cyrilzakka/clinical-trials huggingface dataset:
Anti-CMV Cellular Immunity Quantification Using an IGRA Test in Kidney Transplant récipients and Hemodialysis Patients, Comparison to Control Patients

Evaluation of anti-CMV T cellular immunity using an IGRA test (Quantiferon-CMV test) in kidney transplant recipients and hemodialysis patients, comparison to control patients.

Cytomegalovirus (CMV) infection is a common opportunistic complication after kidney transplantation (KT). It has been associated with high morbidity and mortality in kidney transplant recipients (KTR). Its actual management is only based on the humoral immunity : the main risk factor for CMV infection after KT is the association of a seropositive donor and a seronegative recipient (so-called "D+/R- mismatch").

However several studies have highlighted the essential role of cellular immunity to control CMV infection. The Quantiferon-CMV (QF-CMV) is an IGRA test (Interferon Gamma Releasing Assay) which evaluates T CD8 lymphocytes production of Interferon Gamma (IFNy) exposed to CMV antigens. Some studies have shown the possible interest of the QF-CMV in predicting CMV infection after antiviral prophylaxis discontinuation or when CMV viremia is detected.

However some limits have been underlined. First its positivity threshold hasn't been approved in KTR. Hemodialysis patients (HP) called to receive a renal allograft also suffered from altered immunity. No study has directly compared the QF-CMV value in KTR, HP and control patients.

That's why we propose evaluating the expression of basal cellular immunity against CMV (far from any active infection) in KTR and HP using the QF-CMV and comparing it to control patients population (not suffering from kidney dysfunction or immunosuppression).

Eligibility Criteria:
Inclusion Criteria :

* For all patients :

  * to be seropositive for CMV
  * to not be opposed to the study
* For kidney transplant recipients :

  * to have received a kidney graft for over 1 year
  * to have received an induction therapy at transplantation time by anti-lymphocytes antibodies and steroids
  * to be currently receiving immunosuppressive therapy by calcineurins inhibitors (tacrolimus or cyclosporine), mycophenolic acid with or without steroids
  * to not suffer from another cause of immunosuppression
* For hemodialysis patients :

  * to be treated by hemodialysis for end stage renal disease
  * without prior solid organ transplant history
  * to not suffer from another cause of immunosuppression
* For control patients :

  * with normal kidney function (estimated GFR \> 90 ml/min)
  * to not suffer from another cause of immunosuppression

Exclusion Criteria :

* patient under guardianship or deprived of his liberty
Retrospective Analysis on Small Bowel Perforations

A retrospective, monocentric, code-related data analysis of patients with small bowel perforations was performed for the period 2010 to 2019.

Analyzed parameters were etiology and timing of perforation, associated morbidity and mortality, type of therapy and its success, and long-term consequences for patients, such as the development of short bowel syndrome.

Eligibility Criteria:
Inclusion Criteria:

* small bowel perforation in adults

Exclusion Criteria:

* age \< 18 years
A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC

This study will evaluate the efficacy, safety, pharmacokinetics and immunogenicity of RC148 injection as a single agent or in combination for the treatment of locally advanced or metastatic non-small cell lung cancer

Primary objective: to evaluate the efficacy of RC148 injection as monotherapy or combination therapy in patients locally advanced or metastatic non-small cell lung cancer;

Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily participate in the study and signed the ICF;
2. Be willing to and able to act on the trial and the follow up procedures;
3. Male or female, aged 18-80 years;
4. Expected survival ≥ 3 months;
5. ECOG PS score 0 or 1;
6. All participants to be enrolled in cohorts 1-5 must be diagnosed with histopathologically or cytologically confirmed, unresectable locally advanced or metastatic NSCLC (stage IIIB//IIIC/IV according to the 8th edition of UICC/AJCC) and not amendable to curative surgery or radiation as assessed by investigator.

Exclusion Criteria:

1. Histopathologically or cytologically confirmed small cell lung cancer;
2. Received major surgeries and still in recovery within 28 days before the first dose;
3. Received any live vaccine within 28 days prior to the first dose or plan to be vaccinated during the study (except for COVID-19 vaccine);
4. Received immune checkpoint inhibitor (anti-PD-1/PD-L1/CTLA-4 antibody) or other immune checkpoint inhibitor treatment within 28 days prior to the first dose, or experienced prior permanent immunotherapy discontinuation due to immunotoxicity;
5. Participated in other clinical trials and received other investigational anti-tumor therapy within 28 days prior to the first dose;
6. Poor compliance and unable to complete the study procedures as assessed by investigator;
7. Have any other medical conditions, abnormal physical examinations or laboratory examinations that would be suspected interfere with participation or evaluation of the trial or increase the risk to the participant, in view of the investigator.
The Effect of Pecans on Biomarkers of Risk for Cardiovascular Disease and Diabetes

The objective of this randomized, controlled feeding study is to investigate the potential health benefits of a pecan-containing diet. The investigators hypothesize the chronic consumption of pecans will improve an array of biomarkers related to cardiovascular disease and type 2 diabetes risk, including indices of oxidative stress, antioxidant activity, inflammation, endothelial function, and insulin resistance when compared with a control diet that is absent nuts.


Eligibility Criteria:
Inclusion Criteria:

* Men \& postmenopausal women, age 50 years and over
* BMI 25-35 kg/m2
* Waist/hip \>0.8 for women and \>0.9 for men
* Blood pressure between 120/80 and 159/99

Exclusion Criteria:

* Cigarette smoking and/or nicotine replacement use
* Individuals taking estrogen
* Use of cholesterol-lowering medications
* Use of blood pressure-lowering medications
* Regular use of any stomach acid-lowering medications, laxatives (including fiber supplements) or anti-diarrheal medications (prescription or over-the-counter \[OTC\])
* Cardiovascular (heart) disease
* Gastrointestinal disease
* Kidney disease
* Endocrine disease: including diabetes, unstable thyroid disease
* Autoimmune disease: including rheumatoid arthritis, gout, lupus, HIV
* Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
* Systolic blood pressure \> 159 mmHg and/or diastolic blood pressure \> 99 mmHg
* Regular use of oral or injectable steroids
* Gain or loss of \> 10% of body weight within previous 3 months; unwillingness to maintain your weight
* Regular daily intake of ≥ 2 alcoholic drinks
* Vegetarians
* Current allergy to any kind of nut
* Dietary supplement use, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission
Functional-three-dimensional Reconstruction of Liver by 99MTc-GSA-SPECT Scan

The aims of this study were divided into three parts:

1. To develop a new software to carry out the functional-three- dimensional-reconstruction of the liver by 99mTc-GSA-SPECT scintigraphy
2. To probe a new dynamic model of the metabolism of the 99mTc-GSA.
3. To evaluate the liver function by 99mTc-GSA-SPECT scintigraphy before surgical treatment.

Study design:

1. Collectivity type: Prospective，randomized, controlled, multi-central clinical study.
2. Patients: The subjects were from different hospitals including: Peking Union Medical College Hospital (PUMCH).

Study arrangement:

This study was consisted of three parts:


Eligibility Criteria:
Inclusion Criteria:

* Patients that with benign tumor、hepatitis and hepatic carcinoma (with or without cirrhosis)diagnosed by examination of CT, ultrasound-B, and/or pathology.
Participation in Occupations and Perception of Quality of Life, Comparing Adults With and Without PTSD

This study assesses the relationship between participation and quality of life the way adults with and without Post Traumatic Stress Disorder (PTSD) experience it in everyday life. Both groups will fill out Questionnaires and the answers will be compared. In addition different aspects of dissociation will be taken in to consideration.

Post Traumatic Stress Disorder has been known to severely impair participation in everyday activities such as work, recreation and social participation. In turn, these impairments can diminish quality of life. However, the relationship between PTSD, functioning and quality of life remains incompletely understood.

Since achieving full participation in daily activities is the main goal of occupational therapy, and since quality of life is a primary treatment success measure, it is important to fully understand the relationship between PTSD, participation and quality of life.

Various studies show that dissociation affects different body functions that manage and monitor mental functioning. Since quality of life is a subjective measure that relies on one's ability to mentally represent himself and others it is important to tack into consideration the way that dissociation affects the relationships described above.

The research contains 4 Questionnaires that will be filed out by the participants and the data from the Questionnaires will be analyzed and compared.

Eligibility Criteria:
Inclusion Criteria:

* Hebrew speaking, read and write in Hebrew, have been diagnosed with PTSD following a trauma that occurred over one year before the current study.

Exclusion Criteria:

* Other psychiatric disorders, cognitive or physical impairments.
Does Perineural Dexamethasone Increase the Duration of an Ulnar Nerve Block When Controlling for Systemic Effects?

Investigators will assess if perineural dexamethasone can increase the duration of an ulnar nerve block when controlling for systemic effects in healthy volunteers.

Healthy volunteers will have bilateral ulnar nerve blocks performed with bupivacaine on two different days with a minimum of 14 days wash-out. On one day, the participants will also receive dexamethasone in one arm and placebo in the other. On the other day, the participants will also receive placebo in one arm and lidocaine in the other. By this using this design, the investigators will be able to assess if perineural dexamethasone can increase the duration of an ulnar nerve block when controlling for the systemic effects. Furthermore, to ensure blinding, the investigators have also incorporated the lidocaine group which also allows for the assessment of the effects of adding lidocaine to a peripheral nerve block with bupivacaine. The order of which the participant will receive dexamethasone and lidocaine will be random. It will also be random in which arm the participant receives dexamethasone and lidocaine.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or above
* Must fully understand the protocol and sign written informed consent
* American Society of Anaesthesiologists Physical Status Classification System of 1 or 2
* Body Mass Index above 18 kg/m\^2
* For fertile women, safe contraceptives for the last month and negative urine human chorionic gonadotropin is required

Exclusion Criteria:

* Participants unable to cooperate
* Participants unable to speak or read Danish
* Age above 65 years
* Cardiovascular disease
* Allergy to study medication
* History of alcohol or substance abuse
* Intake of corticosteroids within the last 14 days
* Daily intake of prescription analgesia within the last four weeks
* Intake of over-the-counter analgesia within the last 48 hours
* Neuromuscular diseases or wounds on the arms or hands preventing adequate test or block performance.
* Diabetes mellitus
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma

The objective of this pilot study is to evaluate the safety, tolerability and activity of the monoclonal antibody CT-011 administered intravenously to patients with Primary Hepatocellular Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 18 years and above, both genders.
2. Histologically or cytologically confirmed Primary Hepatocellular Carcinoma (HCC)
3. No fibrolamellar subtype HCC
4. Not eligible for any other systemic anti-neoplastic treatment approved for HCC
5. Not eligible for Transarterial chemoembolization (TACE ).
6. No more than 1 prior systemic therapy. Previous TACE or Radiofrequency ablation (RFA) that were used for HCC, are permitted.
7. Not a candidate for curative surgical resection or liver transplantation
8. Measurable disease defined by the identification at least 1 measurable lesion by MRI using RECIST criteria. Tumor in area of TACE or RFA must be enlarging post-procedure to be considered measurable disease.
9. Alpha-fetoprotein (AFP) greater than the upper limit of normal (ULN)
10. Child's Pugh classification A
11. ECOG performance status 0-1

Exclusion Criteria:

1. Patients progressing to liver failure.
2. No core biopsy within the past 7 days
3. Patients who are eligible for Transarterial Chemoembolization (TACE)
4. Patients on concurrent anti-neoplastic therapy (including interferon)
5. Patients who have received any systemic anti-neoplastic therapy not approved for the treatment of HCC.
6. Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
7. Presence of metastasis.
Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain

The purpose of this study is to evaluate the efficacy and safety of Praga formulation in the treatment of neuropathic pain.


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants of 18 years and older;
* Diagnosis of type 2 or type 1 diabetes for at least 1 year;
* No change in antidiabetic medication winthin 3 months;
* Diagnosis of painful sensorimotor diabetic polyneuropathy;
* Presence of at least one of the following symptoms: i. numbness in the toes, feet and / or legs; ii. paresthesias (tingling and / or neuropathic pain) in the toes, feet and / or legs.
* Presence of at least one of the following signs: i. symmetrical hypoesthesia of tactile, thermal or painful sensation (s) in the distal region of the legs; ii. hypoactive or abolished achilles reflexes;
* Glycated hemoglobin ≤ 11%;
* Score ≥ 12 points on the LANSS pain scale (Leeds Assessment of Neuropathic Symptoms and Signs); j) Participants with moderate to severe pain, a score ≥ 4 on the numerical pain scale (0-10 points);
* Participants with moderate to severe neuropathic pain who recorded in the diary a minimum of 4 of the 7 days from the period to assess the baseline pain score.

Exclusion Criteria:

* Known hypersensitivity to the formula components used during the clinical trial;
* History of alcohol and/or substance abuse within 2 years;
* Pregnant women, breastfeeding or planning to become pregnant, or women with the potential to become pregnant who are not using a reliable method of contraception;
* History of pernicious anemia, uncontrolled hypothyroidism, chronic hepatitis B;
* HIV diagnosis;
* History of neurological disorder unrelated to diabetic neuropathy;
* Non-responders to previous pregabalin treatment;
* High variability in the baseline pain score;
* Other conditions that may alter the sensitivity in the affected dermatome or in the area involved in neuropathic pain that may confuse pain assessment;
* Severe psychiatric condition;
* Cognitive decline that affect the participant from correctly answering the scales and questionnaires;
* Clinically relevant cardiac abnormalities, which at the researcher's discretion represent a risk to participation in the trial;
* Participant who has amputated lower limb due to complications from diabetes;
* Renal failure, defined by the estimated glomerular filtration rate \[eGFR\] \<60 mL / min / 1.73 m2.
Sedative Premedication in Coronary Angiography

Evaluation of the possible positive effect of sedative premedication prior to coronary angiography in regards to pain and anxiety.

Coronary angiography is an invasive procedure that can cause patient discomfort. Sedative premedication before coronary angiography could be used to reduce anxiety and pain, but evidence is lacking. Previous trials were predominantly conducted in men and in coronary interventions with femoral access. Recently, radial access has become the preferred route for performing coronary angiograms (RIVAL trial) In this setting, sedative premedication could be of interest to reduce radial spasms, patient anxiety and pain.

Eligibility Criteria:
Inclusion Criteria:

* elective coronary angiography

Exclusion Criteria:

* planned PCI
* use of sedative medication at home
* use of alcohol
Comparison of Nebivolol and Metoprolol With Exercise and Angiotensin II in Hypertensive Patients

The purpose of this study is to determine if Nebivolol a) attenuates the angiotensin II (Ang II)-induced increase in oxidative stress, thereby attenuating Ang II-induced vasoconstriction; and b) attenuates sympathetic mediated vasoconstriction during exercise, thereby reducing functional skeletal muscle ischemia in hypertensive patients.

In 40 untreated, stage I hypertensive subjects, Investigators will measure sympathetic nerve activity (microneurography); total forearm blood flow (high-resolution ultrasonography); skeletal muscle oxygenation (Near Infrared spectroscopy); plasma F2-isoprostanes; cardiac output (non-invasive impedance plethysmography); and blood pressure at baseline and after a) rhythmic handgrip exercise at 30% of maximal voluntary contraction alone for 3 minutes, b) rhythmic handgrip at the same intensity of exercise plus lower body negative pressure (LBNP) to activate sympathetic nerve activity (SNA) for 2 minutes, and c) during intravenous infusion of Angiotensin II at the dose of 1, 2, and 3 ng/kg/min for 15 minutes at each dose.

Each subject will then be randomized to receive 12 weeks of Nebivolol (Bystolic, 5-20 mg/day) or Metoprolol Succinate (Toprol XL, 100-300 mg/day), using a randomized crossover design. There will be a 2-week washout period between the two treatment periods. During drug treatment, blood pressure will be monitored every 4 weeks and the doses of Nebivolol and Metoprolol will be titrated to keep BP \<140/90 mmHg. SNA, total forearm blood flow, skeletal muscle blood flow, muscle oxygenation, cardiac output, and blood pressure responses to Nebivolol will be compared to responses during Metoprolol in the same subjects.

Eligibility Criteria:
Inclusion Criteria:

* Stage I hypertension (140-159/90-99 mmHg)
* Men and women age 18-65

Exclusion Criteria:

* Congestive heart failure or coronary artery disease
* Blood pressure averaging \>159/99 mmHg or resting heart rate \< 55 bpm
* Serum creatinine \> 1.4 mg/dL
* Asthma or chronic obstructive pulmonary diseases
* Left ventricular hypertrophy by echocardiography or ECG
* Pregnancy
* Hypersensitivity to beta blockers, microbubble contrast agents, or angiotensin
* Any history of substance abuse (other than tobacco)
* Concomitant drug treatment which raises endogenous nitric oxide levels such as nitrates or phosphodiesterase V inhibitors (Viagra, Levitra, or Cialis)
* History of symptomatic bradycardia or heart block
Prevalence of Traumatic Events and PTSD in Immigrant and Non-immigrant Patients With Psychotic Disorder

Higher rates of psychosis are described in migrant population. Likewise, this populations could suffer several adversities during migration process that could lead to higher exposure to traumatic events and higher rates of posttraumatic stress disorder (PTSD). There is a growing evidence that trauma is associated with psychosis onset.

The aim of this research is to study the association between psychosis and traumatic events exposure/PTSD in immigrant population. Our hypothesis is that the higher incidence of psychosis described in immigrant population is associated to higher trauma exposure.

A case-control observational study is performed. Patients who presented at least one psychotic episode are recruited from acute and chronic units at "Parc Salut Mar" (Barcelona). Estimated total sample is 196 individuals. Trauma exposure is assessed by validated trauma scales. Known factors associated with psychosis are controled during the statistic analysis.


Eligibility Criteria:
Inclusion Criteria:

* To present history of one or more psychotic episodes defined according to DSM-5 criteria, including patients with diagnoses of Schizophrenia, Schizoaffective Disorder and non-specific psychotic disorders.
* Patients of non-local origins who have undergone a migration process along the life line (as case individuals) and autochthonous patients (as control individuals).
* Age between 18 and 65 years.

Exclusion Criteria:

* Patients who have not clinical stability.
* Important cognitive limitations to understand informed consent nor applied questionnaires.
* Language barrier that limits understanding informed consent nor applied questionnaires.
Establishment and Standardization of a Platform for In-depth Tumour Profiling (TUPRO) in Patients With Advanced and Metastatic High-Grade Adenocarcinoma of Ovarian, Tubal or Peritoneal Origin (TUPRO-Gyn)

The aim of this prospective, multi-centre, exploratory research project is the establishment of a platform for in-depth tumour profiling in patients with advanced and metastatic High-Grade Adenocarcinoma (HGAC) of ovarian, tubal or peritoneal origin.

TUPRO-Gyn is part of the Tumour Profiler (TUPRO) research collaboration, which aims to help generate information about patients' individual tumour biology for patients with advanced malignancies, using innovative biotechnologies and computational analyses for in-depth molecular profiling. The TUPRO-Gyn study focuses on improving treatment for patients with advanced ovarian, tubal, or peritoneal cancer, who often face poor outcomes and limited options after initial therapy. The study aims to use advanced molecular profiling technologies to identify specific characteristics of tumors that can be targeted with personalized treatments. By building a comprehensive platform for in-depth tumor analysis, the project hopes to discover new biomarkers and support future clinical trials that match treatments to the molecular profile of individual tumors, potentially leading to better patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Eastern Cooperative Oncology Group performance status score ≤ 2 (not bedridden for more than 50% of waking hours)
* Primary or recurrent HGAC of ovarian, tubal or peritoneal origin International Federation of Gynecology and Obstetrics (FIGO) stage III or IV
* Written informed consent according to national legal and regulatory requirements prior to any project specific procedures

Exclusion Criteria:

* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the project leader may interfere with the project or affect patient compliance
* Legal incompetence