cyrilzakka/clinical-trials huggingface dataset:
The Prognostic Impact of Symptoms and Lesion Depth in Partial Removal of Carious Tissue

The goal of this prospective, observational clinical cohort study is to study the effect of the preoperative condition of the tooth on the outcome of partial removal of carious tissue in mature teeth in adults. The main questions the study aims to answer are:

* Do preoperative symptoms affect the outcome?
* Does the depth of the carious lesion affect the outcome?

One hundred participants will be recruited. Patients who meet the eligibility criteria will be asked to give their informed consent to participate in the study. Partial carious tissue removal will be performed regardless of participation in the study because selective carious tissue removal is the standard treatment of choice for a vital tooth with a deep carious lesion according to the Finnish national treatment guidelines. Participants will be asked to fill in a questionnaire regarding symptoms 7 days post-treatment. The teeth will then be followed up for 12-24 months.

The null hypothesis is that there is no difference in the success between i) deep and extremely deep carious lesions and ii) initial and mild pulpitis.


Eligibility Criteria:
Inclusion Criteria:

* the patient is communicating in the Finnish or English language
* a deep primary or secondary carious lesion in 1st or 2nd premolar or molar on occlusal or proximal surface, extending to the deepest quarter of dentine assessed from the radiograph
* asymptomatic or symptoms not more severe than reversible pulpitis (mild pulpitis according to the new pulpitis classification proposal)
* pulp responding to the electric pulp testing and cold testing
* the periodontal stage of the tooth should be I or II.

In case the patient has several teeth fulfilling the inclusion criteria, the one with the deepest lesion and/or most severe symptoms is chosen to the study.

Exclusion Criteria:

* general medical condition which makes the patient more susceptible to odontogenic infection complications
* pregnancy, breastfeeding
* mental retardation, memory disorder
* the carious lesion is extending to more than three surfaces or to both proximal surfaces
* the tooth has previous other filling(s): i) extending deeper than to the outer third of dentine; or ii) the filling is larger than Class I or II; or iii) Class II filling is not restricted to enamel; or iv) the filling has secondary/residual caries
* the tooth is not restorable
* periapical changes in the periapical radiograph
* sensitivity to percussion; swelling; sinus tract; increased mobility; resorption
* furcal lesion more severe than Class I
* ongoing orthodontic treatment
* declining to sign the written consent.
A Study of Aerobic Exercise for Adolescents With Subthreshold Mood Syndromes

This study will investigate the effects of aerobic exercise on mental states, cognition, and long-term outcomes in adolescents with subthreshold depressive and/or hypomanic syndromes and in non-clinical school children

Subthreshold depressive and hypomanic symptoms are common in adolescents, increasing the risk of developping into depression or bipolar disorder. Preliminary evidence shows that aerobic exercise might have positive effects in enhancing cognition and improving clinical symptoms in non-clinical and preclinical population and patients with mood disorders. This randomized controlled trial will investigate short-term (3 months) effects of aerobic exercise on cognition and clinical symptoms as well as the long-term (18 months) effects on the clinical outcomes of high-risk states.

Eligibility Criteria:
Inclusion Criteria:

1. 2 or more DSM-IV defined depressive symptoms, with one as core symptoms ( lost interest or pleasure in activity or depressed mood), lasting for 1 week.
2. 2 or more DSM-IV defined manic symptoms, last for 4 days, but falling short of the criteria for hypomania; or meeting DSM-5 defined symptoms criteria for hypomania, lasting 2-3 days.
3. non-clinical subjects

Exclusion Criteria:

* DSM-IV defined major depressive disorder
* DSM-IV defined hypo/mania
* History of or current other Axis I Disorders
* Diagnosed neurological or musculoskeletal disorder/injury,
* Uncontrolled cardiovascular or metabolic diseases that are not suitable for running
* Diagnosed hypertension
* Other diagnosed serious medical conditions that are not suitable for cycling
* Severe suicidal ideation
* Mental retardation
* Currently participating in a exercise program or activity, defined as 30 minutes of vigorous physical activity 4-5 times per week
CArdiac cT in the Treatment of Acute CHest Pain 2 - Myocardial CT Perfusion

The aim of this study is to assess whether the clinical management of patients with recent acute-onset chest pain without acute coronary syndrome may be optimized by a combined coronary CT angiography (CTA) + CT myocardial perfusion (CTP) guided, rapid diagnostic strategy as compared to CTA alone. CT diagnostic evaluation and potential referral for invasive testing will be performed within 2 weeks after hospital discharge.

The following main hypothesis will be tested:

- Combined assessment of coronary anatomy and myocardial perfusion using 320 MDCT results in a safe and optimized, cost-effective invasive treatment strategy

MATERIAL

- Consecutive patients referred with chest pain in whom acute coronary syndrome has been excluded, yet with a maintained clinical suspicion of coronary artery disease will be included in the study. Only patients deemed clinically suited for subsequent invasive evaluation and treatment will be included.

METHODS

-If the patients accept participation in the trial a computerized 1:1 randomization for CTA alone (control group) or CTA and CTP combined (intervention group) within 2 weeks from discharge will be conducted. CT angiography and CT myocardial perfusion imaging will be performed using a 320-slice MSCT Toshiba VISION Edition Aquilion One scanner according to recommendations from the vendor and clinical routine developed at Rigshospitalet. Based on CTA and/or CTP findings patients will be referred for invasive evaluation including fractional flow reserve assessment (FFR) and treatment within 30 days. Invasive procedures will be performed according to international guidelines and the frequency of revascularization procedures recorded. Clinical outcome data according to specified secondary endpoints will be recorded from hospital charts and medical registries.

Eligibility Criteria:
Inclusion Criteria:

* Recent acute-onset chest pain where coronary artery disease is suspected
* During initial acute hospitalization:

  1. Normal coronary biomarkers (Troponins)
  2. No or non-diagnostic ECG changes (LV hypertrophy, bundle branch blok, pacemaker rhythm)
* Age ≥50 years
* ≥ 1 cardiovascular risk factor (family history of CAD, hypertension, hypercholesterolemia, diabetes, smoking) corresponding to a Duke clinical score ≥20%

Exclusion Criteria:

* Known Iodine contrast allergy
* Estimated GFR below 50 ml/min
* Adenosine intolerance - known allergic asthma
* Previous CABG
* Patient related circumstances which preclude informed consent from the patient
* Patients in whom psychiatric, physical or geographic conditions do not allow long-term clinical followup
* Expected survival of less that 2 years
Does Cognitive Rehabilitation Demonstrate Benefits in the Group Setting With People Whom Have Experienced Brain Injury?

The purpose of this study is to determine whether there is benefit from providing cognitive rehabilitation in the group setting. Several standardized tools will be used to measure progress when a participant enters the group, leaves the group and at a one year follow-up.

This research study will look at the outcome benefits of providing cognitive rehabilitation, utilizing the group process. Criteria for selecting the appropriate participants, group format and structure, as well as use of standardized assessments. The assessments used: Three Step Calendar Approach, (Sohlberg and Mateer) Satisfaction With Life scale (SWLS), Community Integration Questionnaire (CIQ), Independent Living Scale, and the Vocational Independence Scale. The group setting provides an atmosphere to work on building communication skills through peer feedback and to develop psychological coping strategies. Techniques such as the problem solving format and a calendar system. Analysis and outcomes of 17 past group participants were analyzed supporting cognitive rehabilitation in the group setting.

Of the 20 participants, 3 chose not to be included.

Eligibility Criteria:
Inclusion Criteria:

* All participants involved in the Cognitive Rehabilitation Outpatient Group within the study time frame are eligible to be in the study.
Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis

Prospective, randomized controlled trial comparing Endoscopic Ultrasound (EUS) Guided cystogastrostomy or cystoduodenostomy and endoscopic necrosectomy to minimally invasive surgical necrosectomy, in patients with necrotizing pancreatitis.

Patients will be randomly allocated to either treatment arm in a 1:1 ratio. Following intervention, patients will be assessed at regular intervals until study completion at 6 months post-discharge. Primary outcome is a composite of major complications and/or mortality, measured to 6 months post-discharge.

Eligibility Criteria:
Inclusion Criteria:

* Necrotic collection

  * Infected (suspected and confirmed): clinical signs of infection (septic, positive cultures, febrile), systemic inflammatory response syndrome, gas within the collection on imaging (not iatrogenic), or positive culture of collection contents
* Necrotic collection is within 15mm of the lumen of the gastrointestinal tract.
* 18 years and older
* Informed consent obtained from the patient or their medical representative.
* Medically fit for general anesthetic
* Collection amenable to either endoscopic or minimally invasive surgical necrosectomy and drainage.

Exclusion Criteria:

* \<18 years old
* Unable to obtain informed consent from the patient or their medical representative.
* Medically unfit for general anesthesia
* Pregnant
* Necrotic collection not accessible by either or both techniques
* The collection is \>15mm from the lumen of the gastrointestinal tract.
* Irreversible coagulopathy: International Normalized Ratio (INR) \>1.5
* Irreversible thrombocytopenia: platelet count \<50 x10\^9/L
* Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure
* Surgical or endoscopic necrosectomy or pseudocyst drainage has been performed within the preceding 12 months
* Necrotic collection secondary to trauma or other surgical event that requires additional interventions such as management of liver lacerations or vascular injury.
* Pre-existing percutaneous drain
Body Image Functioning Among Surgically Treated Patients With Head and Neck Cancer

Objectives:

The purpose of this study is to obtain descriptive information about the nature and extent of body image concerns among surgical patients with head and neck cancer, satisfaction with care received regarding body image issues, and interest in psychosocial services targeting body image disturbance. Findings from this study provide important preliminary data to guide future large scale research on the critical, yet understudied, psychosocial issue of body image functioning for head and neck cancer patients. Information obtained from this study can specifically be used to facilitate the development of appropriate disease-specific body image instruments and to determine the need for body image focused psychosocial interventions to enhance quality of life and the survivorship experience for these patients.

Primary Aims

1. To characterize the nature and extent of body image concerns in surgically treated patients with head and neck cancer and determine preferences for psychosocial intervention.
2. To compare body image and quality of life outcomes for patients at different time points relative to initiation of treatment. Specific time points of interest are pre-treatment, within one year of initial surgical treatment, and greater than 1 year following initial surgical treatment.

Secondary Aim

1. To compare body image and quality of life outcomes for patients with oral cavity, cutaneous, and midface cancers.

If you agree to take part in this study, you will be asked to fill out 1 questionnaire. This questionnaire can be filled out while you are waiting to be seen by your head and neck doctor and will take about 15-20 minutes to complete.

In this questionnaire, you will be asked questions such as your age, gender, education level, and smoking history. You will also be asked about your treatment for cancer and how it has affected your appearance and body. There will also be questions about your mood, physical health, alcohol use, and social well-being.

Length of Study:

You will be off study after you complete the questionnaire.

This is an investigational study. Up to 350 people will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Able to provide written informed consent to participate
3. Diagnosis of oral cavity, cutaneous or other midface cancer involving the head and neck region
4. Treatment plan includes surgical intervention
5. English speaking

Exclusion Criteria:

1. Significant preexisting facial disfigurement from a previous trauma or congenital defect
2. Diagnosis of a serious mental illness involving formal thought disorder (e.g., schizophrenia) documented in medical record
3. Cognitive impairment (e.g., dementia, delirium)
Early Viscosupplementation After Partial Meniscectomy: a Randomized Controlled Trial

The rational of intra-articular viscosupplementation is based on both the biological and mechanical properties of HA, which exerts positive effects on the modulation of the entire joint environment.

The aim of the present double blind controlled study was to evaluate the effects in terms of pain control and functional recovery provided by a single intra-operative injection of HA performed at the end of arthroscopic partial meniscectomy.

Patients included in this trial were randomized in two treatment groups: the first one received a single injection of HA (Hymovis 24 mg/3ml, Fidia Farmaceutici Spa, Padova, Italy) at the end of the arthroscopic meniscectomy, whereas the second group was treated by surgery alone.

All patients were evaluated basally, at 15, 30, 60, and 180 days after surgery by the following evaluation tools: IKDC (International Knee Documentation Committee) subjective, VAS (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the operated and contralateral knee were documented; also in addition, the trans-patellar circumference of both knees was registered to assess the trend of knee swelling over time.


Eligibility Criteria:
Inclusion Criteria:

1. chronic symptomatic meniscal tears requiring partial resection;
2. healthy contra-lateral knee (i.e. no pain or functional limitation in the contra-lateral joint);

Exclusion Criteria:

1. previous surgery on the index knee;
2. other concurrent articular lesion requiring surgical treatment (e.g.: cartilage or ligament injuries);
3. history of knee infectious arthritis;
4. concurrent rheumatic, metabolic or severe systemic disease;
5. Body Mass Index (BMI) \> 30;
6. known hypersensibility or allergy to/towards HA ;
7. alcohol or other substances abuse/excess.
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)

This phase IV clinical study was designed to evaluate the safety and immunogenicity of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 65 years of age at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-1-6 month schedule.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy people aged over 18 years old on the day of enrollment
2. Axillary temperature is below than 37.0 ℃
3. Blood pressure is not higher than 160/100 mmHg (with or without any medicine)
4. Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
5. Able to understand this study information and willing to comply with all study requirements.
6. Willing to participate in this study and sign informed consent form.

Exclusion Criteria:

1. Participated in any other clinical trial during the study period.
2. Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period.
3. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.
4. Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period.
5. Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study.
6. Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.
7. Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor, .or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).
8. History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain.
9. Pregnant or breastfeeding
10. Allergic history to any component of this vaccine.
11. Other medical, psychological, social or occupational factors that, according to the investigators' judgment,might affect the individual's ability to obey the protocol or sign the informed consent.
Frailty in People Living With HIV Aged 70 Years or More

The ANRS EP66 SEPTAVIH Study aims to screen feasibility of evaluating frailty in people living with HIV aged 70 or older, to estimate its prevalence, to analyse associated risk factors and to evaluate the impact of frailty on pejorative events.

SEPTAVIH is a French, multicentre, prospective, observational study which will include 500 HIV-infected participants

The primary objective is to assess the prevalence of frailty at baseline in People living with HIV (PLWH) aged 70 years and older, using the Fried index.

The main secondary objectives of this study are :

* To assess frequency frailty according to different indexes or scores (Fried, Health deficits Index, HAS score, VACS index)
* To evaluate the association between frailty and specific HIV-related characteristics (for example known duration of HIV infection), or non-specific factors (such as non- HIV-related diseases or living conditions)
* To evaluate theproportion of subjects with a pejorative event at 60 months of follow-up (recurrent or serious falls, emergency department visit, unscheduled hospitalization, institutionalization, loss of one point on the IADL scale or death)
* To evaluate the association between baseline frailty status and early / long-term pejorative events incidence
* Association between baseline evaluation of frailty and pejorative events incidence during the 60 months of follow-up.
* Transition between frail or non frail status during the 60 months of follow-up
* To assess the prevalence of sarcopenia and osteoporosis
* To describe study population including :

  * Demographic characteristics
  * HIV medical history and antiretroviral therapy
  * Comorbidities, polymedication and evaluation of drug-drug interactions
  * Mental Health, quality of life, socioeconomic status
  * Healthcare use and additional care implementation (nursing, physical therapy, home care services, ...)
* Assessment of Inflammatory and Immunosenescence biomarkers at Baseline
* Anthropologic substudy about HIV and polypathologies management
* Focus on COVID-19 with clinical questionnaire, self-administrated questionnaire, SARS CoV2 serology and biobank (serum library)

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 70 years and older
* HIV-1 infection
* Antiretroviral therapy for at least 12 months
* Free and signed informed consent (article L1122-1-1-1 of the French Public Health Code)
* Person affiliated or benefiting from a social security scheme -

Exclusion Criteria:

* Participation in another research study excluding participation in other studies
* Person under legal protection or deprived of liberty by a judicial or administrative decision
* Isolated HIV-2 infection
* Life expectancy of less than 6 months
Exenatide on GI Motor Function and Permeability in Short Bowel Syndrome

We plan to examine the gastrointestinal (GI) physiologic profile of Exenatide, a glucagon-like peptide (GLP-1) analog as a possible intestino-trophic growth factor capable of inducing small bowel adaptation and regeneration in patients with short bowel syndrome (SBS), with the potential to decrease parenteral nutrition dependence.


Eligibility Criteria:
Patients with short bowel syndrome, between the ages of 18-85 who are dependent on parenteral nutrition for at least a year and are being closely followed by the Mayo Clinic Home Parenteral Nutrition Program (HPN) with at least one multisystem evaluation a year.