cyrilzakka/clinical-trials huggingface dataset:
Analysis of Suicide Dynamics in Link to the COVID-19 Pandemic

Covid is a virus that first appeared in China in 2019 and was quickly described as a pandemic virus by its globalized nature. The unprecedented occurrence of the virus has led to several health and restrictive government measures. The Covid-19 pandemic and health measures have been able to contribute to the deterioration of the mental health of citizens as it has already been observed during the former pandemic context (Sars covid in 2003 in China or the Spanish flu).

Among the consequences of a negative impact on mental health, investigators assume that there is an increase in transitions to the completed suicidal act. However, current studies and observations tend to note that there has been no major change in the dynamics of successful suicides during the Covid period.

However, there are biases in the studies conducted: some suicide deaths may have been hidden and not reported as such, due to several factors. For example, the measure of the evolution of suicide attempts that was most often made by the measure of the evolution of the number of hospitalizations for this reason can be a source ofestimate whether people who did this gesture were not hospitalized after a visit to the emergency room or if they gave up attending because of the pandemic. Moreover, suicide deaths are more difficult to report as such when they occur at home than after hospitalization.

It is therefore interesting to study the dynamics of suicide during this health crisis retrospectively based on data from the Strasbourg Institute of Forensic Medicine containing the census of the Alsace region, which was hit hard by the pandemic.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Died between 01/01/2018 and 12/31/2021
* Absence of opposition from the patient expressed in writing during his lifetime to the reuse of his personal data for scientific research purposes.

Exclusion Criteria:

* Presence of opposition by the patient expressed in writing during his lifetime to the reuse of his personal data for scientific research purposes.
The Effect Of A Neurodynamic Treatment On Nerve Conduction In Clients With Low Back Pain

The purpose of this study is to determine if a certain treatment for low back pain can change the way nerves in the leg send messages. Specifically, the investigators will examine whether a particular type of physical therapy treatment for individuals with low back pain (neurodynamic techniques) changes the speed that nerves send/receive signals to/from the leg, as compared to a different physical therapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 years and older
* Participants who can speak English and read, understand, and fill out the consent form and questionnaires
* Participants will have a certain level of low back pain graded numerically, with or without radiation to the leg
* Clinical decision (by same individual) as safe to participate in study based on subjective history and objective examination.

Exclusion Criteria:

* An inability to tolerate sitting for 10 minutes
* Nerve conduction disorders diagnosed by a physician such as, diabetes or MS
* Current participant in an investigational drug study (within past 3 months)
Remote Ischemic Preconditioning in ACS Patients

Remote ischemic preconditioning is a process of serial blood pressure cuff inflations and deflations that are performed prior to a procedure and have been shown in various other areas (coronary bypass surgery, vascular surgery, ST elevation myocardial infarctions) to decrease the rates of adverse events related to ischemic burden and renal injury. This procedure has not yet been studied in the population presenting with an acute coronary syndrome (ACS), even though ACS patients represent the majority of patients seen in the catheterization lab. The purpose of this study is to evaluate the efficacy of this simple and safe procedure in this particular population.


Eligibility Criteria:
Inclusion Criteria:

- Presenting with an acute coronary syndrome including non-ST elevation myocardial infarction or unstable angina on optimal medical therapy with aspirin, P2Y12 inhibitors, unfractionated heparin, statin, +/- beta blocker, +/- ace inhibitor

Exclusion Criteria:

* Presenting with ST elevation myocardial infarction
* Patients requiring circulatory support
* Need for emergent percutaneous coronary intervention
* Systemic hypotension (systolic blood pressure \<90 mmHg)
* Patients in cardiogenic shock defined by requiring inotropes or vasopressors
* Patients currently on hemodialysis
* Presence of an arteriovenous dialysis fistula or graft or lymphedema in either arm
* Patients enrolled in other active cardiovascular investigational studies
* Severe comorbidities with a life expectancy of less than 6 months
* Pregnant or lactating women
* Patients unable to provide consent
* Patient taking the medication glibenclamide for treatment of diabetes
The Post-Vitrectomy Lenstatin™ Study

To determine the efficacy of Lenstatin™, an over-the-counter nutritional supplement, in inhibiting the progression of nuclear cataract in eyes after pars plana vitrectomy.

BACKGROUND AND RATIONALE

There are conflicting reports on the effectiveness of nutritional antioxidants in preventing or slowing the growth of age related cataracts, despite extensive laboratory evidence suggesting that oxidative damage to lens epithelial cells is a common underlying etiologic factor in cataractogenesis. One reported review of nine clinical trials involving over 117,000 patients suggested that beta-carotene, Vitamin E, and Vitamin C had no effect in preventing or slowing the progression of age-related cataract. Conversely, a randomized trial of over 14,000 US male physicians indicated that long-term daily multivitamin use modestly and significantly decreased the risk of cataract.

Cataract formation following pars plana vitrectomy is a well recognized post-operative complication of the procedure, with the reported incidence of clinically significant cataract development as high as 80% within 2 years after pars plana vitrectomy.

INVESTIGATIONAL AGENT

Lenstatin™ is a proprietary formulated nutritional supplement containing 11 micronutrients and anti-oxidants intended to be taken for the nutritional support of the human crystalline lens.

INTERVENTION

Participants will be randomized to treatment with Lenstatin or Placebo for (6) months following pars plana vitrectomy.

STUDY METHODS

Participants will have baseline nuclear density (cataract) measurements using the Pentacam Nucleus Staging (PNS) program. The Pentacam Scheimpflug imaging system is a non-contact and non-invasive anterior segment imaging device which has been shown to provide an immediate, quantitative, examiner-independent measurement of lens density which correlates with the LOCS III cataract grade. Serial Pentacam nuclear density measurements will be taken on each participant at (1) month intervals for (6) months.

Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 18
* Post pars plana vitrectomy surgery

Exclusion Criteria:

* Pediatric patients under the age of 18
* Pregnant women
* Hypersensitivity to any of the ingredients in Lenstatin
The Effect of a Pre- and Postoperative Orthogeriatric Service

The investigators' aim is to assess the effect of a model of preoperative as well as early postoperative care, treatment and rehabilitation in a dedicated orthogeriatric ward in a single-blind randomised study.

The investigators' main hypothesis is that an orthogeriatric service may improve long-time cognitive outcome.

The study will be carried out in close cooperation between the Orthopaedic Centre and the Department of Geriatric Medicine. The patients will be randomized in the Emergency Department in accordance with procedures already established for a recently finished trial. The intervention group will be transferred as soon as possible to the orthogeriatric ward, stabilised there preoperatively, and transferred back to the same ward postoperatively for further treatment and rehabilitation, while the control group will be treated in a traditional orthopaedic ward. Operative and anaesthesiologic procedures will be the same in the two groups.

The primary endpoint is chosen in order to optimize clinical relevance as well as sensitivity to change within a wide range of functional performance, and will be recorded four months after the fracture. Our main hypothesis is that an orthogeriatric service may improve long-time cognitive outcome. Accordingly, we will use a composite endpoint tapping cognitive functioning in the lower as well as the higher spectre of performance by these two instruments:

* Clinical Dementia Rating Scale (CDR), proxy-based scale for severity of dementia, that is able to detect differences also between patients with severe dementia. The scale consists of six questions, each rated 0-3, adding up to a sumscore of 0-18 ("sum of boxes"). The scale is frequently used in dementia treatment trials, and is shown to be valid and reliable. CDR will be scored based on the best available source (relative, staff in nursing home or home nursing service)
* The 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD). This test is shown to be sensitive for memory changes in persons that have a good or fairly good cognitive functioning. We will use the immediate recall and the delayed recall parts of this task, i.e. two scales.

The primary endpoint will be assessed after four months, by a specially trained research assistant blinded to allocation. The patients will be re-assessed after 12 months.

Eligibility Criteria:
Inclusion Criteria:

• Eligible patients will be admitted acutely for a femoral neck fracture, a trochanteric or a subtrochanteric femoral fracture.

Exclusion Criteria:

* Hip fracture as part of multi-trauma or high energy trauma (defined as a fall from a higher level than 1 metre). One recent fracture in addition to the hip fracture (e.g. radius or shoulder) is acceptable.
* Regarded as moribund at admittance.
* Absence of a valid informed consent or assent.
A Study to Assess the Immunogenicity and Safety of CSL's 2012/2013 Formulation of Enzira® Vaccine in Healthy Volunteers

This is a study to assess the immune (antibody) response and safety of the 2012/2013 formulation of Enzira® (CSL Influenza vaccine) in healthy adult volunteers aged 18 years or older.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 years or older at the time of vaccination.
* Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.

Exclusion Criteria:

* Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine.
* Clinical signs of an active infection.
* A clinically significant medical condition.
* Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
* Females who are pregnant or lactating.
OIT Effect on FAQLQ

Patients with food allergy and their parents will answer a food allergy quality of life questionnaire that will be translated to Hebrew and validated. Questionnaires will be filled also by patients undergoing oral immunotherapy (OIT).

The food allergy quality of life questionnaires (FAQLQ) for children 8-12 y/o, teenagers 13-17 y/o and adults \> 18 y/o and parents to children 0-12 y/o and to teenagers will be translated to Hebrew. Questionnaires will be given to patients with food allergy followed at Asaf Harofeh Medical Center. Questionnaires will be examined for internal consistency. The Food Allergy Independent Measure (FAIM) questionnaire for the same age groups will also be translated to Hebrew. The FAQLQ will be validated by correlation with the FAIM.

The questionnaires will then be administered to patients and families undergoing food oral immunotherpy, before during and following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected food allergy

Exclusion Criteria:

* none
ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study

The ITHACA study is a phase I study evaluating the safety and toxicity of a peritumorally injected PD-1 checkpoint inhibitor, in combination with a multifunctional CTLA-4 inhibitor, in early-stage cervical cancer.

In this single arm, open label phase I study, the investigators will study the safety and toxicity of the combination of a PD-1 checkpoint inhibitor and a multifunctional CTLA-4 inhibitor when injected peritumorally prior to surgery in early-stage cervical cancer. Additional objectives are to describe dose limiting toxicities, to determine the maximum tolerated doses and to study the effects on the tumor and lymph node microenvironment, and on immune subsets in peripheral blood.

Eligibility Criteria:
Inclusion Criteria:

* early-stage cervical cancer
* scheduled for (radical) hysterectomy and pelvic lymph node dissection

Exclusion Criteria:

* previous treatment with checkpoint inhibitors
* use of immunosuppressive medication within 28 days of the injection of the study medication
* history of other malignancy
Investigation of Pharmacokinetic Interaction Between Rosuvastatin and Olmesartan in Healthy Male Volunteers

This study investigates pharmacokinetics and drug-drug interaction between Rosuvastatin and Olmesartan in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease

Exclusion Criteria:

* History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
* Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
* Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
* Use of any substance that could induce or inhibit drug metabolism enzymes
Transfusion of Biotin-Labeled Red Blood Cells

The purpose of this research is to evaluate the impact of genetic and biologic factors in blood donors on red blood cell storage stability after autologous transfusion over the different range of storage period of 5-7 days and 35-42 days in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 years and older
* Weight ≥110 lbs
* Hemoglobin ≥ 12.5 g/dL or hematocrit ≥ 38% for women and hemoglobin ≥ 13.0 g/dL or hematocrit ≥ 39% for men.
* Meet criteria for autologous blood donation

Exclusion Criteria:

* Subjects with a past medical history or symptoms of blood dyscrasia, diabetes mellitus, hyperlipidemia, obstructive sleep apnea, renal disease, congestive heart failure, significant cardiac disease and / or known peripheral arterial disease.
* Moderate to severe systemic hypertension (systolic blood pressure \>140 mmHg and/or diastolic blood pressure \> 95 mmHg
* Systolic blood pressure \<100 mmHg and/or diastolic blood pressure \< 60 mmHg on the study day.
* Positive Direct Antiglobulin Test
* Consumption of biotin supplements or raw eggs within 30 days
* Treatment with antibiotics in the week before initiating study participation to avoid suppression of erythropoiesis, which may accompany infection.
* Blood loss in the previous 8 weeks due to epistaxis, trauma, hemoptysis, gastrointestinal bleeding, diagnostic phlebotomy (\> 30 ml)
* Subjects who report tobacco or marijuana smoking within 6 months of study.
* Cognitively impaired subjects, or institutionalized persons and subjects unable or unwilling to complete written informed consent
* Subjects with a history of blood donation within the last 56 days.
* Use of other investigational drugs/devices within 30 days of screening.
* Subjects taking any medication for the treatment of diabetes including insulin
* Females of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with positive pregnancy testing on screening day will be excluded.
* History of prior transfusion reaction to blood products.
* Allergic reaction to biotin
* Donors with naturally occurring antibodies against BioRBCs will be excluded from the study
Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma

Study Objective :

To assess the efficacy and the safety of the combination of Oxaliplatin, and Vinorelbine with or without Trastuzumab as a salvage regimen in patients with Metastatic Breast Cancer


Eligibility Criteria:
Inclusion Criteria:

* Metastatic, histologically or cytologically proven breast cancer.
* At least one bi-dimensionally measurable lesion.
* Previous treatment with chemotherapy as first line for metastatic disease is mandatory especially with anthracyclines +/- the Taxanes.
* Treatment as adjuvant is allowed.
* World Health Organization-ECOG performance status 0-2.
* Adequate renal function (Creatinine \<= 1.4 or Creatinine clearance \>= 30 ml/min)
* Adequate hepatic function (Liver Function Tests not more than 3 times the normal values)
* Adequate bone marrow reserve is required (Neutrophils (PMN) \>= 2000/mm2 and Platelets \>= 100,000/mm2)
* Patient who will receive Herceptin should have an over-expression of HER2-neu.

Exclusion Criteria:

* Symptomatic peripheral neuropathy (National Cancer Institute common toxicity criteria grade more than one).
* Pregnant or breast-feeding.
* History of prior malignancies (with the exception of excised cervical carcinoma-in-situ or non-melanoma cell skin carcinoma).
* Receiving or had received, any treatment with experimental drugs.
* Had known brain or leptomeningeal involvement.
* Had a serious medical condition like congestive heart failure or an Ejection Fraction ≥ 40 %.
* The presence of bone as a sole site of metastasis.
* Radiation therapy to all areas of measurable disease less than four weeks before treatment.
* Creatinine two times above the normal range
* Hypercalcemia
* Evaluable but not a measurable disease as a sole site of metastasis: pleural effusion - Ascites - Pericardial effusion.
* Concomitant steroid intake for \> 4 weeks
* Bilirubin two times above the normal range

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid

This is a phase Ⅲ, multicenter, randomized, double-blind, study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from malignant solid tumors. The purpose of this study is to determine if JMT103 is non-inferior to zoledronic acid.


Eligibility Criteria:
Inclusion Criteria:

1. Age: older than 18 years;
2. Breast cancer, prostate cancer, lung cancer and other solid tumors diagnosed by histological or cytological examination (prostate patients should also meet: castration-resistant prostate cancer with serum testosterone \<50 ng/dL or 1.7 nmol/L and serum PSA progression after surgery or drug castration treatment);
3. Patients with imaging studies showing at least one tumor bone metastasis;
4. With a good organ function;
5. Expected survival of at least 6 months.

Exclusion Criteria:

1. Previous or ongoing osteomyelitis or osteonecrosis of the jaw; dental or oral surgery; acute dental or jaw disease requiring oral surgery; invasive dental procedures planned during the study; patients with pulpitis during the screening period;
2. Radiotherapy or surgery for the bone metastases is planned during the study;
3. Patients with brain metastasis or meningeal metastasis (patients with neurological symptoms should undergo MRI/CT examination to exclude patients with brain metastasis);
4. Patients with bone metabolic diseases \[e.g., Paget's disease, Cushing's syndrome, hyperprolactinemia, hyperthyroidism/hypothyroid (except for hypothyroidism with normal TSH, FT3, and FT4 after stable thyroid hormone replacement therapy, and subclinical hypothyroidism that does not need to be treated), hyper/hypoparathyroidism, etc.\];
5. Uncontrolled concurrent diseases, including but not limited to: uncontrolled diabetes mellitus (≥grade 3, NCI-CTCAE 5.0), symptomatic congestive heart failure, hypertension (BP\> 150/90 mmHg after standard therapy), unstable angina, arrhythmia requiring medical or instrumental treatment, history of myocardial infarction within 6 months, echocardiography with left ventricular ejection fraction \<50%;
6. Treatment with anti-RANKL antibody, bisphosphonates (except for bone scan purposes) within 6 months prior to the first dose;
7. Patients considered by the investigator as unsuitable for this study (such as poor compliance, etc.).
Prediction of Pulmonary Rehabilitation Outcomes in Patients With Chronic Respiratory Disease Based on Metabolomics: a Prospective Cohort Study

To comprehensively evaluate the pulmonary rehabilitation (PR) outcomes of patients with chronic respiratory disease (CRD), and to screen biomarkers for predicting different PR outcomes of patients with CRD using metabolomics methods, and to build a prediction model.


Eligibility Criteria:
Inclusion Criteria:

* For COPD

  1. Meets the Global initiative for chronic obstructive lung disease (GOLD) 2022 definition of stable COPD;
  2. Age 30-75 years;
  3. Lung CT images only showed chronic bronchitis and emphysema;
  4. Agree to participate in the study and is able to cooperate with exhaled breath condensate collection.
* For bronchiectasis

  1. Lung CT showed bronchiectasis;
  2. Age 18-75 years;
  3. Spirometry suggests obstructive ventilatory dysfunction: forced expiratory volume in one second (FEV1) is less than 70% of forced vital capacity (FVC) post bronchodilator inhalation.

Exclusion Criteria:

1. Asthma or other respiratory diseases
2. History of pulmonary surgery
3. α1 antitrypsin deficiency
4. Autoimmune diseases
5. Patients with acute myocardial infarction, chronic heart failure, severe cerebral infarction or cerebral hemorrhage
6. A history of malignant disease now or within 2 years
7. History of acute exacerbation or change of medication in the past 4 weeks
8. A history of blood transfusion within the last 4 weeks
9. Drugs or alcohol abuse
10. Breastfeeding or pregnant women
11. Unable to cooperate with pulmonary rehabilitation for various reasons