cyrilzakka/clinical-trials huggingface dataset:
Prognostic Study of Via Dynamic Change of dT-DNA in Drainage Fluid After Radical Prostatectomy

This study investigates the prognostic value of dynamic changes in Drainage Tumor DNA(dT-DNA) levels found in the peritoneal drainage fluid after radical prostatectomy. Prostate cancer is one of the most common cancers in men, and radical prostatectomy is a standard treatment. While PSA levels in the blood are commonly used as a marker for diagnosis, this study focuses on the significance of dT-DNA levels in the prognosis of prostate cancer. The findings may provide insights into improved post-surgical monitoring and more tailored therapeutic strategies for prostate cancer patients.

This study examines the prognostic significance of dT-DNA levels in the peritoneal drainage fluid following radical prostatectomy, a common surgical treatment for prostate cancer. PSA is widely used as a biomarker for prostate cancer diagnosis, treatment response, and recurrence monitoring in the blood. However, this research seeks to explore the prognostic value of dT-DNA in the drainage fluid.

The study involves continuous monitoring of dT-DNA levels in the drainage fluid after radical prostatectomy, with the hypothesis that dynamic changes in these levels could serve as an early warning system for potential tumor recurrence, residual disease, or metastasis. The research will correlate these fluid dT-DNA levels with patient outcomes, recurrence rates, and other clinical factors to determine their predictive value.

By investigating this novel source of dT-DNA monitoring, the study aims to reduce invasive tests, enhance post-operative surveillance, and improve early detection of disease recurrence for prostate cancer patients. This research could contribute to refining post-surgical care protocols, offering a new tool for predict long-term outcomes for individuals undergoing radical prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer patients treated with radical prostatectomy

Exclusion Criteria:

* 1. Received neoadjuvant endocrine/chemotherapy before surgery;
* 2. Urine leakage after surgery (positive creatinine test of drainage fluid).
ANEUFIX for Endoleak Type II Repair

The study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of ANEUFIX to treat patients with isolated type II endoleak in the presence of a growing AAA-sac following an EVAR procedure more than 6 months ago.

The investigational device is called ANEUFIX, which is a product treating the endoleak by blockage of backflowing blood vessels, i.e. by filling the endoleak void and nidus of feeding artery and exit of existing draining arteries.

ANEUFIX is a polymer that cures rapidly (2-4 min at 37°C) after injection into the AAA-sac close to the nidus.

Eligibility Criteria:
Inclusion Criteria:

1. Persistent type II endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
2. An endoleak confirmed on a CT scan that should be done within 180 days prior to procedure but preferably within 90 days prior to screening demonstrating the high likelihood of the isolated nature of the endoleak; AND
3. An aneurysm sac growing after EVAR of minimal 10 mm (per European Guidelines) as documented in the preceding 90 days by means of CT-imaging (or alternative imaging techniques) and based upon sac diameter measurements; AND
4. An aneurysm sac that can be punctured via a translumbar approach; AND
5. Possibility to withhold anti-thrombogenic medication temporarily; AND
6. Ability and willingness to undergo the translumbar procedure; AND
7. Being older than 18 years.

Exclusion Criteria:

1. Patient not able or willing to give written Informed Consent; OR
2. Patient undergoing emergency procedures; OR
3. Patient with traumatic vascular injury; OR
4. Patient with haemostatic disorder (including bleeding disorders) or who is clinically unstable; OR
5. Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR
6. Patient who is allergic to contrast media or anticoagulants; OR
7. Patient with renal impairment (eGFR \< 30 ml/min); OR
8. Patient with a contra-indication for temporal positioning of a translumbar needle/catheter; OR
9. Patient who is participating in another trial with an investigational drug or medical device, or where a medical device/drug is used outside its labelling and its approved intended use; OR
10. Pre-menopausal women, OR
11. Patient with a life expectancy of less than 12 months, OR
12. Patient with an intra aneurysm systolic blood pressure \> 125 mmHg
Clinical Evaluation, Biomarkers and Metabolomics of Sarcopenia in Frail Older Adults at Ambulatory Clinics

Sarcopenia related mobility dysfunction was a preventable presentation in transitional variation of frailty. However, the definition, associated risk factors, clinical course and outcome of sarcopenia in Taiwanese older adults are still under-clarified and need for further study.


Eligibility Criteria:
Inclusion Criteria:

* functional decline in recent one year
* cognitive impairment
* depressive symptom
* mobility impairment
* fall in recent one year
* eating or feeding problems
* weight loss
* co-morbid conditions≧5
* tracking by different physician ≧3 in recent half year
* poly-pharmacy≧8 in recent 3 months
* hospitalization ≧1 in recent one year
* emergency visits≧2 in recent one year
* aged ≧ 80.

Exclusion Criteria:

* non-ambulatory (bed-ridden) patients
* long-term residents at nursing homes
* patients with a life expectancy shorter than six months
* impairment in vision, hearing, or communicative ability, making convenience of clinical evaluation during the study period impossible.
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study

This safety surveillance study of GlaxoSmithKline's quadrivalent meningococcal ACWY conjugate vaccine (Meningococcal quadrivalent CRM-197) among children 2 months through 23 months of age is a post-marketing study required by the United States Food and Drug Administration.

It is an observational study of children 2-23 months of age who receive at least one dose of MenACWY-CRM vaccine at a Kaiser Permanente Southern California facility (KPSC) while enrolled as a KPSC health plan member.

The objective of the infant study is to describe medical events that require emergency room visit or hospitalization in 6 months following MenACWY-CRM vaccination in children 2-23 months of age in a health maintenance organization in the United States. Outcomes include medical events that require emergency room visits or hospitalizations in children 2-23 months of age following any dose of MenACWY-CRM vaccination. Events with a history of the same diagnosis prior to the first dose of MenACWY-CRM vaccination will be excluded as a pre-existing condition.


Eligibility Criteria:
Inclusion Criteria:

* children 2-23 months of age at the time of MenACWY-CRM vaccination
* hold KPSC membership at the time of MenACWY-CRM vaccination
* vaccinated with MenACWY-CRM during the study period in KPSC

Exclusion Criteria:

* None
Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications

The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.


Eligibility Criteria:
Inclusion Criteria:

Patient has been prescribed the implantation of an SORIN GROUP OvatioTM DR 6550 / VR 6250 system according to relevant currently-approved guidelines

* CHF since \> 3 months and
* LVEF \< 35% and
* NYHA class II or III

OR

* Prior Myocardial infarction since more than 4 weeks and
* LVEF \< 30%

Exclusion Criteria:

* Documented spontaneous sustained ventricular tachycardia
* Prior implant of any device for ventricular cardiac pacing
* Existing indication for permanent ventricular pacing
* Myocardial infarction within 4 weeks prior to enrollment
* Arrhythmogenic RV-Dysplasia
* Brugada syndrome
* Long QT syndrome
* Performed within 3 months prior to enrollment or scheduled (within 3 months) cardiac revascularization (interventional or surgical)
* Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.
* Excisting or planned administration of amiodarone - initiation of amiodarone therapy during the run of the study will lead to immediate exclusion of the patient
* Permanent chronic atrial fibrillation / flutter
* Patient is unable to attend the scheduled follow-up visits at the participating centre
* Patient is already included in another ongoing clinical study
* Patient is unable to understand the objectives of the study
* Patient refuses to cooperate
* Patient is unable or refuses to provide informed consent
* Patient is minor (less than 18-year old)
* Patient has life expectancy of less than 1 year
* Patient is pregnant.
Criteria Used by Health Professionals on the Selection of Allergen Immunotherapy in Real Clinical Practice

Background : Allergen Immunotherapy (AIT) is the only etiological treatment for allergic respiratory diseases. In order to improve the competence on the use of AIT, it is important to extend the investigator's knowledge on its use in routine clinical practice, outside the experimental setting of clinical trials, in real life population of patients receiving AIT.

Objective: To evaluate the clinical criteria used by treating clinicians and by the patients themselves, when establishing AIT as treatment in a patient with respiratory disease caused by an IgE-dependent-hypersensitivity to aeroallergens Methods: In 6 country (Denmark, France, Germany, Norway, Spain \& Sweden), the national coordinator will be directly responsible for selection of Survey Doctor's participants (Investigators).

During 12 months:

* Firstly, each investigator will complete the Survey Doctor, online, on SurveyMonkey platform to explain what are the key drivers in Allergen Immunotherapy (AIT) selection (Doctors' Questionnaire, DQ).
* On the other hand, at each AIT prescription to a patient, doctors will complete the Survey Patient, on the same platform, to explain how and why they have chosen this type of AIT (Patients' Questionnaire, PQ).


Eligibility Criteria:
Inclusion criteria:

* Patients with IgE mediated respiratory allergy
* Patients who will initiate any type of aeroallergen AIT according to real life clinical standards of practice
* Any type of aeroallergen for AIT will be included : pollen, house dust mite, animal, dander, moulds
* Patient who is under the care of the Doctor participating in the survey

Exclusion criteria:

* Patients who refuse to give their informed consent
* Food immunotherapy
* Venom Immunotherapy
High- and Low-dose Radiotherapy Combined With PD-1 Inhibitors for MSS CRLM

This pilot phase I trial aims to investigate the efficacy and safety of high- and low-dose radiotherapy combined with programmed cell death-1 (PD-1) inhibitors in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) that have failed second-line immunotherapy or above.

This pilot phase I trial aims to investigate the efficacy and safety of high- and low-dose radiotherapy combined with programmed cell death-1 (PD-1) inhibitors in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) that have failed second-line immunotherapy or above. 30 participants will be enrolled in this study. All will take part at Jiangsu Cancer Hospital.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with microsatellite stable colorectal liver metastases and failure with second-line or above therapy, and no subsequent standard treatment regimen.
2. Patients with an ECOG score of 0 or 1, and an expected survival period of ≥6 months.
3. During the study, they are willing to follow the arrangement and not use other systemic anti-tumor drugs such as chemotherapy, targeted, Chinese herbal medicine, and proprietary Chinese medicine.
4. 18-70 years old, no gender limit.

Exclusion Criteria:

1. Those with a history of severe immediate allergy to the drugs used in this study.
2. Cancer patients who require urgent surgical intervention, such as high-risk pathological fractures, life-threatening bleeding symptoms, etc.
3. Any of the following conditions in the 6 months before screening: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient cerebral ischemia Onset or symptomatic pulmonary embolism. Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria or left ventricular ejection fraction \<50% must adopt an optimized and stable medical plan determined by the treating doctor. If appropriate, you can consult a cardiologist.
4. Patients with active infection requiring systemic treatment.
A Study to Look at How a Single Oral Dose of Carbon-14-Labelled [14C] BIIB091 Moves Through and is Processed by the Body in Healthy Male Participants

The main goal of this study is to learn how \[14C\]-BIIB091 moves through and is processed by the body and to look at how much of BIIB091's metabolites (what is produced when BIIB091 is broken down by the body) appears in the blood, urine, and stool in healthy male participants. The study will also help researchers learn more about the safety of BIIB091 in healthy male participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Have a body mass index (BMI) of 18 to 32 kilograms per meter square (kg/m\^2) and a total body weight greater than (\>) 50 kg, as measured at Screening.
* History of regular bowel movements (averaging 1 or more bowel movements per day).
* Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Day -1.

Key Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease or other major disease, as determined by the Investigator.
* Participants enrolled in a previous radionucleotide study within 12 months prior to screening or who have received radiotherapy within 12 months prior to screening or such that total radioactivity would exceed acceptable dosimetry.
* Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1.
* Current enrollment in any other drug, biological, device, or clinical study or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Day -1 (24 weeks for biologics), or 5 half-lives, whichever is longer.
* Prior exposure to BIIB091 or any lymphocyte-depleting therapy or exposure to any lymphocyte-targeting therapy within 3 months prior to Day -1.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms

This pilot study proposes to gain a better understanding of the health benefits of the popular "paleo-diet" in patients with irritable bowel syndrome (IBS) and explore underlying mechanisms of benefit.

In the proposed study, the primary hypothesis is that, compared with a customary diet, consumption of a paleo-diet will improve psychological and gastrointestinal symptoms in patients with irritable bowel syndrome. Investigators also hypothesize consumption of the Paleolithic diet will result in decreased intestinal permeability, decreased inflammatory markers, and changes in the gut microbiome and microbiologic profiles.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate Irritable Bowel Syndrome (IBS) and mild to moderate anxiety or depression
* Other causes of bowel symptoms excluded to the satisfaction of the Study Team
* Age at least 18 years at initial screening visit
* Patients who are able to sign and understand the study's informed consent form
* Patients able to complete all screening evaluations and procedures

Exclusion Criteria:

* Patients in inpatient hospital care
* Severe or refractory bowel or psychological symptoms
* Current consumption of a Paleolithic diet
* Known Celiac disease
* Uncontrolled thyroid disease as indicated by an abnormal thyroid stimulating hormone (TSH) level
* Uncontrolled diabetes as indicated by a HbA1c equal to 6.5 or greater
* Patients unable to speak English
* Inability to obtain informed consent
* Pregnant or nursing women
* Any condition, which in the opinion of the investigator, would interfere with study requirements
Cervical Preparation for Same-Day Dilation & Evacuation

This is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation \& Evacuation (D\&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure.

The primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in D\&E operative time.

Secondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety.


Eligibility Criteria:
Inclusion Criteria:

* Between 16 weeks 0 days - 18 weeks 6 days gestational age who are pursuing termination, based on reliable gestational age (defined as ultrasonography performed by a clinical provider, or a certain last menstrual period)
* Able to provide informed consent
* English- or Spanish-speaking
* Singleton intrauterine pregnancy

Exclusion Criteria:

* Allergy to betadine, aquacryl hydrogel, latex-free silicone single-balloon catheter, synthetic or natural osmotic dilators
* Fetal demise or known fetal anomaly
* BMI \>45
* Incarceration or other inability to give informed consent
* Decide to undergo cervical preparation overnight prior to next-day D\&E
Effects on Glutamine on the Outcome of Allogeneic Bone Marrow Transplant Recipients

The primary purpose of this project is to investigate if addition of glutamine, an amino acid, to standard parenteral nutrition, may improve the clinical outcome of the bone marrrow transplantation reducing the occurrence of veno-occlusive disease and severity of mucositis.


Eligibility Criteria:
Inclusion Criteria:

* Allogeneic bone marrow transplant recipients using busulfan and cyclophosphamide as conditioning.
MeDiNa Pilot Study for Evaluation of the MeDiNa Concept of Homely Rehabilitation After Myocardial Infarction

In this study feasibility of the MeDiNa concept is looked at, which means telemedical services for homely rehabilitation. With the help of microsystems technology, the relevant vital signs are measured at the patient's home, then transmitted to the MeDiNa- Homebox- Tablet PC (by bluetooth) and then transferred into a central database, the MeDiNa eHealth- portal (by HSDPA, UMTS). These parameters can be continuously monitored by authorized network participants such as the family doctor or the patients themselves. In future, beyond cost advantages this will help to supervise risk patients or inspire patients to take more care of their health during homely rehab.

Patients after myocard infarction who undergo homely rehab post stationary are divided into two groups of 10 patients each. The patients of group A undergo home monitoring for 4 weeks with the MeDiNa Homebox and afterwards 4 weeks without home monitoring. Group B starts vice versa, without home monitoring first and then undergoes home monitoring for 4 weeks (cross over,controlled intra-individually). During home monitoring with the MeDiNa Homebox patients measure vital parameters (weight, blood pressure, ECG (by chest strap including micro sensors), pulse and activity (also by chest strap including accelerometer) several times a day. The pseudonomized data which are transferred via the MeDiNa Homebox- Tablet PC to the MeDiNa eHealth Internet Portal (UMTS, HSDPA) to which the responsible authorized medicines will have access will be evaluated descriptively.

Eligibility Criteria:
Inclusion Criteria:

* female and male patients minimum 60 years old
* myocardial infarction
* post stationary rehabilitation at home
* Internet access or mobile phone reception possible
* able to give informed consent

Exclusion Criteria:

* patients with dementia
* aphasic impairment
* serious pulmonary diseases
* motional resriction (e.g. amputee)
A Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)

The purpose of this study is to evaluate the efficacy and safety of camrelizumab (an engineered anti-programmed death-ligand 1 \[PD-1\] antibody) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (TNBC). Participants will be randomized in a 1:1 ratio to Arm A (camrelizumab +chemotherapy) or Arm B (placebo + chemotherapy).


Eligibility Criteria:
Inclusion Criteria:

* ECOG Performance Status of 0-1.
* Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
* Tumor stage: II-III.
* Adequate hematologic and organ function.
* Must be willing to use an adequate method of contraception for the course of the study.

Exclusion Criteria:

* Has a history of breast cancer.
* Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
* Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
* Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 \[CTLA-4\].
* Has a diagnosis of immunodeficiency or autoimmune diseases.
* Has received any form of immunosuppressive therapy within 4 weeks prior to the first dose of study treatment.
* Severe pulmonary or cardiac disease.
* Known active hepatitis C virus, or known active hepatitis B virus.
* History of organ or bone marrow transplantation.
* Pregnant or breast-feeding women.
A Realworld Study of Acute Respiratory Distress Syndrome in China

ARDS is a critical respiratory disease caused by endogenous and exogenous factors. The mortality of ARDS varies from 30 to 70%. In 2012, a new international diagnostic criterion has been put forward. Yet, its feasibility, reliability and validity need to be tested. Meanwhile, the correlation of different severity and prognosis remains unclear. As so far, the epidemiological information about ARDS in China is lacking.

Investigators plan to conduct a multi-center observational study（real-life study） to investigate the risk factors, morbidity, management and prognosis of ARDS in China, in order to facilitate standardization of diagnosis and management of ARDS and provide basic data and idea for further clinical intervention studies.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age; hospitalized patients with main diagnosis as ARDS.

Exclusion Criteria:

* \<18 years of age
* Patients or their families refused to participate in the study
* Patients diagnosed as COPD, pulmonary fibrosis or bronchiectasis