cyrilzakka/clinical-trials huggingface dataset:
EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging

This is a multicenter, observational study of the use of EmboCube Embolization Gelatin to control hemorrhaging and bleeding. The study is designed to enable the collection, analysis, and reporting of data from "real-world" use of EmboCube used in accordance with the Instructions for Use (IFU) associated with the product's CE Mark approval.

Data collection will include that relating to safety and effectiveness and the period of observation during which data will be collected will extend from the index procedure through 28 days post procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Subject requires embolization and is suitable for treatment with EmboCube in accordance with device Instructions For Use for the treatment of bleeding or hemorrhage.
3. Subject provides written informed consent to study data collection.

Exclusion Criteria:

1. Bleeding site in the neck, head, or brain.
2. Subject has co-morbidity with survival prognosis of less than 30 days, in the opinion of the treating physician
3. In the investigator's opinion, participation in the study may not be in the subject's best interest.
Biomarkers of Pain and Stress Perception and Dry Needling Technique Application

The use of the dry needling technique has become widespread in recent years for the treatment of musculoskeletal pain. Although dry needling has been shown to be effective in the treatment of shoulder pain, elbow pain, headache, etc., we do not yet have a clear understanding of the mechanisms of action that justify its beneficial effects.

In this study, we propose to analyse the biochemical markers of pain generated by the application of a dry needling technique on the lumbar musculature in patients with mechanical lumbar pain of non-specific origin.

The aim of this study will be to evaluate the effects of dry needling technique on the plasmatic concentration of biochemical markers.Furthermore, the test subjects will be randomly distributed into two groups.

An experimental group where the subjects will receive a real dry needling technique.

Another group will be treated with a sham technique.


Eligibility Criteria:
Inclusion Criteria:

* Mechanical lumbar pain of more than three months of evolution.

Exclusion Criteria:

* Medical diagnosis of lumbar disc herniation or protrusion.
* Low back and leg pain.
* Pregnancy.
* Fibromyalgia.
* Fear of needles.
* Medication with anticoagulants
Risk Factors Identification of Sepsis and Septic Shock After Major Abdominal Surgery Based on Artificial Intelligence

The goal of this observational study is to identify the risk factors and build the early warning system of sepsis and septic shock after major abdominal surgery based on artificial intelligence. The main questions it aims to answer are:

What are the high risk factors of postoperative sepsis? Which factors can accelerate the progression of sepsis? Researchers will collect perioperative characteristics to construct predictive models of postoperative sepsis in a retrospective abdominal surgical population based on artificial intelligence, and the accuracy of the models were tested in an external dataset.


Eligibility Criteria:
Inclusion Criteria：

1. Patients undergoing major abdominal surgery.
2. The surgeon performing the operation has extensive experience in specialized surgeries such as upper gastrointestinal, hepatobiliary and pancreatic, colorectal, gynecological, and urological surgeries, having completed at least 50 corresponding specialized surgical cases.
3. The anesthesiologist performing the operation has more than 5 years of clinical experience.
4. All surgical patients receive general anesthesia.
5. Patients are aged ≥ 18 years. Exclusion Criteria：

1. Pregnancy-related surgeries (cesarean section, abortion surgery). 2. Patients with known preoperative infection or suspected infection. 3. Severely malnourished patients (BMI reference values are 17 kg/m² for patients \< 70 years old and 17.8 kg/m² for patients \> 70 years old).

4. Patients who have previously undergone abdominal surgery. 5. Patients without sufficient data, including demographic variables (such as age, gender), surgical details (surgery duration, surgical grade, anesthesia grade, anesthesia duration), and hospitalization details (such as ICU stay, in-hospital mortality).
Children, Adolescents and Young Adults with Myeloproliferative Neoplasia: Study of Clinico-biological Characteristics and Complications (VYP)

The creation of a national database will provide access to solid data on the diagnosis of myeloproliferative neoplasia for patients under 30, giving a true picture of their care. It will also make it possible to identify the biological samples (histological and molecular) available in routine laboratories, enabling teams of researchers and anatomopathologists to (re)perform certain analyses to re-evaluate diagnoses and search for hitherto unknown molecular prognostic factors.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with non-LMC MPN before the age of 30 (PV or TE or MFP or PreMF) according to the 2016 WHO criteria.
* Signature of the consent form for participation in the FIMBANK project.
* Agreement to participate in the VYP study.
* Patient of legal age at the time of inclusion in VYP.
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Refusal to participate by patients of full age
* Patient under legal protection (guardianship, curatorship, etc.)
Study of Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI)

The purpose of this study is to assess the efficacy of pidotimod as treatment in participants with recurrent respiratory tract infections.


Eligibility Criteria:
Inclusion Criteria:

* Participants having the study informed consent signed by their parent(s) / guardian. Participants will also assent specifically for their study participation signing an independent assent form. Site specific ethics requirements will be followed
* Participants with history of respiratory tract infections (Chinese Clinical Concept and management of recurrent respiratory tract infections in children \[revised\] (2008) (Zhonghua er ke za zhi = Chinese journal of Pediatrics; 46 (2): 108-10) of either:

  * at least the following episodes of upper respiratory tract infections (ear/nose/throat) in the last year: 6 for those aged 3-5 years old at inclusion; 5 for those aged 6-14 years old at inclusion
  * OR at least 2 episodes of lower respiratory tract infections (trachea/bronchia/lungs) in the last 12 months
* Participants compliant with the pidotimod Chinese approved label (package insert) requirements

Exclusion Criteria:

* Participants with any immunodeficiency condition, either primary or secondary (including Acquired immunodeficiency syndrome \[AIDS\], cancers of the immune system, immune-complex disease, chemotherapy, and radiation)
* Participants with known allergies or hypersensitivity to pidotimod or any of its excipients. Antibiotics allergic participant will not be excluded; but due warning will be given
* Participants with immunomodulatory treatment washout period of less than 4 weeks up to baseline visit
* Participants with any concomitant severe disease at the time of screening that are judged by the investigator that could be detrimental to the participant or could compromise the study (e.g. congenital heart disease, Rheumatic immune disease, congenital deformity of trachea, chronic pulmonary disease, chronic liver and kidney disease, etc)
* Female pregnant or of child bearing potential, for whom the investigator suspects might maintain sexual intercourse, unless she has a negative blood pregnancy test at screening and agrees to use two methods of contraception during the study
* Participants who has previously completed or withdrawn from this study
* Participants with evidence of significant active neuropsychiatric disease, alcohol abuse or drug abuse, in the investigator's opinion
* Participants currently enrolled in, or discontinued within the last 30 days prior to baseline from a clinical study involving an off-label/new use of an investigational drug or device, or concurrently enrolled in a non-observational clinical study or any other type of medical research judged not to be scientifically or medically compatible with this study
* Participants who is unreliable and unwilling to make him/herself available for the duration of the study and who will not abide by the research unit policy and procedure and study restrictions
* Parents/Caregivers without cell phone, tablet or computer availability
Phenotypic and Genotypic Characterization of Malassezia Species Isolated From Malassezia Associated Skin Diseases

Genus Malassezia includes 14 species, namely M. furfur, M. sympodialis, M. globosa, M. restricta, M. slooffiae, M. obtusa, M. dermatis, M. japonica and M. yamatoensis associated with normal human flora but can also cause skin lesions, and M. pachydermatis, M. nana, M. equina, M. caprae and M. cuniculiare associated with animals. Few studies found that M. pachydermatis may be transmitted to humans from pets. M. pachydermmatis is the only lipid independent species while others are lipid dependent .

As Malassezia species have similar morphological and biochemical features, the currently used phenotypic techniques for diagnosis of Pityriasis versicolor usually do not allow rapid and exact characterization. In addition; they are time-consuming, multi-step processes requiring several experimental methods. Therefore, several molecular typing methods have been used successfully, resulting in identification and classification of new Malassezia species

Aim of the work:

1. Phenotypic and Genotypic Characterization of Malassezia Species.
2. Identify antifungal resistance pattern among isolated fungus.


Eligibility Criteria:
Inclusion Criteria:

Characteristic lesions of hypopigmented or hyperpigmented scaly macules and patches which may be associated with itching in patients with Pityriasis versicolor and scales of Seborrheic dermatitis and scales from patients with Atopic dermatitis.

Exclusion Criteria:

Patients with skin lesions of extensive desquamation or inflammation that do not match Pityriasis versicolor , Seborrheic dermatitis or Atopic dermatitis. Patients who had received topical antifungal therapy within last three months or oral antifungal therapy within the last six months
The Use of Noninvasive Brain Stimulation in Post-traumatic Stress Disorder

The purpose of this trial is to study the effect of noninvasive brain stimulation in adults with post-traumatic stress disorder.

The purpose of this trial is to study the effect of noninvasive brain stimulation on symptoms severity in adults with post-traumatic stress disorder.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old

Exclusion Criteria:

* Transcranial magnetic stimulation ineligibility
Age, Risk Factors for CVD and Cognitive Functioning

To relate cardiovascular disease (CHD) risk factors to cognitive performance among middle-aged and elderly men and women over a 10 year longitudinal study period.

BACKGROUND:

The Framingham Heart Study is a major epidemiological investigation of prospective relationships between risk factors for the development of cardiovascular disease (CVD risk factors) and CVD risk factor outcomes. The Framingham Study and other large, prospective studies have resulted in an extensive literature on the impact of CVD risk factors (including age) and CVD outcomes. Comparatively, there have been many fewer studies of the impact of CVD risk factors on cognitive functioning, and possibly no studies of the effect of objectively measured, competing risk factors on cognitive functioning.

DESIGN NARRATIVE:

Dr. Elias and colleagues used cardiovascular risk factor data from the Framingham Heart Study (N= 2,123) in a prospective design allowing them to relate CVD risk factors (including age and gender) to two outcome measures: (1) level of cognitive performance and (2) change in cognitive performance over a 10 year longitudinal study period. The overall goals were to determine the best multivariate combination of biological and psychosocial risk factors for the prediction of lowered cognitive ability in middle-aged and elderly men and women, and to evaluate the relative impact of age, gender, and other biological and psychosocial risk factors on cognitive functioning.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement

The goal of this randomised controlled trial is to compare the success of two types of hip replacement in patients with hip arthritis. The main question it aims to answer is whether a new type of hip replacement (called a hip resurfacing) can be as successful as an existing hip replacement (called a total hip replacement). Patients will be given either the new hip resurfacing or the existing total hip replacement and researchers will compare their function, complication rate and physical activity.

The H1 Implant is a cementless, ceramic hip resurfacing arthroplasty (HRA) device. The intended purpose of the H1 Implant is to provide an artificial substitute for a disease-damaged hip joint to replace the articulating surfaces of the hip while preserving the underlying femoral head and natural femoral neck. This is standard for a resurfacing hip prosthesis. This study will randomise patients to receive either The H1 Implant or a primary cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement (THR). Composite clinical success (CCS) scores, physical activity levels and patient reported outcome measures (PROMs) will be compared for the two groups. The primary objective of the study is to determine whether the H1 Implant is non-inferior to cementless THR in terms of CCS. The key secondary objective is to determine whether the H1 Implant is superior compared to cementless THR in terms of physical activity and PROMs. Other secondary objectives are to compare the H1 Implant and THR with respect to: safety, through collection of all device-related, operative site-related and systemic adverse events; and noise generation, through patient survey.

Eligibility Criteria:
Inclusion Criteria:

* Patient requires unilateral primary hip arthroplasty due to primary osteoarthritis, osteoarthritis secondary to e.g. trauma, avascular necrosis or developmental hip dysplasia, or inflammatory arthritis.
* Patient is willing to comply with study requirements.
* Patient plans to be available through 10 years postoperative follow-up.

Exclusion Criteria:

* Patient has a BMI greater than 40 kg/m².
* Patient has active infection or sepsis (treated or untreated).
* Patient has insufficient bone stock at the hip (\>1/3 necrosis of the femoral head or large and multiple cysts) or in general as in severe osteopenia or osteoporosis (t-score \< -2.5 as measured with BMD).
* Patient is not skeletally mature.
* Patient meets the contraindication criteria of the control device.
* Patient already has another lower limb arthroplasty or arthrodesis or will require a further lower limb arthroplasty or arthrodesis within the subsequent 2 years.
* Patient lacks capacity to consent.
* Patient is unable to understand the native language of the country where their procedure is taking place
A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

The purposes of this study are to provide medical management by giving treatment to the mother that will bring up the fetal platelet count and to minimize the number of invasive procedures to the fetus (which may result in serious fetal injuries).


Eligibility Criteria:
Inclusion Criteria:

Pregnant women are eligible for inclusion into the Very High Risk Group if they:

* are PLA-1 (platelet antigen A1) negative and have known platelet incompatibility with their fetus
* have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation (as best as could be estimated)
* are less than 19 weeks gestation

Pregnant women are eligible for inclusion into the High Risk Group if they:

* are PLA-1 negative and have known platelet incompatibility with the fetus
* have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation (as best as could be estimated)
* are between 12-30 weeks gestation

Pregnant women are eligible for inclusion into the Standard Risk Group if they:

* are PLA-1 negative and have known platelet incompatibility with the fetus
* have not had a previous child who suffered an antenatal hemorrhage
* are between 20-30 weeks gestation

Exclusion Criteria:

Women are not eligible for inclusion into the Very High Risk Group if they:

* have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation
* are greater than 19 weeks gestation

Women are not eligible for inclusion into the High Risk Group if they:

* have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation
* are greater than 30 weeks gestation

Women are not eligible for inclusion into the Standard Risk Group if they:

* have had a previous child who suffered an antenatal hemorrhage
* are greater than 30 weeks gestation
Cancer and Mild Cognitive Impairment a Patient-Caregiver Behavioral Intervention

The purpose of this study is to see whether programs that include both a patient and their spouse or a patient and family caregiver (known as a dyad) are helpful for families in which one member of the dyad has cancer and mild memory difficulties and/or concerns. Participant and their spouse or participant and their family caregiver will have six, 60-minute video-conference sessions which will be scheduled at their convenience. The investigator will loan participants a tablet computer (iPad) to use for videoconferencing and train the participant in its use. Participant and their spouse or participant and their family caregiver will complete three assessments - one before starting the sessions, one after the sixth session, and one after 1 month. Each assessment will include surveys, which the participant will complete separately from their spouse or family caregiver. For most people, it will take upwards of 2 - 4 months to complete this study.


Eligibility Criteria:
Inclusion Criteria:

Patient inclusion criteria include:

1. Patients with Stage I-IV breast, colon, rectal, or lung cancer (newly diagnosed within 6 months; age 65 or older.
2. Participants must be living at home (either in her/his own home).
3. Participants must be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.
4. Exhibit Mild Cognitive Impairment.
5. Have an informal family caregiver.

Inclusion Criteria:

(Partner or family member) inclusion criteria include:

1. Caregivers are 18 older.
2. Be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.
3. Either co-reside with the patient or spend at least 3-4 hours day caregiving.
4. Not exhibit cognitive impairment.

Exclusion Criteria for both patients and caregivers:

1. Participant has visual or hearing impairments that preclude participation.
2. Participant has dementia and do not have the capacity to participate.
3. Have a serious untreated psychiatric illness as documented in medical chart review.
4. The patient and the caregiver score less than a 3 on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) on a scale 0 to 10 to screen for distress.
A Multicenter, Randomized, Parallel, Two-period, Non-inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment

A phase III study, multicenter, randomized, parallel, open, two-period, comparative non-inferiority of Eurofarma versus Alenia® in the treatment of moderate to severe persistent asthma with and without obstructive pulmonary disease (COPD).

⚠️study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

In the first study period (Period 1), patients with moderate to severe persistent asthma according to GINA criteria, with or without COPD, will be randomized at a 1: 1 ratio to receive formoterol 12mcg / budesonide 400mcg Eurofarma or Alenia® 12mcg / 400mcg during 12 weeks Participants who maintain asthma control at the end of this treatment period (no more than one exacerbation during this period) will be included in Period 2, in which the dose of each investigational product will be reduced (step-down), and the patients will receive formoterol 6mcg / budesonide 200mcg Eurofarma or Alenia® 6mcg / 200mcg, respectively, for an additional 12 weeks. The primary non-inferiority assessment will be performed at the end of 24 weeks of treatment, with intermediate assessment at the end of week 12.

The study will be conducted in an open label since the devices for inhalation of products have different aspects, making it impossible to blind the treatments of the study. The primary efficacy variable (forced expiratory volume in one second \[FEV1\]) minimizes the potential bias arising from the open label of the study.

⚠️study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 12 years
* Presence of moderate to severe persistent asthma according to Global Initiative for Asthma (GINA) 1 criteria for at least 1 year, clinically stable (controlled) for at least 30 days.

Exclusion Criteria:

* Occurrence of asthma exacerbation within 30 days prior to initiation of study treatment.
* Presence of acute or chronic symptomatic airway infection.