cyrilzakka/clinical-trials huggingface dataset:
Second Extension Study to Evaluate Safety and Tolerability of Influenza Vaccines in Adults and Elderly, and to Evaluate Immunogenicity and Concomitant Vaccination With Pneumococcal Vaccine in a Subgroup

The study primarily aims to evaluate immunogenicity and safety of influenza vaccines (cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)) when administered alone and when administered concomitantly with pneumococcal polysaccharide vaccine (PV) in elderly subjects. The study also aimed to evaluate safety and immunogenicity (subset) of annual vaccination with either cTIV or eTIV_a in adults and elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* participation in the V58P4 study
* mentally competent to understand the nature, the scope and the consequences of the study
* able and willing to give written informed consent prior to study entry
* available for all the visits scheduled in the study

Exclusion Criteria:

* receipt of another investigational agent within 90 days prior to, or before completion of the safety follow-up period in another study, whichever is longer, prior to Visit 7 and unwilling to refuse participation in another clinical study through the end of the present study
* history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine components
* any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or experienced fever (i.e., axillary temperature ≥ 38°C) within the 5 days prior to Visit 7
* pregnant/breast feeding women, or women of childbearing potential who refuse to use a reliable contraceptive method during the three weeks after vaccination
Analysis of Transcriptomic Profile of Graft-versus-host Disease (GHVD) After Allogeneic Grafting of Hematopoietic Stem Cells

Graft-versus-host disease (GVHD) is a frequent and severe complication of hematopoietic stem cell transplantation (HSC), and is responsible for significant early mortality despite prophylactic strategies developed in recent decades, Especially since it is resistant to first-line treatment.

The present diagnosis is difficult, non-specific and is based on the combination of an evocative clinical context (CSH allograft, time to appearance before J100, characteristic clinical manifestations), suggestive anatomo-pathological analysis (predominantly inflammatory infiltrate Lymphocyte, mucosal edema and presence of apoptotic bodies), and the exclusion of any differential diagnosis (in particular serology / negative viral PCR).

However, to date there is no molecular characterization of this manifestation, and therefore no specific treatment.

The nCounter® nanostring technology allows the rapid and simple analysis of the simultaneous expression of a group of genes (up to 800 on the same sample), from a very small amount of RNA, and from samples with difficulty Such as fabrics already fixed to formaldehyde and included in paraffin. It allows the detection of a "molecular signature" of the tissue analyzed.

No transcriptomic analysis has ever been performed on human tissues with GVHD.


Eligibility Criteria:
Inclusion Criteria:

* Person aged ≥ 18 years
* Patients who have received an HSC allograft since June 2012
* Having presented a suspicion of cutaneous or digestive GVHD before J100 post-allograft
* Of which the diagnosis was retained by the combination of clinical and histological criteria
* Or whose diagnosis has been reversed by histological analysis, for the reactive / inflammatory biopsies that serve as control
* The diagnosis of which was made between 01/01/2013 and 31/12/2015
* Survived at least 1 month to monitor clinical progress

Exclusion Criteria:

* Whose biopsy specimens were also the sites of a viral reactivation (EBV, CMV, HHV) that could mimic a GVHD
* Having survived less than 1 month after the diagnosis of GVHD
Jewel ACL Post Market Clinical Follow Up Study

The objective of the study is to assess re-rupture rates and patient outcomes from subjects with at least 5 year follow up, treated with the JewelACL device for ACL reconstruction. The impact of fixation type and autograft augmentation will also be assessed. All adverse events related to the JewelACL device will be recorded. This study is Sponsored by Xiros.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years
* Patients previously implanted with the JewelACL for Anterior Cruciate Ligament (ACL) reconstruction (Primary JewelACL cases only, no revision cases)

Exclusion Criteria:

* Age less than 18 years
* Any implantations for non-indicated conditions, as stated in the Instructions For Use Instructions for use (IFU)
* Revision cases
A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine

This study will evaluate the long-term safety, efficacy and tolerability of atogepant 60 mg daily for the prevention of migraine in Japanese participants with chronic or episodic migraine.


Eligibility Criteria:
Inclusion Criteria:

3101-303-002 Completers:

* Eligible participants who completed Visit 7, and Visit 8 if applicable, of the Study 3101-303-002 without significant protocol deviations and who did not experience an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.

De Novo EM Participants:

* Age of the participant at the time of migraine onset \< 50 years.
* At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018.
* History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1 in the investigator's judgment.
* 4 to 14 migraine days in the 28-day baseline period per eDiary.
* Completed at least 20 out of 28 days in the eDiary during baseline period and is able to read, understand, and complete the study questionnaires and eDiary per investigator's judgment.

Exclusion Criteria:

* Requirement for any medication, diet, or nonpharmacological treatment that is on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative medication or treatment.
* Participants with an ECG indicating clinically significant abnormalities at Visit -1 (De Novo Episodic Migraine Participants) or Visit 1 (3103-303-002 Completers).
* Hypertension as defined by sitting systolic BP \> 160 mm Hg or sitting diastolic BP \> 100 mm Hg at Visit 1.
* Significant risk of self-harm based on clinical interview and responses on the (Columbia-Suicide Severity Rating Scale \[C-SSRS\]), or of harm to others in the opinion of the investigator.
* Any clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

De Novo EM Participants only:

* Difficulty distinguishing migraine headaches from tension-type or other headaches.
* Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018.
* Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018.
* Has \>= 15 headache days per month on average across the 3 months prior to Visit 1 in the investigator's judgment.
* Has \>= 15 headache days in the 28-day baseline period per eDiary.
* Usage of opioids or barbiturates \> 2 days/month, triptans or ergots \>= 10 days/month, or simple analgesics \>= 15 days/month in the 3 months prior to Visit 1 per investigator's judgment or during the baseline period.
rTMS-enhanced Psychotherapy for Borderline Personality Disorder

This project assesses the effectiveness and lasting impact of combining Dialectical Behavioral Therapy (DBT) with prefrontal repetitive transcranial magnetic stimulation (rTMS) in patients with borderline personality disorder.

The proposed project aims to evaluate the effectiveness of combining Dialectical Behavioral Therapy (DBT) with prefrontal repetitive transcranial magnetic stimulation (rTMS) in individuals with borderline personality disorder (BPD). The study includes four groups of patients: 1) DBT combined with active prefrontal rTMS treatment (rTMS-DBT group), 2) DBT combined with sham rTMS treatment (sham-DBT group), 3) active prefrontal rTMS treatment only (rTMS-only group), and 4) sham rTMS treatment only (sham-only group). The study will include assessments conducted before (T1) and after the rTMS treatment (T2) composed of self-reported questionnaires, clinical interviews assessing self-harming behavior and healthcare utilization, ecological momentary assessment of emotional variability, functional magnetic resonance imaging (fMRI) during emotional task, and control clinical EEG measurements. Follow-up measurements will be conducted at T3 (three months after rTMS), and for DBT group also at T4 (six months after rTMS), and T5 (twelve months after rTMS) for to track long-term effects.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of borderline personality disorder according to Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria (rated by Structured Clinical Interview for DSM-5 for Personality Disorders, BPD section)
* minimum age 16, informed consent of the patient
* informed consent of patient's legal representative in case of patients under age 18

Exclusion Criteria:

* neurological disorder
* comorbid affective disorder or schizophrenia-related disorder
* intelligence quotient\<70
* contraindications for MRI measurement
* contraindication for rTMS treatment
* pregnancy
CHD Risk, Behavioral Stress and Reproductive Hormones

To determine the effects of behavioral stress and reproductive hormones on coronary heart disease (CHD) risk.

DESIGN NARRATIVE:

The behavioral study determines whether sex differences in stress responses may assist in explaining sex differences in CHD. The ongoing research program has documented differences in psychological responses to acute stress between men and women and among women who vary in reproductive hormone status. Building on these findings, but also departing from previous efforts in strategy and design, five studies are conducted. Study 1 measures hemodynamic measures that underlie sex differences in cardiovascular responses to behavioral challenge. Using longitudinal designs, Study 2 compares women's stress responses prior to and three months after surgical menopause, whereas Study 3 compares healthy women's stress responses prior to and three months after a "temporary menopause" due to the administration of a GnRH agonist. In both studies, some women after the second testing are administered estrogen replacement therapy and stress responses are again measured. Thus, Studies 2 and 3 also address the effects of estrogen replacement therapy on stress responses. These studies gain significance from the fact that surgical menopause is associated with heightened risk for CHD, whereas estrogen replacement therapy is associated with protection from CHD. Study 4 describes the extent of sex differences in exposure to psychological stressors among men and women from two levels of social class. Social class is included in the design because it is a risk factor for psychological stress and for CHD. The final study tests the hypothesis that sex differences in stress responses are attenuated during a task within a feminine area of competency and accentuated during a task within a masculine area of competency.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Effects of An ACP Programme for Older People With Early Dementia

Advance care planning (ACP) has been widely advocated for persons with early stage dementia (PWEDs). This proposed study attempts to promote the uptake of ACP for this population and their family caregivers in the community and to examine the effects of an ACP programme "Have a Say" for this population. It is hypothesized that participants in the intervention group will be more engaged in ACP and their dyadic concordance on end-of-life care preference with their family caregivers will be significantly higher than that in the control group.

This study aims to evaluate the effects of an advance care planning (ACP) programme "Have a Say" for persons with early stage dementia (PWEDs) and their family caregivers in the community. A randomized controlled trial with repeated blinded outcome assessment will be conducted to assess the effects of an ACP programme on dyads of PWEDs and their family caregivers recruited from elderly community centres. Individuals who have a clinical diagnosis of any form of dementia at the early stage or have a Global Deterioration Score (GDS) 3 or 4 will be eligible to this study. Participants in the experimental group will receive a 4-session ACP programme. It includes an educational component, guided reflection and ACP discussion through a series of group-based activity and dyadic discussion delivered by trained ACP facilitator and guided by an ACP booklet. Dyads of participants will be provided with information about the trajectory of dementia, their future healthcare needs and caring options. Their values and care preferences on future care will be elicited in a consistent manner. They will be supported to have an individualized ACP discussion. Individuals assigned to the control group will receive attention-control health talks. The primary study outcome is the ACP engagement level of PWEDs. Secondary outcome is the dyadic concordance on end-of-life care preference. Adverse outcomes such as depression and caregivers' burden will also be evaluated. Data collection will be conducted at baseline, immediately after, and one-month after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* being Chinese,
* being a Cantonese speaker,
* having a formal diagnosis of any form of dementia at the early stage, or having a Global Deterioration Scale score 3-4,
* having a designated family caregiver in direct contact and willing to participate in this study.

Exclusion Criteria:

* non-communicable,
* mentally incompetent,
* received an ACP intervention,
* have previously signed an advance directive,
* have other life-limiting chronic illnesses.

A family caregiver involved in primary responsibility for caring and care-related decisions for the PWED will also be recruited. Paid caregivers are to be excluded.
Phenotypic and Genotypic Characterization of New-onset Type I Diabetes

The goal of DIATAG study is the identification of biomarkers of T1D evolution in a pediatric cohort.

Type 1 diabetes (T1D) is a common chronic disease in childhood. Clinical presentation at onset of T1D can vary among patients from long-standing diabetes triad symptoms (polyuria, polydipsia and weight loss) to coma and ketoacidosis. The initial clinical presentation of T1D was shown to have long-term influence on glycemic control of the patient. The investigators initiated a collaborative consortium including six pediatric clinics in Belgium to better characterize new-onset T1D patients.

Hypothesis :

1. Different subgroups of T1D patients might exist, underlying different physiopathology of T1D :

   * The investigators will first investigate the presence of biomarkers in different fluids (e.g. urine, blood, feces,...).
   * The investigators will correlate results with clinical parameters of glycemic control. Dynamic tests (HOMA and stimulated C peptide) will be realized at 2 defined time points of the follow-up.
2. Glucose variability can be influenced by external factors (e.g. diet, physical activity, Quality of Life (QoL),...) The investigators will evaluate those external factors using approved questionnaires. They will presented to the patient and its parents at 2 defined time points.

Eligibility Criteria:
Inclusion Criteria:

1. Type 1 diabetes de novo according to American Diabetes Association criteria:

   1. Polyuria, polydipsia, weight loss ± ketoacidosis
   2. Fasting blood glucose ≥126 mg/dL AND/OR blood glucose ≥200 mg/dL at the 120th minute of an Oral Glucose Tolerance Test (OGTT) AND/OR HbA1c ≥6.5% AND/OR a patient with symptoms of hyperglycemia/hyperglycemic crisis (see 8. a. 2.) with random blood glucose ≥200 mg/dL.
   3. Presence in the serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)
2. Age between 6 months and 18 years.
3. Male or female.
4. Positive for one or more autoantibodies typically associated with Type 1 Diabetes (TD1).
5. Free written and oral consent.

Exclusion Criteria:

1. Children under 6 months of age.
2. Treatment that interferes with insulin secretion and insulin sensitivity (e. g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).
3. Presence of celiac disease (diagnosis based on pathological duodenal biopsy), recently diagnosed (within 1 month), at the time of inclusion.
4. Autoimmune/auto-inflammatory disease (other than type 1 diabetes) or active malignant disease present at inclusion.
5. Obesity defined by a Body Mass Index (BMI) with a z-score \>+3 Standard Deviation.
6. Hepatic, renal or adrenal insufficiency.
7. History of spinal cord allograft.
8. History of post-hemolytic-uremic diabetes.
9. Absence of anti-pancreatic islet auto-antibodies.
10. Dysmorphic with suspicion of underlying genetic syndrome.
11. Participation in another study within the previous 3 months, with administration of blood derivatives or potentially immunomodulating treatments.
The Validation of the Turkish Version of the LUMP Questionnaire

Purpose of the study is the validity and reliability of the Turkish version of the Laryngopharyngeal Measure of Perceived Sensation (T-LUMP) Questionnaire, so that it would be used as an assessment tool for Turkish globus pharyngeus patients.

Globus pharyngeus or sensation may be defined as a feeling of something a lump in the throat without dysphagia. The study will assess the construct validity and reliability of the Turkish version of Laryngopharyngeal Measure of Perceived Sensation (T-LUMP) Questionnaire. The investigators developed the Turkish version of this questionnaire (T-LUMP), according to the cross-cultural adaptation guidelines. Two translators translated the LUMP into Turkish and a native English language speaker reverse-translated it into English. The back translation was sent to the original author for proofreading. The final version of the LUMP questionnaire consisted of 8 basic and understandable questions related with globus pharyngeus symptoms.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with globus pharyngeus in study group
* Able to speak, read, understand and write in Turkish
* give a consent form

Exclusion Criteria:

* patients with dysphagia or odynophagia
* laryngeal organic pathologies
* pharyngeal organic pathologies
* epiglottic retroversion
* malignancy
* pregnancy
* mental disorders
* neurological disorders
* major psychiatric disorders
* Underwent laryngectomy/neck dissection/tracheostomy/neck radiotherapy
* Underwent any surgery last a year
* Cognitive limitations
* give not a consent form
Remote Ischemic Preconditioning Prior to Vascular Surgery

The investigators have previously shown that elective vascular surgery is a high-risk operation with an anticipated risk of either death or heart attack of 15%. This study is testing whether a protocol of remote ischemic preconditioning (RIPC) applied 24 hours prior to the operation is safe, feasible and reduces the incidence of an adverse, perioperative cardiac complication.

The proposed investigation has a single blind, randomized design and plans to enroll 180-205 patients who are scheduled to have major, elective vascular surgery for occlusive carotid disease, expanding abdominal aortic aneurysm (AAA), occlusive lower extremity disease and/or critical limb ischemia at the Minneapolis VA Health Care Center. 24 hours prior to the patient's scheduled vascular operation, RIPC therapy will be applied to one of the participant's upper arms to cause forearm ischemia. Clinically collected, pre-operative troponins, creatine kinase MBs (CK-MBs), EKGs along with troponins, CK-MBs and EKGs collected on day 1, 2, 3 and day 7 (if still hospitalized) will be utilized to evaluate the occurrence of perioperative, adverse cardiac events.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective major vascular surgery at the Minneapolis VA Medical Center for abdominal aortic aneurysm, carotid disease or limb ischemia.
* Age \> 18.
* Provides informed consent.

Exclusion Criteria:

* Hypertensive crisis
* Peripheral arterial disease of the upper extremities
* Arteriovenous (AV) fistula
* Acute Coronary Syndrome (ACS) in the last 6 months
* Severe valvular heart disease
* Pregnant women
* Unable to provide consent
Unexpected Diagnosis in Right Lower Quadrant Pain: Right Colon Diverticulitis

BACKGROUND: Acute right lower quadrant pain is a common symptom in emergency departments. The most common etiology is thought to be acute appendicitis. Other etiologies may be overlooked. Acute right colon diverticulitis is one of them. It is usually seen in male and young patients. It is more common in Asian population and rare in Western countries. Ultrasonography (USG) and computed tomography (CT) are used for radiologic diagnosis.

OBJECTIVES: The aim of this study was to investigate the diagnosis, treatment and surgical management of right colon diverticulitis.

DESIGN: Retrospective cross-sectional analysis SETTING: Research and training hospital (Tertiary care center) In our study, patients hospitalized in our hospital clinic between 2018 and 2022 with the diagnosis of right colon diverticulitis were retrospectively analyzed. Age, gender, WSES grade, whether surgery was performed or not, laboratory values, iv antibiotherapies given, length of hospitalization and mortality were evaluated.

MAIN OUTCOME MEASURES: The CRP, the need for surgical intervention vs conservative treatment .

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with right colonic diverticulitis

Exclusion Criteria:

* \<18 years of age
Registry for Evaluating Outcome of Acute Ischemic Stroke Patients Treated With Mechanical Thrombectomy.

The Bernese-European RegistrY for ischemic stroke patients treated Outside current guidelines with Neurothrombectomy Devices using the SOLITAIRE™ FR With the Intention For Thrombectomy (BEYOND-SWIFT) is a retrospective, multi-center, non-randomized observational study aims to investigate the safety and efficacy of a Medtronic market-released neurothrombectomy device (applied as initial devices used for intervention) in acute ischemic stroke patients who do not fulfill treatment eligibility according to current guidelines. Patients will be treated or were treated at the discretion of the investigator, independent of participation in this registry. Primary Analysis is the Impact of successful reperfusion on functional outcome at day 90 in patients presenting with large infarct cores (ASPECTS\<6) or minor symptoms (NIHSS\<8).


Eligibility Criteria:
Inclusion Criteria:

* Patients or patient's legally authorized representative have given informed consent according to Good Clinical Practices (GCP) and/or IRB and/or local or institutional policies.
* The patient presents with an intracranial large vessel occlusion and therewith-related neurological symptoms and has been or will be treated with a Medtronic marketed-release neurothrombectomy device (applied as first device to attempt retrieving the thrombus).

Exclusion Criteria:

* Current participation in another clinical trial