a diagnostic and therapeutic challenge. The current mainstay of treatment is pharmacotherapy consisting of powerful analgesics combined with different classes of drugs that change nerve cell membrane properties. However, response to pharmacotherapy is often poor and mandates interventional strategies. Among the latest and most promising interventional strategies is the use of neurostimulation to targeted brain areas, specifically the primary motor cortex . Motor cortex stimulation , both invasive and noninvasive (using megnetic or electical stimulation), has emerged as a highly beneficial treatment, and is currently included in different professional guidelines for the treatment of medically refractory neuropathic pain.

A possible alternative way to achieve stimulation of the motor cortex is by using EEG based neurofeedback. This design, which is actually a Brain Computer Interface (BCI) enables the patient to voluntarily modulate the activity of a circumscribed brain area after a few training sessions. While EEG based neurofeedfback is decades old, it has never been tested in neuropathic pain patients.

This experiment is intended to compare both the clinical effects and the brain correlates of a BCI based self modulation of M1 activity and of exogenous magnetic brain stimulation in a population of patients suffering from chronic neuropathic pain of an upper limb. 15 such patients will receive a course of 10 daily magnetic stimulation sessions with stimulation of M1 as described in the literature. A further 30 patients will be divided into two groups: 15 will perform a course of 10 real BCI neurofeedback sessions modulating motor cortex activity and 15 will perform a course of 10 sham neurofeedback sessions. The participants' baseline chronic pain levels and their response to acute painful stimuli will be clinically evaluated before and after the course, and for an additional 1 month. Furthermore, before and after the course patients will be scanned using functional MRI during rest (baseline pain levels) and during acute pain. These scans are performed both to describe the neural correlates of the analgesia induced by motor cortex magnetic stimulation , and to compare the observed networks to the network effect of a BCI neurofeedback modulation of motor cortex activity.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old, treated medically for neuropathic pain of an upper arm with unsatisfactory results (average daily VAS score over 4)

Exclusion Criteria:

* Cognitive decline,
* malignant disease,
* focal neurological deficit,
* illegal substance abuse
* noncompliance with medical therapy or follow up.
Detection of Prostate Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC

Prostate cancer is a leading cause of mortality and morbidity.

The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC, T-cells and circulated tumor DNA in prostate cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent: The patient must sign the appropriate approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* Pregnant women
* Minors (subjects less than 18 years of age)
* Prisoners
* Patients having other than one cancer
* Subjects unable to consent for themselves
* Symptomatic of acute prostatitis
Clinical Benefit, Safety and PK of Raxibacumab in Subjects Exposed to Bacillus Anthracis

This field study is designed such that it may be implemented for any individual who has been administered raxibacumab for treatment of anthrax or for post-exposure prophylaxis including sporadic cases, small anthrax incidents and/or a mass event. This study is designed to describe the clinical effectiveness (including course of illness and survival), safety profile, and raxibacumab pharmacokinetics (PK) from patients who are treated with raxibacumab as part of their clinical care following exposure to B. anthracis. Study data and samples for PK and other investigational research will be collected prospectively to the extent possible at pre-specified time points. However, because of the logistical complexities that would likely accompany a mass anthrax event, most data in this study is anticipated to be collected retrospectively. During such a mass anthrax event scavenged blood samples will be utilized where possible to maximize sample analyses for PK and other investigational parameters. Therefore, both retrospective and prospective data collection are allowed in this protocol in order to maximize the amount of information obtained in subjects who have been administered raxibacumab. This field study will be the first opportunity to collect data on B. anthracis-exposed patients treated with raxibacumab, to better understand the clinical benefit and safety of the drug and to further inform patient care and treatment choices for management of anthrax

The protocol is a post-marketing requirement from the FDA to evaluate the clinical benefit, safety and pharmacokinetic of raxibacumab administered to patients as part of their medical care following exposure to Bacillus anthracis.

Eligibility Criteria:
Inclusion Criteria:

* Women-including pregnant and lactating women, men, and children of all ages who receive treatment with raxibacumab as part of their clinical care for anthrax infection or for post-exposure prophylaxis will be eligible to enroll in this study.
* Subjects willing and able to adhere to the procedures stated in the protocol
* Subjects or legally acceptable representative of minors and unconscious adults willing and able to give written informed consent to participate in the study.

Exclusion Criteria:

* There are no exclusion criteria for subjects enrolling in this study.
Accuracy Evaluation of Different "All on Four" Impression Techniques Using Plaster Jig

This study will be conducted to evaluate the accuracy of different implant impression techniques using plaster jig Participants will have three types of impression techniques


Eligibility Criteria:
Inclusion Criteria:

Non smokers Good oral hygiene Free from any signs of implant failure and requesting a fixed prosthesis

Exclusion Criteria:

* patients that have severe bone resorption or excessive interarch space
Zalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer

The purpose of this study is to investigate the safety of zalutumumab in combination with chemotherapy and radiotherapy as treatment of patients with head and neck cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx

Exclusion Criteria:

* Prior treatment with radiotherapy in the head and neck area
* Prior treatment with chemotherapy
* Prior treatment with similar drugs (e.g. EGFr antibodies, EGFr inhibitors)
* Previous surgery with curative intent for head and neck cancer
Traumatic Extradural Hematoma in Paediatric Age Group

The aim of this study is to assess the clinical and radiological characteristics of children with traumatic extradural hematoma and factors affecting the initial neurological status and outcome.

Extradural hematoma (EDH) represents 2.7-4% of traumatic brain injury .EDH is a potentially lethal condition which is easily cured if diagnosed early .EDH is less frequent in pediatric age group than in adults. The mean age of pediatric patients harboring EDH is between 6 and 10 years and it is rare among infants under the age of 12 months. EDH in children differs significantly from adults in terms of mode of injury, prognostic factors, and outcome. EDH in children may follow a trivial trauma and the course is more insidious and associated skull fractures is less frequent and these factors make it difficult to diagnose and often challenging to manage. The reported rate of mortality from EDH in children is varying from 0% and 17%, The criteria for choosing the surgical evacuation Vs. conservative management in pediatric age group still ill-defined this is what encouraged the investigators to carry this study to present our experience in the management of EDH in children aged less than 18 years.

Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients with traumatic extradural hematoma presenting at our institute and managed surgically.

Exclusion Criteria:

* Patients aged more than 18 years old.
* patients with other traumatic brain injuries like: acute subdural hematoma, intra-cerebral hematoma and subarachnoid hemorrhage.
Depth of Anaesthesia and Cognitive Dysfunction

The purpose of this study is to investigate if there is an association between the depth of anaesthesia and the presence of cognitive deterioration after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age above 60
* Surgery in general anesthesia
* surgery \> 1 hour
* ASA: 1-3

Exclusion Criteria:

* Dementia
* Excessive Use of alcohol or anxiolytics
* Unable to understand danish
* MMSE score \< 24
Breast Cancer and Kinesiophobia and Physical Activity

Breast cancer is the most common type of cancer in women worldwide. A significant number of breast cancer survivors develop many complications. Breast cancer and survivors may develop a fear of physical activity avoidance and movement, called kinesiophobia, due to upper extremity pain, numbness, restricted arm/shoulder range of motion, and risk of lymphedema. Therefore, in the present study, it is aimed to compare the effect of fear of movement on physical activity, quality of life and psychological states in women who have had breast cancer with healthy people.


Eligibility Criteria:
Inclusion Criteria:

* • Women diagnosed with stage I-II-III breast cancer with surgery as the first treatment

  * The patient whose first treatment was completed at least three months ago (surgery, radiotherapy and / or chemotherapy)
  * 18-75 years old woman
  * Does not have a Turkish literacy problem

Exclusion Criteria:

* • A serious chronic disease (rheumatoid arthritis, multiple sclerosis, amyotrophic lateral sclerosis, kidney disease, heart failure, neurological disorders or diabetes mellitus type I or II patients)

  * Having severe musculoskeletal pain or disease
  * Serious psychiatric illness
  * Patients with current cancer attack or metastasis
  * Persons with cognitive impairment
Comparison of the Two Validated German Versions of the "Tinnitus Functional Index" for Switzerland and for Germany

Tinnitus is defined as a perception of sound without any external sound source. Chronic tinnitus is a frequent condition that can affect the quality of life. The questionnaire "Tinnitus Functional Index (TFI)" promises to be the new gold standard in tinnitus evaluation. Due to the forward and backward translation of this questionnaire, there are two different German versions of TFI for Switzerland and Germany. Both German versions were validated. The aim of this study is to compare the two German versions of the TFI with each other and to recommend the better one for the further use in tinnitus evaluation for the German speaking population.


Eligibility Criteria:
Inclusion Criteria:

* Electronic given informed consent
* Older than 18 years
* Existing tinnitus
* Sufficient knowledge of the German language

Exclusion Criteria:

* Insufficient knowledge of the German language
* Impossibility to fulfill an online questionnaire due to cognitive or physical limitation
* No tinnitus
* Younger than 18 years
International Register of Open Abdomen

To evaluate the different indications to Open Abdomen, the different techniques used to perform it, it's management, it's definitive closure and mortality rates linked to the different variables. Moreover to evaluate the 1 month and 1 year follow up in patients underwent to Open Abdomen.


Eligibility Criteria:
Inclusion Criteria:

* No age limit
* Indication to Open Abdomen
* Informed consent

Exclusion Criteria:

* Informed consent refusal
* No indication to Open Abdomen
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?

The objective of our project is to find procedures and/or parameters to predict the diagnostic recovery (≥ 60% of the administered fluid volume) of bronchoalveolar lavage (BAL) fluid before bronchoscopy and to assess the impact of using non-invasive mechanical ventilation (NMV) or continuous positive airway pressure (CPAP) to achieve diagnostic recovery in patients with chronic obstructive pulmonary disease (COPD) and interstinal lungs disease for whom BAL performed during ordinary bronchoscopy turns out to be non-diagnostic.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with diagnosed stable COPD (Stages 1-3) - experimental group; Patients with interstitial lung disease - experimental group
2. Former and current smokers with normal lung function - potential control group 1;
3. Never-smokers with normal lung ventilation - potential control group 2.

Exclusion Criteria:

1. No written, informed consent to participate in the research project.
2. Severe respiratory failure (SaO2 \< 90%)
3. The patient qualified for home oxygen treatment or home mechanical ventilation
4. Severe heart failure (NYHA class IV)
5. COPD mMRC IV
6. Myocardial infarction in the last two weeks or unstable angina
7. Severe, particularly ventricular arrhythmias
8. Platelet count \< 20,000/ul
9. INR \> 2 or APPT \> 36 sec
10. Very severe obstruction: forced expiratory volume in 1 second (FEV1) \< 30% of predicted.
Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults

Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults with a Body mass index (BMI) of 16.00 to 29.99 kg/m2
* Self-reported constipation according to the Rome IV criteria

Exclusion Criteria:

* Pregnancy
* Crohn's disease or any other inflammatory bowel disease
* Pelvic floor dyssynergia
* Have congenital diseases such as liver disease, diabetes, and thyroid dysfunction. hypercalcemia neurological disease
* Drink alcohol or smoke regularly.
* During the past 1 month or while in the project, have received antibiotics, steroids, NSAIDs, blood pressure-lowering drugs, antidepressants, anticonvulsants, or Parkinson's disease medications
* History of food allergy to Haruna's ingredients
* There has been a change in body weight (increase or decrease of 5 kilograms over a period of 6 months).
* During the past 2 weeks or while in the project, have received probiotics or other prebiotics
Fecal Microbiota Transplantation in aGvHD After ASCT

Acute graft-versus-host-disease (aGvHD) is a typical complication after allogeneic hematopoetic stem cell transplantation (ASCT). About 30-60% of patients after ASCT are affected by aGvHD, which constitutes a relevant burden of morbidity and mortality in these patients.

Fecal microbiota transplantation (FMT) is a therapeutic concept to treat intestinal dysbiosis of various origin by infusion of the stool microbiota of a healthy donor into the gastrointestinal tract (GI) of a patient. FMT can be performed endoscopically by colonoscopic deployment of the donor microbiota into the patient´s caecum and terminal ileum.

Patients with gastrointestinal aGvHD (GI-aGvHD) are known to comprise a significant dysbiotic colonic microbiota that can be attenuated by FMT.


Eligibility Criteria:
Inclusion Criteria:

* first episode of histologically confirmed, steroid-refractory GI-aGvHD
* reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA measurement
* eligibility for repeated colonoscopic procedures
* informed consent

Exclusion Criteria:

* complications during a previous colonoscopy
* recurrent episode of GI-aGvHD
* lacking cardiopulmonary fitness for repeated colonoscopic procedures
* septic infection
* acute extraintestinal organ failure (excluding bone marrow)
* mechanical ileus
Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer

This study is a prospective, multicenter, randomized, open controlled clinical trial aimed at evaluating the effectiveness and safety of serplulimab plus chemoradiotherapy in FIGO 2018 stage III or IVA cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma patients who have not received prior treatment.

Cervical cancer is the most prevalent malignant tumor of the female reproductive system in China, with an estimated 150,700 new cases and 55,700 new deaths annually. Concurrent chemoradiotherapy (CRT) remains the standard treatment for locally advanced cervical cancer (LACC). However, for high-risk LACC (HR-LACC) patients, the 2-year progression-free survival (PFS) rate is only 57%-62%, and the 5-year overall survival (OS) rate is 52%-64%, which are the leading causes of patient mortality. The KEYNOTE-A18 study demonstrated that the combination of pembrolizumab and CRT reduced the progression risk and death risk by 30% and 27%, respectively, for HR-LACC patients. Following this, the FDA approved pembrolizumab in combination with CRT for the treatment of newly diagnosed stages III-IVA cervical cancer in January 2024. This prospective, multicenter, randomized, controlled clinical trial study aims to evaluate the effectiveness and safety of serplulimab induced and combined chemoradiotherapy in FIGO 2018 stage III or IVA cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma patients who have not received prior treatment.

Eligibility Criteria:
Main Inclusion Criteria:

1. Age ≥ 18 years and ≤ 75 years at time of study entry.
2. Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.
3. The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages III-IVA.
4. Diagnosed with PD-L1-positive (combined positive score ≥1).
5. Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer.
6. WHO/ECOG performance status of 0 or 1.
7. Patient must have at least one measurable disease as defined by RECIST 1.1.

Main Exclusion Criteria:

1. Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent o..
2. Ongoing participation in another clinical study, or planned initiation of treatment in this study less than 28 days from the end of treatment in the previous clinical study.
3. Known history of serious allergy to any active ingredie or any excipients list in monoclonal antibody.
4. The patient has other factors that, in the judgment of the investigator, may lead to forced early termination of the study.