cyrilzakka/clinical-trials huggingface dataset:
The Changes in Carotid Plaque Neovascularization After Elovocumab Therapy

150 selected patients will be recruited, who have at least one atherosclerotic plaque in the carotid artery that is thicker than 2.0 mm and which is determined to be uniformly or predominantly echolucent by standard ultrasonography. For each of the plaques, standard ultrasonography will be used to evaluate lesion echogenicity, while contrast-enhanced ultrasonography (CEUS) will be used to perform the visual and quantitative analysis of neovascularization. Each technique will be applied at baseline (at the time of study enrollment) and following 0.5、1 year of Elococumab Injection treatment. During the study, these patients will be treated with Elococumab Injection (1ml:140mg),ih, every two weeks.


Eligibility Criteria:
Inclusion Criteria:

* 1. have at least one atherosclerotic plaque in the carotid artery that is thicker than 2.0 mm and which is determined to be uniformly or predominantly echolucent by standard ultrasonography;
* 2.patients were referred for optimal medical treatment;
* 3.patients agreed to undergo follow-up CEUS at half-year and 1-year interval.

Exclusion Criteria:

* 1.patients had previous history of cerebral thrombosis or cerebral embolism;
* 2.patients were contraindicated to the usage of contrast media;
* 3.image quality of baseline or follow-up CEUS was severely impaired (in presence of severe artifact, non-diagnostic);
* 4.patients withdrew the informed consents during follow-up;
* 5.patients experienced major adverse cerebrovascular events during follow-up;
* 6.patients refused to undergo follow-up CEUS;
* 7.lost follow-up
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants


Eligibility Criteria:
Inclusion Criteria:

* Male or female infants born at \>36 weeks of gestation and 2 months of age at the time of consent.
* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion Criteria:

* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
* Major known congenital malformation or serious chronic disorder
* Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
* Previous receipt of \>1 dose of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at \>30 days old, or previous receipt of any licensed or investigational pneumococcal vaccine, or planned receipt through study participation
Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block in Sinus Surgery

Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG) block, infraorbital nerve block and nasociliary block. As the current evidences regarding the benefit of SPG block after FESS is controversial, efficacy of sphenopalatine ganglion block will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult patients undergoing FESS under general anaesthesia in this study.

Functional endoscopic sinus surgery (FESS) is a minimally invasive and safe technique for the treatment of sinonasal disease. Although it is a minimally invasive and less traumatic procedure, it is usually associated with pain of mild to moderate intensity which reaches its maximum level in the first few postoperative hours. However, even low-level postoperative pain may be associated with delayed functional recovery and it frequently contributes to dissatisfaction with the procedure delay in return to work and readmission after surgery. Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG) block, infraorbital nerve block and nasociliary block. As the sensory innervations of the SPG supplies the nasal turbinates, nasopharynx and palate, SPG block is expected to provide perioperative analgesia after FESS. Integration of regional anaesthesia with general anaesthesia technique can provide a better hemodynamic control, less perioperative opioid use, less bleeding and higher level of patients' satisfaction. Reduction in surgical bleeding in FESS can improve surgical field and also surgeons' satisfaction and a reduced opioid use may be translated into a less postoperative nausea \& vomiting, rapid recovery and early hospital discharge. But, the current evidences regarding the benefit of SPG block after FESS is controversial. In this randomized controlled trial, efficacy of sphenopalatine ganglion block will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult patients undergoing FESS under general anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* 60 American Society of Anesthesiologists (ASA) physical status I and II patients
* aged 18-60 years scheduled to undergo elective functional endoscopic sinus surgery for sinonasal disease such as rhinosinusitis, polyps and deviated nasal septum were enrolled

Exclusion Criteria:

* Severe cardiovascular, pulmonary, hepatic, renal, neurologic or metabolic disease or coagulopathy
* History of allergy to any of the medications being used in the study
* Previous surgery for sinonasal disease
* Pre-existing chronic pain not related to chronic rhinosinusitis
* Taking prescription pain medications or antidepressants
* Chronic alcohol or drug abuse
* Inability to comprehend the study protocol
* Pregnancy
Anal Cancer Radiotherapy Study

This is a prospective study of patients receiving radiotherapy or chemoradiotherapy for anal cancer. Treatment effect in terms of survival and local recurrence will be analyzed. The utility of PET-CT and MRI for radiotherapy and for prediction of treatment effect will be investigated. Molecular and genetic markers in tumor and blood will be analyzed for prognostic and predictive effects. Patient-reported outcomes, such as faecal incontinence, sexual dysfunction and quality of life will be assessed. A structured intervention program for management of late effects will be evaluated. Symptom relief of palliative radiotherapy will be investigated. The main purpose of the study is to increase the knowledge of anal cancer treatment, improve treatment results, and improve anal cancer survivor care.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified anal squamous cell carcinoma
* Radiotherapy or chemoradiotherapy planned
* ECOG performance status 0-2
* \>= 18 years of age
* Signed informed consent and expected cooperation of the patients for treatment and follow up

Exclusion Criteria:

- Cognitive or physical condition resulting in inability to sign informed consent or cooperation during treatment
Comparative Efficacy of the Suppository Versus Guaiacol Suppository Versus Guaifenesin Syrup in Pediatric Patients With Cough Due the Infectious Origin

It is believed that the suppository consisting of guaiacol, menthol, camphor and eucalyptol, by their pharmacological properties already established for each component, has the ability to reduce the signs and symptoms related to upper respiratory infections in a manner equivalent (not inferior) to medicine used as a comparator in this study and higher than the suppository containing only guaiacol concentration of 12.5 mg.


Eligibility Criteria:
Inclusion Criteria:

* Patients that parents or legal guardians agree to their participation in the study and agree on the terms proposed in the IC, signing it;
* Patients aged ≥ (greater than or equal to) 02 years and ≤ (less than or equal to) 6 years, 11 months and 29 days, of any ethnicity, class or social group.
* Patients with acute respiratory disease of upper respiratory viral diseases (URI);
* Patients with productive cough;
* Clinical picture of URI defined by the doctor that started less than 48 hours.

Exclusion Criteria:

* Patients being treated with antibiotics;
* Presence of clinical features of bacterial infection of the upper airways and / or pulmonary (acute bacterial sinusitis, pneumonia, etc.).
* Patients with non-productive cough;
* Treatment with immunosuppressive drugs;
* Presence of any medical condition that, according to the investigator, should prevent the patient from the study;
* Participation in clinical trials in the 12 months preceding the study, according to Resolution 251 (ANVISA), August 7, 1997, item III, sub-item J;
* Patients with serious diseases;
* Patients who require multidrug treatment;
* Presence of other concomitant pulmonary diseases
* History of hypersensitivity to drugs of the same pharmacological classes of substances under investigation;
* Patients with diseases that interfere with lung function, such as cerebral palsy or muscular atrophies;
* Patients under medication or supplement (eg physiotherapy) that may interfere with the cough;
* Patients with severe dysfunction of the hepatorenal function;
* Patients with x-ray of the chest or sinus compatible with picture of bacterial infection;
* Patients with blood cell count suggestive of bacterial infection;
* Changes in laboratory, clinical, physical and / or radiological agents that, judged by investigators, could compromise patient health or reliability of the data.
The Use of CoreBone Coral Particles vs. Cones for Preservation of Alveolar Bone

Normally, dentists do not graft the socket after extraction of teeth. When they do graft they use particulate graft devices. The purpose of this study is to examine whether coral particles of 300-450um in comparison to coral cones of 4-5mm wide and 8-10 mm long will preserve alveolar ridge of maxilla or mandible when grafted immediately after tooth extraction. The coral grafting devices are processed from Porites corals grown in aquariums, under controlled environment. The devices are cleansed and sterilized by gamma irradiation. The measurements during follow ups will be performed from CT x rays and measurements by caliber and models.The width and height measurements from follow up x rays and models. The study will be performed on 10 patients, that two parallel teeth are diagnosed to be extracted, in same patient.The data will be analysed for bone loss and compared to previous published studies. Also comparison between two devices will be performed.

Normally, dentists do not graft the socket after extraction of teeth. When they do graft they use particulate graft devices.The purpose of this study is to examine whether coral particles of 300-450um in comparison to coral cones of 4-5mm wide and 8-10 mm long will preserve alveolar ridge of maxilla or mandible when grafted immediately after tooth extraction.

Methods: 10 patients adults that are diagnosed for extraction of same tooth number ,each on different side of jaw. A non traumatic extraction will be performed, on both sides, sometimes not on same date. After extraction, coral device 'CoreBone500' sterile particles will fill the extraction site. Usually 0.3cc will be used. On the other side of same jaw 'CoreBone' Cone sterile of 4-5mm width and 8-10mm height will be placed in socket. Sutures will be placed and efforts will be put in covering the opening by soft tissues. Follow up of the alveolar ridge preservation will be performed using CT at time of grafting and 6 month later. Measurements during follow ups will be performed by caliber the width and height of alveolar ridge 2 weeks, 3month and 6 month follow up. A clinical follow up of healing soft tissues after grafting and patients complaints of pain will be addressed. If any unusual complaints from patients appears the study will be terminated immediately. From our preclinical studies no adverse effects were found. The analysis of data will be statistically analysed and compared to published data. We expect that CoreBone Cones are more effective in ridge preservation.

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals

Exclusion Criteria:

* smoking
* wound healing is disturbance
Reducing Secondary Distress in Violence Researchers: a Randomised Trial of the Effectiveness of Group Debriefings.

The objectives of the study were: To (1) describe the epidemiology of emotional distress experienced by Ugandan violence researchers; to (2) assess the effectiveness of group debriefings in mitigating secondary distress; to (3) assess risk and protective factors. Eligible participants were 59 Ugandan researchers employed by the Good Schools Study (GSS, NCT01678846) to interview children and adults who experienced violence. Recruited participants were randomly assigned to group debriefings (intervention) or film viewing (control). The primary outcome was change in levels of emotional distress.

Background: Secondary distress including emotional distress, vicarious trauma (VT) and secondary traumatic stress (STS) due to exposure to primary trauma victims have been described in helping professionals and in violence researchers. To our knowledge, there are few prevalence studies, and no tailored interventions have been tested to reduce secondary distress in violence researchers.

Objective: To (1) describe the epidemiology of emotional distress experienced by Ugandan violence researchers; to (2) assess the effectiveness of group debriefings in mitigating secondary distress; to (3) assess risk and protective factors.

Methods: An unblinded, individually randomised trial with parallel assignment was conducted. Eligible participants were 59 Ugandan researchers employed by the Good Schools Study (GSS, NCT01678846) to interview children and adults who experienced violence in the district of Luwero, Uganda. 53 researchers agreed to participate and were randomly allocated. The intervention group (n=26) participated in three group debriefings and the control group (n=27) participated in three leisure sessions (film viewing).The primary outcome was change in levels of emotional distress (SRQ-20); secondary outcomes were levels of VT and STS at end-line.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants were all 59 Ugandan researchers who had been employed by the GSS.

Exclusion Criteria:

* none
A Clinical Investigation to Evaluate the Healing of Tooth Extraction Sites Filled With BioRestore™

The aim of this study was to evaluate by histology and MSCT scans during a 7-month period, the efficacy of a bioactive glass (Inion BioRestore™) placed in human extraction sockets in the maintenance of alveolar ridge.

14 subjects in need of implant therapy were enrolled in the study. A total of 32 teeth were extracted and the fresh sockets underwent to ridge preservation procedures using Inion BioRestore™. Two different time points (1 week and 3 months after RPP) MSCT scans for each patient were used as a basis for bone change analysis occurred in the localized grafted alveolar sites. Twenty-two biopsied, representative of intermediate (3-4 months, n=10) and late phase (6-7 months, n=12) of healing, were harvested and histologically analysed.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy females or males subjects.
* They did not smoke
* Did not take any medications.

Exclusion Criteria:

* Subjects with less than 18 years of age,
* with current alcohol or drug abuse,
* with systemic/local conditions that would interfere with wound healing or osseointegration
* with a history of chemotherapy and radiotherapy in the head and neck region.
Oral Manifestations of Human Immunodeficiency Virus Infection in High Risk Groups

OBJECTIVES: I. Evaluate the development of oral manifestations of human immunodeficiency virus infection in relationship to the onset of immunologic alterations and systemic symptoms in different risk groups: gay/bisexual men, male intravenous drug users, and female intravenous drug users.

II. Evaluate the immune and inflammatory response to periodontal and other microbial pathogens.

III. Evaluate the bacterial species infecting the oral cavity in patients in these risk groups.

PROTOCOL OUTLINE:

Patients undergo a periodontal assessment every 6 months until medically unable to continue. The oral/dental exam includes saliva and gingival crevicular fluid analysis and, as indicated, oral photographs.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Human immunodeficiency virus infection (HIV) seropositive or seronegative At risk for HIV, i.e.: Gay/bisexual men Male intravenous drug users Female intravenous drug users No acquired immunodeficiency syndrome Currently enrolled in Columbia Presbyterian Medical Center protocol "The Natural History and Progression of HIV Infection"
Examining Arts As Targeted Elements of Childhood Cancer Treatment, CREATe Trial

This clinical trial is being done to develop and test how well creative arts interventions (drawing, painting, making sculptures) compared to watching videos can affect symptoms and impact the quality of life in children with cancer. Creative arts mind-body interventions (CrA) are one type of complementary health interventions which have been associated with improved quality of life and reduced symptom burden among children with cancer. CrA is an ideal intervention for children with cancer due to the long hours spent in the hospital setting for treatments, the creativity and developmental focus of children, and their potential ability to communicate more easily through art than words. Researchers want to develop and test a CrA intervention to help improve symptoms and the quality of life of children with cancer.

PRIMARY OBJECTIVE:

I. Feasibility of an randomized controlled trial (RCT) of art among children with cancer.

SECONDARY OBJECTIVES:

I. Achieve recruitment rate target. II. Achieve accrual target. III. Achieve fidelity to intervention. IV. Assess initial effect sizes.

OUTLINE:

PHASE I: Patients participate in focus groups to develop CrA intervention on study.

PHASE II: Patients are randomized to 1 of 2 arms.

ARM I: Patients participate in CrA interventions comprising drawing, painting, and making sculptures with a trained artist for 30 minutes once a week for 4 sessions over 12 weeks.

ARM II: Patients passively watch videos for 30 minutes once a week for 4 sessions over 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Aged 8 to 13 years of age
* Have been diagnosed with cancer of any type in the prior 12 months
* Be English literate (we will amend this criterium when the study surveys are validated in Spanish)
* Physically and cognitively able to participate in creative arts

Exclusion Criteria:

* Not English literate
* Otherwise unable to complete study procedures
Supportive Cancer Care Networkers (SCAN)

Aim of the study is to increase the proportion of indicated patients with colorectal cancer undergoing adjuvant chemotherapy following surgical resection through an optimized symptom management and logistical support.

Patients with colorectal cancer in Germany today are exposed to several Problems related to care continuity and access to health care professionals. In order to increase the utilization of adjuvant therapies, patients in the intervention group are offered an additional nursing intervention in the period between discharge after inpatient treatment and the beginning of adjuvant therapy. This includes a telephone follow-up conducted according to guidelines serving to disclose patients' current supportive needs in order to determine potential intervention approaches as early as possible. Hence, the intervention aims to motivate patients not to discontinue the treatment. An early detection of therapy-related physical and psychological impairments aims at optimizing treatment management.

Patients in the intervention group therefore are visited by nursing staff specialized in cancer care (Supportive Cancer Care Networkers, SCAN) during their in-patient stay and are informed about the intervention. An assignment for the SCAN is to support patients in getting access to health care services (e.g. specialists). Patients are given certain information, as for example contact to specialists, voluntary services and the next steps and appointments of the treatment plan are discussed. Within a consultation at the day before hospital discharge, the SCAN takes up the contact information and appoints weekly telephone consultations for the time up to the adjuvant therapy. The SCAN hands out information materials and explains the study documents, as for example patient-held records (PHR) in order to improve therapy compliance.

Eligibility Criteria:
Inclusion Criteria:

* colorectal carcinoma (ICD-10: C18, C19, C20)
* indication for adjuvant chemo therapy following S3-Guideline on colorectal Cancer or physician-directed
* living in Saxony-Anhalt
* ECOG-Performance Status \<3
* prospective further life expectancy of more than three months

Exclusion Criteria:

* unable to read or understand German properly
* any contra-indication for adjuvant therapy as described in the S3-Guideline such as inadequate liver, bone marrow, and kidney function or coronary heart disease (NYHA III-IV).
Continuous Theta Burst Stimulation (cTBS) and Postoperative Delirium

To investigate the impact of cTBS on the incidence of postoperative delirium and changes of cognitive function in elderly patients after surgery. To explore whether short-term cTBS can reduce the risk of postoperative delirium as a preventive strategy.

Postoperative delirium is the most common postoperative complications among elderly. Nevertheless, there remains no effective medication or intervention been approved in postoperative delirium. Recent research suggests that continuous theta burst stimulation (cTBS) has shown positive effect on improving global cognitive function in multiple mental disorders. However, the effects on cognitive function in postoperative delirium remain uninvestigated.

Eligibility Criteria:
Participants were included if they:

1. were 65 years old or older;
2. had orthopedic surgery under general anesthesia;
3. had normal cognitive function at enrolment \[for illiterate, Mini-Mental State Examination (MMSE) ≥ 17; for individuals with 1-6 years of education, MMSE ≥ 20; for individuals with 7 or more years of education, MMSE ≥ 24\];
4. were able to complete cognitive assessments and the Confusion Assessment Method (CAM);
5. Chinese Mandarin as their native language;
6. were willing to participate and being competent to provide informed consent.

Patients were excluded if they:

1. had delirium assessed by CAM before surgery;
2. had neurological diseases (e.g., stroke, Parkinson's disease, etc.) according to International Statistical Classification of Diseases and Related Health Problems 11th Revision (ICD-11);
3. had mental disorders (e.g., major depressive disorder, dementia, etc.) according to Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5);
4. had contraindications of cTBS (e.g., head trauma, history of epilepsy or metal implants in the head);
5. participating in other clinical studies at the time of screening;
6. having postoperative complications such as pulmonary infection, pulmonary embolism and stroke.