cyrilzakka/clinical-trials huggingface dataset:
RNA Extraction and Amplification From Biopsy Specimens in Subjects With Metastatic Renal Cell Carcinoma (AGS-NTS-017)

The primary objective is to evaluate methods for AGS-003 production from surgical (stage I) and metastatic biopsy (stage II) Renal Cell Carcinoma (RCC) and a small subset of other GU cancers (expansion cohort) specimens using core needle biopsy in subjects with RCC or other GU cancers. Specifically, this study will evaluate the feasibility of RNA amplification from total tumor RNA isolated from tissues obtained by core needle tumor biopsy.


Eligibility Criteria:
Inclusion Criteria:

A subject with metastatic RCC, who in the opinion of the treating physician, is a potential candidate for inclusion in this study if all of the following criteria apply:

1. 18 years of age or older.
2. Suspected RCC, in the opinion of the investigator
3. Availability of either:

   * Nephrectomy or other surgically removed tissue (Stage I); or,
   * Metastatic RCC biopsy tissue utilizing needle or core biopsy procedures (Stage II).
4. ≥5 biopsy specimens available from BRPC.

   * Subjects who are having a surgical procedure (i.e. metastasectomy, nephrectomy) will have these core biopsies obtained from the surgical specimen, per the BRPC protocol.
5. Not currently being treated with systemic therapy.

Exclusion Criteria:

1. Tumor tissue is committed to other use or inadequate for RNA analysis.
2. Insufficient tissue is collected in the BRPC.

Expansion Cohort for Genitourinary Cancers:

Inclusion Criteria:

1. 18 years of age or older
2. Suspected bladder, prostate, or testicular cancer, in the opinion of the investigator.
3. Availability of surgically removed tissue or biopsy tissue.
4. At least 2 biopsy specimens available from BRPC
5. Not currently being treated with systemic therapy.

Exclusion Criteria:

1. Tumor tissue is committed to other use or inadequate for RNA analysis.
2. Insufficient tissue is collected in the BRPC.
Role of Inflammasomes in COVID-19 Disease

As of March 25, 2020, 414,179 cases and 18,440 deaths secondary to Coronavirus 2019 disease (COVID-19) have been reported worldwide. The unfavorable course of the patients is characterized on the immunological level by an intense pro-inflammatory response which can go as far as a cytokinic storm. This pandemic affects a naive world population from an immunological point of view with respect to SARS-CoV-2 responsible for COVID-19. The evolution is favorable without hospitalization in almost 85% of cases. Among patients hospitalized for pneumonia, some will not require ventilatory support while others will need intensive care. To date, two main types of unfavorable evolution have been described. The first is a bi-phasic evolution beginning with a paucisymptomatic form which is worsened secondarily with respiratory distress associated with a decrease in the viral load in the airways. The second is associated with persistent high viral loads in the airways and detection of the virus in the blood. These different clinical profiles could depend on the quantitative and qualitative response of the innate immune system.

At the early stage of a viral infection the innate immunity is capable of detecting certain conserved microbial patterns (PAMP, pathogen-associated molecular pattern) recognized by receptors dedicated to these patterns (PRR, pattern recognition receptor). This process allows to initiate the pro-inflammatory response via different signaling pathways.

Activating multiprotein complexes called inflammasomes, which cause pro-IL-1β and pro-IL-18 to be transformed into active pro-inflammatory cytokines are one of these pathways.

The central role of inflammasomes in the secretion of these pro-inflammatory cytokines deserves an in-depth study of their activation during COVID-19, whereas the inadequate inflammatory response appears to be the determining factor in the unfavorable development of patients.

The objective of this project is to analyze the level of activation of the inflammasomes and then to search for inactivating or activating mutations among the genes which code for the proteins constituting the inflammasomes in Covid-19 patients. The identification of mutations in patients with a serious clinical presentation or even death would be followed by fundamental work by analyzing in a cellular model the impact of these mutations on the secretion of IL-1β.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years old. SARS-CoV-2 infection confirmed by RT PCR or by serology Hospitalised patients with less than 14 days of COVID-19 symptoms. Date of first symptom being defined as to the date of one of the following symptoms : cough, dyspnea, fever above 38 °C, anosmia, dysgeusia or ageusia, chilblain Lupus erythematous Women of fertile age using at least one contraceptive method Health insurance Written informed consent

Exclusion criteria

* Pregnant or breastfeeding female
* Human immunodeficiency virus infection with CD4 under 200 cell/mm3
* Aplasia
* at-risk patients (minor, patient under judicial protection or tutorship)
The Effect of Mannitol Volume with Changes in Osmolarity in Traumatic Brain Injury

This observational study is designed to research the effect of mannitol volume administration with changes in osmolarity in patients with traumatic brain injury to guide the safe use of mannitol in these patients.

This study used an analytic observational design with a prospective cohort approach to evaluate the relationship between mannitol administration volume and changes in osmolarity in TBI patients at Dr. Kariadi Central General Hospital, Semarang, Indonesia. The study included 32 non-operative TBI patients admitted to the Emergency Department (ED) and inpatient wards from November 2023 to January 2024. Samples were selected using a consecutive sampling method based on the inclusion criteria. The independent variable in this study was the volume of mannitol administered (3x125 cc, 2x250 cc, 3x250 cc; each 250 cc contains 50g mannitol) given as an IV drip for 15-20 minutes, while the dependent variable was blood osmolarity (mOsm/L).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-40 years
* Glasgow Coma Scale (GCS) score indicating mild (14-13) or moderate (12-10)

Exclusion Criteria:

* Renal impairment
* Multiple trauma with bleeding shock
* Diabetes mellitus
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)

The purpose of this study is to demonstrate the durability of protection against hepatitis B virus (HBV) infection approximately 8-9 years after vaccination with Vaxelis®. This is an estimation study, and no formal hypothesis testing was performed.


Eligibility Criteria:
Inclusion Criteria:

* Is healthy (based on a review of medical history and targeted physical examination) based on the clinical judgment of the investigator.
* Has participated in Protocol V419-007 and received a 3 + 1 Vaxelis® schedule or participated in Protocol V419-008 and received a 2 + 1 Vaxelis® schedule.
* The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study.

Exclusion Criteria:

* Has a history of diagnosis (clinical, serological, or microbiological) of HBV infection.
* Has a known or suspected impairment of immunological function (e.g., human immunodeficiency virus (HIV), splenectomy).
* Has a known hypersensitivity to any component of the study vaccine.
* Has a known or suspected blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopoietic and lymphatic system.
* Has a bleeding disorder contraindicating intramuscular vaccinations.
* Has received any hepatitis B vaccine after participation in Protocol V419-007 or V419-008.
* Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
RSA Study of Sirius Stem and Exceed Cup

The purpose of this study is to evaluate the efficacy and safety of the Sirius Cemented Stem used in conjunction with the Exceed ABT Cemented Acetabular Cup, either with E1 or Arcom polyethylene, and OptiPac/OptiVac bone cement mixing systems.

This is a comparative, prospective randomized Radiostereometry (RSA) study, lead on 48 patients in a single site.

All 48 patients will be pooled in a single group for the evaluation of the primary criterion for evaluation, but randomized into four groups for the evaluation of the secondary criteria for evaluation

The objectives of the study are to:

1. Demonstrate a comparable migration pattern as is described in published literature on other double tapered polished cemented stems
2. Measure wear pattern in the cup made of vitamin-E doped polyethylene or conventional Arcom polyethylene

2)Demonstrate non-inferiority of Optipac vs. Optivac cement mixing systems on the stem side 3)Evaluate the clinical outcome and survivorship of the implant

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are eligible for cemented total hip arthroplasty
2. Patients diagnosed with primary Osteoarthritis
3. Patients who are fit for elective surgery (ASA I - III)
4. Patients with a BMI between 16 and 40
5. Patients who are skeletally mature
6. Patients aged over 18 at the time of surgery
7. Patients willing to return for follow-up evaluations
8. Patients who have the ability to follow instructions
9. Patients with sufficient bone stock and quality

Exclusion Criteria:

1. Female patients who are pregnant or planning pregnancy during the course of the study (no use of adequate birth control)
2. Patients with diagnosed active infection
3. Patients with marked bone loss which could preclude or compromise adequate fixation of the device
4. Patients with Parkinson disease
5. Patients using immunosuppressive drugs
6. Patients with an immunosuppressive disease
7. Patients with BMI \<16
8. Patient with BMI \>40
9. Patients who are unfit for surgery (ASA IV - V)
10. Patients with acetabular or femoral osteotomy
11. Patients who had a THA on the contralateral side within last 6 months
12. Patients belonging to the vulnerable population: children, patients with mental
A Prospective Trial of the Intelon BOSS(TM) System

A prospective, open-label, single-site clinical trial designed to evaluate the repeatability and reproducibility of biomechanical imaging by the BOSS device. Subjects will undergo unilateral biomechanical mapping of the cornea and lens by three BOSS devices operated by three (3) different operators.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Availability, willingness and sufficient cognitive awareness to comply with the examination procedures and schedule
3. Signed Written Informed Consent

Exclusion Criteria:

1. No light perception or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images
2. Presence of corneal opacity
3. Presence of cortical cataracts visible in an undilated pupil
4. Any systemic disease or disorder which would prohibit image acquisition (e.g., Parkinson's Disease).
A Dose-Finding Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Adalimumab in Subjects With Refractory Asthma

To evaluate the efficacy of SC injections of 3 regimens of adalimumab vs. placebo in the change in post-bronchodilator FEV1 from Baseline to Week 16 when used in the treatment of refractory asthma.


Eligibility Criteria:
Inclusion Criteria:

* Documented history of refractory asthma, as defined by the American Thoracic Society,31 defined as 1 major and at least 2 minor criteria
* Actual or documented history of reversible airway obstruction
* Baseline FEV1 of 40% - 80% of the predicted for height, age, and sex at Screening, as demonstrated 6 or more hours after a short-acting -agonist and/or 24 or more hours after a long-acting -agonist
* History of at least 1 asthma exacerbation leading to oral, IV or IM corticosteroid or ER/Urgent Care Center visit or hospitalization within the past year prior to Screening. This asthma exacerbation should not have been within 30 days prior to Screening
* Adequate cardiac, renal and hepatic function as determined by the principal investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits
* Subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication

Exclusion Criteria:

* Active lung diseases (e.g., bronchitis, chronic obstructive pulmonary disease \[COPD\], interstitial lung disease, pulmonary fibrosis) other than asthma
* Current treatment for corticosteroid-resistant asthma (e.g., methotrexate \[MTX\], cyclosporine, gold salts, troleandomycin, immune globulin intravenous \[IGIV\], mycophenolate mofetil)
* History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma - in-situ of the cervix.
* History of listeria, human immunodeficiency virus (HIV), chronic or active Hepatitis B, an immunodeficiency syndrome, central nervous system (CNS) demyelinating disease or active TB
* Females who are pregnant or will not discontinue breast-feeding.
* Subject with a history of clinically significant drug or alcohol abuse in the last year
* Subjects with a poorly controlled medical condition.
* Abnormal, clinically significant screening laboratory and other analyses (including ECG).
* Subjects with any prior exposure to Tysabri® (natalizumab)
* Prior treatment with any TNF antagonist, including adalimumab
A Pilot Study of the Utility of 3D Printed Masks for ALS Subjects

Non-invasive ventilation (NIV) is an important therapy for patients with a number of neurological diseases. Specifically, NIV has been shown to be an effective treatment for people with amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), which is a fatal, non-curable, progressive disease of the motor neurons. However, due to changes in facial structure associated with the disease, many ALS patients find that traditional NIV masks don't fit well. In this study, investigators will perform a feasibility study on NIV mask interfaces which are custom designed for each ALS patient and then manufactured via 3D printing.

Non-invasive ventilation (NIV) is an important therapy for patients with a number of neurological diseases. Specifically, for amyotrophic lateral sclerosis (ALS)--a fatal, non-curable, progressive disease of the motor neurons--NIV represents one of the most effective treatments with a survival benefit of greater than 1 year. Despite this survival advantage, and the corresponding improvement in Quality of Life (QoL), compliance with NIV can be poor. Factors contributing to poor compliance to NIV include bulbar onset disease and mask leaks. In addition to reduced adherence to therapy, elevated mask leaks can compromise the pressure adjustment algorithm in average volume assured pressure support (AVAPS) ventilation, a commonly used mode of bilevel (positive airway pressure) PAP therapy in ALS. In an effort to increase NIV compliance in subjects with neurological conditions, and specifically ALS, investigators hypothesize that a better fit achieved through 3D printed NIV mask interfaces may improve utilization by decreasing mask leaks, decreasing the required delivery pressures and improving compliance with therapy. Investigators therefore propose a feasibility study to investigate the use of 3D printing to manufacture customized NIV mask interfaces for subjects with ALS who encounter difficulty using NIV because of poorly fitting mask interfaces despite exhausting available commercial mask options.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18
2. Ability to communicate in English
3. Diagnosis of ALS
4. Subject followed in the ALS Clinic at University of Michigan
5. Current use of NIV.
6. Problematic mask leak defined as one of the following:

   A. A clinical complaint of mask leak impeding use of PAP AND PAP use \<6 hours per night AND/OR B. Average percentage of the night in large leak on download of \>10% (AVAPS)
7. At least 1 month of NIV use

Exclusion Criteria:

1. Subjects successfully using a commercially available mask without objective or subjective leak with good compliance (average use \>6 hours per night)
2. Silicone allergy
Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer

To evaluate the feasibility and precision of stereotaxic navigation in laparoscopic surgery for colorectal cancer.

* In minimally invasive surgery, the proper identification of the correct anatomical planes can be difficult due to a lack of tactile feedback and the inability to manually palpate the organ prior to resection. Although this can be minimized by careful preoperative planning, the information that can be obtained by images is also of limited utility. Conventional imaging, such as magnetic resonance imaging (MRI) and computed tomography (CT-scan), can provide a detailed view of 2D or 3D internal anatomical structures. However, during surgery, surgeons still have to use their subjective interpretation to translate this information into three-dimensional spatial relationships (ie the patient's actual volume). For this reason, in order to perform adequate resection and avoid injury, the surgeon must constantly infer what is the actual location of the anatomical structures and what is the position of the surgical instruments in relation thereto.
* The proposed study aims to evaluate the feasibility of surgical navigation in patients with colorectal cancer (sigmoid rectum-right-left rectum) and measure its performance in the perspective of a more specific application to rectal cancer approached laparoscopically through the abdomen and / or the anus. The study is proposed to patients with cancer because the measurement of accuracy will be done on predefined anatomical points that will be detectable in the surgical field after oncologic dissection. Benign pathologies do not require this type of extensive dissection and the application of navigation would imply additional risks for patients.
* Surgical navigation will be performed on the basis of preoperative images or intraoperative images.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is over 18 years old
2. Patient presents with cancer
3. Patient has no contraindication to anesthesia and surgical resection
4. Patient able to receive and understand information about the study and give written informed consent
5. Patient (s) affiliated to the national social security system.

Exclusion Criteria:

1. Patient operated on urgently.
2. Pregnant or lactating patient
3. Patient in an exclusion period (determined by previous or current study).
4. Patient under the protection of justice.
5. Patient under guardianship or curatorship.
Time Efficient Exercise to Reverse Sarcopenia and Improve Cardio-metabolic Health

Participants will be 60-80 y men and women who vary their physical activity (steps/day) while their lipid metabolism is studied (n=24). Thereafter, another group (n=60) will perform 6 months of exercise training focused on developing maximal cycling power, during which their changes in muscle mass and practical function will be carefully measured.

In a society that is growing in the number of older adults who are also becoming more sedentary, it is critical to identify the types of exercise that harness significant health benefits. First, we hypothesize that older adults (60-80 y) need a certain background level of physical activity, judged by number of steps per day. This is important, especially to fat metabolism. Secondly, because older adults claim they don't have time to exercise, we have developed a time efficient program (10 min/day) that has shown promise for offsetting sarcopenia and significantly improving cardiovascular function.

Our Aim 1 is to determine the range of daily step counts in older adults (60-80 y; n=24) that is needed to prevent acute impairment of post-prandial fat metabolism, measured the morning after exercise. We have recently shown in young adults that when their level of background physical activity drops below the range of 5,000 - 8,500±500 steps/d, that they don't adapt positively to an acute 1 h bout of exercise (i.e.; 'exercise resistance') that normally improves fat metabolism.

Our Aim 2 is to determine the ability of a time-efficient 24-week program of exercise training for both maximal neuromuscular power and aerobic power to counteract sarcopenia and declines in aerobic power and functional tests in men and women 60-80 y. We have recently found in a preliminary study of older men and women (50-70 y) that performing multiple maximal 4 s sprints of rapid acceleration cycling bouts for only 8 weeks, eliciting maximal power, displayed significant (p\<0.05) increases in muscle thigh volume (MRI), whole body muscle mass, maximal neuromuscular power and peak oxygen consumption. We now propose to train older men and women (i.e.; 60-80 y; n=60) for longer durations (i.e.; 24 weeks) and describe the time course of adaptations. We will additionally monitor their background levels of daily physical activity and determine if it correlates with improvements in neuromuscular and cardiovascular function.

Eligibility Criteria:
Inclusion Criteria:

* relatively healthy

Exclusion Criteria:

* relatively unhealthy
Evaluation of the Effectiveness of Prepectoral Breast Reconstruction

The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.

The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.

The study plans to collect robust data to support the prepectoral implant placement and complete coverage of implant with acellular dermal matrix in the clinical practice.

Consequently, the project plans to move toward evidence-based medicine in breast reconstruction, avoiding marketing influences and surgeon experience as the sole source of evidence.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent
2. Not smokers
3. No vascular comorbidities (diabetic, vasculitis, coagulation disorders)
4. BMI\<30
5. CUP B-C (or mastectomy estimated weight less than 550gm)
6. Good subcutaneous layer (\>1cm on pinch test measured in upper/medial quadrant)
7. No previous breast surgery
8. No previous breast irradiation
9. Breast Ptosis 1-2 according to Renault's classification
10. DCIS tumors
11. T1 T2 pN0 breast tumor with known favourable biologic features

Exclusion Criteria:

1. Impossibility of immediate reconstruction with definitive implants due to inadequacy of mastectomy flaps (inadequate in quantity and/or quality)
2. Positive sentinel node biopsy requiring complete axillary dissection