cyrilzakka/clinical-trials huggingface dataset:
Stopping Antiviral Treatment in Chronic Hepatitis B

Chronic hepatitis B (CHB) infection affected 292 million individuals in the world, translating to about 3.9% of global prevalence. Up to 40% of patients with CHB will develop liver-related complications. Many patients require long-term oral antiviral therapy since off-treatment sustained virological control can only be achieved in a minority of patients. It is uncommon for patients taking long-term antivirals to be able to stop the treatment if favorable factors are not present. Those include low viral load, long enough duration of treatment, and absence of cirrhosis. Some studies have found that inducing a mild flare is beneficial for achieving functional cure in chronic hepatitis B infection. There is lack of data in the immunological and virological profile in patients who stop their long-term antiviral therapy, and in those who developed flare after treatment cessation.

Chronic hepatitis B infection (CHB) affected 292 million individuals in the world in 2016 according to the Polaris Observatory estimation, translating to about 3.9% global prevalence. Up to 40% of patients with CHB will develop liver-related complications and there were 890,000 deaths from these complications in 2015. Current antiviral therapy is aimed to achieve effective viral suppression, biochemical remission, histological improvement, and risk reductions in liver-related complications including cirrhosis and liver cancer. Many patients require long-term oral nucleos(t)ide analogues (NA) since off-treatment sustained virological control can only be achieved in a minority of patients. For HBeAg-negative CHB patients, variable rates of durable virological response were observed after cessation of NA. Only a small proportion of HBeAg-negative Asian patients (\<10%) can successfully stop NA without virological breakthrough, compared to more than 60% of Caucasian patients maintaining a durable virologic response and even HBsAg seroclearance in up to 30%. Therefore, current guidelines in general recommend indefinite duration of NA therapy in HBeAg-negative patients, unless guaranteed close monitoring could be provided after cessation of NA in suitable subjects. Favourable factors predictive of partial cure include lower baseline HBV DNA, lower HBsAg titre or hepatitis B core-related antigen at NA cessation and longer duration of consolidation therapy in HBeAg-negative patients. There is lack of data in the immunological and virological profile in patients who stop their long-term NA, and in those who developed post-NA cessation flare.

The investigators aim to study the virological and immunological profile in patients who stopped long-term NA therapy, with or without post-NA cessation flare. In addition, the investigators would like to investigate the effect of mild flare after monitored NA-cessation on subsequent virological activity and HBsAg seroclearance.

Eligibility Criteria:
Inclusion Criteria:

* HBeAg-negative
* non-cirrhotic
* on long-term NA ≥3 years (entecavir or tenofovir)
* undetectable serum HBV DNA

Exclusion Criteria:

* HCC, cirrhosis, history of liver transplantation, or on immunosuppressants,
Lymph Node Pathologic Grading Strategy

The percentage of high-grade patterns in metastatic LNs (mLNs) that can predict poor outcomes has yet to be determined. Additionally, the potential implications of other histologic patterns in metastatic lymph nodes on patient outcomes warrant further investigation.

We conducted a retrospective cohort study to investigate the prognostic value of pathologic pattern in metastatic lymph nodes.


Eligibility Criteria:
Inclusion Criteria:

From January 2011 to September 2021, we consecutively collected patients with invasive LUAD who underwent surgical resection at the Department of Thoracic Surgery, Fudan University Shanghai Cancer Center.

Exclusion Criteria:

1. adenocarcinoma in situ, minimally invasive adenocarcinoma, invasive mucinous adenocarcinoma, and other variants of adenocarcinoma;
2. incomplete common driver mutation data;
3. unavailable pathologic slides.
Naps and Pulses of Bright Light in Shift Workers

Design: paired trials without and with naps and bright light. Setting: Real driving on a private road circuit. Environmental controlled car. Participants: 9 shift workers on tree shifts (morning-afternoon-night) Measurements: Sleepiness at the wheel was measured by ambulatory polysomnography and assessed using 30 seconds segments of recordings when the percentage of theta EEG was at least 50% (15 seconds) of the period recorded. Subjects were also called to rate their sleepiness on the 7-point Stanford Sleepiness Scale (SSS).

Intervention: Participants drove the same car on two similar 24 hours periods of work, with three pilots in each shift (morning, afternoon, night), separated by three weeks. During the baseline period, the subjects were told to manage their rest as they usually do in the real life. During the second experimental period, they had to rest lied in a dark room during two naps of 20 minutes and then exposed to bright light pulse (5000 lux) during 10 minutes.

Results are submitted to publication

Eligibility Criteria:
Inclusion Criteria:

* A professional experience of at least one year

Exclusion Criteria:

* With an history of chronic disease,treatments (or toxic)
* Subjects with a suspicion of sleep disorders
* Snorers
AMIStem-H Radiographic Analysis

Total hip replacement (THP) is widely used for hip osteoarthritis treatment. Surgeons are constantly looking to improve all aspects related to this procedure weather is improvement of implant design, instrumentation or surgical technique. Excellent clinical and radiological results were observed at medium and long term in the last years for AMIStem system.

This observational study has the objective to survey hip prosthesis stability and function of the operated hip in patients who are not exposed to surgical risks. The principal investigator will contact all patients in order to perform the follow-up visit according to standard practice. Patients operated between January 2010 and December 2011 will be invited in the study during the clinical visit organised according to standard practice. Preoperative clinical and radiological data, intraoperative details and postoperative follow-up data at 1-year will be retrospectively collected. Five-year and ten-year data will be prospectively collected after inclusion in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Patient who has received a total hip arthroplasty between January 2010 and December 2011
2. Patient who has received an AMIStem H femoral component
3. Patient who have signed the information letter in order to give agreement for the clinical data treatment

Exclusion Criteria:

1. Minor patient
2. Pregnant or breast feeding woman
3. Any patient who cannot or will not provide informed consent for participation in the study
CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy

This study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* B-cell CLL
* No previous chemotherapy, radiotherapy, or immunotherapy

Exclusion Criteria:

* Reduced organ function, or bone marrow dysfunction not due to CLL
* Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer
* Patients with a history of severe cardiac disease.
Nebulized Procaterol Versus Nebule Salbutamol for the Treatment of Moderate Acute Asthma

The purpose of this study is to compare the efficacy and safety of nebule procaterol with nebule salbutamol in the treatment of moderate acute asthma.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with moderate acute asthma according to Global Initiative for Asthma (GINA) 1998 (Appendix 1). Patients with moderate acute asthma according to Modified Global Initiative for Asthma (GINA) 1998 (Patients with asthma score 5 - 11; PEFR ≤ 80% predicted)
2. Patients of both gender aged 15 to 60 years
3. Patients still have the ability to undergo examinations and give written informed consent

Exclusion Criteria:

1. Pregnant and lactating women
2. Smokers
3. Patients with heart disease, hyperthyroidism, diabetes mellitus, COPD or other chronic diseases
4. Patients with signs of severe infections
Intermediate Cervical Block Under Ultrasound for Thyroid Surgery: Impact on Per and Postoperative Opioid Consumption

The investigators included prospectively 35 patients undergoing an intermediate cervical block under ultrasound (GP1) before a thyroidectomy ,compared to a group of 35 patients without a block (GP2).

The investigators performed prospective trial with 70 patients randomized in two groups each of 35:

* Group 1 (GP1): bilateral echo-guided intermediate cervical plexus bloc (ICB) by 10 ml of isobaric Bupivacaine (0.25%).
* Group 2 (GP2): control.

Ten minutes after ICB, general anesthesia was realised. Total dose of Remifentanil is calculated upon awakening, the postoperative pain is determined by visual analog scale from 0 to 10 (VAS) statements to H0, H2, H4, H6, H12 and H24. Whenever VAS is greater than or equal to 4, a morphine titration was administered.

Total dose consumption, side effects and satisfaction are noted at the end of protocol.

Eligibility Criteria:
Inclusion Criteria:

* candidate for thyroidectomy
* reoperation l

Exclusion Criteria:

* no consent
* BMI\> 34
* allergy to any of the products used
* reoperation
Coconut Oil in Treatment of Periodontitis

Virgin Coconut Oil (VCO) is a vegetable oil extracted from coconut fleshcontains unsaturated fatty acids in the form of oleic acid and linoleic acid and flavonoids which function as anti-inflammatory. Periodontitis is an inflammatory disease of the periodontal tissues with a high prevalence worldwide. The main etiology of plaque periodontitis is biofilm containing colonies of pathogenic microorganisms. The aim of the study is to evaluate and compare the effect of scaling and root debridement alone versus the use of topically applied coconut oil as adjunctive to scaling and root debridement in treatment of Stage II and III Grade B periodontitis.


Eligibility Criteria:
Inclusion Criteria:

* patients age group \>35 years without ant systemic disease
* Willing to take part in the study. Patients with more than 16 natural teeth and have test teeth with both mesial and distal neighboring teeth with periodontitis with clinical attachment loss \>3 mm and radiographic percentage of bone loss/age ranged between 0.25 to 1.
* Patients with no history of allergies to coconut

Exclusion Criteria:

* smokers
* pregnant
* lactating women
* Teeth with both endodontic-periodontal lesion.
Assessment of Myocardial Disease in Man Using Novel Non-invasive Diagnostic Tools

This study will be testing two devices which are designed to detect cardiovascular disease in patients as early as possible. As there are now many therapies to prevent and treat this condition it is believed that detecting it early will help reduce the burden of the disease and permit more effective treatment.

The two devices the investigators are testing are the ViScope developed by HD Medical and a device developed by CSIRO. Both of these devices are simple, non-invasive and may provide useful information on how well the heart contracts and relaxes as well as valve function of the heart.

The investigators are planning to enroll 100 healthy subjects, 100 participants with risk factors for heart failure and 300 patients with varying types of heart failure.

The data collected from the experimental devices will be compared to the results from standard tests.

Patients will not have any of their therapies altered as part of this study.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Have provided consent

Risk factor patients also require:

* Hypertension \> 2 years
* Diabetes \> 2 years
* Known ischemia, TIA, or stroke
* Arrhythmia; or reduced renal function (eGFR\<50 ml/min)

Heart Failure patients also require:

* LVEF \<40%
* Receiving standard medication for the treatment of symptomatic systolic heart failure with an NYHA Class of II-IV.

Exclusion Criteria:

Health patients (must not have any of the following):

1. Cardiovascular disease
2. Receiving cardiovascular medication
3. Not in normal sinus rhythm (also required for HF patients)
The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Spinal Taps

The reported rate of unsuccessful spinal taps in children, especially young infants, is high. Our hypothesis is that ultrasound assistance can improve the success rate of spinal taps.

The reported rate of unsuccessful spinal taps in children is high. At the Children's Hospital of Philadelphia (CHOP), quality improvement data demonstrates a failure rate of \~40-50%. Research has shown that bedside ultrasound can improve visualization and improve the success rate of spinal taps. Increasing the proportion of successful spinal taps in the emergency department could significantly reduce the rate of unnecessary hospitalizations, additional interventional procedures and antibiotic use. Our objective is to determine if bedside ultrasound-assisted site marking will increase the proportion of first attempt successful spinal taps. This will be a prospective, randomized controlled study that will take place over the course of 18 months with the goal to recruit a sample of approximately 128 patients. We will recruit subjects from the CHOP Emergency Department. The patients will be randomized into an ultrasound-assisted group versus a non-ultrasound-assisted group. Our hypothesis is that bedside ultrasound-assisted site marking will increase the number of successful spinal taps.

Eligibility Criteria:
Inclusion Criteria:

* Less than or equal to six months of age
* Plan for diagnostic or therapeutic lumbar puncture as per front line clinician
* Availability of a study sonographer to perform bedside ultrasound

Exclusion Criteria:

* Known spinal cord abnormality (e.g., tethered cord, spina bifida)
A Study of Darunavir in Combination With Cobicistat or Ritonavir, and Dabigatran Etexilate in Healthy Participants

The purpose of this study is to evaluate effect of single and repeated doses of darunavir (DRV) in combination with cobicistat (DRV/COBI) and with ritonavir (DRV+rtv) on the pharmacokinetics of single dose dabigatran etexilate (measured in plasma as free and total dabigatran) when co-administered in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Must have a body mass index (BMI) (weight in kilogram \[kg\]/height\^2 in square meters \[m\^2\] ) between 18.0 and 30.0 kg/m\^2 (inclusive) and body weight not less than 50.0 kg
* Must sign an informed consent form (ICF) indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study
* A woman must have a negative highly sensitive serum beta human chorionic gonadotropin (beta hCG) pregnancy test at screening, on Day -1 (only if the test performed at screening was greater than \[\>\] 4 days before dosing), and at the end of the study
* Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 90 days after receiving the last dose of study drug
* Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last dose of study drug

Exclusion Criteria:

* Clinically significant abnormalities during physical examination, vital signs, or 12 lead - electrocardiogram (ECG) at screening as deemed appropriate by the investigator
* With any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
* With a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
* Has donated blood or blood products or had substantial loss of blood (more than 500 milliliter \[mL\]) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study
* Has received an investigational drug or used an investigational medical device within 60 days before the first intake of study drug
A Randomized Study Comparing Lamivudine Versus Adefovir Dipivoxil for Prevention of zHBV Reactivation in HBsAg Seropositive Patients Undergoing Cytotoxic Chemotherapy

Liver diseases due to hepatitis B reactivation are serious causes of morbidity and mortality in hepatitis B infected patients treated with chemotherapy. We have previously shown that with pre-emptive use of lamivudine, one can drastically reduce liver-related morbidity and mortality in such patients. However, due to the development of hepatitis B virus resistance to lamivudine, some of these hepatitis B infected patients still develop hepatitis. This is a research study aiming to compare the use of adefovir dipivoxil to lamivudine in hepatitis B infected patients treated with chemotherapy. Both of these drugs have been approved for the treatment of the hepatitis B infection in the United States, European Union and Hong Kong.

All patients who were recruited in this study will receive study medication, either lamivudine 100 mg daily or adefovir dipivoxil 10 mg daily to cover the entire period of chemotherapy for 72 weeks. All patients will be follow-up for an additional 24 weeks thereafter. Altogether, 70 subjects will be recruited from Queen Mary Hospital, Hong Kong SAR.

This is an open-label study, which means that the patients and the study doctor will know which treatment the subjects are assigned into. If a subject decides to take part in the study and is found eligible, he/she will be randomly (like flipping of coin) assigned to one of the following dose groups:

Lamivudine (100 mg) tablet Adefovir dipivoxil (10 mg) tablet


Eligibility Criteria:
Inclusion Criteria:

* HBsAg+, nucleoside/nucleotide analogue naïve, malignant disease for iv chemotherapy

Exclusion Criteria:

* HCV+ HDV+
Comparison of Changes in Tumor Burden in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in Metastatic Castration-resistant Prostate Cancer

To demonstrate the prognostic value of using post-therapy 177Lu-PSMA SPECT/CT versus 68Ga-PSMA-11 PET/CT in mCPRC patients progressing despite chemotherapy and treated with 177Lu-PSMA.

Since few years, therapy by 177Lu-PSMA in nancy hospital began. A lot's of datas were collected. Prostate cancer is the number one killer in france and this is very important to find a diagnostic tool.

The hypothesis of this study is to demonstrate the prognostic value of using post-therapy 177Lu-PSMA SPECT/CT versus 68Ga-PSMA-11 PET/CT in mCPRC patients progressing despite chemotherapy and treated with 177Lu-PSMA.

Eligibility Criteria:
Inclusion Criteria:

* patient who received a dose of 177lu-PSMA
* patient who had imaging by 68Ga-PSMA
* patient treated in Nancy hospital for its cancer prostate

Exclusion Criteria:

* no social security
* no acceptation to participating in retrospective study
Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia.

The goal of this clinical trial is to test the impact of Virtual Reality (VR) assistance for anxiety management of patients undergoing prostate biopsies in local anaesthesia.

The main question it aims to answer:

- Is there a significant decrease on anxiety level thanks to VR-assistance?

Participants will be equipped with VR headset providing an immersive visual experience accompanied with a hypnoses oriented audio during the entire procedure.

Researchers will compare standardised anxiety scores with a control group.


Eligibility Criteria:
Inclusion Criteria:

* Indication for prostate biopsies
* Informed consent

Exclusion Criteria:

* Local anaesthesia contra-indication (allergy)
* Claustrophobia
* Major cognitive impairment and impossibility of answering the standardised questionnaires
Turmeric Based Therapy in the Treatment of Psoriasis: A Clinical Trial

Psoriasis affects around 4% of world population. The disease could be disabling and disfiguring dermatologic condition. World Health Organization (WHO) has recently drawn the attention to the inadequate treatment options psoriasis patients suffer from among other problems. Furthermore, the available treatment options have many side effects. A lot of the effective treatment options are either expensive or not appropriate for hepatic patients who represent a large subset of Egyptian psoriatic patients. This highlights the need for inexpensive and safe alternative. The effectiveness of Turmeric in psoriasis treatment have been addressed in few reports. Having an immune modulatory effect especially as anti NFκB it is expected to be effective therapy with minimal side effect. Up to the investigator's knowledge this is the first study addressing the efficacy of combined turmeric and olive oil based topical therapy in psoriasis treatment

Psoriasis is a prevalent skin disorder. It affects around 4% of world's population. It can be disfiguring and disabling in severe cases. There is dysregulated immune response in psoriatic patients to unknown injurious agents with upregulation of Th1/Th17 pathways which is mediated via Nuclear Factor kappa B (NFκB). NFκB is a key player in psoriasis development; its activation and nuclear translocation is present in every step of the way of psoriasis starting from keratinocyte release of cytokines -in response to stress- to the maturation and activation of dendritic cells, to the continuous loop of T cell activation.

Turmeric extract has anti-inflammatory, anti-oxidant, anti-microbial and anti-carcinogenic effects. It has inhibitory effects on NF-κB and various cytokines production.

In this clinical trial 5 groups of patients with mild to moderate psoriasis are recruited; group (A) Receiving the Turmeric extract based ointment only. Group (B) receiving Turmeric extract + olive oil based treatment. Group (C) will serve as negative control receiving only petrolatum base. Group (D) will receive NB UVB serving as positive control. Group (E) will receive established topical treatment serving as positive control.

Each patient will be assessed on weekly bases clinically for the disease severity using PASI score and via dermatoscope. Histopathological evaluation (H\& E along with NFkB expression analysis) will be done at 4 points of time baseline, 4 weeks, 8 weeks, 12 weeks through the study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with mild to moderate psoriasis vulgaris of any age \& gender.
2. Patient didn't receive any systemic or topical therapy for psoriasis the last 4 weeks.

Exclusion Criteria:

1. Patients previously received topical or systemic therapy for psoriasis in the past 4 weeks.
2. Patients with pustular or erythrodermic psoriasis.
3. Patients with other dermatological diseases.
4. Patients have hypersensitivity from the active ingredients of the therapy.