cyrilzakka/clinical-trials huggingface dataset:
Combination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer

The prognosis of pancreatic cancer is extremely poor. NCCN guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen. Studies have shown that immunotherapy with Anti-PD-1 antibody can effectively increase the response rate and prolong patient survival in a number of cancer diseases. Here investigators intend to compare the therapeutic effects of modified-FOLFIRINOX alone and the combination of modified-FOLFIRINOX and Anti-PD-1 antibody in patients with metastatic pancreatic cancer.

Metastatic pancreatic cancer patients will be enrolled in this trial. Investigators will assign patients to the treatment after randomization. The primary endpoint is overall survival. Response rate, progression-free survival, drugs related side effects and other endpoints events will be recorded and analyzed, to assess the combination treatment with modified-FOLFIRINOX and Anti-PD-1 antibody could or couldn't benefit the patients with metastatic pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* •Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).

  * Recurrent disease or metastatic disease (such as liver, peritoneum, lung) evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary.
  * Never receive any systematic treatment or Progression after fisrt line Gemcitabine base chemotherapy
  * ECOG score 0 or 1.
  * Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x ULN.
  * ALT and AST are less than 2 x ULN.
  * Signed informed consent.

Exclusion Criteria:

* •History of participation of other clinical trails within 4 weeks

  * History of autoimmune disease or other condition receiving glucocorticoid treatment
  * History of receiving chemotherapy within 2 weeks
  * History of radiotherapy and molecular target therapy within 2 weeks
  * History if active tuberculosis
  * History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma
  * Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.
  * Hematological precancerous diseases, such as myelodysplastic syndromes.
  * Evidence of clinical-related or previous interstitial lung disease, such as noninfectious pneumonia or pulmonary fibrosis, or baseline chest CT scan or chest X-ray findings
  * Previous or physical findings of central nervous system disease, except for adequately treated (e.g. primary brain tumors, uncontrolled seizures or strokes with standard medications)
  * Preexisting neuropathy \> 1 (NCI CTCAE).
  * Immune deficiency syndrome, such as active tuberculosis and HIV infection.
  * Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.
  * Severe serious wounds, ulcers or fractures.
  * Clinical evaluation is unacceptable
A Study to Learn About the Patients With COVID-19 Prescribed Paxlovid in Morocco

The purpose of this study is to collect information on the:

* general information of a group of people such as their age, sex, and other facts.
* clinical information of the patients such as any other illness before having COVID 19.

In adult patients with COVID-19 who have been prescribed nirmatrelvir and ritonavir treatment.

This study will be conducted in Morocco. The study will capture information of the adult COVID-19 outpatients and inpatients who have been prescribed nirmatrelvir, ritonavir treatment. The inpatients will be admitted in the hospital for other reasons than COVID-19.

This study will have about 150 patients. The study will involve collection of patient information from medical records. The information collected can be either from papers or from computers.

The study will include patient information of those who:

* are confirmed to have COVID-19 infection during the study period from 01 June 2022 to 30 June 2023.
* are 18 years of age or older.
* are prescribed Nirmatrelvir and ritonavir. This study will help to inform decision-making on use of Paxlovid at the national level.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19 infection during the study period from 01 June 2022 to 30 June 2023
* Nirmatrelvir, ritonavir written prescription

Exclusion Criteria:

* There are no exclusion criteria for this study.
Pilot Trial in Sleep Laboratory Setting to Compare the Physiology of Night Time Bladder Function in Subjects With Overactive Bladder (OAB) Versus Subjects That Have Insomnia and Healthy Normal Subjects

This is an observational, physiology pilot study of subjects with overactive bladder, insomnia and normal subjects. No study drug will be given. All subjects will complete a one week sleep diary and a 3-day bladder diary. After one week, subjects meeting eligibility requirements will complete a single sleep night stay in a sleep laboratory setting. During the sleep night stay, subjects will be evaluated using cystometry and polysomnography. In the morning following the sleep night stay, subjects will complete a sleep questionnaire and this will complete their participation in the study.


Eligibility Criteria:
Inclusion Criteria:

* Must not have a urinary tract infection
* Time in bed between 6.5 and 9 hours for at least 5 nights per week for preceding month
* Usual bed time is before midnight (24:00 hours) and typically does not vary by ± 1 hour for preceding month
* OAB subjects

  * OAB symptoms for \>= 3 months
  * Documented detrusor overactivity episodes within 6 months
* Insomnia subjects

  * Diagnosis of chronic primary insomnia
  * History of \> 1 month of waking up more than 2 times per night and being awake for more than 60 minutes per night for at least 3 months

Exclusion Criteria:

* Diagnosis of both OAB and primary insomnia
* Diagnosis of nocturnal polyuria
* Diagnosis of BPH
* BMI \>= 34
Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease

The main purpose of this study is to see whether PT20 can help people with a high level of phosphate in their blood (called Hyperphosphatemia) that are being treated with dialysis for kidney disease.

PT20 represents a mechanism to address many of the limitations associated with current phosphate binding agents. The available clinical and non clinical evidence suggests that PT20 binds phosphate and prevents its uptake more efficiently than other phosphate binding drugs and may therefore either reduce the pill burden associated with controlling phosphate levels, or result in lower phosphate levels with the same pill burden.

The this study is the first to investigate the efficacy and safety of PT20 in subjects with dialysis-dependent chronic kidney disease (CKD).

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 90 years
* Subject must have a stable dialysis prescription for at least 28 days prior to start of Screening.
* Subject must have the most recent serum phosphate measurement, taken during the 28 days prior to the start of Screening, of ≥ 4.0 mg/dL and ≤ 8 mg/dL.

Exclusion Criteria:

* Subject's most recent historical pre-dialysis serum bicarbonate value within 14 days prior to the start of Screening (Visit 1) is \< 18 mg/dL.
* Subject has, in the opinion of the investigator, severe chronic lung disease and/or carbon dioxide retention.
Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE

The purpose of the study is to evaluate the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years.
* Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI).
* Somatostatin receptor-positive (SSTR+) disease.

Exclusion Criteria:

* Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin).
* Prior (Peptide Receptor Radionuclide Therapy) PRRT.
* Any major surgery within 4 weeks prior to randomization in the trial.
* Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization.
* Other known malignancies.
* Serious non-malignant disease.
* Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments.
* Pregnant or breastfeeding women.
* Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.
MEtatastic Renal Carcinoma LINes

The hypothesis of this study are as follows:

* Prognostic evaluation of patients based on an integrative model provides better assessment of overall survival, and thus improves setting of care goals.
* In a routine care population, antitumour drugs may have a significant impact on overall survival through their targeted antitumor effect, but also through their toxicity profile and their impact on comorbidities.
* The optimization of patient support (supportive care, drug tolerance monitoring) can have an impact on the prognosis.


Eligibility Criteria:
Inclusion criteria:

1. Patients with locally advanced or metastatic renal cell carcinoma
2. Whose first-line treatment included at least one anti-angiogenic agent (tyrosine kinase inhibitor or monoclonal antibodies) and / or an mTOR inhibitor;
3. Whatever was the overall ECOG-PS score (Eastern Cooperative Oncology Group Performance Status) at treatment initiation time
4. With first-line treatment carried out between 2007 and June 2016.

Exclusion criteria:

1. Patient previously treated with only one cytokine (Interferon α2a, high-dose interleukin-2)
2. Refusal of processing of personal data
The DDI Study of SP2086 and Valsartan

The purpose of the study is to investigate the potential PK interaction between SP2086 and Valsartan after multiple oral doses treatment in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2.

Exclusion Criteria:

* History of diabetes
* History of heart failure or renal insufficiency
* Urinary tract infections, or vulvovaginal mycotic infections
* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy to SP2086 or Valsartan or any of the excipients of the formulation of SP2086 or Valsartan
Comparison of Sensitivity Between Presepsine and Lactate for the Diagnosis of Severe Sepsis.

Severe sepsis and sepsis shock are common in emergency department, with a high mortality rate. The potential severity of this disease impose a diagnosis as early as possible to start antibiotic therapy and hemodynamic support. Conventional biomarkers are an important support for the emergency physician. However, comparison of sensitivity and specificity for new biomarkers, like presepsine, suggests that they can be more efficient in this area.

In this single-center, prospective, non-interventional study, we propose to compare the sensitivity of presepsine to that of lactate for the diagnosis of severe sepsis and septic shock We emit to main hypothesis that the sensitivity of presepsine is higher than that of lactate for the diagnosis of severe sepsis.

Severe sepsis and sepsis shock are common in emergency department, with a high mortality rate. The potential severity of this disease impose a diagnosis as early as possible to start antibiotic therapy and hemodynamic support. The conventional biomarkers are an important support for the emergency physician. However, comparison of sensitivity and specificity for new biomarkers, like presepsine, suggest that they can be more efficient in this indication. Presepsine is a soluble fragment of CD14, its concentration is a reflection of cellular activity (macrophages and monocytes) in response of a sepsis's aggression. Today, it's possible to asses the presepsine value at bedside, with new device (PATHFAST), in just 17 minutes, reinforcing the interest for this biomarker.

We will conduct a single-center, prospective, non-interventional study, between december 2014 and July 2015 in the university emergency department of Nice. The primary outcome is to compare the sensitivity of presepsine to lactate for the diagnosis of severe sepsis and septic shock. The dosage of presepsine will be made in 194 patients over 18 years old , with at least two S.I.R.S criteria, a suspected infection, and the presence of one organ failure.

The secondary outcomes are to asses the link between the presepsine value and the germ responsible of sepsis, the correlation between presepsine value at the admission and the mortality at J-28. And we will try to determine if there is a correlation between the initial presepsine value, and the P.I.R.O score.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* Presence of at least two SIRS criteria (T °\> 38.3 ° or \<36 °, tachycardia\> 90 / min, tachypnea\> 20 / min, recent alteration of consciousness)
* Suspected Infection
* Indication of an arterial lactate assay on medical advice
* Affiliation to social security
* Informed Consent

Exclusion Criteria:

* Renal dialysis
* Scalable neoplasia chemotherapy
* Patient Palliative Care
* Private Patient freedom or under legal protection
A Pilot Study to Investigate the Effect of Motor Imagery on Dynamic Balance of Asymptomatic Students

This study intended to investigate the effect of imagining a movement task on dynamic balance of sedentary university students. Two groups with good mental imaging ability were studied; one group receiving instructions on mental imagery and the other served as a control receiving no particular intervention. Any improvement in the balance ability was measured using the star excursion balance test (SEBT); for it has good to excellent test-retest reliability and validity as established by several researchers.

Motor imagery (MI) refers to a cognitive process during which the representation of a specific motor action is internally simulated without producing an overt body movement. Motor imagery is now widely used as a technique to enhance motor learning and to enhance recovery during rehabilitation of various conditions such as sports injuries, stroke, etc. Several studies have also shown improvement in strength, function, and use of both upper and lower extremities in chronic stroke. Present study aimed to identify its effectiveness in improving dynamic balance of individuals without any clinical problem. Such improvement, if any, may be useful in early balance and proprioceptive training during the maximum protection phase of joint injuries, fractures, or even rehabilitation of other clinical conditions affecting balance. It may have benefits in maintaining / improving movements in athletes after injuries as well as the general less active population, including the elderly population.

Eligibility Criteria:
Inclusion Criteria:

* No prior involvement in any physical or mental balance training
* Good mental imaging ability as determined using the motor imagery questionnaire

Exclusion Criteria:

* neuromusculoskeletal condition that may alter balance
* vestibular disorders or VBA related disorders
* painful conditions of the body
* H/o seizure, schizophrenia, meningitis, migraine, diplopia, spinal injuries, lower extremity injuries
Blood Flow Restriction and High-intense Resistance Training in Aging: Interactions Between Neuroplasticity and Muscle

BRAIN-M is a randomized controlled trial designed to examine the effects of a single bout or 12 weeks of blood-flow restriction training or high-intensity resistance training on cognitive function, brain health, muscular properties and physical performance in healthy older men 60-75 years old.

The BRAIN-M project is driven by the idea that understanding the mechanisms through which muscle and brain interact could offer new approaches to magnifying the beneficial and detrimental effects of exercise training on health at older age. Specifically, the investigators aim at identifying brain, blood, and muscle biomarkers that could serve as predictors of response to exercise training at either cognitive, brain, muscle or physical performance levels and study the associations between biomarkers in order to suggest a physiological model of brain-muscle and muscle-brain crosstalk in ageing. 60 male older adults (60-75y old) will be included in either 12 weeks of high-intense blood-flow restriction training (n = 20), muscle damaging resistance training (n = 20) or no exercise (n = 20). The control group will be asked to maintain their usual lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* healthy male older adults
* able to speak and read fluent Lithuanian
* living in community during the study

Exclusion Criteria:

* cognitive and neurological disorders (e.g. dementia, stroke, Parkinson, multiple sclerosis)
* previous lower extremity injury
* diabetes mellitus type I or II
* no oncologic disease
* no bone fractures in the previous year
* deep vein thrombosis
* cardiovascular disorders (e.g. congestive heart failure, angina pectoris, uncontrolled arrhythmia, history of myocardial infarction or coronary bypass grafting in the past year)
* obesity (BMI \>30kg/m²)
* chronic fatigue, chronic headache, or chronic dizziness
* ineligibility to MRI scanning (e.g. due to claustrofobia or metal implants)
* The participants should not be engaged in any regular exercise programme during the previous 6 months (according to IPAQ), but able to perform 10 sit-ups
* Any other consideration that interferes with the study aims and/or risk to the participant, at the discretion of the researcher
PATHOS Study Pain Assessment in Thoracic Oncologic Surgery

A randomized prospective trial to assess whether the use of loco regional anesthesia as adjuvant analgesic therapy is more effective of intravenous analgesia only.

A prospective randomized trial comparing intravenous analgesia alone and in association with loco regional anesthesia consisting in a homolateral Serratus Plan Block (SPB). Loco regional blockade of the serratus is further examined by allocating the patients to two different approaches: the block being performed under US guidance by the Anesthesiologist before the beginning of the procedure, or under direct visualization, by the operating surgeon, before entering the pleural cavity.

Eligibility Criteria:
Inclusion Criteria:

* Lobectomy/ Segmentectomy plus lymphadenectomy (systematic or sampling) for cancer (not necessarily NSCLC) performed with a standardized, three portal minimally invasive approach.

Exclusion Criteria:

* Patients who are pregnant or lactating
* Morbid obesity (BMI \> 35 )
* Inability to understand and sign the Informed consent
* Proven allergy to local anesthetic drugs as required by this protocol
* Patients under chronic analgesics or neuroleptic therapy for any reason and/ or with baseline pain score (NRS scale) of 3 or more.
Saving Brain in Uganda and Burkina Faso

The study will estimate the effect of peer-counseling for exclusive breast feeding (EBF) in the first 6 months of life on cognition and other determinants of human capital formation including behavioral and emotional status; school readiness and attainment; health status; fine and gross motor skills; physical growth; and household economic status.

Between 2006 and 2008 we carried out a cluster randomized study (PROMISE-EBF) to establish the effect of individual home based peer counselling on exclusive breast feeding (EBF). The results, published in the Lancet in 2011 were remarkable(Tylleskar T, et al). The PROMISE-EBF trial which compared mothers in the intervention arm that were offered at least 5 peer-visits promoting EBF to mothers in the control arm, that received the standard of care showed a doubling in the prevalence of EBF in the intervention arm. Community-based peer counsellors increased the EBF rate in Uganda and Burkina Faso from about 40% to 80%.

The current study will trace and re-enrol at least 70% of the children involved in the PROMISE-EBF study. These children are now aged between 5 and 7 years.

The primary objective of the current study is to evaluate the effect of peer-counselling for EBF in the first six months of life on human capital formation among children in Uganda and Burkina Faso.

This study will contribute to a crucial wider discussion on external validity regarding the relationship between EBF and intellectual performance and mental health. In the social area, this study will identify solutions to potential barriers that limit scale up for peer-counselling for EBF. From the business perspective, the study will identify the best business model for affordable, acceptable and cost effective ways of delivering peer counselling for EBF in Burkina Faso and Uganda. If this intervention is found effective, and is adopted, it could improve productivity in adulthood and work towards breaking the cycle of poverty.

Eligibility Criteria:
Inclusion Criteria:

* Children whose mothers participated in the original intervention of peer support for exclusive breastfeeding (EBF).
* Informed caregiver consent

Exclusion Criteria:
The Estrogen Replacement and Atherosclerosis Trial ; Primary Outcome Measure is Mean Minimal Coronary Artery Diameter After Avg of 3.2 Yrs.

Background: Heart disease is a major cause of illness and death in women. To understand better the role of estrogen in the treatment and prevention of heart disease, more information is needed about its effects on coronary atherosclerosis and the extent to which concomitant progestin therapy may modify these effects.

Methods: The investigators randomly assigned a total of 309 women with angiographically verified coronary disease to receive 0.625 mg of conjugated estrogen per day, 0.625 mg of conjugated estrogen plus 2.5 mg of medroxyprogesterone acetate per day, or placebo. The women were followed for a mean (±SD) of 3.2±0.6 years. Base-line and follow-up coronary angiograms were were analyzed by quantitative methods. Follow-up coronary angiograms were obtained after an average of 3.2 years of follow up.


Eligibility Criteria:
Inclusion Criteria:

* postmenopausal
* not currently receiving estrogen-replacement treatment
* one or more epicardial coronary stenoses of at least 30 percent of the luminal diameter, as measured by quantitative coronary angiography

Exclusion Criteria:

* known or suspected breast or endometrial carcinoma
* previous or planned coronary-artery bypass surgery,
* a history of deep-vein thrombosis or pulmonary embolism,
* symptomatic gallstones,
* serum aspartate aminotransferase level more than 1.5 times the normal value,
* fasting triglyceride level of more than 400 mg per deciliter
* serum creatinine level of more than 2.0 mg per deciliter
* more than 70 percent stenosis of the left main coronary artery,
* uncontrolled hypertension, or
* uncontrolled diabetes.