cyrilzakka/clinical-trials huggingface dataset:
Immunological Response to COVID-19 Vaccine in Patients With Autoimmune and Inflammatory Diseases Treated With Immunosuppressants and/or Biologics

Vaccination against the new coronavirus (SARS-CoV-2) was extended to patients at risk of severe forms of Covid-19, including in particular patients with autoimmune and inflammatory diseases treated by immunosuppressants and/or biologics.

In this particular population, the effectiveness of vaccines, in particular influenza and pneumococcal vaccinations, is often reduced, especially in case of treatment with rituximab and / or methotrexate.

Regarding the SARS-CoV-2 vaccine, the studies that allowed the marketing authorization of the available vaccines did not include patients treated with immunosuppressants or immunomodulators.

Thus, the impact of treatments on the production of neutralizing antibodies and specific T lymphocytes is not known.

The goal of this study is to assess the immune response to the SARS-CoV-2 vaccine in patients with autoimmune and inflammatory diseases treated with immunosuppressants or immunomodulators.


Eligibility Criteria:
Inclusion Criteria:

* Group 1 :
* Patient over 18 years old,
* Patient informed and not opposed to participate
* Patient followed for an autoimmune or inflammatory disease (vasculitis, systemic lupus, systemic sclerosis, non-infectious uveitis)
* Treatment with immunosuppressant and / or immunomodulator
* Group 2 :
* Patient over 18 years old,
* Patient informed and not opposed to participate
* Patient not followed for an autoimmune or inflammatory disease (vasculitis, systemic lupus, systemic sclerosis, non-infectious uveitis)
* Absence of treatment with immunosuppressant and / or immunomodulator

Exclusion Criteria:

* Contraindication to vaccination
* Progressive cancer
* Pregnant or breastfeeding woman
* Current infection less than 3 weeks old
* Weight less than 40 kg
* Patient under tutor- or curator-ship
* Patient without health insurance
A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma

The purpose of this study is to test the effectiveness and safety of various nivolumab combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer


Eligibility Criteria:
Inclusion Criteria:

* Advanced Renal Cell Carcinoma
* Must have at least 1 lesion with measurable disease
* Life expectancy of at least 3 months
* Karnofsky Performance Status (KPS) must be =\>70%

Exclusion Criteria:

* Patients/subjects with suspected or known central nervous system metastases unless adequately treated
* Patients/subjects with autoimmune disease
* Patients/subjects who need daily oxygen therapy

Other protocol defined inclusion/exclusion criteria apply
Early Intervention to Promote Return to Work for People With Spinal Cord Injury

For many people with spinal cord injury, seeking employment after injury is an important goal. There are services available to help people with disabilities. However, the best ways to coordinate and deliver these services are not yet known. This project will compare two ways of coordinating and delivering services that are designed to help people with spinal cord injury obtain employment.

Employment is important for financial security, social connection, and life satisfaction. Unfortunately, rates of unemployment remain high among people with spinal cord injury (SCI). To help address this challenge, the Northern New Jersey Spinal Cord Injury System (NNJSCIS) is conducting a single-site, randomized, controlled trial to compare two programs intended to increase rates of employment among people with SCI. The project will enroll 162 recently injured adults with SCI who are interested in becoming employed or returning to work and will compare different ways of delivering employment-related services in the first year after injury. Services will begin in inpatient rehabilitation and may include education, therapy, equipment provision, counseling, and other interventions. Information about employment status, earnings, community participation, and health will be collected through a combination of questionnaires and databases. Participants and service providers will also share their impressions of the programs via survey and focus groups. Analyses will examine the rate of participants employed at 1 year in each group, time to employment, earnings, community participation, and other aspects of well-being. Findings from this study will be used to determine which ways of delivering services are most effective in enabling employment by 1 year after injury, and to provide information to help other rehabilitation centers adopt effective programs.

Eligibility Criteria:
Inclusion Criteria:

* adults age 18 to 62
* a neurological impairment secondary to an SCI that occurred less than 12 months prior to enrollment
* receiving inpatient rehabilitation at Kessler Institute for Rehabilitation (KIR)
* community living in the state of NJ after discharge from KIR
* have a goal to pursue competitive integrated employment or education/retraining leading to competitive integrated employment
Efficacy and Safety of Nerve Growth Factor or Edaravone on Alcohol-induced Brain Injury

Alcohol is one of most common harmful substance, and alcohol intake brings great burden on health worldwide. Excess alcohol intake may lead to alcohol-related brain injuries and cognitive impairment. Although both nerve growth factor and antioxidative treatment were effective to relieve alcohol-related injuries in central nervous system in the preclinical studies, there is no relevant clinical trial about their efficacy and safety on patients. Since nerve growth factor and one of the antioxidative medication, edaravone, have been used in some neural diseases in clinical trials, we tend to evaluate the efficacy and safety of nerve growth factor, or edaravone on alcohol-induced brain injuries. The study is a randomized-controlled study and the patients will be assigned into one of the following three groups randomly: (1) regular treatment (combination of vitamin B1, B6, C, E and mecobalamine) with nerve growth factor for 2 weeks and subsequently regular treatment for 6 months; (2) regular treatment (RT) with edaravone for 2 weeks and subsequently RT for 6 months; (3) RT alone for 6 months. The patients will be followed up for 6 months. Cognitive functions, recurrence of alcohol dependence, duration of abstention, alcohol intake, craving for alcohol and other psychological assessments will be recorded and compared among the 3 treatment groups and the efficacy of nerve growth factor or edaravone will be evaluated in our study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis as alcohol dependence according to DSM-IV criteria
* MRI-proved demyelinating lesions or atrophy in the brain of the patient
* No definite history of neurological diseases and psychological problems
* Volunteer to participate the study, cooperate to be followed up

Exclusion Criteria:

* Acute withdrawal state and CIWA score \> 9
* With other neurological diseases and psychological problems
* With ever brain trauma and damage
* With other psychological medications or other substance dependence
Assessing Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA-7.3) (18F) in Healthy Volunteers and Subjects With Prostate Cancer

A Phase 1, Open-label Study to Assess Safety, Biodistribution, and Internal Radiation Dosimetry of rhPSMA-7.3 (18F) Injection in Healthy Volunteers, and to Assess Safety and Investigate the Imaging Characteristics in Subjects With Prostate Cancer.


Eligibility Criteria:
Key Inclusion Criteria: Healthy Volunteers

1. Male and females 21-65 years.
2. Clinically acceptable medical history

Key Exclusion Criteria: Healthy Volunteers

1. Received ionising radiation exposure from clinical trials or medical examinations or treatment in the last 12 months.
2. Suffers from claustrophobia.
3. Bilateral hip prostheses.

Key Inclusion Criteria: Patients

1. Male 18-80 years.
2. Histologically confirmed adenocarcinoma of the prostate
3. Clinically acceptable medical history
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Key Exclusion Criteria: Patients

1. Biopsy 28 days prior to enrollment.
2. Extensive metastatic disease.
3. Underlying disease which might confound interpretation.
4. Bilateral hip prostheses.
5. High energy (\>300 Kiloelectron Volt (keV)) gamma-emitting radioisotope administered within five physical half-lives, or any intravenous iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days prior to study drug administration.
6. X-ray contrast agent (\<24 hr for intravenous agents and \<5 days for oral agents).
7. History of claustrophobia.
Recombinant Human Endostatin Combined With NP in Neoadjuvant Chemotherapy of Stage ⅢA NSCLC

This study mainly to observe the anti angiogenic drugs Endostatin (Endostar) combined with vinorelbine and Cisplatin (NP) as neoadjuvant therapy in patients with non small cell lung cancer clinical efficiency and safety. Through anti angiogenesis therapy combined with neoadjuvant chemotherapy improve the treatment of neoadjuvant therapy in tumor response rate and the rate of resection, At the same time, the study before and after the anti angiogenesis therapy in patients with peripheral blood circulation endothelial cells(CECs), levels of Endothelial progenitor cells（EPC）, micro vascular density（MVD） and vascular endothelial growth factor(VEGF) expression level, to understanding the correlation between the clinical efficacy of anti angiogenesis therapy combined with chemotherapy and the change of all these markers. In order to find the reference basis for the prediction of the effect of curative effect. The changes of blood volume, blood flow and vascular permeability of the lung cancer before and after treatment with CT perfusion imaging are studied.


Eligibility Criteria:
Inclusion Criteria:

* The pathology proved to be non small cell lung cancer (must be histologically).
* At present, the patients with ⅢA stage (N2) were evaluated by the assistant examination;
* The patients were evaluated by imaging, laboratory examination and other examination;
* Without chemotherapy or anti angiogenic therapy;
* There can be measured lesions
* Informed consent.

Exclusion Criteria:

* Pregnant, lactating women, or patients with fertility but did not take contraceptive measures.
* Severe infection.
* Severe heart disease.Neuropsychiatric disorders, which is not easy to control.
* Severe diabetes.
* There is obvious bleeding tendency.
* The 5 years history of other tumors
EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial)

The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and surgery in patients with resectable distal malignant biliary obstruction.

Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) has been extended as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO). However, there are clinical trials which have compared it with ERCP as a first line treatment for MDBO in palliative patients, showing similar clinical and technical success and adverse events (AEs) rate between both techniques. Data about the benefit of this techique in resectable patients is still limited.

A recent retrospective study (Janet J et al, Ann Surg Oncol 2023) which included resectable patients, found that EUS-CDS group had significantly less delay (days) between biliary drainage and surgery than the ERCP group, with fewer endoscopy and surgery AEs.

Thus, our hypothesis is that EUS-CDS has benefits in terms of decreasing delay between biliary drainage when compared to ERCP in MDBO in resectable patients.

Eligibility Criteria:
Inclusion Criteria:

* Malignant distal biliary obstruction diagnosed in patient considered RESECTABLE with biliary drainage indication: i) impaired hepatic enzymes (including hyperbilirubinemia) x3 times upper the superior normal value. ii) Radiologic singns of extrahepatic bile duct obstruction with presence of retrograde dilatation, of at least 12-mm axial diameter.
* Consensual malignancy by a bilio-pancreatic multidisciplinar committe (histological confirmation is not mandatory)
* Patient capable of understanding and/or singning the informed consent.
* Patient who understands the type of study and will comply with all follow-up tests throughout its duration

Exclusion Criteria:

* Pregnancy or lactation.
* Severe coagulation disorder: INR \> 1.5 non correctable with plasma administration and/or platelet count \< 50.000/mm3.
* Distal malignant biliary strictures in patients considered borderline, non-surgical, unresectable, or palliative
* Benign or uncertain etiology of biliary strictures or strictures located proximally or in close proximity to the hilum.
* Patients with prior biliary stents or other biliary drainages (e.g., PTCD).
* Altered intestinal anatomy due to prior surgery that prevents or hinders papillary access (e.g., gastric bypass, Billroth II, duodenal switch, Roux-en-Y).
* Stenosis in the antral or duodenal region that prevents access to the duodenum and reaching the papilla.
* Situations that do not allow for upper gastrointestinal endoscopy (e.g., esophageal stricture).
* Patients with functional diversity, who lack the capacity to understand the nature and potential consequences of the study, except when a legal representative is available.
* Patients incapable of maintaining follow-up appointments (lack of adherence).
* Lack of informed consent.
Predicting Changes in Core Muscles During Female Sexual Dysfunction: A Comprehensive Analysis Using Machine and Deep Learning

The purpose of this study is to Predicting changes in core muscles during female sexual dysfunction by A Comprehensive Analysis Using Machine and Deep Learning Female sexual dysfunction (FSD) is a common condition that affects womenof all ages. It is characterized by a range of symptoms, including decreased libido, difficulty achieving orgasm, and pain during intercourse. One potential cause of FSD is muscular weakness or changes in the core muscles. These muscles play an important role in sexual function, and changes in their strength or activation patterns can lead to FSD. Additionally, the development of a machine learning model for this purpose could pave the way for future studies exploring the use of artificial intelligence in the diagnosis and treatment of other musculoskeletal disorder and female health issues.


Eligibility Criteria:
Inclusion Criteria:

* a number of parities ≤ three
* normal vaginal deliveries

Exclusion Criteria:

* History of a recto-vaginal or vesico-vaginal fistula, undiagnosed uterine bleeding urinary tract infection,
* diabetes,
* intrauterine device
* sexual disorder
Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor

This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.

Patients were randomized (1:1) to receive buparlisib (100 mg/day) or placebo with fulvestrant (500 mg); randomization was stratified by PI3K pathway activation status (activated, non-activated, unknown determined in archival tumor tissue) and visceral disease status (present or absent). Tumor evaluation was performed 6 weeks after the randomization date and then every 8 weeks until radiological progression (based on Response Evaluation Criteria In Solid Tumors \[RECIST\] version 1.1).

Novartis made the decision not to pursue further development of buparlisib and to terminate the ongoing studies in the program. Accordingly, on 19-Dec-2016, Novartis notified all the Investigators about the decision not to pursue further development of buparlisib in Breast Cancer. As a result, the CBKM120F2302 study was terminated on 19-Apr-2019 (last subject last visit).

Eligibility Criteria:
Key Inclusion Criteria:

* Locally advanced or metastatic breast cancer
* HER2-negative and hormone receptor-positive status (common breast cancer classification tests)
* Postmenopausal woman
* A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PI3K activation status)
* Progression or recurrence of breast cancer while on or after aromatase inhibitor treatment
* Measurable disease or non measurable disease bone lesions in the absence of measurable disease as per RECIST 1.1
* Adequate bone marrow and organ function defined by laboratory values

Key Exclusion Criteria:

* Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant
* More than one prior chemotherapy line for metastatic disease
* Symptomatic brain metastases
* Increasing or chronic treatment (\> 5 days) with corticosteroids or another immunosuppressive agent
* Active heart (cardiac) disease as defined in the protocol
* Certain scores on an anxiety and depression mood questionnaires
Benefit of a Hospital Intervention in Patients with Hepatic Steatosis

The objective of this clinical trial is to determine whether a specialized consultation for controlling metabolic syndrome effectively treats hepatic steatosis in adults. The primary questions it aims to answer are:

• Does this specialized consultation increase the number of patients with hepatic steatosis who show improvement after one year of clinical follow-up in said consultation?

The improvement of the disease will be assessed through the following parameters:

* liver laboratory tests
* weight loss
* improvement in cholesterol and triglyceride levels. Researchers will compare follow-up in the specialized consultation to standard follow-up to assess the effectiveness of the specialized consultation in treating hepatic steatosis.

Participants will be randomly assigned to two groups. The first group will be visited in the specialized consultation every three months for one year and will continue to receive the rest of their follow-up visits. The second group will undergo their usual follow-up visits but will not be visited in the specialized consultation.


Eligibility Criteria:
Inclusion Criteria:

* Patients seen in outpatient gastroenterology clinics with hepatic steatosis.
* Diagnosed with hepatic steatosis through ultrasound or abdominal CT scan
* Mild to moderate fibrosis as assessed by elastography or FibroScan (F1-F3) or with a Fibrosis-4 (FIB-4) Index less than 3.5.
* Signature of informed consent for study inclusion, either by the participant themselves or by their legal representative.

Exclusion Criteria:

* Patients who do not have any hepatic imaging test conducted in the last 5 years.
* Conditions other than hepatic steatosis requiring gastroenterological follow-up.
* Abusive alcohol consumption, defined as weekly intake of \> 50 g in women and more than 70 g in men.
* Cognitive or affective disorders limiting the ability to cooperate with study procedures.
* Participation in another clinical trial involving experimental intervention during the period of this trial and/or establishing visit schedules incompatible with this trial.
Impact of Infant Formula on Caregiver-perceived Intolerance

Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms


Eligibility Criteria:
Inclusion Criteria:

* Healthy infant
* Full-term (\> 37 weeks gestation)
* Birth weight \> 2500 and \< 4500 g
* 14-60 days of age on enrollment
* Singleton birth
* Infant's mother has elected not to breastfeed prior to enrollment
* Infant exclusively formula-fed for at least 5 days prior to enrollment
* Caregiver perceives infant as very or extremely fussy according to perceived fussiness based on the previous 3 days
* Caregiver wishes to switch infant's formula
* Has not received solid foods
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Known or suspected cow-milk allergy
* Currently receiving a specialty infant formula (e.g. thickened, extensively hydrolyzed, amino acid-based, metabolic)
* Has switched formula more than two times since hospital discharge
* Currently experiencing gastrointestinal or respiratory symptoms secondary to an ongoing infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu)
* Congenital illness or malformation that may affect infant feeding and/or growth
* Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
* Receiving probiotic supplements
* Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen).
* Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition.
The Trend of Copeptin Levels and Its Clinical Value for Postoperative CDI in Pediatric Patients After NSI in ICU

Central diabetes insipidus (CDI),a disease caused by the decrease of AVP (a hormone involved in the control of water-electrolyte balance ) secretion and characerized by polyuria, is a common complication after neurosurgerical intervention and there is a lack of diagnostic criteria.Since the surgry casuses damage to patients' AVP-secreting neuronal cells, transient CDI (t-CDI) usually occurs 24-48h postoperatively and gradually resolves in about 10 days.However,permanent CDI (p-CDI) occurs in a small percentage of patients.Copeptin is a fragment of AVP, which has been shown to response the secretion of AVP.Multiple international studies have identified clinical applications for the use of copeptin to differentially diagnose adults with CDI , to assess electrolyte disturbances associated with AVP regulation, and to predict postoperative CDI after pituitary surgery.This study aims to investigate the trend of serum copeptin levels and its clinical value for postoperative CDI in pediatric patients after neurosurgerical intervention in ICU.

In children and adolescents, the concentration distribution of copeptin has been gradually explored in recent years,but International studies have not yet shown the trend of copeptin levels in pediatric patients after neurosurgical intervention and its value in predicting CDI.

The primary objective of this study is to investigate the trend of serum copetin levels in ICU children after neurosurgerical intervention and compare differences of copeptide levels in children with CDI (t-CDI, p-CDI) and non-CDI. The secondary objective is to evaluate the optimal detection time and CUT OFF of copeptin in predicting the postoperative secondary CDI .

Blood sampling time points of serum copeptin levels are listed as follow:

presurgery(T0), 1h (T1), 1 day (T2), 2 days (T3), 3 days (T4), 4 days (T5), 5 day (T6) after surgury.

Eligibility Criteria:
Inclusion Criteria:

* Male and female,age ≥29 days and \<18 years
* After neurosurgical intervention
* The patient agrees to comply with the requirements of the program, including follow-up visits and other related matters

Exclusion Criteria:

* Structural diseases of the genitourinary system (with the possibility of nephrogenic diabetes insipidus)
* Preoperative symptoms of diabetes insipidus
* Diabetes mellitus (HbA1c \>8.5%)
* Drugs causing excessive drinking and urination (e.g., sodium-glucose cotransporter-2 inhibitors and diuretics)
* Lack of follow-up data after 3 months