cyrilzakka/clinical-trials huggingface dataset:
Social Cognition in Ageing and in Frontotemporal Lobar Degeneration

The purpose of this study is to examine the age and the neurodegenerative disease effects on social cognition. Secondary goals are to better understand the relationships between different component of social cognition, executive functioning, and behavior and describing the neuronal substrates associated to the alteration of the social cognition in ageing and dementia.


Eligibility Criteria:
Inclusion Criteria:

* All the participants

  * Age between 40 and 80 years
  * Minimum of 7 years of education
  * French native speaker
* Healthy subjects

  * Non pathological Dementia rating scale score
* Patients

  * Clinical diagnosis of frontotemporal lobar degeneration

Exclusion Criteria:

* Chronic neurological disease
* Encephalitis
* Endocrinal disease
* Hepatic disease
* Case history of head injury with loss of consciousness of more than one hour
* Case history of stroke
* Case history of cancer during the five last years except squamous cell carcinomas
* Alcoholism or drug addiction
* Major psychiatric disorders according the Diagnostic and Statistical Manual of Mental Disorders
A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis

This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 4 different doses of GLPG2222 administered for 4 weeks to adult subjects with a confirmed diagnosis of CF and homozygous for the F508del Cystic Fibrosis Transmembrane conductance Regulator (CFTR) mutation.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject ≥ 18 years of age, on the day of signing the Informed Consent Form (ICF).
2. A confirmed clinical diagnosis of CF and homozygous for the F508del CFTR mutation
3. Weight ≥ 40 kg.
4. Stable concomitant treatment for at least 4 weeks (28 days) prior to baseline
5. Forced expiratory volume in 1 second (FEV1) ≥ 40% of predicted normal for age, gender and height at screening

Exclusion Criteria:

1. History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.
2. Unstable pulmonary status or respiratory tract infection requiring a change in therapy within 4 weeks of baseline.
3. Need for supplemental oxygen during the day, and \>2 liters per minute (LPM) while sleeping.
4. Use of CFTR modulator therapy (e.g. lumacaftor or ivacaftor) within 4 weeks prior to the first study drug administration.
5. History of hepatic cirrhosis with portal hypertension.
6. Abnormal liver function test at screening; defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/ or alkaline phosphatase and/or gamma-glutamyl transferase (GGT) ≥ 3x the upper limit of normal (ULN); and/or total bilirubin (\>1.5 times ULN)
7. Estimated creatinine clearance \< 60 mL/min using the Cockcroft-Gault formula at screening.
The Effect of Rehabilitation for Patients Living With an Implantable Cardioverter Defibrillator

The purpose of this study is to describe the effect and meaning of an outpatient-nursing programme including physical activity for patients with implantable cardioverter defibrillators (ICD).

Hypothesis: The outpatient nursing programme will increase the perceived health and quality of life; improve the management of life from a patient perspective; reduce fear of exercise and increase physical capability and reduce the number of treatment-demanding arrhythmias.

Implantable cardioverter defibrillators (ICD) are used in the treatment of life-threatening heart arrhythmia and the prevention of sudden cardiac death (SCD). The ICD terminates arrhythmia by delivering therapy in the form of electrical impulses to the heart. Patients have described the high energy shock administered by the devise as feeling like a painful kick in the chest.

Patients, who receive an ICD are very much protected against SCD and it is assumed that they are less worried and effected by their heart disease than others. That is not correct though. Studies have shown, that living with an ICD can lead to anxiety, fear of shock and avoidance of situations, places and objects that are associated to shock. It often leads to social isolation, avoidance of physical activity and mood-disturbances.

The purpose of this study is to describe the effect and meaning of an outpatient-nursing programme including physical activity for patients with ICD.

Hypothesis: see above

Intervention: The outpatient nursing programme has a duration of 1 year and is directed towards parameters that ICD reportedly affect. The focus is prevention of the known risks and problems. The content is partly information and education in managing an ICD, partly emotional reactions and further discussion of handling life with ICD. 3-month into the program physical training lead by a physical therapist is started. It is optimal whether to carry out the twice-weekly physical training program at home or at the hospital.

180 patients, who get an ICD transplanted at Copenhagen university Hospital, Rigshospitalet, are included in the study prior to discharge. 90 patients in the intervention group and 90 controls.

Using questionnaires, qualitative interviews, work-test, 6 MWT and decoding ICD the effect and meaning of the programme is evaluated.

Eligibility Criteria:
Inclusion Criteria:

* In-patients at Copenhagen University Hospital who just received an ICD for the first time.

Exclusion Criteria:

* Patients who:

  * do not understand the instructions,
  * are under 18 years old,
  * are diagnosed with a mental disease,
  * suffer from a competing disease,
  * can not participate in physical training.
Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.

The purpose of this study is to compare and determine the efficacy of letrozole administration to that of laparoscopic ovarian diathermy (LOD) in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.

In the letrozole group, withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation, then 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days up to six cycles. All patients in the control group underwent laparoscopic ovarian diathermy, then followed up for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* CC resistant PCOS

Exclusion Criteria:

* Congenital adrenal hyperplasia
* Cushing syndrome
* Androgen secreting tumors
Open Registry Measuring Impact of Genomic Testing on Treatment Decision After Biopsy in Newly Diagnosed Prostate Cancer Patients

This registry is intended to measure the impact of Prolaris® testing on therapeutic decisions when added to standard clinical-pathological parameters in men with newly diagnosed prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed (≤6 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics.
* Clinically localized (no evidence on clinical or imaging studies of advanced disease.
* No hormonal therapy including LHRH agonist or antagonist, anti-androgen, 5-alpha reductase inhibitor, estrogens or exogenous androgens, when applicable.
* Sufficient amount of tissue remains from biopsy to perform genomic testing.

Exclusion Criteria:

* Patients with known history of hypogonadism will be excluded from the registry
Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer

The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.

This study include a multicenter, randomized, double-blind, placebo, parallel controlled clinical trial.The randomized clinical trial will enroll approximately 212 patients. Participants will be randomly divided into experimental (n=106) and control groups (n=106).Patients in the experimental group was treated with Yiqiuyang Jiedu prescription within 6-8 months after radical gastroctomy and after the completion of standard regimen (XELOX and SOX) for at least 6 cycles of adjuvant chemotherapy. Patients in the control group will receive the placebo.The primary endpoint is 2-year DFS (Disease-free survival) rate after surgery, that refers to the proportion of patients who do not have recurrence, metastasis or death (from any cause) within 2 years after surgery. The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.

Eligibility Criteria:
Inclusion Criteria:

1. The non-esophagogastric junction gastric cancer of stage II-III that met the diagnostic criteria, and no tumor recurrence and metastasis was determined by imaging;
2. Within 6-8 months after radical gastrectomy for gastric cancer (R0), adjuvant chemotherapy of standard regimen (XELOX and SOX) has been completed for at least 6 cycles;
3. ECOG score 0-2;
4. 18-75 years old, male or female;
5. The expected survival time is ≥3 months;
6. Voluntary participation in the study, signing informed consent, good compliance with follow-up.

Exclusion Criteria:

1. Patients with other primary tumors;
2. Gastric cancer patients were pathologically diagnosed as adenosquamous carcinoma, with lymphoid stromal carcinoma (medullary carcinoma), hepatoid adenocarcinoma, squamous cell carcinoma, signed-ring cell carcinoma, undifferentiated carcinoma, gastric neuroendocrine tumor, gastric mesenchymal tumor, gastric malignant lymphoma and other gastric malignancies;
3. Patients who had previously received preoperative neoadjuvant chemotherapy;
4. Patients with past or current targeted drug therapy;
5. Patients undergoing previous or ongoing gastric radiotherapy;
6. Patients with past or ongoing tumor immunotherapy;
7. Mental patients;
8. Patients with serious and uncontrolled organic diseases or infections, such as decompensated heart, lung and renal failure, which lead to intolerance of chemotherapy;
9. Patients who received clinical trials of small molecule drugs within 28 days or large molecule drugs within 3 months;
10. Patients who are known to be allergic or intolerant to the study drug.
Gait Profile and Variables in Pediatric Rheumatic Disease Using a Smart Insole System

In pediatric rheumatic diseases, joint swelling, effusion, tenderness, and painful restriction of joint movement, particularly in weight-bearing joints, frequently alter walking function. These changes affect temporal and spatial parameters of gait, as well as kinematic and kinetic characteristics, leading to functional limitations. Comprehensive physical assessments in patients may not always predict changes in gait parameters. Therefore, incorporating objective methods related to gait and balance into physical evaluations is essential for functional insights and clinical decision-making, aiming to prevent adaptive mechanisms that could negatively affect gait function in the long term. In this context, smart insoles have emerged as a new tool for gait analysis, offering an alternative to high-cost, lab-based equipment. The Digitsole Pro® system can measure gait profile and variables in real-life conditions. A review of the literature reveals no studies utilizing smart insole-based gait assessments in pediatric rheumatic patients. The aim of our study is to investigate the gait profile and variables of children and adolescents with pediatric rheumatic disease using the next-generation Digitsole Pro® smart insole system, and to compare the results with those of healthy peers.


Eligibility Criteria:
Inclusion Criteria:

Children and adolescents with pediatric rheumatic disease:

* Aged 6-18 years
* Diagnosed with JIA or FMF at least 6 months ago at the Istanbul Medical Faculty Pediatric Rheumatology Clinic

Healthy children and adolescents:

* Aged 6-18 years
* Willing to participate in the study

Exclusion Criteria:

Exclusion criteria for children and adolescents with pediatric rheumatic disease:

* History of trauma or surgery affecting the musculoskeletal system in the last 6 months
* Presence of a chronic disease other than JIA or FMF
* Acute pain for any reason
* Visual or hearing problems
* Cognitive impairment that prevents understanding of given instructions

Exclusion criteria for healthy children and adolescents:

* History of trauma or surgery affecting the musculoskeletal system in the last 6 months
* Hearing or visual problems
* Acute pain for any reason
Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease

The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.


Eligibility Criteria:
Inclusion Criteria:

* male/female
* 18 - 75 years inclusive
* diagnosis of Crohn's disease confirmed
* moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
* no previous treatment with anti-tumor necrosis factor (anti-TNF) medications

Exclusion Criteria:

* previous participation in a certolizumab pegol study
* general exclusion criteria as common for studies in this indication
Developing an Integrated Community of Care in Singapore

The investigators will provide an integrated community of care to a socioeconomically disadvantaged population. This included an extended cycle of care from tertiary care to primary care and linkages with social care agencies in the community.

Socioeconomically disadvantaged patients are at higher risk of unplanned readmissions, ill health from higher chronic disease burden and utilize more healthcare resources. In Singapore, people at the lowest strata of socioeconomic status have an 8 times higher risk of inpatient utilization and twice the risk of having multiple chronic diseases, while utilizing less primary care compared to the general population. The reasons for poorer health outcomes are many, including lack of social support, and a subsidy system that encourages acute hospital utilization instead of primary care utilization. A community-based intervention program that extends into the rubric of these communities is required to address the social determinants of poor health, and break the intractable cycle of low socioeconomic status and poor health. The investigators will develop an integrated community of care comprising of integrated practice units (IPUs) such as the Integrated Clinical Care Service, Transitional Home Care from Singapore General Hospital, Care Closer to Home Program from the Agency of Integrated Care, Chinatown Point Family Medicine Clinic and Ageing gracefully at home from the grassroots to systematically deliver primary, transitional and social care to a socioeconomically disadvantaged population at the Chin Swee and Banda residential estate. A community-based integrated care team will support and connect the various IPUs in the form of a community virtual ward. Residents enrolled into the intervention program will be followed up prospectively for one year. The effectiveness of an integrated community of care in improving health outcomes will be evaluated and the investigators hypothesize that the program will be cost-effective in improving the health status of socioeconomically disadvantaged populations in Singapore. The results of the study will be informative to policy makers to deliver value based healthcare and acts as a blueprint for other regional health systems to deliver care to similar populations.

Eligibility Criteria:
Inclusion Criteria:

1. Residents \> 60 years old
2. Staying in 1 or 2 room rental flats in the Block 51 and 52 Chin Swee and Block 5 Banda Street residential estate
3. Have at least 1 episode of the following:

   1. SGH Specialist outpatient clinic attendance
   2. SGH A\&E attendance
   3. SGH Inpatient stay

Exclusion Criteria:

1. Patient declines service
2. Patient has aggressive / abusive behaviour
Evaluation of Salivary Biomarker Levels of Individuals With Different Periodontal Diseases

The aim of this study is; detection of leucine rich α-2 glycoprotein1 (LRG1), c-reactive protein (CRP) levels in saliva samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases. Materials and methods: Samples of saliva were obtained from 60 systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20). Full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine LRG and CRP levels in the biological samples.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.)
* At least twenty permanent teeth in the mouth
* Non-smoker
* No medication for continuous use
* Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.
* Not in pregnancy or lactation period.
* For the periodontitis group that has not received periodontal treatment in the last 6 months
* For the periodontitis group; According to the evaluation made in 6 regions of each tooth, individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss
* For the gingivitis group; According to the evaluation made in 6 regions of each tooth, individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss
* For healthy group; According to the evaluation made in 6 regions of each tooth,individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study.

Exclusion Criteria:

* Any oral or systemic disease
* Regularly using a systemic medication
* During pregnancy or lactation
* Received periodontal treatment within the last 6 months.
* Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months
* Smokers are not included in the study
123I-MIBG SPECT/CT for Assessment of Cardiac Sympathetic Innervation

Myocardial scintigraphy with 123I-MIBG allows for visual and semi-quantitative assessment of sympathetic cardiac innervation using the hear to mediastinum ratio (HMR). Impaired cardiac MIBG clearance may occur in patients with congestive heart failure (CHF). The purpose of present study was to develop and validate a quantitative index for the assessment of cardiac MIBG uptake kinetics using SPECT/CT for diagnosis of CHF


Eligibility Criteria:
Inclusion Criteria:

* age\>40

Exclusion Criteria:

* none
Doppler Ultrasound in Rewarming After Targeted Control Management in Cardiac Arrest

The aim of the study is to describe CBF modifications during rewarming after targeted temperature management in cardiac arrest patients


Eligibility Criteria:
Inclusion Criteria:

Major Cardiac arrest Targeted temperature management

Exclusion Criteria:

GCS\>8 after cardiac arrest Neurologic cause of cardiac arrest
Physical Activity of Participants in Different Age Groups

The subject of the research is to determine the physical activity levels of the participants in different age categories and to determine and analyse participants' perceptions of the benefits of physical activity and the factors that prevent from doing physical activity.

The subject of the research is to determine the physical activity levels of the participants in different age categories and to determine and analyse participants' perceptions of the benefits of physical activity and the factors that prevent from doing physical activity. In this study, it is aimed to determine the physical activity levels of individuals in different age categories and to determine the barriers and benefit perceptions of physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old

Exclusion Criteria:

* Not volunteering for research
* Those with incomplete evaluation forms
Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO)

This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant after 6 months of treatment. In the study arm Ranibizumab will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with visual impairment due to macular edema following BRVO
* Diagnosis of BRVO at maximum 6 months prior to Screening
* BCVA using ETDRS charts of 20/40 to 20/400 in the study eye

Exclusion Criteria:

* Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs
* Central retinal thickness (CRT) \< 250 µm in the study eye
* Prior episode of RVO in the study eye
* Active formation of new vessels in the study eye
* Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline
* IOP ≥ 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment
* Improvement of \> 10 letters on BCVA between Screening and Baseline

Other protocol-defined inclusion/exclusion criteria may apply
Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-onset Sepsis.

This study aims to compare the clinical outcomes, safety and PD target attainment of the model-based dose and empirical dose of piperacillin/tazobactam in the treatment of LOS in premature neonates, so as to optimize the piperacillin/tazobactam dose regimen.


Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates: gestational age \<34 weeks;
* Postnatal age \> 72h;
* Postmenstrual age \<36 weeks;
* Newly diagnosed as late-onset sepsis;
* Parental written consent.

Exclusion Criteria:

* Patient with bacterial meningitis, osteomyelitis, septic arthritis or necrotizing enterocolitis requiring surgery.
* High suspicion of/confirmed fungal infection.
* Severe congenital malformations and/or severe organ failure.
* Administration of any systemic antibiotic regimen 24 h before screening.
* Administration of other systemic trial drug therapy.
* Other factors that the researcher considers unsuitable for inclusion.
* Post-randomization Exclusion: ①Patients with a positive baseline blood culture and the pathogen resistant to PIP/TAZO. ②Patients with bacterial meningitis, fungal infection, osteomyelitis, septic arthritis or necrotizing enterocolitis requiring surgery after randomization.
Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study

Local injection of 5-fluorouracil into a chalazion (stye) is as effective as local injection of triamcinolone (steroid) and incision and curettage for treatment of chalazia.

This is a prospective randomized interventional study comparing four current standard-of-care treatments for chalazia: incision and curettage, local injection of triamcinolone, local injection of 5-FU, and local injection of combination triamcinolone/5-FU.

Eligibility Criteria:
Inclusion Criteria:

* Single or multiple chalazia in a single eyelid

Exclusion Criteria:

* Chalazia present for less than one month and no previous injection or incision and curettage