cyrilzakka/clinical-trials huggingface dataset:
A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults

The purpose of this pragmatic randomized trial is to evaluate the relative vaccine effectiveness of high-dose quadrivalent influenza vaccine (QIV-HD) vs. standard-dose quadrivalent influenza vaccine (QIV-SD) in older adults. Participants will be randomized 1:1 to either QIV-HD or QIV-SD.

The study is a pragmatic, registry-based, open-label, active-controlled, individually randomized trial. The Danish nationwide administrative health registries will be used for data collection including baseline information, follow-up data, and safety monitoring. The study aims to randomize 339,700 participants over 3 influenza seasons. In each season, participants will be individually randomized 1:1 to receive either QIV-HD or QIV-SD. During the 2023/2024 and 2024/2025 seasons, up to 12,000 participants will be enrolled in a sub-cohort where participants are asked to perform home self-swabs and answer symptom questionnaires in case of influenza-like illness to enable further assessment of the impact of QIV-HD vs. QIV-SD on patient-reported outcomes among individuals with influenza-like illness and laboratory-confirmed influenza.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years and above (this inclusion criterion will be modified according to the Danish government's official recommendations for the 2022/2023 and 2023/2024 influenza seasons)
* Informed consent form has been signed and dated

Exclusion Criteria:

* There are no specific exclusion criteria for this study
Efficacy and Safety of ARTRA (Glucosamine Plus Chondroitin Sulfate Combination) in Treatment of Chronic Low Back Pain

To study the safety and efficacy of ARTRA (glucosamine chondroitin sulfate) in the treatment of non-specific low-back pain of lumbosacral localization in ambulatory care.

We enrolled patients between 40 and 65 years of age who had low back pain for at least 12 weeks with a pain intensity \>3 on a 0-10 point visual analogue scale (VAS). Major exclusion criteria were presence of fibromyalgia, degenerative spondylolisthesis, and alcohol and/or drug abuse. All patients were treated with ARTRA (combination of glucosamine hydrochloride 500 mg and chondroitin sulfate 500 mg in tab; Unipharm Inc.) at a dose of 1 tab bid for the first month and then 1 tab daily for the next two months. The primary endpoint was pain intensity (at rest and movement) as measured on a 0-10 point VAS. Secondary endpoints included Oswestry Disability Index, patient global assessment of efficacy (0-5 scale) and NSAID consumption.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 40-65 years, inclusively.
2. Pain intensity according to Visual Analogue Scale (VAS) \> 3 points.
3. Duration of back pain \> 12 weeks.
4. Pain reinforcement during movement in lumbar spine.
5. Osteoarthritis, spondylarthrosis, osteochondrosis.
6. Given written Informed consent form for participation in the study.
7. Treatment with ARTRA

Exclusion Criteria:

1. History of allergic reactions to chondroprotectors.
2. Participation in another clinical study within 30 days before screening or during this study.
3. Fibromyalgia.
4. Active neoplastic disease, history of neoplastic disease within 3 years before screening.
5. Paget's disease.
6. Degenerative spondylolisthesis.
7. Administration of anticonvulsant, antidepressant, barbiturate, anxiolytic, or muscle relaxant drugs for more than one week prior screening.
8. History of alcohol or drug abuse.
9. Frequent episodes of nausea, dyspepsia, pain in the epigastric region, diarrhea, face and extremities edema, dizziness and headache.
10. History of any disease that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the subject during participation in the study
11. Clinically significant renal disorders.

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To Evaluate the Efficacy, Safety, and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex)

This study is to evaluate 24-week efficacy and 52 week immunogenicity of subcutaneous Eporon versus Epoetin Alfa (Eprex) in the treatment of anemia associated with chronic renal failure in pre-dialysis patients. A total of 214 patients will be enrolled in Turkey.


Eligibility Criteria:
Inclusion Criteria:

* Glomerular Filtration Rate \<60 mL/min/1.73m2 (estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)
* Hemoglobin (Hb) level in the range of ≥7 g/dL and \<10 g/dL at screening
* Erythropoiesis Stimulating Agent (ESA) naïve subjects or previously treated subjects with ESA-free period of \>3 months (in case of pre-treatment with long-acting ESA such as pegylated epoetin, the long-acting ESA-free period of \>6 months)

Exclusion Criteria:

* Subjects who have received steady dialysis or subjects who are currently on dialysis
* Subjects who have rapid progression of chronic renal failure (as per investigators' discretion; e.g., a GFR decrease of \>20% within 12 weeks prior to screening)
* Subjects who have already undergone renal transplantation or who are scheduled for renal transplantation
Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy

This research investigates the use of autologous bone marrow stem cells for the treatment of medically refractory temporal lobe epilepsy patients.

The aim of this study is to evaluate autologous bone marrow stem cells transplantation as a safe and potentially beneficial treatment for patients with temporal lobe refractory epilepsy. We are mainly evaluating seizure frequency, hippocampal volume an cognitive performance

Eligibility Criteria:
Inclusion Criteria:

* temporal lobe medically refractory epilepsy patients with hippocampal atrophy

Exclusion Criteria:

* under 18 or over 65 years old patients
* previous neurological surgery
* other neurodegenerative diseases
Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Adjunctive Therapies

The aim of this study was to evaluate the effect of two different treatment agents used in conjunction with subepithelial connective graft technique on root coverage outcomes in multiple recession defects. Half of patients will receive root treatment with antimicrobial photodynamic therapy and the other half will receive photobiomodulation therapy by laser on surgery site.

Antimicrobial photodynamic therapy has been widely used in Periodontics to obtain reduction of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial resistance. Also, it has properties of root demineralization and exposure of collagen fibers. These properties may enhance root coverage in procedures of subepithelial connective graft. Laser photobiomodulation has the potential to increase healing and repair, this can generate gains in the root coverage and dental hypersensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Multiple Gingival recession - two or more Miller's class I or II (2 to 5 mm of height)
* Indication of root coverage by dentin hypersensitivity or esthetic.
* Minimum palate thickness (1,5mm)
* Visible Enamel cement junction (JCE) on the teeth to be treated and pulp vitality
* Patients without signs of periodontal disease activity and with plaque index and bleeding on probing throughout ≤20%;

Exclusion Criteria:

* Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based contraceptives, steroids)
* Smokers
* Pregnancy
* Diabetics
* History of head and neck radiotherapy
* Teeth with mobility
* Malpositioned teeth
* History of periodontal surgery at the area on the last 12 months
* Patients with orthodontic therapy in progression
The Effect of Prolotherapy in the Care Process of Pressure Injuries

The goal of this \[type of study: randomized controlled clinical trial\] is to \[Determining the effect of prolotherapy use on the wound care process\]. The main question it aims to answer is:

• \[The use of proliferative substances in the care of 1st, 2nd and 3rd stage pressure injuries has a positive effect on the wound healing period\].

Participants will \[in patients with pressure injuries, wound irrigation with saline and wound irrigation with gelofusin were applied\]. Researchers will compare \[depth, length and width of the wound\].

In the study, wound irrigation with saline and wound irrigation with gelofusin will be applied to patients with pressure injuries.

Cleaning of the wound can be done with gases moistened with saline, or irrigation method can be applied with the help of an injector. Sufficient pressure can be provided with an 18G needle attached injector. Irrigation with 50-100cc saline per square centimeter is recommended.

In the experimental group, the wound will be washed with gelofusine as prolotherapy, and the wound will be closed with sterile sponge and fixative tape. In the control group, the wound will be covered with sterile sponge and fixative tape by washing with physiological saline. This process will be repeated 2 times a day and will be repeated and observed for 3 days in line with the literature.

In this study, while the wound is irrigated, the solution will first be drawn into a 50 cc syringe and prepared. A protective cover will be used to prevent the sterile sponge, fixation tape, gloves and solution required for dressing from contaminating the patient bed. The patient will be given an appropriate position according to the location of the wound. The needle of the syringe containing the solution will be removed and kept at a distance of 3 cm from the wound area, and the solution will be slowly poured over the entire wound. When the irrigation process is finished, the wound area will be dried and the wound will be closed with sterile sponge.

Eligibility Criteria:
Inclusion Criteria:

* Patients with 1st, 2nd and 3rd stage pressure injuries
* Patients over 18 years of age
* Patients who volunteered to participate in the study

Exclusion Criteria:

* Patients without 1st, 2nd and 3rd stage pressure injuries
* Patients under 18 years of age
* Patients who did not volunteer to participate in the study
* Patients allergic to gelofusin solution
GilteRInf 2022 Study (Gilteritinib Related Infections)

The study is observational, retrospective-prospective, multicenter "real-life" study involving 26 centers belonging to the SEIFEM group. The goal of this study is to obtain a real-life experience in the management and outcome of infectious issues of patients with relapsed/resistant acute myeloid leukemia who receive Gilteritinib therapy, given that recent approval of this drug.

The study is observational, retrospective-prospective, multicenter "real-life" study. Regarding the retrospective part, clinical data will be collected on all patients with acute myeloid leukemia FLT3+ treated with Gilteritinib from when the drug was approved and marketed in Italy (April 2, 2020) until April 30, 2022. Enrollment in the prospective cohort will have an estimated duration of 24 months from the time of study approval. Patients enrolled in the last month will be followed for six months from the date of enrollment to check for the occurrence of any infections. For each case of a patient receiving salvage monotherapy with Gilteritinib, a control patient with relapsed/refractory FLT3+ acute myeloid leukemia on salvage chemotherapy should also be included.

Eligibility Criteria:
Inclusion Criteria:

Population

* All patients with FLT3+ relapsed/refractory AML to any line of therapy treated with Gilteritinib
* Patients ≥18 years of age
* Signature of appropriate informed consent

Exclusion criteria:

- Patients \< 18 years old
Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, with chronic genotype 1 HCV infection
* HCV RNA equal to or greater than 10,000 IU/mL at screening
* Cirrhosis determination; a liver biopsy may be required
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner
* Current or prior history of clinical hepatic decompensation
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Ovarian Cancer Treatment Platinum-sensitive Relapse - Cohort Study (PROSPECTYON)

The French cooperative group GINECO proposes to implement an observational study to describe a real situation, in daily practice tolerance and methods of administration of trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®, in ovarian platinum sensitive cancer relapse.

Population : Patients aged 18 years and older with an epithelial ovarian cancer, fallopian tube or primary peritoneal with platinum-sensitive recurrent witch it was decided to initiate a treatment with trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and over,
* Patients with an epithelial ovarian cancer, fallopian tube or peritoneal who will receive Yondelis®-Caelyx® in relapse platinum-sensitive
* Patients should be informed of the study orally and should not have any objection their data to be processed

Exclusion Criteria:

* Patient participation in a clinical trial
* Patient non-affiliated to a social security scheme.
Priming in Repetitive Transcranial Magnetic Stimulation in the Treatment of Obsessive Compulsive Disorder

Obsessive Compulsive Disorder results in high social impact, affecting quality of life and tending to a chronic course. A considerable proportion of patients, up tp 60%, remain with symptoms even thought treatment is administrated. Therefore, new therapeutic interventions are highly necessary. In this context, repetitive transcranial magnetic stimulation has been used for several psychiatric conditions, including OCD treatment. Moreover, many approaches of neuromodulation seem to reach a better result when used a priming stimulation. In an attemp to optimize particularities of the thecnique applied, this study aims to assess if a priming stimulation with rTMS might impact in a better outcome when compared with rTMS without previous stimulation.

This is a randomized, double-blind, sham-controlled clinical trial. Neuropsychological tests and a sociodemographic and clinical questionnaire will be used to assess and characterize the subjects. Participants captured by the Laboratory of Studies in Aging and Neuroscience at the Federal University of Paraíba will be divided into 02 groups, each with 16 patients, totaling 50 volunteers: Active - participants who will receive real priming stimulation; Sham - participants who will receive simulated priming stimulation. Participants entered through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1.

In the active priming, the parameters are: frequency of 6 Hz for 10 minutos, 80% do Motor Threshold (MT), 20 trains of 5 seconds, with intertrain interval of 25 seconds, a total f 600 stimulations. The group of innactive priming will have the same parameters, but without active atimulation. After this previous stimulation, all participants will receive the main stimulation: 10 sessions of rTMS, each lasting around 20 minutes, for 5 days a week, during two consecutive weeks.

The target area will be the supplementary motor area. Primary outcome will be assessed by change in Yale-Brown Obsessive Compulsive Scale scores. As secondary outcomes, it will be used HAM-A for anxiety, HAM-D for depression, CGI-S for global clinical impression and SF-36 for quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Being right-handed;
* Age between 18 and 60;
* Diagnose of OCD according to DSM-5;
* Score in YBOCS between 16 and 23;
* No change in dose prescription in the previous 3 months;
* Signature of informed consent term.

Exclusion Criteria:

* Being pregnant;
* Having cognitive deficit;
* Diagnose of drug use disorder;
* In current psychotherapy (or interrupted in less than 3 months);
* Diagnose of severe Major Depression;
* Risk of suicide;
* Patients with metallic implants in the brain;
* Epileptics.
Functional MRI of the Lower Extremities

In this project, the investigators propose to use high-resolution magnetic resonance imaging (MRI) to measure blood perfusion in different groups of calf muscle. This imaging approach is standard of care for evaluation of coronary artery disease (CAD), and has never been successfully applied to PAD. Preliminary results show distinct patterns of muscle perfusion between healthy and PAD patients, and thus great promise of the technique. The investigators will first verify the reproducibility of the technique, and then compare the calf muscle perfusion measures in PAD patients against healthy age-matched controls. This comparison will test the feasibility of detecting functional abnormality in PAD patients. After the baseline scans, the PAD patients will opt to undergo a 12-week supervised exercise therapy, and then a post-therapy MRI scan. Comparison of the pre- and post-therapy measurements will indicate how the therapy improves the calf-muscle perfusion, and how this perfusion change correlates with increases in patient's walking ability.

The long term goals of this project are to develop an improved diagnostic test for patients with PAD to predict who will benefit from therapeutic intervention. The MRI perfusion studies of calf muscle can be performed in conjunction with routine peripheral MR angiography to assess the functional significance of vascular stenosis.


Eligibility Criteria:
Inclusion Criteria:

PAD patients with

* Intermittent claudication
* Ankle-brachial blood-pressure index (ABI) \< 0.9

Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2
* Chronic pulmonary diseases
* Arthritis or other joint ailments
Test-Retest Reliability of the German Version of the Headache Disability Questionnaire (HDQ).

a translated and cultural adapted version of the HDQ will be tested on two occasions with headache patients who are currently in physiotherapeutic treatment due to their headache condition

The test-retest reliability of the German version of the HDQ will be tested to assess the reproducibility of the test results with a stable condition of the participants over a short period of time. For this purpose, it is planned to administer the questionnaire twice in row at an interval of 48 - 72 hours to headache patients in outpatient physiotherapy. The chosen setting limits the sample to a common intervention measure (physiotherapy), so that primary and secondary headache types can be included and the requirements of the original study can be maintained. In the period between the two tests, subjects should not receive physiotherapy, because it can often have different effects on headache. This can lead to uneven changes in the sample and affect the variance of the test results. However, subjects are allowed to take their usual medications. To avoid recall bias, an online survey tool (RedCAP) to conduct the questionnaire will be used. It is designed so that, only one question appears per slide, no overview of responses is allowed and the questions are displayed in a different order at the second testing. The lower prevalence of headaches after the age of 65 years is taken into account in the inclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* within physiotherapeutic care due to headache for no longer than 3 months
* headache conditions for at least one month and at least once /month
* live in Switzerland
* give informed consent

Exclusion Criteria:

* not in physiotherapeutic care
* in physiotherapeutic care due to other conditions not associated with headache
* younger than 18 and older than 65 years
text4FATHER R21: Social Media - Efficacy Trial

This project will be the first to examine the efficacy of a text messaging intervention designed to recruit first-time fathers-to-be using social media across the U.S. to become involved during pregnancy through two months of postnatal age to support infant, mother, and father well-being.

Father engagement in the prenatal and infant periods is associated with improved infant outcomes (e.g., physical, social and emotional health and development), and mother and father well-being. However, this key window of opportunity has been insufficiently leveraged to promote father engagement, especially, first-time fathers-to-be.

text4FATHER, a multi-modal text messaging program, is designed to increase first-time fathers' knowledge, self-efficacy, and behavioral engagement. text4FATHER sends texts twice-weekly to fathers with threaded content to support infant, partner, and father well-being including resource weblinks to support behavior change from mid-pregnancy through 2 months postnatally. Text content was developed using formative research and feedback from the target population, consensus building with experts, and an evidence-based review.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Live in the U.S.
* Speak English
* Mother gestational age at enrollment less than 25 weeks
* First-time father-to-be
* Willing/able to receive texts.

Exclusion Criteria:

* Individuals who are minors
* Do not speak English
* Unable to provide informed consent
* Not a first-time father
* Not willing/unable to receive texts
* In the past 12 months, any safety concern reported between father-to-be and the mother-to-be, including report of any physical, emotional, sexual harm, threatening behaviors, police involvement, restraining or protective order