cyrilzakka/clinical-trials huggingface dataset:
A Non-interventional Study for the Collection of Biospecimens From Patients With Parkinson's Disease

This study aims to collect, analyze and preserve biospecimens from patients with or without LRRK2-associated Parkinson's Disease for the purpose of discovering and developing new treatments and novel biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥40
* Clinical diagnosis of Parkinson's disease meeting United Kingdom Brain Bank criteria and modified Hoehn and Yahr Stage I, II, or III;
* Willing to undergo genetic testing for neurologic genotyping panel; -If being treated for Parkinson's disease, must have been on a stable dose of anti- Parkinson's disease medications for a minimum of 30 days prior to Day 1;
* If taking statins, fibrates, antipsychotic or anticonvulsant medications at Day 1, must have been on a stable dose for a minimum of 30 days, and are not likely to require a change in dosage for the remainder of the study;

Exclusion Criteria:

* Any major medical illness or unstable medical condition within 6 months of screening that, in the opinion of the Investigator or Sponsor, may interfere with the subject's ability to comply with study procedures or abide by study restrictions.
* Diagnosis of a significant central nervous system disease other than Parkinson's disease(eg, Huntington's disease, frontotemporal dementia, multi-infarct dementia, normal pressure hydrocephalus, multiple system atrophy, progressive supranuclear palsy, drug- induced parkinsonism, Alzheimer's disease)
* History of stroke;
* History of epilepsy or seizure disorder other than febrile seizures as a child, or any seizure or unexpected loss of consciousness (eg, syncope) within 6 months prior to Day 1;
* History of traumatic brain injury with residual neurological deficit; -If taking anti-Parkinson's disease medication(s)and are likely to require a change in anti- Parkinson's disease medication(s) during the study;
* Known active infectious disease or active infections within 30 days prior to Day 1;
* Any vaccination within 21 days prior to Day 1;
* Currently taking, or planning to take, anti-coagulant medications or antiplatelet medications during the study;
* Allergy to Lidocaine (xylocaine) or its derivatives or any other LP contraindications;
* Any other condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the subject's risk by participating in the study; -Any systemic glucocorticoids taken within 14 days prior to Day 1 or non-steroidal anti- inflammatory drugs taken within 4 days prior to Day 1;
* Received blood products within 30 days prior to Day 1;
* Donated blood within 30 days prior to Day 1.
A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer

The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. How long the treatment will stop the growth of the cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of metastatic breast cancer
2. Able to visit the doctor's office at least every 14 days during the actual treatment
3. Able to care for yourself, even if you cannot work or participate in other normal activities
4. Your blood results must be adequate for therapy.
5. If you are a female of childbearing potential and test negative for pregnancy, use a reliable method of birth control during and for three months following the last dose of study drug.

Exclusion Criteria:

1. Have received gemcitabine, paraplatin, or trastuzumab for your cancer.
2. Be pregnant or breastfeeding
3. Have cancer to the brain and has not been treated
4. Have another active cancer besides breast cancer
5. Have received stem cell or bone marrow transplant for hematologic (blood type) cancer
18F-FDG Uptake Measurements in Malignant Solid Tumors on PET/CT and PET/MR

In the current study, the investigators plan to expand the knowledge of Positron Emission Tomography/Magnetic Resonance (PET/MR) reliability by assessing the repeatability of fludeoxyglucose (FDG) standardized uptake values (SUV) measurements, as well as apparent diffusion coefficients (ADC) measurements, in a broad population of patients with malignant solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed malignant solid tumors (local or metastatic, newly diagnosed or recurrent disease).
* Patient must have at least one lesion measuring ≥ 2.0 cm.
* 18 years of age or older.
* Ability to provide informed consent.

Exclusion Criteria:

* Cancer therapy within 30 days of baseline imaging.
* Uncontrolled intercurrent illness including, but not limited to active infections.
* Patients with insulin-dependent diabetes.
* Patients with metal devices in the body including, but not limited to metallic joint prostheses, artificial heart valves, pacemakers, and cochlear implants.
* Patients who are pregnant or nursing.
* Inability to tolerate 60 minutes of PET imaging.
* Inability to comply with study procedures.
AIR2 Extension Study to Demonstrate Longer-term (> 1 Year) Durability of Effectiveness

The objective of this study is to evaluate durability of effectiveness (beyond one year) of the Alair System in patients with severe persistent asthma. The study will consist of Alair-group subjects who are currently in the follow-up phase (out to 5 years) of the AIR2 Trial (Protocol #04-02, clinicaltrials.gov number NCT00231114).

Durability of the treatment effect will be evaluated by comparing the proportion of subjects who experience severe exacerbations during the first year after Alair treatment with the proportion of subjects who experience severe exacerbations during subsequent 12 month periods out to 5 years.

All Alair group subjects in the AIR2 Trial are being followed out to 5 years as per the AIR2 Trial protocol. The data that are to be used to determine durability of effectiveness as described in the present protocol (Protocol #10-01) are being collected under the existing AIR2 Trial protocol (Protocol # 04-02).

Study Hypothesis: An empirical demonstration of the durability of the treatment effect will be used to show that the proportion of subjects experiencing severe exacerbations for the first year compared with the proportions of subjects experiencing severe exacerbations in subsequent years do not get substantially worse.

The primary statistical objective is to demonstrate that the proportion of subjects who experience severe exacerbations in the subsequent 12-month follow-up (for Year 2, Year 3, Year 4 and Year 5 \[in 12-month periods\]) is not statistically worse when compared with the proportion of first 12-months, which begins 6-weeks after the last Alair treatment. This objective will be met if the upper 95% confidence limit of the difference in proportions (i.e., the subsequent 12-month proportion minus the first 12-month proportion) is less than 20%.

This will be an open-label, single arm study designed to demonstrate the durability of effectiveness (beyond one year) of the Alair System in patients with severe persistent asthma.

Durability of treatment effect will be evaluated by comparison of the proportion of subjects experiencing severe exacerbations during the first year after the Alair treatment to subsequent 12-month periods out to 5 years.

The 12-month periods will begin 6 weeks post-last Alair bronchoscopy.

Eligibility Criteria:
Inclusion Criteria:

* All Alair group subjects who have participated in the AIR2 Trial (NCT00231114) and were not lost to follow-up at the end of the 12 month premarket visit, and those who are willing to comply with the study protocol and routine visits for the duration of the study will be included in the post-approval study

Exclusion Criteria:

* None.
Early Versus Differed Arterial Catheterization in Critically Ill Patients With Acute Circulatory Failure:

The objective of the present research is a combination of a one-sided test of non-inferiority and a one-sided test of superiority. A stepped approach will be used to evaluate these hypotheses:

1. a less invasive intervention (i.e., no indwelling arterial catheter insertion until felt absolutely needed, according to consensual and predefined safety criteria) is non inferior to usual care (i.e., systematic indwelling arterial catheter insertion in the early hours of shock) in terms of mortality at day 28 (non-inferiority margin of 5%).
2. a less invasive intervention is not only non-inferior but also superior to usual care in terms of mortality.

Multi-centre, pragmatic, randomised, controlled, open, two-parallel group, non-inferiority clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years the day of inclusion
* Existence of an acute circulatory failure defined by the presence of the following items 1 and 2:

  1. Persisting hypotension (systolic blood pressure less than 90 mmHg or mean arterial blood pressure less than 65 mmHg) for more than 15 min at intensive care unit admission or within the following 24 hours, OR requirement of continuous intravenous vasopressor treatment (i.e. any dose of norepinephrine / epinephrine)
  2. Presence at least one of the following signs of hypoperfusion: alteration of mental status; skin mottling; oliguria defined as a urine output \< 0.5 mL/kg body weight for at least one hour; arterial lactate \> 2 mmol/L; peripheral venous lactate \> 3.2 mmol/L; ScvO2 \<70%
* Free express oral and informed consent of the patient or a proxy in case of impossibility for the patient to consent; emergency inclusion possible when legal representatives and patient's family are not available
* French health insurance holder

Exclusion Criteria:

* Acute circulatory failure, as defined by items 1 and 2 in inclusion criteria list (cf. supra) present for more than 24 hours
* Non invasive blood pressure (NIBP) device fails to display a blood pressure value, or cuff placement impossible
* Patient for whom an Extra-Corporeal Membrane Oxygenation (ECMO) therapy (either veno-arterial or venous-venous) is already in place or is to be initiated within the next 6 hours
* Patient treated with vasopressor doses of more than 2.5 μg/kg/min of norepinephrine tartrate plus epinephrine for at least 2 hours (i.e., for instance, more than 8 mg of norepinephrine tartrate in 50 mL at the rate of 66 mL/hour for a patient weighing 70 kg) (please note that in fact this dosage corresponds to 1.25 μg/kg/min of norepinephrine base)
* Severe traumatic brain injury (i.e., traumatic brain injury with a Glasgow coma scale score of less than 9 before sedation)
* Patient previously included in the trial
* Body mass index (BMI) above 40 kg/m2
* Pregnancy
* Brain death
* Moribund patient
* Patient known, at time of inclusion, as being under guardianship, authorship or curators
Esketamine and Butorphanol for Post-Lobectomy Pain

Post-thoracotomy pain syndrome (PTPS) affects respiratory function, hindering sputum clearance and ventilation, and represents a significant complication of thoracic surgery. The analgesic effect of esketamine combined with butorphanol in PTPS is still unclear, so this study focused on this aspect.

Post-thoracotomy pain syndrome affects respiratory function, hindering sputum clearance and ventilation, and represents a significant complication of thoracic surgery. Esketamine, the left-handed optical isomer of racemic ketamine, acts as an antagonist of the N-methyl-D-aspartate (NMDA) receptor, reversing central sensitization and improving postoperative pain. Butorphanol, an opioid receptor agonist-antagonist, can alleviate visceral pain, reduce the risk of respiratory depression, and decrease postoperative morphine consumption. However, research on the analgesic effects of esketamine combined with butorphanol in thoracoscopic surgery remains limited. Therefore, this study investigated the impact of esketamine combined with butorphanol on acute pain, chronic pain, and related side effects during the perioperative period in patients undergoing video-assisted lobectomy.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20-70 years
* Classified as American Society of Anesthesiologists I-III
* Undergoing video-assisted lobectomy

Exclusion Criteria:

* Operative duration \< 1 hour
* Significant comorbidities affecting vital organs such as liver, kidney, and heart
* Severe infections
* Immunodeficiency
* Coagulation disorders
* History of analgesic drug abuse
* Severe dementia or communication barriers
* Mental illnesses.
Intraosseous Infusion for Neonatal Asphyxiated Resuscitation

Intraosseous infusion is better than umbilical vein infusion for neonatal asphyxiated resuscitation


Eligibility Criteria:
Inclusion Criteria:

* newborns who need resucitation

Exclusion Criteria:

-
Chest dRain rEmoval intrAoperatively afTer thoracOscopic Wedge Resection

Chest drain is used routinely after lung surgery. Despite preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal, these are either retrospective or mainly concerning benign disease.

Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, reduced opioid usage without increasing postoperative complications than participants treated with standard post-operative chest tube, and could possibly be discharged earlier.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Patients referred for elective three port video-assisted thoracoscopic surgery wedge resection of the lung for suspected or confirmed malignant nodules.
* first second forced expiratory volume ≥60% of expected.
* No increased bleeding risk (e.g. preoperative international normalized ratio \>2, overdue discontinuation of anticoagulants according to guidelines by the Danish Society for Thrombosis and Haemostasis, known coagulopathy).
* Not scheduled for frozen section pathology of wedge resection and subsequent lobectomy.
* Able and willing to give informed consent.

Exclusion Criteria:

* Increased risk of post-operative air leak assessed perioperatively by the surgeon (e.g. severe adhesions, bullous/emphysematous lung tissue, defects of the visceral pleura due to iatrogenic or other reasons, suturing in the lung tissue, deep lung resection).
* Increased risk of post-operative bleeding assessed perioperatively by the surgeon (e.g. intraoperative bleeding or oozing).
* Air leak during intraoperative air leak test.
The PRE-D Trial: Effect of Dapagliflozin, Metformin and Physical Activity in Pre-diabetes

The overall objective is to compare the short-term (3 months) effectiveness of three glucose-lowering interventions (dapagliflozin, metformin and physical activity) on glucose variability, body composition, and cardiometabolic risk factors in overweight or obese individuals with pre-diabetes (HbA1c 5.7-6.4% / 39-47 mmol/mol).

Different medical therapies and lifestyle modification for the prevention of type 2 diabetes have yet to be compared head-to-head in individuals with pre-diabetes. This research project will compare different glucose-lowering interventions in overweight and obese individuals with HbA1c levels in the pre-diabetic range.

Eligibility Criteria:
Inclusion Criteria:

* HbA1c: from ≥5.7% (39 mmol/mol) to ≤6.4% (47 mmol/mol)
* Age: from ≥30 to ≤70 years of age
* BMI ≥25 kg/m2

Exclusion Criteria:

* Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, gastrointestinal or psychiatric disease; diabetes or other endocrine disease; immunosuppression;
* Current treatment with hormones which affect glucose metabolism;
* Current treatment with loop diuretics or thiazolidinediones;
* Current treatment with beta blockers or peroral steroids;
* Bariatric surgery within the past 2 years;
* Impaired renal function defined as an estimated GFR\<60 ml/min/1.73m2;
* Neurogenic bladder disorders;
* Alcohol/drug abuse or in treatment with disulfiram (Antabus) at time of inclusion;
* Pregnant or lactating women;
* Fertile women not using birth control agents including oral contraceptives, gestagen injection, subdermal implants, hormonal vaginal ring, transdermal application, or intra-uterine devices;
* Allergic to one or more of the medications used in the study;
* Concomitant participation in other intervention study;
* Unable to understand the informed consent and the study procedures.
Metabolizing Enzyme Genotype Versus Exemestane Metabolism Profiles

It is the investigators hypothesis that exemestane (EXE) metabolism is an important source of the inter-individual variation in EXE metabolic profiles and that polymorphisms in EXE-metabolizing enzymes may potentially play a role in affecting EXE therapeutic efficacy and toxicity. The goals of this clinical study are to (1) establish EXE metabolism profile kinetics, and (2) determine whether correlations exist in vivo between metabolizing enzyme genotype and urinary EXE metabolite profiles in women being treated with EXE. Together, these studies will allow us to fully characterize functionally-relevant polymorphisms in the EXE-metabolizing enzyme pathway that are potentially important in EXE clinical efficacy.

Aromatase inhibitors (AIs) are widely used as adjuvant treatment for estrogen-receptor positive breast cancer in post-menopausal women. AIs have been demonstrated to have equal to or greater efficacy and less toxicity than tamoxifen (TAM), the drug of choice for many years. Exemestane (EXE) is a 3rd-generation AI that has demonstrated efficacy in the treatment of breast cancer patients, and as with TAM and other AIs, there has been considerable inter-individual variability in overall response to EXE and in the occurrence of toxicities, but the causes of this variability have not been elucidated. Differences in drug metabolism can be a source of variability between patients. Genetic variations occur in several of the enzymes involved in phase I and II metabolic reactions and many of these can lead to alterations in enzyme activity which in turn can alter therapeutic response to drugs. EXE is extensively metabolized as unchanged EXE and is found at less than 1% in urine and 10% in plasma. EXE pharmacokinetics will be established in a series of 20 subjects taking EXE. EXE metabolites will then be measured at an optimal time post-EXE dose in the urine of 200 breast cancer patients being treated with EXE to establish whether metabolizing enzyme genotype-EXE metabolism phenotype correlations exist in vivo.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients who have ER+ tumors and are taking 25 mg EXE daily (orally)
* Post-menopausal women or chemically post-menopausal women (who won't become pregnant since they are taking zoladex), or women who are post-menopausal as a result of ovary removal
* Patients may be at any point in their hormonal treatment, but must have completed any planned surgery, radiation and chemotherapy.

Exclusion Criteria:

* Concurrent use of corticosteroids, megestrol, or phenobarbitol (inhaled and internasal steroids are permitted)
* History of allergy to exemestane
A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer

The purpose of this study is to assess the safety, tolerability, and efficacy of CBX-12 in female subjects with platinum resistant or refractory ovarian cancer at 2 doses; 125 mg/m2 every 21 days or 100 mg/m2 every 21 days.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have histologically- or cytologically-diagnosed epithelial high-grade serous cancer of the ovary, fallopian tube cancer or primary peritoneum cancer that is refractory to prior therapy and must have platinum-resistant disease defined as:

  * Subjects who have received only 1 platinum-based chemotherapy regimen for at least 4 cycles of platinum must have disease progression on treatment or occurring ≤ 26 weeks after their last dose of platinum.
  * Patients who have progressed following a second course of a platinum based regimen.
  * Subjects may have up to 2 additional systemic regimens for advanced or metastatic disease. Maintenance regimens (e.g., with a PARP inhibitor or bevacizumab) are not considered separate regimens.
* Age greater than or equal to 18 years at the time of signing the informed consent form (ICF).
* Has measurable disease per RECIST 1.1.
* Has provided written informed consent.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Adequate liver, renal, hematologic, pulmonary and coagulation function.

Exclusion Criteria:

* Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy within 3 weeks prior to the first dose of CBX-12.
* Subjects who are currently receiving any other anticancer or investigational agent(s).
* Clinically significant intercurrent disease.
* Active human immunodeficiency virus (HIV) infection.
* Active hepatitis B or C infection.
Mental Imagery to Enhance Procedural Skills in Peripheral Venous Catheterization

Peripheral venous catheter insertion has a slow learning curve, and is rarely performed by medical students. Most medical interns do not master this procedure independently at the start of their residency.

It's a painful procedure for the patients, and therefore unsuitable for "in vivo" training at the patient's bedside For this type of procedure, it would appear necessary to develop alternative teaching methods, as well as pedagogical tools that can modify the learning curve to make it faster.

Mental imagery is a technique that involves creating vivid, detailed mental images in the mind. It is often used in a variety of contexts, such as mental preparation, stress management, learning or goal achievement Initially used in mental preparation for sports, it made its appearance as a pedagogical tool in the medical field in the 2010s, with several studies demonstrating its value in learning procedural gestures (training in laparoscopic surgery, cystoscopy).

The aim of our study is to investigate the impact of a mental imagery session on peripheral venous catheter placement success in 5th-year medical students, on a simulation mannequin.


Eligibility Criteria:
Inclusion Criteria:

* 5th-year medical student at the Nîmes medical school taking part in the peripheral venous catheter insertion training workshop
* No other conditions required.

Exclusion Criteria:

* None