cyrilzakka/clinical-trials huggingface dataset:
Study of Cardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET

The study is about exploring physiological angiogenesis linked to tissue repair in patients with acute heart infarction or chronic heart ischemia by means of 68Ga-NODAGA-RGD PET/CT imaging.

Several animal studies have demonstrated the expression of αvβ3 integrins on the surface of the endothelium present in neovessels in formation, especially during neoangiogenesis after myocardial ischemic injury.

68Ga-NODAGA-RGD is a positron-emission-tomography (PET) ligand targeted towards αvβ3 integrins. αvβ3 integrins could potentially act as a biomarker for the follow-up of heart infarction.

In the present study, 68Ga-NODAGA-RGD PET/CT imaging is a tool to understand and evaluate tissue repair after heart lesion and its evolution allowing a better management of patients with occluded artery.

Three groups of patients are included : patients with acute infarction, patients with acute infarction requiring reperfusion treatment and patients with chronic ischemic occlusion.

Each patient would benefit from a 82Rb (82rubidium) PET/CT as part of standard management and from a 68Ga-NODAGA-RGD PET/CT as part of the present study.

Patients from groups 1 and 2 will have 3 sets of both exams : one after the ischemic event, one at one month and another at 3 months post event.

Patients form group 3 will have a set of both exams before reperfusion treatment and one at 2 months after reperfusion.

Eligibility Criteria:
Inclusion Criteria:

* patients with acute infarction or patients with acute infarction requiring reperfusion treatment or patients with chronic ischemic occlusion
* Karnofsky ≥ 80%
* signed informed consent

Exclusion Criteria:

* pregnancy, breastfeeding
* claustrophobia
* contra-indication to adenosine administration
* lack of discernment to sign informed consent
Yes/No Questionnaire for Aphasic Patients (YNQ)

Quality of care depends strongly on oral communication with patients. Stroke patients, who have language disorders, have understanding difficulties, but also have difficulties in expressing their needs and in being understood. Available tools do not allow a professional consensus on the assessment of patients' ability to answer reliably to questions asked by caregivers. The investigators propose an answer reliability assessment tool based on yes or no questions. The goal of the present study is to define an optimal score for defining the test positivity, as a compromise between sensitivity and specificity, and by emphasizing the negative predictive value.

In France, about 130,000 persons per year are victims of stroke. Thirty percent of the victims suffer from aphasia during the acute phase. These language impairments have an impact on caregiving. In the context of post-stroke aphasia, the most relevant means of verbal communication is closed-ended questioning. However, the available tools do not allow a professional consensus and the comprehensive assessment tools for aphasia do not provide any indication of the reliability of patients' answers. The investigators have developed a tool, the yes/no questionnaire that consists of 10 closed-ended questions designed to assess the patient's ability to provide a coherent answer. During one year, successive patients taken care in the neurovascular unit at la Rochelle hospital will be assessed for eligibility to the study and their relative will be informed and ask for consent. Aphasic patients will therefore answer the yes/no questionnaire. Based on the speech therapist evaluation, patients will be classified as "reliable respondent" or "unreliable respondent".

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Left-sided stroke
* Right-handed
* Mother language: French
* Hospitalized in neurovascular unit or neurology department
* NIHSS score over 25

Exclusion Criteria:

* Deaf
* Psychiatric history
* Stroke history
* Dementia or pre-stroke cognitive impairment
* Under guardianship
* Refusal to participate (relatives)
Inferonasal MIMS® Procedure: Long-Term Follow-Up Extension Study

A long-term (24 and 30 months) follow-up extension, prospective, non-interventional, open label study for data collection from subjects who underwent prior MIMS® inferonasal surgery, in continuation of the previous clinical investigation with the MIMS® Device (MMS-EEU-5).


Eligibility Criteria:
Inclusion Criteria:

1. Subject who underwent MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment
Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction

The modern treatment of meibomian gland dysfunction(MGD) is based on anti-inflammatory drops or oral antibiotics for decreasing dry eye disease (DED) associated inflammation, warm compresses for liquefying the thicker meibum, and lid hygiene for reducing the bacterial overload. But, such treatments have shown limited effectiveness to a large proportion of patients with MGD, due to the multifactorial background of the disease. Thus, alternative approaches aiming at different aspects of the DED pathophysiology are needed.

Elimination of posterior lid-margin hyperemia with telangiectasia could be a treatment target for reducing the secretion of inflammatory mediators in the course of MGD. Using the mechanism of photocoagulation via selective thermolysis, laser light could contribute to the destruction of abnormal vessels at the posterior lid-margin and thus, the reduction of inflammation. Recently, sub-threshold (micropulse) laser photocoagulation was introduced in ophthalmology and offers significant clinical advantages compared to conventional continuous wave (CW) approach, preventing laser induced thermal damage and related treatment side effects.

This study investigates the effect of sub-threshold (micropulse) laser treatment for dry eye disease due to meibomian gland dysfunction combined with increased eyelid margin vascularity.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years
* chief complaint of more than one of dryness, foreign-body sensation, burning, and tearing for 3 months
* diagnosis of MGD with palpebral telangiectasia in both eyes

Exclusion Criteria:

* ocular structural abnormalities
* history of ocular trauma or surgery
* use of any treatment for DE or MGD, other than artificial tears, within the past month
* active allergy, infection, or inflammatory disease at the ocular surface unrelated to DE or MGD
* lacrimal drainage-system anomalies
* contact-lens wear
* use of any systemic anti-inflammatory medicine
Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With EGFR Gene Mutation

This is a randomized ,opened, prospective controlled trial of clinical effectiveness for Icotinib as the adjunctive treatment after surgery in stage I-IIIB lung adenocarcinoma patients with epidermal growth factor receptor gene mutation

In this trial the investigators will enlist 100 patients who accepted surgery and with epidermal growth factor receptor gene mutation,these patients will be divided into 2 groups (chemotherapy group and Icotinib group),compare the PFS,RFS,OS after 5 years follow up

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* Lung adenocarcinoma patients with epidermal growth factor receptor gene mutation,stage I-IIIB after surgery
* The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2

Exclusion Criteria:

* Mismatch conditions above
* Have used other anti-cancer therapy drug before the trial and may influence the outcome
ReOxy Therapy in the Rehabilitation of Chronic Low Back Pain Patients With Comorbidity

The aim of this study is to assess the effect of the respiratory therapy method based on short-term intermittent exposures to hypoxia and hyperoxia (ReOxy therapy) on the pain intensity, restoration of the lumbar range of motion, physical capacity, disability, mental and vegetative status in Chronic Low Back Pain patients with Multiple Chronic Conditions.

This is a randomized, single-blinded, placebo-controlled trial, with chronic non-specific low back pain with multiple chronic conditions. Comorbidity constitutes a serious challenge for rehabilitative medicine - significantly reduces the patients' quality of life and restoration of the working capacity.

The objective of the present study will be to evaluate the effectiveness of the combined non-medicinal rehabilitation programe which include a course of ReOxy- therapy and conventional therapy back pain treatment.

90 patients will be randomly allocated to three treatment groups: experimental ("hypoxic group" - ReOxy therapy + conventional therapy back pain treatment), placebo ("sham hypoxic group"- sham- ReOxy therapy + conventional therapy back pain treatment) and control (only conventional therapy back pain treatment).

The clinical outcomes will be obtained at the completion of treatment (2 weeks) and at 1 month after randomization. The statistical analysis will follow the intention-to-treat principles and the between-group differences will be calculated by using mixed linear models.

The outcomes of interest are pain intensity, lumbar range of motion function, general physical and mental status.

Eligibility Criteria:
Inclusion Criteria:

* Patient with non-specific chronic low back pain for at least 3 months;
* A pain intensity of at least 5 points measured by 0 -10 points pain rating scale;
* Co-morbidity - IHD and/or CHF and/or COPD and/or chronic bronchitis)
* Willing and able to consent, complete all assessment and study procedures;

Exclusion Criteria:

* Specific types of back pain (metastatic cancer or bone cancer or secondary cancers, vertebral fractures, spinal infection, active inflammatory disease);
* Low back surgery within past 3 months;
* Serious cardiovascular, cerebrovascular, neuromuscular and other systemic diseases or other diseases affecting physical activity;
* Any significant systemic illness or medical condition that could affect safety or compliance with study;
* Major active or chronic unstable psychiatric illness (e.g. depression, bipolar disorder, obsessive compulsive disorder, schizophrenia) within the previous year;
* Tumour disease except being successfully treated and off treatment with \>2 years. Tumour disease except being successfully treated and off treatment with \>2 years.
* Use of other investigational agents or interventions one month prior to entry and for the duration of the trial;
Blood Cell RNA-Based Cancer Detection

Early diagnosis of cancer may provide patients with more treatment options and hopefully prolong survival. The purpose of this multi-center study is to collect peripheral blood from newly diagnosed cancer patients and healthy donors to establish a blood cell RNA-based model for the differentiation of cancer patients and healthy donors. The area under the receiver operating characteristic (AUROC), sensitivity and specificity of the test in the early detection of multiple cancers will be measured.


Eligibility Criteria:
Inclusion Criteria for All the Participants

1. Age 18 years or older
2. Provide informed consent

Exclusion Criteria for All the Participants:

1. Pregnancy or lactating women
2. Received a blood transfusion within 1 month
3. Received anti-cancer treatment within 3 years
4. Known prior diagnosis of cancer
5. Poor health status or unfit to tolerate blood draw
Efficacy of Transfer Factor to Prevent Upper Respiratory Tract Infections in Healthy Adults

The goals of our study are to critically evaluate if a healthy population supplemented with Transfer factor experiences fewer incidences of colds and flu, or experience shorter duration of illness compared to an identical population taking placebo. In this study we will give either Transfer factor or a placebo to two groups of healthy adult men and women for a period of 7 weeks in a double-blind experimental design. The frequency and duration of colds and flu-like symptoms will be recorded during the course of the study. Saliva samples will be collected weekly and assessed for salivary IgA secretion rate. Data from this study will establish the efficacy of Transfer Factor to support a healthy immune system.


Eligibility Criteria:
Inclusion Criteria:

* Males and females (18 - 40) who are in good health

Exclusion Criteria:

* Subjects who are allergic to eggs (on which the supplement is based). If a volunteer is not sure if they are allergic to eggs or milk. Those who are currently smoking, have cardiovascular disease, cancer, diabetes, liver disease, renal insufficiency, any chronic disease that might interfere with study participation, BMI above 40 kg/m2, consumption of \>12 alcoholic drinks weekly, or unwillingness to stop current supplement intake. Women who are pregnant or lactating will also be excluded from the study.
Combined Effect of Laser Acupuncture and Electroacupuncture in Knee Osteoarthritis Patients

Background:

Knee osteoarthritis (KOA) is a common degenerative joint disorder affected 250 million people globally. It can not only result in disability, but also associated with cardiovascular disease and mortality. The most common treatment for KOA is non-steroidal anti-inflammatory drug. However, the effect of analgesic is limited and may complicate with side effect. Hence, many patients search for complementary and alternative medicine. Acupuncture is one of the most popular complementary treatment with good analgesic effect and less side effect. Electroacupuncture (EA) or laser acupuncture (LA) was reported effective in pain control in knee osteoarthritis patients. However, there is no study about combination effect of EA and LA.

Methods:

This protocol is a randomized controlled trial investigating the combination effect of EA and LA on KOA. Fifty participants diagnosed KOA with aged more than 50 years old and knee pain more than 3 months were recruited and randomly assigned to the experimental group (EA plus LA) or sham group (EA plus LA without laser output) in clinical research center. The subjects will undergo EA plus LA treatment thrice a weeks for 4 weeks. The experimental group will receive acupuncture at GB33, GB34, SP9, SP10, and ST36 with transcutaneous electrical nerve stimulator on the GB34+33 and SP9+10., and the LA deliver 6 Joule of energy at EX-LE5, ST35, and BL40. The subjects in sham group will receive the same way but the LA is without any laser output. Outcome measurement will include visual analogue scale (VAS), Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and osteoarthritis outcome (KOOS), body composition analysis, knee range of motion test, muscle stiffness test, standing on one foot test, and the 30-second chair stand test before intervention and after 4 weeks intervention. The result will be analyze and compared between the experimental group and sham group using the paired t test and one-way analysis of variance.

Objectives:

The aim of this protocol is to investigate the combination effect of EA and LA in KOA patients.


Eligibility Criteria:
Inclusion Criteria:

* VAS more than 3 point when daily activity
* Kellgren-Lawrence Grading Scale grade 1 to 3 on knee X-ray
* Provided informed consent

Exclusion Criteria:

* History of knee arthroplasty, traumatic injury related joint deformity,
* Body mass index more than 35
* pacemaker insertion, photosensitivity
* who had undergone intra-articular injection or acupuncture in recent one month
* other factors that may affect the evaluation of the outcome, such as psychiatric disorder or moderate mental retardation etc.
Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation

The primary objective of this study is to investigate the impact of early corticosteroid withdrawal in paediatric renal transplant patients on growth expressed as change in height standard deviation score (SDS) from baseline to end of study as the primary endpoint. The expected advantages are reduced growth suppression, lower incidence of arterial hypertension and post transplant diabetes mellitus (PTDM) and improved lipid metabolism, expressed by lower serum lipid values.

Comparing efficacy \& safety of steroid withdrawal with tacrolimus, mycophenolate mofetil (MMF) with induction in children after kidney transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient younger than 18 but not younger than 2 years of age
* Skeletal age of boys \< or = 17, girls \< or = 15 years
* Patient has end stage kidney disease
* Female patient of childbearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control during the study and 6 weeks thereafter.
* The patient, or in case the patient is a minor, the patient's parent(s) or their legal representative, has been fully informed and has given written informed consent

Exclusion Criteria:

* Patient has a most recently measured panel reactive antibody (PRA) grade of \> or = 50%
* Patient is allergic to or intolerant of study medication
* Patient and/or donor is known to be HIV positive.
* Patient has significant liver disease
* Patient with malignancy or history of malignancy
* Patient has previously received or is receiving an organ transplant other than kidney.
* Patient has been previously enrolled in this study.
* Patient with the relapsing and non-diarrhoeal form of haemolytic uraemic syndrome.
Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion

To compare the effect of vaginal dinoprostone versus vaginal misoprostol and Isonicotinic Acid Hydrazide administered before the copper intrauterine device(IUD) insertion in reducing IUD inertion pain and the difficulty in inserting the IUD in nulliparous women.

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility Criteria:
Inclusion Criteria:

* nulliparous women requesting copper IUD insertion

Exclusion Criteria:

* pregnancy,
* Parous women,
* contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion,
* untreated active cervicitis or vaginitis,
* undiagnosed abnormal uterine bleeding
ERAS vs Conventional Approach in Peptic Perforation-RCT

This study compares 2 different ways of perioperative management in patients of peptic perforation. Experimental arm is the ERAS arm( Enhanced recovery after surgery) and the comparative arm is Conventional arm.

While the conventional approach to perioperative management can potentially prolong the post operative hospital stay, ERAS(Enhanced recovery after surgery), a multi-modal and multispeciality approach to perioperative management may reduce the length of hospital stay. In the preoperative period, patients will be counselled regarding the operative procedure and particulars of the perioperative management.In the intra-operative period short acting general anesthetic agents and short acting muscle relaxants will be used.Intravenous fluid administration will be goal directed. After the operative procedure, bilateral rectus sheath block will be administered. Patient will also receive post-operative nausea and vomiting prophylaxis. Nasogastric tube will be removed immediately after the operative procedure. In the post operative period, patients will be encouraged to ambulate early. Enteral nutrition will be initiated as early as possible. Indwelling catheters will be removed in the early post-operative procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Patient diagnosed with peptic perforation intra -operatively
2. Perforation of size \<=1 cm
3. Patient age more than 18 years
4. American Society of Anesthesiologists score of I or II

Exclusion Criteria:

1. Refractory septic shock at presentation.
2. Known Chronic kidney disease/ Chronic liver disease patients
3. Pregnant patients.
4. Patients with history of chronic steroid abuse.
5. Intraoperatively

   * Patient with coexistent peptic perforation with bleeding ulcer.
   * Peptic perforation requiring procedure other than Omental patch repair.
   * Sealed perforations.
   * Malignant perforation.
6. Patient requiring Positive Pressure Ventilator support post operatively for more than 12 hours.
7. Patient requiring urinary catheterization for other indications.
8. Coexistent neurological or psychiatric illness or unable to understand the study.
9. Patient refusing for consent.
Classifying and Predicting Long-term Pain and Function in Older Adults

This project will use novel methods to detect clinically meaningful subgroups of older adults based on long-term trajectories of bothersome pain and function. It will then identify older adults at high risk of experiencing poor long-term pain and function. Anticipated results will provide new insights into long-term patterns of pain and function across the aging process and identify potential predictors of each trajectory.

The long-term goal of this planned line of research is to reduce the burden of pain and maximize function in older adults as they age. This line of research will begin by completing the following Aims: Aim 1) Identify and describe clinically meaningful long-term trajectories of bothersome pain and functional decline in a population-based sample of older adults and Aim 2) Estimate the association between candidate prognostic factors typically available in electronic health records and long-term bothersome pain and function trajectories to inform the development of eventual risk prediction models. This will be a retrospective cohort study using longitudinal data from the population-based National Health and Aging Trends Study (NHATS). This project will use novel methods to identify clinically meaningful subgroups of older adults based on long-term trajectories of bothersome pain and function. Group-based trajectory modeling (GBTM) is a novel method to model dynamic phenomena such as pain and function. Older adults at high risk of experiencing poor long-term pain and function outcomes will be identified by leveraging potential prognostic factors typically available in electronic health records or administrative data. It is anticipated that our results will provide new insights into long-term patterns of pain and function across the aging process and identify potential predictors of each trajectory.

Eligibility Criteria:
Inclusion Criteria:

* community-dwelling older adults from Round 1 of the NHATS cohort

Exclusion Criteria:

* participants who are non-ambulatory (require a wheelchair or scooter for mobility) at Round 1