cyrilzakka/clinical-trials huggingface dataset:
Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures

Percutaneous vertebroplasty is now a common procedures of patients with acute osteoporotic vertebral compression fractures in medical units all over China, but the efficacy and essentiality of the surgery remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment. Because of the procedure , neither patients nor investigators were blinded. The primary outcome was pain relief at 1 month and 1 year.

This study will use a randomised controlled trial to access the efficacy and essentiality of the surgery for vertebral compression fractures. Patients aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss) will be invited to take part. Patients will be randomised into 2 arms with average amount. The participants in the intervention arm will have percutaneous vertebroplasty ; those randomised to the control arm will receive current standard conservative treatment methods.

Patients were clinically assessed at baseline (the day of surgery or treatment), and at 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year afterwards. The primary outcome will be the pain release , categorised according to WHO classification.

Eligibility Criteria:
Inclusion Criteria:

* vertebral compression fracture on spine radiograph (minimum 15% height loss)
* level of fracture at Th5 or lower; back pain for 6 weeks or less
* focal tenderness at fracture level on physical examination
* bone oedema of vertebral fracture on MRI
* decreased bone density (T scores ≤-1)

Exclusion Criteria:

* severe cardiopulmonary comorbidity
* suspected underlying malignant disease
* radicular syndrome
* spinal-cord compression syndrome
* contraindication for radiography exam
Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm)

The purpose of this study is to evaluate the survival rate of 5 mm short implants compared to longer implants (10 mm) placed in sinus-grafted sites.

Primary aim: Compare bone loss between the two groups Secondary aim: Compare surgical time and patient-reported outcomes (satisfaction and post-operative pain)

34 patients requiring an implant to replace an upper missing tooth in the premolar or 1st molar area with a bone crest height from 5 to 8 mm will be recruited for this trial. Patients will be randomized to either the test (5-mm implant) or control group (10-mm implant) using a computer-generated randomization list . 17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant while the other 17 patients will receive a 5 mm short implant.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-70 years at enrollment
* Systemically healthy patients
* Full-mouth plaque score and full-mouth bleeding score ≤ 30% (measured at four sites per tooth)
* In need of one premolar or 1st molar dental implant in the maxillary area
* Neighboring teeth to the planned implant must have natural root(s) or implant supported restoration.
* Presence of natural tooth/teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crown/s deemed by the investigator as likely to present an initially stable implant situation
* Residual bone height under the maxillary sinus between 5 to 7 mm and a width of at least 7 mm, as measured on cone beam computer tomography (CBCT) scans.

Exclusion Criteria:

* Unlikely to be able to comply with study procedures
* Uncontrolled pathologic processes in the oral cavity
* History of head and neck chemotherapy within 5 years prior to surgery
* Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
* Uncontrolled diabetes mellitus HbA1c \>8
* Taking corticosteroids, IV bisphosphonates, or any other medication that could influence post-operative healing and/or osseointegration
* Smokes more than 10 cigarettes/day
* Bruxer
* Present alcohol and/or drug abuser
* Pregnant, unsure pregnancy status, or lactating females (self-reported)
Breathing and Decision-Making

The study aims to investigate how slow breathing with prolonged exhalation (i.e., ProlEx breathing) modulates decision-making under risk in healthy participants. To do this, a short-term breathing intervention is combined with a decision-making paradigm while neural, physiological, and behavioral data are recorded.

This interventional study investigates the modulatory effect of slow breathing with prolonged exhalation (i.e., ProlEx breathing) on decision-making under risk. Using functional magnetic resonance imaging (fMRI), the researchers seek to identify brain regions influenced by the breathing intervention during the decision-making task.

Sixty healthy participants will be invited to perform ProlEx breathing during a risky decision-making task. After initial preparations, each individual's spontaneous breathing rhythm will be determined (i.e., Eupnea, control condition). This step is to i) ensure a natural breathing pace for each participant and ii) incorporate cue-assisted breathing into the control condition to allow comparability across conditions. To further investigate the effect of ProlEx on sympathovagal tone, physiological measures of respiration, electrocardiogram, pulse, electrodermal activity, and pupil are acquired. During scanning, the participant will perform a decision-making task based on the paradigm by Tom et al. (2007). The breathing intervention is applied simultaneously with continuous cue-assisted breathing for both conditions (Eupnea, ProlEx) throughout the duration of the task. The experiment follows a block design with counterbalanced orders to control for confounding effects. After completion of the scans, the participants fill out additional questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Normal vision (no glasses or contact lenses required)

Exclusion Criteria:

* Smokers
* Extreme athletes
* Extensive lung function (e.g., professional musician, abnoedivers)
* Excessive stress
* Former or current physical or psychological illness (e.g., lung diseases)
* Current or previous medication within 2 weeks before the appointment
* Left-handedness
* Claustrophobia
* Tinnitus
* Non-removable metal parts or implants inside or on the body (e.g., hip replacements, copper IUD)
* Non-removable ferromagnetic objects inside or on the body (e.g., joint replacements)
* Non-removable magnetic objects inside or on the body (e.g., artificial eye)
* Large tattoos
* Young (\>18 years) or old (\>40 years) subjects
* Over- or underweight (BMI \<18 or \>25 kg/m2)
* Pregnancy
* Abnormal circadian rhythm (e.g., during shift work)
* Excessive alcohol consumption
* Illegal drug consumption within 2 weeks before the appointment
* Missing consent to participate
* Missing consent to receive incidental findings (MRI)
Big Data and Genomic Imaging for the Development of Biomarkers and Nanovector Drugs Innovative for Diagnosis and Therapy of Inflammatory Processes in Dementia

The correlation between data obtained by "imaging" in patients with neurodegenerative diseases characterized by inflammation and the presence in the peripheral blood of the same patients "biopsies liquid biopsies" of specific circulating nucleic acids, could enable the development of methods and algorithms capable of identifying novel biomarkers that serve as targets for the development of probes diagnostics and therapeutics. This is the context for the project idea, which is aimed at developing development of a performant multi parameter system capable of identifying novel biomarkers of microglial polarization that can be used for diagnostic and prognostic purposes in determining the staging/progression of neurodegenerative disease


Eligibility Criteria:
Inclusion Criteria:

All subjects of either sex aged 18 to 85 years who are able to provide voluntary consent, suffering from neurodegenerative diseases (AD and PD)

Exclusion Criteria:

All patients for whom there are contraindications to performing MRI. Also excluded from the study will be subjects who are pregnant, or presumed to be pregnant or undergoing of lactation and subjects with claustrophobia
Prevention of Functional and Cognitive Impairment in Hospitalized Oncogeriatric Patients

Hospitalized older patients usually remain bedridden for many hours and this may lead to the appearance of unwanted negative consequences, such as cognitive or physical decline upon discharge. Our study will analyze whether an intervention consisting of a multicomponent training programme applied to patients over the age of 60 who are hospitalized for acute medical conditions in an Oncology Department of a tertiary hospital improves functional capacity and cognitive function. A total of 50 hospitalized older adult patients will be recruited in the Hospital Universitario de Navarra, Pamplona, Spain. The participants will be randomized and included in an exercise intervention (n = 25) or a control (n = 25) group (hospital usual-care). The intervention consists of a multicomponent exercise training programme that will take place for 3 consecutive days (2 sessions/day). The control group will receive usual hospital care, which will include physical rehabilitation when needed. Functional and cognitive impairment after and during acute hospitalization in older adults are major determinants of the later need for health resources. If our hypothesis is correct and shows that a multicomponent, individualized and progressive exercise programme is an effective therapy for improving the functional capacity of acutely hospitalized older patients compared to usual care, a change in the current system of hospitalization may be justified in oncogeriatric patients with medical conditions


Eligibility Criteria:
Inclusion Criteria:

* Age \> 65 years
* Barthel Index ≥60 points
* Able to ambulate (with/without assistance)
* Sign the informed consent
* Able to communicate

Exclusion Criteria:

* Expected length of stay \< 6 days
* Terminal illness
* Very severe cognitive decline (i.e., GDS 7)
* Uncontrolled arrhythmias, acute pulmonary embolism, acute myocardial infarction or limb bone fracture in the past 3 months.
Effects of Salmeterol on Walking Capacity in Patients With COPD

This study was designed to test the following hypothesis:

The acute changes in exercise tolerance during the endurance shuttle walk will be greater with salmeterol compared to placebo in patients with chronic obstructive pulmonary disease.

Background: Little is known about the responsiveness of the endurance shuttle walking test (ESWT) to pharmacotherapy in patients with chronic obstructive pulmonary disease (COPD). This exercise testing modality needs to be further investigated because of its relevance for activity of daily living.

Objective: To evaluate, in patients with COPD, the responsiveness of the ESWT to detect improvement in walking performance after single dose of salmeterol.

Methods: In a randomised, double-blind, placebo-controlled, crossover study, 20 patients with COPD will perform, on two separate days, an ESWT at 80% of peak capacity, 2 hours after inhaling either a placebo or 50µg of salmeterol. Cardiorespiratory parameters will be monitored breath-by-breath during each walking test with a portable telemetric gas analyzer (Oxycom Mobile, Jaeger, Germany). Inspiratory capacities and Borg ratings for dyspnea were obtained every other minute throughout the tests.

Planned analysis. The main outcome will be endurance time. This variable will be compared between the two treatment arms using a paired t test. The time course of the cardiorespiratory parameters and dyspnea over time will be compared between the two exercise modalities. Comparisons will be done using a repeated measure design (ANOVA). Significance level will be set at a p value of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* age \> 50 years
* smoking history \> 10 packs/year
* FEV1 \< 70% of predicted and FEV1/FVC \< 70%.

Exclusion Criteria:

* respiratory exacerbation within the 2 months preceding the study
* history of asthma
* significant O2 desaturation (SaO2 \< 85%) at rest or during exercise
* presence of another pathology that could influence exercise tolerance.
Retrospective Observational Study About Evolution of Patients With Breast Cancer in Hospitals From GEICAM Group

This study is a non-interventional (NIS), multicenter, retrospective cohort study, which will obtain data from patients diagnosed with invasive breast cancer between 2002 and 2005 in the medical oncology departments of hospitals that are members of GEICAM (using information obtained from patient medical histories).

There is no specific treatment regimen for this study. This is an observational retrospective study in which the clinical decisions concerning the optimal strategy in the treatment of the disease for each patient have been taken independently and prior to the physician's decision to include patient data in this registry, in keeping with the drug information, local treatment guidelines and/or standard clinical practice.

The study target population are all patients (men and women) who have been newly diagnosed with invasive breast cancer between January 1, 2002 and December 31, 2005 and treated in the medical oncology departments of participating sites, ensuring an approximate follow-up of 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose first primary breast invasive tumor diagnosis occurred between January 1, 2002 and December 31, 2005 and who have received treatment in the medical oncology departments of participating sites.
* Patients who were diagnosed at the participating site; otherwise the site where the initial diagnosis was made should be contacted with in order to confirm that the patient has not already been enrolled in the study or pending inclusion. The objective is to avoid duplicate records for displaced patients.

Exclusion Criteria:

* Patients with a single diagnosis of in situ carcinoma (without infiltrating component).
Transition Care Model for Adolescents With Congenital Heart Disease

The primary aim of this study is to assess the effectiveness of a standardized transition care model (TC) on the perceived mental and physical health of adolescents with congenital heart disease (CHD). Furthermore, the secondary aims of this research are focused on providing a description of the impact of a standardized TC on overall healthcare needs, satisfaction, and engagement.

Therefore, a prospective, randomized, controlled, single-blind, and multi-center study will be conducted.

Congenital heart diseases (CHD) are some of the most prevalent and serious birth defects, representing a major global health problem. With a prevalence of 9.1 for 1000 live births, the CHD are the leading causes of birth defects associated with morbidity, mortality, and medical expenditures. Currently, 1.3 million children live with a CHD worldwide (3), and approximately 90% of them can survive into adulthood. In this scenario, the transition from childhood to adulthood is one of the most complex and delicate part of life for CHD patients. The multi-disciplinary standardized interventions to educate and support patients with CHD, described as "Transition Clinic" (TC), represent a key element in delivering care for patients during the transition from childhood to adulthood. However, most recent literature focuses on the CHD childhood clinical management or the CHD adulthood challenges (i.e., GUCH challenges). Thus, the attention to exploring the peculiarities of the transition period from childhood to adulthood in patients with CHD is underinvestigated by the lack of experimental studies \[i.e. randomized controlled trial (RCT)\] as the published evidence is related to the assessment of effects of the same model on outcomes without a control arm (pre-post test study design).

Eligibility Criteria:
Inclusion Criteria:

* Adolescent patients (aged between 12 and 18 years)
* Diagnosis of CHD, according to 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease
* All patients who express the willingness to participate in the study through the signing of the informed consent form and signature of informed consent by patients' parents
* Moderate and Complex CHD, according to the classification described by Warnes

Exclusion Criteria:

* Chromosomal abnormalities such as Down's syndrome and Marfan's syndrome
* Patients with cognitive impairment (assessed using Six Item Screener, SIS): if SIS ≤4
* Not understanding the Italian language
* Patients in pregnancy
* Simple CHD, according to Warnes (2001) (25).
Evaluation of Sodium Hypochlorite as a Denture Cleanser

The present study tried to integrate all aspects of denture care: patient satisfaction with the treatment, denture decontamination and base material defects after decontamination processing.

Considering that it is necessary to stipulate a simple and effective routine protocol for denture cleaning the aim of this study was to evaluate, in vivo, the efficacy of 0.5% sodium hypochlorite (NaOCl) as a denture cleanser and its effect on color stability and surface roughness of complete dentures. The patients' satisfaction with the denture cleaning method was also assessed.

Eligibility Criteria:
Inclusion Criteria:

* complete denture wearers; adequate general health conditions
* ability to comply with the experimental protocol
* time of denture use: at least one year prior the study
* denture base material: heat-polymerized acrylic resin.

Exclusion Criteria:

* the use of antifungal agents or antiseptic mouthwashes during the pre-experimental and experimental period.
Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma

To evaluate the clinical application value in bone marrow protection of Trilaciclib in the neoadjuvant treatment of stage II/III classic osteosarcoma in combination with pirarubicin and lobaplatin.

Classic osteosarcoma is the most common primary bone malignancy. At present, osteosarcoma is usually treated with preoperative chemotherapy, surgical operation and postoperative chemotherapy. Treatment with preoperative chemotherapy is also known as neoadjuvant chemotherapy. Neoadjuvant chemotherapy has brought benefits to patients, but safety concerns are inevitable. Myelosuppression is a major factor affecting the compliance of patients treated by chemotherapy. Patients with chemotherapy-induced myelosuppression(CIM) have higher rates of infection, sepsis, bleeding, and fatigue, resulting in hospitalization, hematopoietic growth factor support, blood transfusions (red blood cells and/or platelets) and even death. In addition, CIM often leads to dose reduction and delayed administration, which limits the therapeutic dose intensity and therefore affects the anti-tumor efficacy of chemotherapy.

Currently, there are no approved treatments in osteosarcoma to prevent chemotherapy-induced cell damage. Although some treatments may help to address CIM when it occurs such as blood transfusions and growth factors, these treatments are pedigree specific, being used after hematopoietic stem progenitor cells damage and could bring additional toxicity.

Trilaciclib is a highly effective, selective and temporarily reversible inhibitor of CDK4/6. The proliferation of bone marrow hematopoietic stem cells depends on CDK4/6 activity. Bone marrow hematopoietic stem cells are blocked in the G1 phase of the cell cycle after exposure to Trilaciclib before chemotherapy is given.

Therefore, this study is conducted to evaluate the clinical application value in bone marrow protection of Trilaciclib in the neoadjuvant treatment of stage II/III classic osteosarcoma in combination with pirarubicin and lobaplatin.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent signed;
2. Classic osteosarcoma confirmed by histopathology (high grade);
3. Newly diagnosed stage Ⅱ-Ⅲ based on Enneking staging criteria;
4. Planned to receive neoadjuvant chemotherapy;
5. Measurable disease on CT by RECIST 1.1.
6. No antitumor system therapy received;
7. ECOG 0-1
8. Adequate organ function.
9. Females of childbearing potential as well as males and their partners must agree to use an effective form of contraception during the study and for 6 months following the last dose of study medication.

Exclusion Criteria:

1. History of malignancies of other type;
2. Allergic to study agent;
3. History of psychotropic substance abuse, alcohol or drug use;
4. The researchers considered inappropriate to join the study of any cause.
Effects of Acetazolamide and CO2 Inhalation on Exercise-induced Periodic Breathing in Heart Failure

To evaluate the effects of CO2 inhalation and acetazolamide treatment on exercise-induced periodic breathing in patients with chronic stable heart failure.

Patients will be given CO2 (2%) during a constant workload exercise. Patients will be also evaluated by maximal cardiopulmonary exercise test without and with acetazolamide acute and chronic treatment.


Eligibility Criteria:
Inclusion Criteria:

* chronic heart failure in stable clinical condition
* exercise-induced periodic breathing

Exclusion Criteria:

* comorbidities
* NYHA class IV
Air Versus Oxygen for Intermediate-Risk Pulmonary Embolism (AIRE)

The primary objective is to evaluate the efficacy of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism.

The secondary objective is to evaluate the safety of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed PE by multidetector computed tomographic pulmonary angiography (MDCT).
* Disfunction of right ventricle (RV to left ventricle \[LV\] diameter ratio \>1.0 in the apical 4-chamber view) in the echocardiogram performed in the first 12 hours after PE diagnosis.
* Signed and dated informed consent of the subject.

Exclusion Criteria:

* \<18 years old.
* Allergy to iodinated contrast.
* Renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula.
* Use of chronic oxygen therapy.
* Hypercapnia (pCO2 \>50 mmHg at the time of diagnosis).
* Technically inadequate basal echocardiography.
* Contraindication to anticoagulant therapy.
* Symptoms duration \>10 days.
* Haemodynamic instability.
* Participation in other clinical trial for PE treatment during the present clinical trial.
* Inability to use mask or nasal prongs.
* Life expectancy less than 90 days.
Long-term Follow-up Study of BHC001 for TDT

Observe long-term safety risk and long-term efficacy after intravenous infusion of BHC001 in TDT subjects.

Observe long-term delayed safety risks such as emerging neoplasms, emerging haematological disorders, and long-term efficacy after intravenous infusion of BHC001 in TDT subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent for this study by subjects, or as applicable, subject's parent(s)/legal guardian(s)
2. Treated with BRL-101 for therapy of transfusion-dependent β-thalassemia.

Exclusion Criteria:

- There are no exclusion criteria for this study