cyrilzakka/clinical-trials huggingface dataset:
Tea Tree Oil in the Treatment of Chronic Blepharitis

The purpose of this study is to determine:

* The prevalence of Demodex sp. in chronic blepharitis.
* The efficacy of the treatment of topical Tree Tea Oil in chronic blepharitis for Demodex sp.

Patients with clinical diagnosis of chronic blepharitis were included in this study. A check list of symptoms and an ophthalmologic examination including best corrected visual acuity and biomicroscopy were performed.

Under a slit lamp visualization, three lashes with cylindrical dandruff of each eyelid were epilated by fine forceps. The lashes were immersed in fluorescein dye and examined under a light microscope at a 20-times magnification. The mites were detected based on its morphological characteristics and movement.

The patients with chronic blepharitis who had Demodex were randomly divided in two groups. The treatment group was prescribed lid hygiene with Tea Tree Oil shampoo 0.25% and ointment 5% daily and Tea Tree Oil oily solution 50% once a week - produced by Ophthalmos, São Paulo. The control group used the same posology of placebo similar products.

After six weeks, all subjects underwent the initial clinical and laboratory examination. The symptoms and the quantity of mites (mites/eye) were compared before and after the treatment in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Blepharitis with out treatment previously

Exclusion Criteria:

* Patients under 18 y.o.
* Pregnant woman
* Others Ocular Surface Disease (Severe Dry Eye, Lagoftalmo, Entropium, Ectropium)
The Efficacy of Biomarker in Patient With Interstitial Cystitis/Painful Bladder Syndrome

The purpose of this study is to evaluate efficacy of biomarker in patient with interstitial cystitis/painful bladder syndrome

This is a observational study

Eligibility Criteria:
Inclusion Criteria:

* 1) must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study 2) Pain VAS ≥4 3) O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2) 4) PUF score ≥ 13 5) cystoscopic record within 2 years

Exclusion Criteria:

1. Patients who are pregnancy or, childbearing age without no contraception
2. Patients with voided volume \<40 or, \> 400ml
3. Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination
4. Patients with urine culture showing evidence of urinary tract infection 1month prior to the study
5. Accompanied medical problem below

   * Tuberculosis in urinary system
   * Bladder cancer, urethral cancer, prostate cancer
   * Recurrent cystitis
   * anatomical disorder
6. Patients had prior surgery (eq, bladder augmentation, cystectomy
7. Patients with neurologic disorder
8. Patients with indwelling catheter or intermittent self-catheterization
9. Patients with psychologic problem
Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe

The primary objective of this study was to evaluate if administration of a seasonal flu vaccine using a jet injector device is comparable to traditional needle and syringe delivery for eliciting an immune response. A secondary objective was to compare the safety of the two delivery methods.

Needle-free jet injection devices create a fine stream of pressurized liquid that is able to deliver vaccines and other pharmaceutical products beneath the skin. Design aspects such as quality, pressure, orifice size, angle of injection relative to skin and injection stream coherence control the depth to which the product is delivered. This technology provides a safer delivery option for patients and healthcare staff by removing the need for needles for the administration of vaccines.

In addition to improved safety, additional benefits of using jet injectors include more consistent and reliable dose volume delivery, reduced vaccine waste, diminished need to transport large quantities of sharps, reduced risk of needle sticks, syringe reuse, and costs associated with sharps waste. Jet injectors offer a needle-free procedure to those individuals who are adverse to needles.

This study compared the efficacy of a disposable syringe jet injection device (Stratis) with traditional needle and syringe (NS) administration for the delivery of a trivalent inactivated influenza vaccine. Efficacy was evaluated by comparing measures of hemagglutination inhibition (HI); specifically GMTs, seroconversion and seroprotection. Safety of the two administration devices was evaluated by comparison of incidence of solicited local and systemic adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Female and male subjects ages 18 to 59 years
* Healthy volunteers
* Able to provide informed consent and understand study procedures per ICH/GCP guidelines
* Plans to remain in study area for length of the trial; able to adhere to study visit and follow-up schedule
* Able to complete study diary

Exclusion Criteria:

* Unwilling or unable to undergo the two blood draws per protocol
* Have received influenza vaccination in the last twelve months
* Have received any vaccination in the last month
* Currently taking antibiotics, steroids, phenytoin, chemotherapy, or other immunosuppressive drugs
* Received recent blood, blood products, or parenteral preparations of immunoglobulin (within 3 months)
* Suffers from allergic reactions to egg, gelatin, or neomycin or has a history of anaphylactic shock, asthma, urticaria, or other allergic reactions to vaccinations.
* Had any serious adverse event associated with a prior vaccination
* Has immunodeficiency or autoimmune disease (including HIV)
* History of chronic alcohol abuse
* Participating in another study concurrently
* Pregnant or breastfeeding during the study
Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.

The aim of this project is to evaluate the impact of pandemic and nonconfinement related to anxiety and eventual immune diseases with several standardized questionnaires : Implant Stability Quotient (ISQ) , Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire -9 (PHQ-9), Post Traumatic Stress Disorder-8 (PTSD-8), and Experiences in Close Relationship Scale (ECRS).

The COVID-19 pandemic and prevention strategise have strongly impacted family lives, social lives, professional lives, and income; resulting in increased reporting of stress and anxiety within patients. This risk of infection 'post-confinement' is an additional source of stress for people returning to their professional and social lives. There are evidence showing a relationship between stress, immunity and the prognosis of several infections and inflammatory diseases.

The COVID-19 pandemic and prevention strategise have strongly impacted family lives and induced a high level of anxiety and other types of stress. This risk of infection 'post-confinement' is an additional source of stress for people returning to their professional and social life.

There are evidences showing a relationship between stress, immunity and the prognosis of several infections and inflammatory diseases.

The aim of this project is to launch an online survey that measures population stress felt during the pandemic and post-confinement time and possible effects on eventual immune mediated disorders (allergies, auto-immunity..) through the report of new events or flares. The stress will first be measured on standardized anxiety GAD-7scale but also on more parameters (ISQ, PHQ-9, PTSD-8, and ECR-S). Socio-economic and environmental parameters will be recorded.

Level of anxiety and other stress parameters as well as occurrence of inflammatory events will be measured according to the calendar and confinement /post confinement timing. Risk factors will be looked for, by multi parametric data analysis.

The survey has been built in a user-friendly, accessible way so the investigators can expect a high number of participants (at least 400), especially as people are highly concerned by the situation and will be motivated to take part.

Eligibility Criteria:
Inclusion Criteria:

* Adult volunteer who agreed to answer the questionnaires
* Age ≥ 18 years old
* Adult affiliated or having a duty to a social security scheme

Exclusion Criteria:

* Children under 18 years old
* Inability to understand information letter, consent, or to use online questionnaire
Morphology of Advanced Symptomatic Cerebral Plaques With High Embolic Potential

The study is to attain early recognition of the unstable plaques which have an imminent embolic risk in patients with intracranial atherosclerotic disease (IAD).

Potential candidates will undergo a cranial MRI and MR angiography. Patients who are found signal void in a relevant intracranial internal carotid artery or middle cerebral artery will proceed to a 30-minute TCD monitoring for MES an angiograms will be analyzed by investigators blind to subjects' clinical information. All recruited patients will receive standard medical therapy throughout the investigation period.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria for the Symptomatic Group:

  1. Patient is 30 to 85 years of age, inclusive.
  2. Patients who have an acute infarct in diffusion-weighted MRI compatible with artery-to-artery thrombo-embolism, a relevant intracranial atherosclerotic stenosis ≥60%, and MES detected by TCD.
  3. Patient who has no contra-indication for the proposed imaging tests.
  4. Patient understands the purpose and requirements of the study, and has provided an informed consent.
* Inclusion Criteria for the Asymptomatic Group:

  1. Patient is 30 to 85 years of age, inclusive.
  2. Patient who has a high-grade (\>60%) intracranial stenosis (signal void in MR angiography) but without infarct in the corresponding vascular territory in DWI or T2-weighted sequence.
  3. Patient has no MES detected on TCD examination.
  4. Patient who has no contra-indication for the proposed imaging tests.
  5. Patient understands the purpose and requirements of the study, and has provided an informed consent.

Exclusion Criteria:

Subject who meets one or more of the following criteria cannot be recruited in the study:

1. Stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as cardioembolism, Moyamoya disease, small vessel disease, etc.
2. A tandem stenosis \>50% at proximal internal carotid artery.
3. Bleeding propensity: active peptic ulcer disease, major systemic hemorrhage within 30 days, thrombocytopenia (platelets \<100 x 109/L), coagulopathy (INR \>1.5).
4. A medical condition that would not allow the patient to adhere to the protocol or complete the study.
Intranasal Ketamine for Suicidal Ideation in Veterans

The objective of the current study is to investigate the safety, efficacy, and feasibility of multiple doses of intranasal (IN) ketamine for suicidal ideation Veterans.

To address the significant need for effective treatment of suicidal ideation in Veterans, this trial is designed as an open label pilot study of intranasal ketamine in 15 people.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients, 21-70 years of age
2. Female individuals who are not of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year) or using a medically accepted reliable means of contraception. Women using oral contraceptive medication for birth control must also be using a barrier contraceptive. Women of childbearing potential must also have a negative pregnancy test at screening and at pre-administration
3. Any non-psychotic disorder diagnosis
4. Score \>4 on the suicide item of the Montgomery-Asberg Depression Rating Scale (MADRS-SI; range 0-6)for clinically significant suicidal ideation or past suicide attempts
5. Each participant must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
6. Each participant must agree to avoid future enrollment in ketamine trials.

Exclusion Criteria:

1. current psychotic symptoms or lifetime history of primary psychotic disorder
2. active substance use in the preceding two weeks or needing medical attention for withdrawal
3. neurodevelopmental disorder (e.g., ASD)
4. major neurocognitive disorder (e.g., Alzheimer's type dementia)
5. serious cardiac disease
6. suicide attempt precipitating current admission requiring medical stabilization
7. Lifetime histories of autism, mental retardation, pervasive developmental disorders, or Tourette's syndrome
8. Women who are either pregnant or nursing
9. Hypertension (systolic BP \>160 mm Hg or diastolic BP \>90 mm Hg) at screening or immediately prior to treatment with study drug
10. Previously received ketamine for refractory depression.
Primary Hormone-sensitive Breast Cancer: Need-driven Health Care Improvement by Patient-centred Digital Application

The investigators designed a prospective, 2-armed, cluster-randomized multicenter clinical trial on the effect of a by a digital application triggered intervention on quality of life and therapy-adherence among breast cancer patients, compared to standard of care.

With validated questionnaires, patient reported outcome monitoring data on quality of life, distress and therapy-adherence are collected. In case of pathologic values, the attending breast center gets advised to intervene according to individual requirements.

For women with breast cancer, disease and therapy come along with loss of quality of life. Therapy and its side effects often result in unauthorized discontinuation of therapy by patients. Non-adherence rates to endocrine therapy (ET) range from 31% to 73%. These patients have a poorer prognosis due to recurrence, progression and cancer deaths. Positive effects to increase therapy-adherence were shown for bidirectional communication. Furthermore the use of apps with reminder functions can increase adherence to cancer therapy. The intention within this project is to improve care of patients with primary breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* primary, hormone-sensitive breast cancer
* indication for adjuvant endocrine therapy (aromatase-inhibitor, tamoxifen, GnRH-analogue allone or in combination with tamoxifen/ aromatas inhibitor; combination of endocrine therapy with CDK 4/6-inhibitor/ antibody therapy/ radiotherapy)
* start of endocrine therapy \<= 3 months ago
* patients with public health ensurance
* patients who are legally competent and able to understand and follow instructions of the study staff
* present informed consent

Exclusion Criteria:

* no use of internet or digital applications
* advanced, metastatic breast cancer
* simultaneous serious disease
* life expectancy \< 2 years
A Study To Evaluate The Efficacy And Safety Of A Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR).

The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Perennial Allergic Rhinitis (PAR)

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of perennial allergic rhinitis (PAR).
* Must comply with study procedures and be literate.

Exclusion criteria:

* Significant concomitant medical conditions.
* Use of corticosteroids.
* Use of allergy medications and some other medications during the study.
* Current tobacco use.
* Clinically significant abnormal ECG or laboratory abnormality.
Multi-Center Prospective Randomized Trial Comparing Standard Esophagectomy Against Chemo-Radiotherapy for Treatment of Squamous Esophageal Cancer - Early Results From the Chinese University Research Group for Esophageal Cancer (CURE)

A multicenter randomized comparison of primary esophagectomy against definitive chemoradiotherapy for the treatment of squamous esophageal cancer.

Cancer of the oesophagus is notorious for its grave prognosis with an overall 5-year survival rate of 10-20%. Surgical resection with curative intent remains the most effective treatment for this disease. To improve the survival, a better treatment approach is in need to manage patients with oesophageal cancer. Unfortunately, the use of preoperative adjuvant chemotherapy or adjuvant radiotherapy does not confer any survival benefit to patients with localized oesophageal cancer as proven in most randomized studies. However, the combination of chemotherapy and radiotherapy has greater clinical efficacy in achieving complete pathological regression of the tumour as well as the response rate as shown in our preliminary results. In fact, treatment of squamous oesophageal cancer by primary chemo-irradiation without surgery is now feasible.

We propose to conduct a multi-center randomized trial to evaluate the efficacy and the patients' survival by comparing primary chemo-irradiation without surgery versus standard surgical resection as the treatment for squamous oesophageal cancer. Those patients with residual cancer after primary chemo-irradiation will have salvage oesophagectomy to control the disease. Over a 3-year period, a total of 80 patients will be recruited from 4 different hospitals with 100 patients being randomized into each treatment arm. Treatment outcomes will be compared on an intention-to-treat analysis basis.

Eligibility Criteria:
Inclusion Criteria:

* mid or lower thoracic esophageal cancers that were confirmed on histology to be a squamous cell carcinoma deemed to be resectable

Exclusion Criteria:

* distant metastasis to solid visceral organs
* local invasion into trachea, descending aorta or recurrent laryngeal nerve.
* patients \> 75 years
* serious premorbid condition
* poor physical status that compromised a thoracotomy
* compromised cardiac function
* creatinine clearance less than 50 ml/min were not eligible.
Open Label Immunotherapy Trial of Inoperable Pancreatic Cancer

Pancreatic cancer (PDA) is the most lethal form of cancer, and the fourth-leading cause of cancer-related death in the United States, with a survival rate of less than 7%.There are currently no treatments found to be effective for patients with advanced disease who are ineligible for surgery, a prognosis representing the majority of pancreatic cancer diagnoses. Pancreatic cancer is not amenable to chemotherapy as compared to other cancer types, leaving patients with practically no options except surgery.

We have made oral tableted therapeutic vaccine, V3-P, derived from pooled blood of patients with PDA in line with similar highly promising approach we have adopted for patients with hepatocellular carcinoma (HCC) and cholangiocarcinoma (CAA). Patients with PDA will be given one tablet per day of V3-P and followed up to see the outcome.

This study is an open label Phase II study aimed to recruit at least 20 patients with inoperable PDA and who are positive for CA19.9 pancreatic tumor marker. The presence of higher than normal levels of CA19.9 is the sole inclusion criteria. Patients will be given one tablet of V3-P daily and followed for three months.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of inoperable pancreatic cancer
* higher than normal of serum CA19.9 tumor marker levels (40 IU/ml)
* must be able to swallow tablets

Exclusion Criteria:

* negative for CA19.9
* pregnant, breast feeding women
* unwillingness to provide written consent
A Study of the Cost for Patients Operated for Adhesive Obstruction (SBO) During a Five-year Period

A cohort study of the cost for patients operated for adhesive small bowel obstruction (SBO) during a five-year period

It is a population-based cohort study of the costs for patients operated for adhesive small bowel obstruction during a five-year period (2007-2012) in two Swedish neighboring regions. Patients were identified by a broad search of operation and International Classification of Diseases (ICD) codes. Data regarding surgery and complications has been analyzed in a previous study (Clinical trials no NCT0353459)

The costs for hospital stay, radiology, Intensive Care Unit (ICU)-care, operation for the index SBO care event were calculated. The cost for revisit, sick leave and recurrent SBO during follow-up were calculated. Patients were followed to 31st January 2017, last medical note or death.

Eligibility Criteria:
Inclusion Criteria:

* Above18 years of age
* Surgery for adhesive surgical bowel obstruction (SBO)

Exclusion Criteria:

• Surgery for SBO of other etiology than adhesions
Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study

The objective of this study is to assess the feasibility of estimating the clearance of iohexol as an indirect measure of glomerular filtration rate in patients with unstable renal function in the intensive care unit through analysis of rich iohexol plasma kinetics.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient admitted to intensive care for less than 12 hours
* Acute circulatory failure
* Patient carrying an arterial catheter
* Informed consent obtained
* Affiliated to social security system

Exclusion Criteria:

* Administration of iohexol the week before intensive care admission
* Administration of iohexol expected within 24 hours of study entry
* Known history of cutaneous immediate or delayed allergic reaction to the injection of the product
* Indication for albumin transfusion within 24 hours of potential inclusion in the study
* Pregnancy or breastfeeding in progress
* Patient under guardianship or judicial protection known at the time of inclusion
* Withdrawal of consent
* Administration of iohexol outside the study within 24 hours after administration of iohexol in the context of the study
* Administration of intravenous albumin in the 24 hours following administration of iohexol in the context of the study
Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis

Previous studies have indicated that patient expectations, beliefs and preferences may have an impact on treatment outcomes. The KIVIS study was primarily designed to compare two effective treatments for knee osteoarthritis (tidal irrigation (medical washout of the knee) or intra-articular corticosteroid injection). At study entry any preference expressed by the patient for each of the treatment interventions was recorded. This study assessed the effects of two treatments given at a single time-point and hence the effects of patient preference could be assessed independently of any compliance issues.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of knee OA
* Knee pain for most days of the prior month
* Radiographic evidence consistent with knee OA
* Aged between 40 and 90 years old

Exclusion Criteria:

* Symptomatic hip OA
* Co-existent inflammatory or crystal arthritis
* Prior knee surgery
* Injury to the knee in the preceding 6 months
* Any intra-articular injection in the preceding 3 months
* Inability to provide informed consent