cyrilzakka/clinical-trials huggingface dataset:
Mapping the Health Status of the Population of French Polynesia: the MATAEA Project

This is a cross-sectional study carried out on a sample of the adult population aged 18 to 69, distributed over the five archipelagos of French Polynesia.

Participation in the study involves: agreement to answer a questionnaire to collect information on socio-demographic characteristics, lifestyle habits and medical history; physical measurements (height, weight, waist circumference, blood pressure and skin pigmentation); and agreement to take biological samples (blood, saliva and stool) for biological, genetic and microbiological analyses.

The aim of the study is to assess the current health status of the population of French Polynesia and to evaluate the influence of contextual risk factors (lifestyle, place of residence, history of infection) and intrinsic susceptibility factors (genetics, age, gender, microbiota) in relation to non-communicable and infectious diseases.


Eligibility Criteria:
Inclusion Criteria:

* be aged 18 or over and under 70 on the date of recruitment
* having signed the consent form

Exclusion Criteria:

* Minors
* Pregnant or parturient women, and nursing mothers
* Persons deprived of their liberty by a judicial or administrative decision
* Adults who are the subject of a legal protection measure or who are unable to express their consent
* People undergoing psychiatric care
* Individuals who are not affiliated to a social security scheme or beneficiaries of such a scheme
* Homeless people
* Disabled people (unable to move)
* People unable to answer the questionnaire
Lavender Aromasticks for Pain Control

The purpose of this randomized pilot study is to collect preliminary data on the impacts of lavender essential oil aromatherapy on the patient-reported quality of pain management provided for the vascular surgery patient population. The investigators hypothesize that individuals who use a lavender aromastick as a part of their pain management plan will report improved perceptions of the quality of their pain management as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R).

Subjects will be randomized to the control (empty aromastick) and intervention group (aromastick infused with lavender oil), and will use this device as an addition to their pain management plan.

Additionally, this pilot study will allow the researchers to evaluate the feasibility of a larger randomized control trial, assess the validity of the survey tool, and collect feedback from patients on the acceptability of the aromatherapy intervention as a complementary therapy during their hospital stay.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects 18 and over admitted to the vascular surgery service line on the Heart and Vascular Progressive Care Unit (HVPCU)
2. Not cognitively impaired
3. Able to perform teach-back of the education regarding safe use of the aromastick
4. Able to demonstrate use of the Numeric Pain Rating Scale (NPRS), as evidenced by their ability to answer the initial NPRS question on the Adult Admission II Form used to admit all patients to the hospital
5. English is the primary language, as identified by the Adult Admission II Form

Exclusion Criteria:

1. Subjects who are unable to consent themselves
2. Subjects who cannot provide teach-back on the safe use of the aromastick
3. Subjects unable to use the NPRS to rate their pain
4. Research team member and/or bedside nurse assess that subject has a cognitive deficit that would prohibit safe use of the aromastick
5. Subjects on suicide precautions
6. Pregnant subjects
7. Prisoners
8. Individuals under age 18
9. Subjects with a current plan to use personal aromatherapy devices during their inpatient stay
10. Subjects with known lavender allergy
Using Intranasal Midazolam (INM) and Lidocaine for Uncooperative Children

Aims: The objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to INM administration.

Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11.

Background and Aims: The use of intranasal midazolam (INM) has been commonly associated with a burning sensation of the nasal mucosa. However, despite its significance, this subject has received little adequate research focus. The objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to INM administration.

Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11, were randomly assigned to one of three groups to receive the drug nasally via a pre-calibrated spray as per the following assignments:

A: received 0.5 mg/kg midazolam, B: received lidocaine 2% prior to 0.5 mg/kg midazolam.

C: received saline 9% (placebo), 0.5mg/kg. Children were asked to record the degree of pain using Wong-Baker-Faces- (WBFS) Scale.

Eligibility Criteria:
Inclusion Criteria:

* uncooperative children scored 1 or 2 on Frankle Scale.
* had no medical history of neurological or cognitive alterations.
* No facial deformities.
* ASA Classification I.
* requiring dental treatment under local anesthesia.

Exclusion Criteria:

* known allergy to midazolam or any other benzodiazepines.
* upper respiratory tract infection with nasal discharge.
Non-adherence and Polypharmacy in Elderly Patients

The study aims to investigate adherence and polypharmacy in elderly patients with chronic kidney disease (CKD) and End Stage Renal Disease (ESRD). The investigators look into possible factors or predictors that may affect adherence and reduce polypharmacy. Factors could be: quality of life, anxiety and depression, beliefs about medicine and cognitive impairment.

The investigators are planning an intervention with the screening tool Screening Tool of Older Person's potentially inappropriate Prescription/Screening tool to Alert to Right Treatment (STOPP/START ) criteria to evaluate medication lists of the participating patients.

The investigators intend to include all patients \> 65 years old, in dialysis treatment (hemodialysis and peritoneal dialysis), as well as patients with CKD stage 5.

The recruitment will be done as follows:

The patients will be screened according to inclusion criteria. Afterwards each patient will be invited to a first meeting that explains the aim of the study, giving the opportunity for discussion and consideration, and presenting the consent information. After giving the consent the patient will be invited to a second meeting with blood tests, data registration, medication registration, undergoing MMS and handing over the questionnaires forms.

Randomization:

After the initial assessment and compliance with the eligibility criteria, participants will be randomized into an intervention group (medication list will be evaluated by STOPP/START criteria) and a control group (medication list will not be evaluated by STOPP/START criteria). Randomization numbers will be generated by a random number generator. A series of numbered, sealed, opaque envelopes will be used to ensure confidentiality. Each envelope will contain a card with information about the group allocation. The group allocation is concealed from the researcher and patients at baseline registration.

Each patients will get questionnaires for: Quality of life using Kidney Disease Quality of Life - Short form 36 (KDQOL-Short form 36 ) and EuroQoL-3D (EQ-3D), beliefs about medicine, Hospital Anxiety and Depression Scale (HADS), Morisky medication adherence scale and visual adherence scale (VAS), sleeping related questionnaires (Epworth, Berlin, Pittsburgh). A Mini Mental Status (MMS) test will be done regarding cognitive function.

Each patients will get the opportunity to have a polysomnograph for one night.

With STOPP/START criteria the medication list will be evaluated for the patients who are randomized in the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* All patients \> 65 years with CKD, stage 5 (eGFR ≤ 12 ml/min), or undergoing treatment with hemodialysis and peritoneal dialysis

Exclusion Criteria:

* Patients not willing to participate
* Patients diagnosed with dementia or severe cognitive disorder (MMS \< 25),
* Patients with hearing impairment
* Patients with language difficulties
Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia

Numerous elderly patients are suffering from aspiration pneumonia due to anatomical or functional predisposing factors including enteral tube feeding, swallowing difficulties, and gastroesophageal reflux disease (GERD). Previous studies have been demonstrated that continuous positive airway pressure (CPAP) is an acceptable means of managing chronic aspiration, atelectasis, and GERD. The purpose of this study is to determine whether nocturnal nasal CPAP is beneficial in patients with aspiration pneumonia and that it would contribute to the rapid clinical stability of aspiration pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* Diagnosis of pneumonia: the presence of new pulmonary infiltration in dependent areas on chest radiographs at the time of hospitalization with at least one of the following

  1. New or increased cough
  2. Abnormal temperature (\< 35.6℃ or \> 37.8℃)
  3. Abnormal serum leukocyte count (leukocytosis, left shift, or leukopenia)
* Aspiration tendency or risk factors for frequent or large volume aspiration with at least one of the following

  1. Altered mental status
  2. Gastrointestinal disorder
  3. Dysphagia or swallowing difficulties
  4. Esophageal motility disorders
  5. Tracheostomy state
  6. Enteral tube feeding
* Informed consent

Exclusion Criteria:

* Severe hypercapnia (PaCO2 \> 70mmHg)
* Respiratory arrest requiring tracheal intubation
* Cardiac arrest, acute coronary syndrome or life threatening arrhythmias
* Failure of more than two organs
* Recent trauma or burns of the neck and face
* Non- cooperation
* Pregnancy
* Withdrawal of consent
* Refusal of treatment
Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients

In this study the investigators compare the traditional way of triggering with a new way in patients with Poly Cystic Ovary Syndrome (PCOS). This to reduce the risque of Ovary Hyper Stimulation Syndrome (OHSS) in In Vitro Fertilization/ IntraCytoplastic Sperm Injection (IVF/ ICSI) treatment. The investigators also compare the number of mature oocytes, embryo's and pregnancy rate.


Eligibility Criteria:
Inclusion Criteria:

* ICSI patients below 38 years
* 1, 2 and 3e IVF cycle
* Body Mass Index (BMI) less than 32
* PCOS patients

Exclusion Criteria:

* endocrinal diseases or problems
Inositol Hexaphosphate: A Novel Treatment Strategy for Bipolar Disorder?

Inositol hexaphosphate (IP6, also called inositol hexakisphosphate, and phytic acid) is a naturally occurring phosphorylated derivative of myo-inositol. Myo-inositol has shown preliminary evidence of efficacy in controlling mood symptoms, and good tolerability in bipolar disorder in some studies, but failed to establish efficacy in subsequent meta-analyses. In the investigators proposed work, the investigators plan to orally administer the calcium/magnesium salt of IP6 (2,000-3,000 mg daily in two divided doses) to paid research subjects with a diagnosis of bipolar disorder who are in a depressed state, and who have failed an adequate course of treatment with lithium monotherapy. The investigators hypothesis is that IP6 may be similar to myo-inositol in terms of relieving depression, but more potent and effective. Our aim is conduct a preliminary pilot study in 30 subjects (15 treated with IP6, 15 treated with lamotrigine, an active comparator) to assess the efficacy and tolerability of IP6 as an adjunctive treatment to lithium, the mood stabilizer most commonly used to treat bipolar disorder.


Eligibility Criteria:
Inclusion Criteria:

* must have bipolar disorder
* must be currently depressed
* must have failed adequate trial of lithium monotherapy
* must have shown partial response of depression to lithium

Exclusion Criteria:

* diagnoses of schizophrenia, major depression, or other psychotic disorder
* currently pregnant
* unstable medical condition
* active drug or alcohol dependence
* concurrent use of antidepressant or mood stabilizer other than lithium
* active suicidal or homicidal ideation
* past adverse reaction to lamotrigine or current skin rash (lamotrigine arm only)
* history of dietary malabsorption or nutritional deficiency (IP6 arm only)
Suicide Gene Therapy Trial

Bone marrow or blood stem cell transplantation is used to treat a wide range of life-threatening conditions. T lymphocytes carried in the graft have powerful beneficial effects and play a vital role in the eradication of leukaemia and in fighting infection, but can also damage healthy tissues and cause graft-versus-host disease (GVHD).

To safeguard against GVHD, the investigators propose modifying T cells to encode a 'switch' so that they can be eliminated if problems arise.

Children receiving half-matched (haploidentical) transplants from a parent are most likely to benefit from this strategy. At present these patients receive blood stem cells from a parent, but the T cells are removed because the risk of serious GVHD is unacceptable. This means that they are much more likely to suffer from life threatening infections or experience a relapse of leukaemia. The investigators want to use gene therapy to produce "safe" T cells which can be used to strengthen the transplant and prevent these serious complications.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with primary immunodeficiencies, haematological malignancies or metabolic disorders at GOSH (children of both sexes, aged 0 to 16 years) undergoing haploidentical transplant
2. Both patient and donor must give informed consent in writing.
3. The donor must be willing, able and available for donation of T cells by collection of whole blood or leukapheresis.
4. The patient should be free of serious intercurrent illness.

Exclusion Criteria:

1. Donor unfit or unavailable
2. Donor positive for Hepatitis B or C, or HTLV-1, or HIV
3. Patient receiving Ganciclovir, Aciclovir, Cidofovir a result of active CMV, adenovirus, varicella zoster or herpes simplex infection infection
4. GVHD ≥ grade II before infusion of gene modified T cells
5. Serious intercurrent illness
Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer

The aim of this study is to evaluate the advantage of mesenteric approach during pancreaticoduodenectomy (PD) for pancreatic ductal adenocarcinoma (PDAC). The design of this study is multicenter randomized clinical trial, comparing oncological and surgical outcomes between mesenteric approach and conventional approach during PD for PDAC.

Mesenteric approach starts from dissection of lymph nodes around the superior mesenteric artery (SMA) and finally performs Kocher's maneuver during PD. The aims of this approach are 1) decrease of intraoperative blood loss volume, 2) increase of R0 rate, and 3) prevention of squeezing cancer cells out into the vessels. However, there have been no evidence of the efficacy of this procedure. Therefore, the aim of this study is to evaluate the efficacy of mesenteric approach during PD for PDAC, by multicenter randomized clinical trial comparing oncological and surgical outcomes between mesenteric approach and conventional approach during PD for PDAC.

Eligibility Criteria:
Inclusion Criteria:

1. Patient who are scheduled to undergo pancreaticoduodenectomy for resectable or borderline resectable (only portal vein invasion) pancreatic ductal adenocarcinoma.
2. Patients whose Eastern Cooperative Oncology Group performance status are 0 or 1.
3. Patients who are 20 years or older.
4. Patients who have adequate organ function.
5. Patients who understand sufficiently the study to provide written informed consent

Exclusion Criteria:

1. Patients who have severe ischemic cardiovascular disease
2. Patients who have liver cirrhosis or active hepatitis
3. Patients who need oxygen due to interstitial pneumonia or lung fibrosis
4. Patients who receive dialysis due to chronic renal failure
5. Patients who need surrounding organ resection
6. Patients who need artery reconstruction
7. Patients who are diagnosed as positive para-aortic lymph node metastases based on preoperative imaging
8. Patients who have active multiple cancer that is thought to influence the occurrence of adverse events
9. Patients who take steroid for the long period that is thought to influence the occurrence of adverse events
10. Patients who undergo laparoscopic or laparoscopy-assisted pancreaticoduodenectomy
11. Patients who cannot understand ths study due to psychotic disease or psychological symptoms
12. Patients whose preoperative biopsy tissues are diagnosed as other pathological findings than pancreatic ductal adenocarcinoma
13. Patients who underwent gastrectomy or colon/ rectum resection previously
14. Patients who have severe drug allergy to iodine and gadolinium
Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation

This study aims to compare 2 alveolar recruitment maneuvers (ARM) in patients with cerebral injuries and acute respiratory distress syndrome (ARDS) in term of efficacy and tolerance.

Two ARM are compared in this study:

* The eSigh or extended sigh with increase of PEEP for 10 minutes to maintain plateau pressure at 40 cmH2O. During ARM, the peak pressure is limited to 50 cm H2O with decrease of tidal volume (Vt) if necessary.
* The continuous positive airway pressure, or Continuous Positive Airway Pressure (CPAP) with application of a positive pressure of 40 cm H2O for 40 seconds without tidal volume.

Patients are randomized to receive in cross-over 2 ARM: CPAP and Extended Sigh (eSigh). The following data: oxygen tissue partial pressure (PtiO2), respiratory parameters, systemic and intracerebral hemodynamic parameters are collected before, after 1 minute, 10 minutes and 60 minutes for each ARM.

Eligibility Criteria:
Inclusion Criteria:

* Patients with brain injuries (subarachnoid hemorrhage, traumatic brain injury, ischemic and hemorrhagic stroke)
* Patients with moderate and severe ARDS criteria (as defined by classification of Berlin)
* Patients under mechanical ventilation

Exclusion Criteria:

* ICP (Intracranial pressure) \> 25 mmHg
* Pregnant women
* Patients with history of chronic respiratory disease
* Patients with bronchopleural fistula
* Patients with hemodynamic instability despite appropriate measures
Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients

This is a prospective cohort study investigating cardiac function and cardiac biomarkers in patients with acute Aneurysmal Subarachnoid Haemorrhage (aSAH). The aims of the study are to document the incidence of myocardial dysfunction,to find the predictive factors of myocardial dysfunction, describe heart rate variability and to assess the impact of all cardiac problems on morbidity and mortality.

Laboratory markers daily: Routine laboratory test (blood gases, haemoglobin, thrombocytes, leukocytes, INR, bilirubin, creatinine, c-reactive protein, CK, CK-MB, Tnt, BNP, sodium, potassium, magnesium) are taken at 8 a.m. Study laboratory tests (sensitive ischemia markers, remodelling marker MMP-9 and CgA as surrogate marker for increased sympathetic activity) are taken four times during study period at the same time as cardiac ECHOes and Holtering. Gene sample is taken once on day one.

Primary outcome measurement is to document the incidence of myocardial dysfunction and the predictive factors during the hospital stay and at three months.

Secondary outcome is to assess the impact of cardiac problems on morbidity and mortality during first three months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with nontraumatic subarachnoid haemorrhage
* Age \> 18 years
* Aneurysmal bleeding

Exclusion Criteria:

* No consent
* Age \< 18 years
* Anticipated brain death \< 24 hours
* Otherwise moribund patient
NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.


Eligibility Criteria:
Key Inclusion Criteria:

* Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
* Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
* Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
* Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
* Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.

Key Exclusion Criteria:

* A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.
* Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
* Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.
Video Assisted Thoracoscopic Surgery (VATS) - Surgical Pleurodesis vs Tube Drainage in Management of Malignant Pleural Effusion (MPE)

Malignant Pleural Effusion (MPE) is considered to be a common presentation at malignant tumors representing 15% of all cancer cases. It carries a burden on our patients with dyspnea being the most common symptom in most of cases.

Management of symptomatic malignant pleural effusion remains to be a point of debate. Data available from literature shows conflicting results lacking high quality evidence which necsscitates further research work. Options differs to include chemical pleurodesis using medical or surgical talc poudrage or slurry. Surgical intervention with abrasion pleurodesis or pleurectomy using VATS approach has been used in many studies. Using indwelling pleural catheters (IPCs) has also proved comparable efficacy at many clinical trials. In this study we want to help answering this question so that we can add to the current knowledge aiming to offer the best care for those patients


Eligibility Criteria:
Inclusion Criteria:

* 1-patients with symptomatic malignant pleural effusion. 2- symptomatic patients with shortness of breath. 3-Lung can be fully expanded.

Exclusion Criteria:

1. Patients with non symptomatic malignant pleural effusion
2. Pleural symphysis with no potentiality for re-expansion
3. Patients managed surgically through open thoracotomy.
4. Pleural effusion due to causes other than malignancy
5. Loculated malignant effusion judged by chest ultrasound
6. Trapped lung due to malignant pleural effusion assessed by multislice CT chest.,
7. .Refusal to share the research project and not to sign the consent.