cyrilzakka/clinical-trials huggingface dataset:
Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation

The investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. Patients (at least 50 years old) before and after lung transplantation will be enrolled. The investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.

Solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for reactivation of all herpesviruses including VZV. Epidemiologic studies show the cumulative incidence in lung transplant recipients of reactivation to be 15-20%. A non-live, recombinant subunit vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older. The investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. Patients (at least 50 years old) before and after lung transplantation will be enrolled. The investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.

Eligibility Criteria:
Inclusion Criteria Post-Transplant Vaccine Group:

* Single or double lung transplant recipient.
* Age ≥50 years

Exclusion Criteria Post-Transplant Vaccine Group:

* Has already received varicella zoster subunit vaccine in the past
* Shingles within the last 12 months
* Ongoing CMV viremia \> 200 IU/mL
* HIV infection
* Diagnosis of malignancy (eg PTLD)

Inclusion Criteria Pre-Transplant Vaccine Group:

* On waiting list for lung transplantation
* Age ≥50 years

Exclusion Criteria Pre-Transplant Vaccine Group:

* Has already received Shingrix or Zostavax (live shingles vaccine) in the past
* Systemic prednisone ≥20 mg per day (or equivalent dose of any corticosteroid)
* Other (than prednisone \< 20mg per day or equivalent dose of any corticosteroid) systemic immunosuppressive therapy such as mycophenolate or tacrolimus
* Shingles within the last 12 months
* HIV infection
Pain Coping Skills and Meaning-Centered Intervention

The proposed study seeks to develop and test a novel psychosocial pain management intervention for patients with advanced cancer. It is hypothesized that the intervention will demonstrate feasibility, acceptability, and preliminary efficacy. The first aim is to develop a combined pain coping skills training and meaning-centered psychotherapy intervention. The second aim is to test the intervention's feasibility and acceptability as well as preliminary efficacy for improving primary outcomes (i.e., pain, pain interference, and meaning in life) and secondary outcomes. Two efficacious, theory-driven interventions will be integrated to address pain management by teaching pain coping skills with a novel emphasis on enhancing a sense of meaning in life. Participants will be patients with advanced cancer and moderate-to-severe pain. The study will be conducted in two phases. Phase I of the study will be intervention development. The intervention content will be guided by theory and mentoring from a team of leading experts in pain management and meaning-centered psychotherapy. Initial intervention content will be further informed by interviews with patients with advanced cancer. Content will then be refined through an iterative patient testing process. Phase II of the study will be a single-arm pilot trial testing the intervention. The intervention will be delivered in-person and consist of four, 45-to-60 minute therapy sessions delivered using videoconferencing technology. Study measures will be collected at baseline (0 weeks), immediately post-intervention (5 weeks), and 4-weeks post-intervention (9 weeks).

Effective pain management is a major healthcare concern for patients with advanced cancer. Compared to patients with early-stage disease, those with advanced cancer report higher levels of pain and greater functional impairment related to pain. There is a critical need for psychosocial pain management interventions that are specifically designed to address the suffering of patients with advanced cancer. The proposed study seeks to develop and assess the feasibility, acceptability, and preliminary efficacy of a novel integration of pain coping skills training and meaning-centered psychotherapy for patients with advanced cancer and moderate-to-severe pain.

Eligibility Criteria:
Inclusion Criteria:

* Stage IV solid tumor cancer diagnosis; or stage III pancreatic or lung cancer diagnosis
* At least moderate pain (pain score \>/= 4) at recruitment
* Clinically elevated distress (NCCN Distress Thermometer \>/= 3) at recruitment
* Eastern Cooperative Oncology Group (ECOG) \</= 2 at recruitment
* Ability to speak and read English

Exclusion Criteria:

* Brain tumor diagnosis
* Significant cognitive impairment
* Serious mental illness that would interfere with engagement in the intervention (e.g., schizophrenia)
I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy

* To evaluate Blood Pressure (BP) reduction to the targeted values (BP ≤ 140/90 mm Hg in non-diabetic patients, and ≤ 130/80 mm Hg in diabetic patients).
* To emphasize and to evaluate the benefit of Irbesartan in the reduction of left ventricular mass index in hypertensive patients with left ventricular hypertrophy.
* To demonstrate safety of Irbesartan in this population.


Eligibility Criteria:
Inclusion Criteria:

* Patients with proven mild to moderate Hypertension.
* Patients must have left ventricular mass index \> 130g/m2 in men, \> 100g/m2 in women, as evidenced by echocardiography before inclusion.
* Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension). OR,
* Patients who were receiving antihypertensive agents (maximum two agents including one diuretic) with blood pressure targets achieved, yet, in the investigator's opinion, those patients would benefit more from switching to the study medication. These patients will undergo a wash out period for not less than 7 days prior to enrollment.

Exclusion Criteria:

* Severe hypertension (Systolic BP ≥ 180 mm Hg or Diastolic BP ≥ 110 mm Hg).
* Patients with left ventricular ejection fraction \< 45%.
* Patients with severe left ventricular hypertrophy.
* Patients with known secondary hypertension (for another cause other than type 2 Diabetes Mellitus).
* Diabetic patients with HbA1c \> 10%.
* Significant chronic renal impairment (Serum creatinine \> 2.0 mg/dL).
* Significant liver disease as shown by SGPT/SGOT (ALT/AST) \> 2.5 times the upper limit of the normal range.
* Currently pregnant or lactating females.
* Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
* Any patient who is in need for a combination antihypertensive therapy from the start (from the medical point of view of his/her physician).
* Known hypersensitivity to irbesartan, other ARBs(Angiotensin Receptor Blockers), hydrochlorothiazide, or other thiazide diuretics.
* Patients with malignancy during the past 5 years, known collagen disease or severe cardiac, cerebrovascular or gastric disease.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Product Surveillance Registry

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.


Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive or be treated with an eligible Medtronic product
* Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment

Exclusion Criteria:

* Patient who is, or will be, inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Registry of Acute Coronary Syndrome in the Regional Cardiovascular Center

The study is a prospective registry of patients consequently admitted to the regional cardiovascular center with a diagnosis of acute coronary syndrome, in order to study the behavior of patients from the first minutes of the onset of the anginal syndrome, and influence of the delay in calling of ambulance on short-term and long-term outcomes of the disease. Other factors which may influence short-term and long-term outcomes will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 18 and over, permanently residing in the Moscow region and in Moscow.
2. Patients hospitalized in the Regional Vascular Center of Stupino Clinical Hospital (GBUZ MO SKB) with a diagnosis of ACS with and without ST-segment elevation.
3. Signing an informed consent form to participate in the study and the processing of personal data, as well as conducting a telephone survey during the follow-up.

Exclusion Criteria:

1. The patient's refusal to participate in the study and to allow the use of personal data during the study.
2. The presence of mental illness.
3. The patient plans to leave Russia for permanent or long-term residence.
Methodology Antiseptic Application, Influence on Oral Biofilm.

The study has the objective to compare two different methodology of application the antiseptic on the oral biofilm will be formed during 48h in situ on a specific device. The first one using the immersion in the antiseptic solution, as much of the authors did in the past. And the second way doing a active mouthwash, as the manufacturer recommends.

The study will compare two different antiseptic solutions, the chlorhexidine (0.2% Oraldine Perio) and the essential oils (Listerine Mentol) with the two different application and compared the bacterial vitality, thickness and covering grade between solutions and with a basal sample.

15 healthy volunteers, between 20 and 45 years old, will use during 48 hours two specific oral devices with 3 glass disks each. After this period, one of the disk will be drawn from the device and it will be immersed in Live/Dead BacLight solution for 15 minutes and then the disk will be analysed by the Confocal Laser Scanning Microscope (CLSM). Immediately, another disk will be removed from the intraoral device and immersed in the antiseptic solution, being analysed by the CLSM as well. After that, the volunteers will do the mouthwash with the antiseptic solution (as stated in the specific protocol) and the last disk will be drawn from the device and will be analysed by the CLSM following the same protocol. The other 3 disk will undergo the same protocol of baseline, immersion and mouthwash, but with the other antiseptic solution.

The CLSM data will be analysed and the bacterial vitality, thickness and covering grade will be calculated. Finally the statistical analysis will be applied (Pairwise comparisons, with the Bonferroni adjustment).

Eligibility Criteria:
Inclusion Criteria:

* good oral health status: a minimum of 24 permanent teeth with no evidence of gingivitis or periodontitis and absence of untreated caries

Exclusion Criteria:

* smoker or former smoker
* presence of dental prostheses or orthodontic devices
* antibiotic treatment or routine use of oral antiseptics in the previous three months
* presence of any systemic disease that could alter the production or composition of saliva
Alternative to Intensive Management of the Active Phase of the Second Stage of Labor

Active phase of the second stage of labor corresponds to period of maternal expulsive efforts (i.e. pushing). An intensive management of this phase is usual in France. This study aims to evaluate the impact of an alternative "moderate" management during this pushing phase on neonatal and maternal issues and mode of delivery.

Management of the active phase of the second stage of labor is not an evidence-based practice. Management of this phase differs between countries. In France, national guidelines recommend to limit maternal expulsive efforts to 30 minutes (grade C). Thus, physicians (midwives and obstetricians) encourage usually women to push 3 times per contractions and to push on every contraction in order to deliver into a 30 minutes timing.

This study aims to evaluate the impact of an alternative "moderate" management during this pushing phase on neonatal and maternal issues and mode of delivery. In the intervention group, i.e. "moderate" pushing, women are encouraged to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.

The hypothesis is that "moderate" management of the active phase of the second stage allows decreasing frequency of neonatal morbidity at birth, decreasing frequency of operative delivery and increasing maternal satisfaction.

Eligibility Criteria:
Inclusion Criteria :

* primiparous women
* singleton fetus
* fetal cephalic presentation
* ≥37 gestational weeks
* living fetus
* Patient with epidural analgesia
* Major Female
* Women understand French

Exclusion Criteria :

* Abnormal fetal heart rate requiring hastening childbirth
* cervical dilatation \< 8 cm
* intrauterine fetal growth restriction \<5e percentile,
* Fetal malformation,
* history of gynecological surgery with uterine scar
* Women do not understand French,
* women with psychiatric condition
* contraindication to intensive management of active second stage (severe myopia, respiratory or cardiac failure)
* no affiliation to a social security scheme (beneficiary or assignee)
Efficacy of 10-day and 14-day Sequential Therapy Versus Triple Therapy on the Eradication of Helicobacter Pylori

Background: Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce the occurence or recurrence of these diseases. However, the eradication rate of clarithromycin-based triple therapy has been declining in recent years, probably related to the increasing resistant rate to clarithromycin. It was estimated that 15-20% of patients would fail from first line standard eradication therapy and need second line rescue therapy. About 15-30% of patient would fail from second line therapy and need to be rescued with third line therapy. In recent years, the concept of sequential therapy has been advocated in the treatment of H. pylori infection. The regimen includes a PPI plus amoxicillin for five days, followed by a PPI plus clarithromycin and tinidazole for another five days. The eradication rate in the first line treatment of sequential therapy had been reported to be as high as 90%. More importantly, it has been demonstrated that the eradication rate among patients with clarithromycin-resistant strains could be as high as 89%. However, tinidazole is not available in many countries. Whether metronidazole would be an effective alternative to tinidazole in the sequential therapy remains unknown. Besides, whether extending the duration of sequential therapy from 10-day to 14-day would result in higher eradication rate also deserves further investigation. Furthermore, data on the efficacy of rescue regimens for patients who failed from first line sequential therapy are also lacking. The impact of clarithromycin, metronidazole resistance and CYP2C19 polymorphism on the sequential therapy containing metronidazole (rather than tinidazole) also has not been reported.

Aims: Therefore, we aim to assess

1. whether the substitution of metronidazole for tinidazole in the sequential therapy is also more effective than clarithromycin-based triple therapy
2. whether extending the duration of sequential therapy from 10-day to 14-day would achieve higher eradication rate
3. whether levofloxacin-based sequential therapy for 14-days is effective as second line rescue regimen for those who failed from first line sequential therapy
4. the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of sequential therapy


Eligibility Criteria:
Inclusion Criteria:

1. Patients are aged greater than 20 years who have H. pylori infection without prior eradication therapy and are willing to receive the sequential therapy will be eligible for enrollment.

Exclusion Criteria:

1. children and teenagers aged less than 20 years,
2. history of gastrectomy,
3. gastric malignancy, including adenocarcinoma and lymphoma,
4. previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin, metronidazole) and prompt pump inhibitors (lansoprazole),
5. contraindication to treatment drugs,
6. pregnant or lactating women,
7. severe concurrent disease,
8. Patients who cannot give informed consent by himself or herself.
Effects of Hypnosis Therapy on Outcomes in Shoulder Replacement Therapy

The purpose of this study is to collect information to evaluate the role of the psychogenic component of pain induced by anxiety on postoperative outcomes in major orthopaedic surgery and to determine whether hypnosis therapy provided during the perioperative period will lead to decreased use of opioid therapy. Patients are randomly assigned to one of two treatment groups: (I) usual care, or; (II) hypnotherapy treatment. Patients have an equal chance of being assigned to one of the two groups.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of primary shoulder osteoarthritis, massive cuff tear arthropathy, and rotator cuff arthropathy requiring a primary total or reverse shoulder replacement,
* the ability to read, speak, and understand English
* the ability and willingness to use a web-based application (OBERD) on a smartphone, pad, or computer, and
* 18 years of age or older.

Exclusion Criteria:

* shoulder replacement for the treatment of acute proximal humerus fractures
* hemiarthroplasty
* revision shoulder replacement
* patients with active cancer or receiving palliative care
* Less than 18 years of age
Mobile Phone-based Smoking Cessation Program

In this online, randomized controlled trial (RCT), the participants will be randomized and allocated in 1:1 ratio to mobile phone-based intervention group or to the wait-list control group. Participants will receive a 12-week intervention with follow-up at week 26. The primary outcome includes biologically verified continuous smoking abstinence at week 26 after the quit date. The main secondary outcomes include seven-day point prevalence smoking abstinence at weeks 1, 2, 3, 4, 8, 12, 16, 20 and 26, self-reported continuous smoking abstinence at weeks 4, 8, 12, 16, 20 and 26 after the quit date. About 2000 smokers with willingness to make a quit attempt within a month from October 2022 to April 2023 or until the recruitment process is complete will be recruited. The final 26-week follow-up will be completed in November 2023. The trial results will be available by the end of 2023 .


Eligibility Criteria:
Inclusion Criteria:

* In this RCT, approximately 2,000 smokers (a smoker is defined as an individual who smoked 100 cigarettes in their lifetime, and currently smoke ≥ 5 cigarettes per day) who are willing to make a quit attempt within one month with CVDs diagnosis or risk.

Exclusion Criteria:

* patients unwilling to quit smoking
ICG-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes

This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence imaging in the detection of prostate tumors and metastatic lymph nodes. By correlating the ICG fluorescence patterns with pathologically confirmed tumor and nodal status, it would be possible to use fluorescence navigation system in helping prostate biopsy and lymph node dissection in the future.

The investigators will conduct an in vivo and in vitro pilot study in order to evaluate the diagnostic performance of fluorescence in the detection of prostate cancer and metastatic lymph nodes. All the patients included in this study will receive a radical prostatectomy after intravenous injection of 0.4 mg/Kg of ICG. ICG will be administered immediately after the patient is anesthetized. The fluorescence analysis will be performed intraoperatively by laparoscopic imaging and after surgery by hand-held imaging. The prostate or lymph nodes specimen with or without fluorescence signal will be sent to the Department of Pathology for pathological analysis. The histopathological procedure will be performed without knowledge of fluorescence analysis.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate cancer;
* Able to accept total prostatectomy;
* Patient has given its informed consent.

Exclusion Criteria:

* Allergic to ICG or iodine;
* High-grade hepatic insufficiency
* refuse attending the study
REASSURE AV Registry

Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.

The Guidant ASSURE device is a fully featured pacemaker with additional atrial and ventricular tachyarrhythmia therapy features. The REASSURE AV study is a clinical evaluation to support approval of these features. This clinical study is intended to provide adequate performance data on two atrial tachyarrhythmia management features, namely the ATS and atrial ATP. In addition data will be collected to verify that the ventricular tachyarrhythmia rescue shock feature performs as intended in the clinical setting in combination with other pacemaker functions.

Eligibility Criteria:
Inclusion Criteria:

* The patient is willing and capable of providing informed consent at an approved clinical investigational center, and able to attend the investigational center as required by the protocol
* Patient is implanted with an investigational B301 device as part of the REASSURE AV study

Exclusion Criteria:

\* None