cyrilzakka/clinical-trials huggingface dataset:
Dual Time Point FDG PET/MRI Scan in Improving the Imaging Cancer Patients With Brain Metastases

This phase IV trial studies how well delaying positron emission tomography (PET)/magnetic resonance imaging (MRI) scan after injection of fluorodeoxyglucose (FDG) can improve the imaging of patients with cancer that has spread to brain (brain metastases). FDG is a type of imaging agent that doctors use to help "see" the images on a scan more clearly. Delaying PET/MRI scan after injecting FDG may improve how well doctors can tell the difference between healthy and unhealthy tissue.

PRIMARY OBJECTIVE:

I. To assess the optimal fludeoxyglucose F-18 (fluorodeoxyglucose) positron emission tomography (FDG PET) imaging time post radiotracer administration that maximizes separation of activity between lesion and non-lesional parenchyma (measured as lesion/background \[L/B\] ratio) in patients with brain metastasis.

SECONDARY OBJECTIVE:

I. To identify genotypic factors in FDG tumor metabolism derived from metrics, including maximum standard uptake value (SUVmax), mean standard uptake value (SUVmean), total lesion glycolysis (TLG), mean tumor volume (MTV), and L/B ratio.

EXPLORATORY OBJECTIVES:

I. To identify patterns of metabolism derived from metrics, such as SUVmax, SUVmean, TLG, MTV, and L/B ratio, and magnetic resonance imaging metrics, such as regional perfusion abnormalities, apparent diffusion coefficient values, fractional diffusivity measures, and magnetic resonance spectroscopic finding.

II. To identify if post treatment changes in lesion metabolism from baseline correlate with treatment success.

OUTLINE:

Patients receive fludeoxyglucose F-18 intravenously (IV) over approximately 1 minute and undergo a PET/MRI scan over 70 minutes. Within 5 hours of receiving fludeoxyglucose F-18, patients undergo a repeat PET/MRI scan over 30 minutes. Scans take place within 2 weeks before scheduled surgery and within 4-6 weeks after radiation treatment.

Eligibility Criteria:
Inclusion Criteria:

* Pre-treatment adult patients with any solid organ metastasis and at least three intraaxial brain metastases including at least one enhancing \> 10 mm lesion
* Rim or solid enhancing lesion(s) WITH a history of non-central nervous system (CNS) pathologic proven metastatic disease will be considered as a consensus between the referring radiation oncologist or neurosurgeon and a neuroradiology
* Planned surgery or radiation to the metastases
* Ability to undergo PET magnetic resonance (MR) examination

Exclusion Criteria:

* Known allergy to FDG or gadolinium based contrast agents
* History of impaired renal function (glomerular filtration rate \[GFR\] \< 30)
* Pregnant women are excluded
PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.

This is a descriptive, prospective, single centre study. This study will assess PSMA expression via the uptake of radiolabelled PSMA-ligand using PET/CT imaging in mTNBC lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory mTNBC using the Lutetium-177 radiolabelled PSMA.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent in accordance with institutional guidelines and obtained prior to any study procedure
* Women with ≥ 18 years-old
* Eastern Cooperative Oncology Group Performance Status of 0 to 2
* Confirmed diagnosis of progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT (performed within 2 weeks) or Brain MRI in case of progressive brain metastases (performed within 4 weeks) prior to PSMA PET/CT.
* Radiolabelled PSMA PET/CT has to be performed before the next treatment line initiation

Exclusion Criteria:

* Pregnant or lactating patients
* Other active neoplastic disease
* Treatment by another molecule that is the object of investigation within 30 days
* Skin only metastatic disease
* Patients with a significant medical, neuro-psychiatric, or surgical condition, which, in the investigator's opinion, may interfere with completion of the study
Myocardial Injury and Outcomes Following COVID-19 Vaccination (MYOVAX Study)

The study will focus on cardiac blood and imaging biomarkers to facilitate early recognition of patients at risk for myocardial injury after COVID-19 vaccination. Ultimately, the intention is to identify patients at risk, reduce adverse events, and determine the need for longer-term follow-up in patients with myocardial injury after vaccination.

Coronavirus disease 2019 (COVID-19) vaccination frequently leads to minor side effects that may be more intense after the second dose, including fatigue and pain. However, there are emerging reports of more serious side effects in a minority of patients including myocarditis. Given the recent introduction of COVID-19 vaccination, there is limited understanding of: (i) prevalence and pattern of myocardial injury post vaccination, (ii) the risk factors for myocardial injury and adverse cardiac events post vaccination, and (iii) imaging and blood biomarkers for early recognition of patients at risk of adverse outcomes.

This study will address the above-mentioned knowledge gaps by focusing on patients who have received at least one dose of a COVID-19 vaccine. The study will focus on cardiac blood and imaging biomarkers to facilitate early recognition of patients at risk for myocardial injury after COVID-19 vaccination. Ultimately, the intention is to identify patients at risk, reduce adverse events, and determine the need for longer-term follow-up in patients with myocardial injury after vaccination.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 17 years (both Cohort A and B)
2. Received at least one dose of a COVID-19 vaccine in the past 6 months (both Cohort A and B)
3. Developed new clinical signs or symptoms suggestive of myocarditis/myocardial injury within one month of COVID vaccine administration without other known cause (Cohort A, only)

Exclusion Criteria:

1. Contraindications to cardiac PET/MRI
2. Current history of COVID-19
Pregabalin Versus Celecoxib on Sevoflurane and Analgesic Consumption in Spine Fixation Surgery

The anti-epileptic drugs such as gabapentin and other non-steroidal anti-inflammatory drugs (NSAID) such as celecoxib were used as a part of multimodal analgesia to control such pain. Gabapentin is an anticonvulsant drug that has analgesic effect in post-herpetic neuralgia, diabetic neuropathy, and neuropathic pain. Celecoxib is one of the NSAIDs, that its analgesic effect is reported in various studies by cyclooxygenase-2 (COX-2) inhibitor.

The aim of this randomized double-blinded study was to asses and compare the efficacy of using gabapentin versus celecoxib as a part of multimodal analgesia in perioperative hemodynamic control and pain relief in patients underwent posterior approach lumbar spine disc fixation surgery.


Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologists (ASA) I and II, aged between 21-60 years old scheduled to undergo elective posterior approach lumbar spine disc surgery

Exclusion Criteria:

* Patients with a known sensitivity to celecoxib or pregabalin, psychotic disorder or cognitive impairment, history of drug dependency or substance addiction, history of chronic medical disease, the presence of coagulation disorders or pregnancy, were excluded from the study.
Outcome After Revisions of Infected Knee Arthroplasties

A prospective multicenter cohort study on all types of revision knee arthroplasty procedures performed due to infection.

A prospective multicenter cohort study on all types of revision knee arthroplasty procedures performed due to infection.

Most previous studies investigating outcomes after revisions of infected knee artrplasties are single-center studies and retrospective. The study group has previously investigated outcome of the surgical treatment of infected knee arthroplasties in Denmark based on nationwide data from Danish registries. These studies revealed that the risk of treatment failure causing re-revision or mortality was 30-40% in Denmark.

Based on these findings, an ongoing randomized controlled trial "one-stage versus two-stage revisions of the infected knee arthroplasty" (ClinicalTrials.gov ID: NCT03435679) has been initiated by the study group in Febuary 2018. It has been possible to include 20% of the patients with surgically demanding periprosthetic knee infections from the including centres in this randomized trial due to in- and exclusions criteria. Hence, the investigators wish to include the remaining patients with periprosthetic knee joint infection in a prospective cohort study in order to obtain high quality prospective data on function, quality of life and complications after all types of surgical procedures performed due to periprosthetic knee joint infection. Based on these data it will be possible to evaluate the surgical treatment overall and it will be possible to evaluate whether the patients included in the randomized trial are representative.

Study aim:

To present patient reported outcome and postoperative complications after all types of surgical procedures performed due to periprosthetic knee infection. Furthermore, to analyze the role of potential risk factors (patient comorbidity, microbiological diagnosis, surgical intervention, antibiotic treatment, duration of symptoms) on outcome of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical signs of periprosthetic knee joint infection and indication for revision surgery
* Speak and understand Danish and have given informed consent

Exclusion Criteria:

* Participation in "one-stage versus two-stage revisions of the infected knee arthroplasty"
HIV Disclosure and Medication Adherence, a Pilot Study

The investigators believe that disclosure of HIV status could influence medication adherence. If disclosure leads to social support, adherence could be improved. This study purpose is to assess correlation between disclosure and medication adherence, and to describe people whose HIV status has been disclosed to.

Pharmacists administer a questionnaire to each consecutive subject taking part in the adherence-enhancing program at the pharmacy of the Department of Ambulatory Care And Community Medicine in Lausanne. This questionnaire assesses disclosure, response to disclosure, and living situation.

Adherence is measured by electronic monitoring and pill count.

Eligibility Criteria:
Inclusion Criteria:

* HIV Infection
* Enrolled in the adherence-enhancing program

Exclusion Criteria:

* Inclusion visit
* Not french or english speaker
Effects of Niaspan™ on High-density Lipoprotein (HDL) in Healthy Male Subjects (0000-069)

This study will evaluate whether chronic dosing with Niaspan™ increases reverse cholesterol transport, high-density lipoprotein cholesterol (HDL-C) levels, and fecal excretion of cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Male Subjects

Exclusion Criteria :

* Subject has a history of stroke, chronic seizures, or major neurological disorder
* Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
Effects of Tadalafil on LMR and MHR in Patients With ED

The aim of the study was to investigate whether daily 5 mg tadalafil over eight weeks affects to Lymphocyte/Monocyte ratio (LMR) and Monocyte/High-Density Lipoprotein ratio (MHR) in patients with erectile dysfunction (ED).

Thirty-one patients with organic ED and 31 healthy controls between July 2017 and November 2018 were included in this retrospective study. To avoid bias, the patients were randomly selected and the controls were also incorporated consecutively. The presence of ED was determined according to the International Erectile Function Index-5 (IIEF-5). The patients and the controls were evaluated in terms of IIEF-5, complete blood count, serum biochemistry, LMR, and MHR.

The medical records of the heterosexual men treated with the diagnosis of organic ED in the Urology department of a private hospital between July 2017 and October 2018 were evaluated retrospectively. The number of samples to be included in the study was determined by the help of the computer-assisted power analysis. Random sampling was performed from all cohorts of patients with ED. Thirty-one male patients between the ages of 39-65 with organic erectile dysfunction more than one year and treated with OAD 5 mg dose of tadalafil for eight weeks were selected as the treatment group (group T)The patients in group T have been assessed both before (T1) and after (T2) the treatment.

Between the ages of 39-65, thirty-one healthy men who were admitted to the internal medicine outpatient clinic for their annual follow-up were selected consecutively and the control group (group C) was formed. All subjects in the control group were sexually active men with regular monogamous heterosexual relationships during the last one year.

.

Eligibility Criteria:
Inclusion Criteria:

* 39-65 years old men with ED
* 39-65 years old, haelthy men
* Patients that have received 5 mg tadalafil/day for 8 weeks
* Patients with informed consent forms
* Patients with no missing variables

Exclusion Criteria:

* Patients with systemic autoimmune and inflammatory disease,
* congestive heart failure,
* chronic renal failure, and chronic hepatobiliary disease,
* chronic lung disease, and thyroid dysfunction,
* patients with acute infection,
* patients with neurological deficits,
* metabolic syndrome and malignancy
* Patients with a history of prostate, penile or pelvic surgery or radiotherapy,,
* patients receiving anticoagulant, beta-blocker, antidepressants and antipsychotics, hormonal therapy,
* patients with alcohol and smoking
Epidemiological Study on Body Constitution Classified by Traditional Chinese Medicine Theory

Background: Different people are classified into different physiological constitution types in the Traditional Chinese Medicine (TCM) theory. Two instruments, the Body Constitution Questionnaire (BCQ) and the Constitution in Chinese Medicine Questionnaire (CCMQ), have been developed in Taiwan and Mainland China respectively to measure constitution. They were adapted and pilot tested in primary care Chinese patients in Hong Kong, which showed acceptable validity and reliability. These instruments have potential applications for epidemiological studies on body constitution.

Aim and objectives: The aim of this study is to establish the prevalence and epidemiology of body constitution classified by the Traditional Chinese Medicine Theory in the Chinese population in Hong Kong. It would also determine whether the prevalence of constitution types change with seasons and whether it is associated with socio-demographic factors, place of origin or residence, life style, or quality of life.

Design and subjects: Two cross-sectional telephone surveys of the Hong Kong (HK) general Chinese population, one in Summer and one in Winter, will be carried out. Sample size for each survey is 3200 subjects.

Methods: Residential-telephone-owning households will be contacted through random dialing by the Social Science and Research Centre of the University of Hong Kong using the Computer-Assisted Telephone Interviewing (CATI) system that covers 95% households in Hong Kong. A member, aged 18 or above, of the contacted household who last had his/her birthday will be invited to the study to answer either the BCQ or the CCMQ and a structured questionnaire on socio-demographics, place of origin, place of residence, health service utilization, life style and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Can be contacted by in a residential telephone number
* Age 18 or above
* Chinese who can communicate in Cantonese or Chinese by telephone;
* Has given verbal consent to take part in the study

Exclusion Criteria:

* Cannot communicate in Cantonese or Chinese
* Persons who cannot communicate by telephone;
* Refuse to give consent
Plan A Birth Control: Randomized Controlled Trial of a Mobile Health Application for Contraception Information

The primary objective of the investigators study was to design a comprehensive and medically accurate contraception counseling mobile health application and evaluate the effects of this contraception counseling application on the contraceptive methods that patients selected and their knowledge of that method.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years of age
* literate in English
* not at that time using a contraceptive method
* willing to switch to a new reversible contraceptive method
* currently sexually active with a male partner and
* intending to avoid pregnancy for at least one year

Exclusion Criteria:

* women not at risk for unintended pregnancy
* those who were pregnant
* seeking pregnancy within the next 12 months
* history of surgical sterilization or
* a current partner who had had a vasectomy
* using long acting reversible birth control method
* menopausal
Noninvasive Ventilation Therapy for the Treatment of Pleural Effusion in Patients With Heart Failure

There are no investigations so far whether an application of positive pressure during non-invasive ventilation might be a therapeutic option for transudative pleural effusion in patients with heart failure. In view of the pathophysiological process with pleural effusion resulting from an increase in intravascular hydrostatic pressure, non-invasive ventilation might provide an improvement.

The aim of the present study is to investigate whether an additional non-invasive ventilation therapy leads to an improved suppression of pleural effusion in heart failure patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to our hospital on a routine or emergency basis
* Patients with heart failure according to the current ESC guidelines and chronic pleural effusion with clinical indication for pleurocentesis
* Non-invasively determined cardiac index of \< 2.5 l/min/m²
* BNP \> 300 pg/ml
* Transudative pleural effusion according to Light criteria
* Effective pleurocentesis with residual effusion on the side affected of \< 500 ml
* Tolerance of non-invasive ventilation without subjective or objective hemodynamic impairment as verified during a test ventilation
* No change in drug or other therapy for the duration of the study (5 days)

Exclusion Criteria:

* Psychological or neurological concomitant disease making an informed consent impossible
* Pregnancy
* Pneumothorax or pneumomediastinum
* Pathologically low blood pressure, particularly associated with intravascular volume depletion
* Liquor discharge, recent head surgery or trauma
* Severe bullous lung disease
* Dehydration
* Current ventilation therapy
* Bilateral pleural effusion \> 500 ml at the time of enrolment
* Exudative pleural effusion
Comparison of Conventional Techniques & Piezosurgery in the Management of the Nasal Bony Pyramid

It is well-known and universally acknowledged that rhinoplasty is the most demanding procedure in facial aesthetic surgery. Postoperatively nasal osteotomies result in variable degrees of edema and ecchymosis and surgeons have tried various techniques, instruments, and postoperative methods to diminish these uncomfortable morbidities. Piezosurgery is used nowadays to decrease the incidence of injured soft tissues and vital structures passing near the osteotomy line. Its use in rhinoplasty was advocated to prevent unwanted back fractures as well as to decrease bleeding while keeping the nasal mucosa intact thus minimizing postoperative sequelae.


Eligibility Criteria:
Inclusion Criteria:

* Patients requesting aesthetic rhinoplasty, post-traumatic rhinoplasty, and post-cleft nose rhinoplasty.

Exclusion Criteria:

* Patients with severe systemic disease (American Society of Anesthesiologists physical status classification system III \& IV).
* Psychological disorders.
* Female patients younger than 16 years of age and male patients younger than 18 years of age.
* Patients with autoimmune and skin diseases.
Preoperative Immunonutrition in Normonourished Patients Undergoing Fast-track Laparoscopic Colorectal Surgery

Immunonutrition (IN) appears to reduce infective complications and in-hospital length of stay (LOS) after gastrointestinal surgery. More specifically, it seems to be beneficial also in colorectal cancer surgery. Potential benefits of combining preoperative IN (PIN) with protocols of enhanced recovery after surgery (ERAS) in reducing LOS in laparoscopic surgery are yet to be determined.


Eligibility Criteria:
Inclusion Criteria:

* laparoscopic colorectal resection for cancer following ERAS protocol
* \>18 years old
* elective setting

Exclusion Criteria:

* age below 18
* malnutrition
* inflammatory bowel disease
* acquired or congenital immunodeficiency
* preoperative infection
* ASA IV
* pregnancy
* emergency setting
* conversion to open surgery
* multivisceral resections
The Effect of Telerehabilitation on Pain, Physical and Biopsychosocial Factors in Parent Carers

This study aimed to investigate the effects of asynchronous video-based exercises on pain, disability, anxiety, care burden and quality of life in parent carers of children with special needs.

This study aimed to investigate the effects of asynchronous video-based exercises on pain, disability, anxiety, care burden and quality of life in parent carers of children with special needs.

Parents carers were invited to participate in the study through a variety of channels, including printed posters, corporate social media posts, phone calls through local administrations and non-governmental associations. At the information meeting, the participants were informed about the benefits of ergonomic training for activities of daily living. Also handbooks containing the same information were distributed. Demographic data were collected, and questionnaires were used to assess pain, disability, physical activity levels, care burden, and quality of life.

Individuals who met the inclusion criteria were randomly assigned to either the exercise group or the control group. The exercise group was informed of the details of the study methodology, technology literacy, and tablet usage. In order to ascertain an appropriate exercise programme for each individual, the researchers identified musculoskeletal problems of participants. The exercise programme comprised videos of relaxation, postural control and muscle strengthening exercises, which were recorded by research team and uploaded to the tablets. Subsequently, the participants were informed of the safety precautions during the exercise programme at home and the ergonomic placement of the tablets.

The eight-week exercise programme required participants to perform the exercises on a regular basis, three times per week, with the assistance of guided videos. Additionally, they were required to record their performance in written exercise diaries, which were distributed to them.

Exercises also supported by online calls made by the researchers once a week. In each interview, the participants were reminded of the next scheduled online interview activity. At the end of the eight-week, final evaluations were obtained through face-to-face interviews.

Eligibility Criteria:
Inclusion Criteria:

* The individual must be the primary caregiver of a child with physical, mental, or a combination of both disabilities.
* The individual must have been in this role for a minimum of six months.
* Willing to participate in the study.
* Able to read and write in Turkish.

Exclusion Criteria:

* A clear cognitive or language disability
* A recent deterioration of family relationships or the presence of factors affecting them (separation of parents, divorce, etc.)
* A history of cardiac or pulmonary disease or diseases (uncontrolled hypertension, arrhythmia, COPD, asthma, etc.), neurological disease, orthopaedic or rheumatological disease (rheumatoid arthritis, ankylosing spondylitis, arthrosis, etc.)
* A disease that may prevent exercise or that has resulted in surgery