louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03351179: Predictors and Outcomes of In-hospital HFpEF in AMI Patients
Official title: Predictors and Outcomes of Hospitalized Heart Failure With Preserved Ejection Fraction Among Patients With First Acute Myocardial Infarction After Reperfusion Treatments
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Heart Failure With Preserved Ejection Fraction
Predictor
Prognosis
Keywords: Heart Failure with Preserved Ejection Fraction
Acute MyocAcute Myocardial Infarction
Predictive factors
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: AMI patients with HFpEF: First AMI subjects undergoing PCI with a diagnosis of HFpEF.

AMI patients without HF: First AMI subjects undergoing PCI without a diagnosis of HF.

Brief summary: This retrospective observation is to investigate the incidence,clinical outcomes and prognosis of hospitalized heart failure with preserved ejection fraction (HFpEF) in patients with acute myocardial infarction(AMI).

Detailed description: 1. Patients with first AMI undergoing primary percutaneous coronary intervention (PCI) in our hospital since January 2013 were retrospectively evaluated. The enrolled subjects were divided into two groups (AMI patients with HFpEF and AMI patients without HF).
2. The investigator collected the clinical data of participants' demographics (age, sex), previous history,risk factors for AMI (hypertension, hyperlipidemia, diabetes mellitus, smoking and stroke), laboratory biomarkers, echocardiographic measurements, clinical characteristics,medical procedures and treatments, as well as in-hospital complications.
3. Two sub-investigators independently analyzed these data by using SPSS software.

Eligibility criteria: Inclusion Criteria:

* First AMI patients undergoing PCI with HFpEF or without HF.

Exclusion Criteria:

* First AMI patients with heart failure with reduced ejection fraction.
* First AMI patients with severe inflammatory diseases, valvular heart disease, non-cardiac caused symptoms, serious hepatic and renal failure, congenital cardiomyopathy,or pericardial diseases.

Primary outcomes:
measure: Risk factors of incident in-hospital HFpEF
timeFrame: Outcome measure will be assessed at discharge, and data will be reported through study completion, an average of 1 year.
Secondary outcomes:
measure: Clinical prognosis in patients with HFpEF
timeFrame: Outcome measure will be assessed at discharge, and data will be reported through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Suzhou
country: China
facility: the First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: First Affiliated Hospital of Soochow University
name: Xiangjun Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02949479: Dissociation Investigation Study in Sex Offenders
Official title: Dissociative Experience During the Offence in Sex Offenders : Clinical and Prognosis Correlates
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sex Offenses
Keywords: sex offenses
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: Adverse childhood experience have been described in sexual offenders but the link with the offence need to be further investigated. Investigators postulate that one of the clinical moderating factors could be dissociative experience, a consequence of these early adverse experiences reactivated during the offence. The purpose of the study is to estimate the prevalence of clinical dissociation during the offence in a male adult population referred to our center for a sexual offence and to explore its correlations with epidemiological and clinical data (personal, legal history, psychiatric comorbidities), clinical trauma and dissociation, prognosis estimates.

Detailed description: The study will be proposed to the subjects after their usual clinical evaluation in the center for sexual offence and to extend this evaluation by a specific focus on childhood abuse and neglect trauma and dissociative history. After receiving complete information, the participants will sign the consent form and be referred to a unique on-site visit of approximately 2 hours long. During this visit, the participants will benefit from a psychiatric examination in search for clinical features of dissociation during the offence, lifetime dissociative experience, lifetime post-traumatic stress disorder; they will have to complete bioevaluation forms for dissociation (Dissociative Experience Scale) and childhood abuse and neglect (Childhood Experience of Care and Abuse). After this completion, they will benefit from a second part psychiatric examination, so as to complete the assessment and answer their questions if any.

Eligibility criteria: Inclusion Criteria:

* male subject referred to the center for having committed a sexual offense; social insurance affiliation

Exclusion Criteria:

* schizophrenia, mental retardation (IQ\<70)

Primary outcomes:
measure: point prevalence of clinical dissociation during the offence, assessed with the use of clinical examination (narrative and DSM-5 criteria)
timeFrame: 3 years
Secondary outcomes:
measure: lifetime dissociation
timeFrame: 3 years
measure: childhood abuse or neglect
timeFrame: 3 years
measure: psychiatric comorbidities
timeFrame: 3 years
measure: prognosis issues
timeFrame: 3 years
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre Hospitalier Le Vinatier
state: Rhône Alpes
Study officials:
affiliation: Centre Hospitalier le Vinatier
name: Mouchet-Mages Sabine, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03670979: Periodontal Osseous Wall Piezosplitting and EDTA Root Surface Etching
Official title: A Novel Approach of Periodontal Osseous Wall Piezosplitting and EDTA Root Surface Etching in Management of Localized Intrabony Defects With Wide Angulation. Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 16
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to investigate the use of minimally invasive Piezo knife to harvest vascularized interceptal bone pedicle in treating intrabony defects.

Detailed description: Sixteen non-smoking patients with severe chronic periodontitis participated in this prospective, randomized clinical study. Patients were randomly assigned into one of a 2 groups (8 patients each): bone substitute grafting of the intrabony defect, control group (Gr1), intrabony defect osseous wall swaging (OWS) combined xenograft (Gr2). In both groups root surfaces where treated with a neutral 24% EDTA gel and saline irrigation. Clinical and radiographic measurements were reassessed at 6 months after surgery.

Eligibility criteria: Inclusion Criteria:

1. good compliance with plaque control instructions following initial therapy
2. teeth involved were all vital with no mobility ;
3. each subject contributed a single predominately 2 or 3-wall intrabony interproximal defect around premolar or molar teeth without furcation involvement;

Exclusion Criteria:

1. no systemic diseases which could influence the outcome of therapy;
2. absence of periodontal treatment during the previous year.

Primary outcomes:
measure: Radiographic evaluation
timeFrame: 3 months
Secondary outcomes:
measure: Clinical pocket depth
timeFrame: 3month
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University
name: ahmed y gamal, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06679179: Effect of Flozin (dapagliflozin) Administration on Myocardial and Peripheral Vascular Remodeling
Official title: Effect of Flozin (dapagliflozin) Administration on Myocardial and Peripheral Vascular Remodeling
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients over 18 years of age of both sexes with diagnosed heart failure NYHA class II and III.

Brief summary: The aim of this study is to assess the effect of treatment with flozin (dapagliflozin 10mg once a day) on haemodynamic parameters and myocardial and peripheral vascular remodeling in patients with NYHA class II-III heart failure.

Detailed description: In the available literature, there are reports of beneficial effects of flozins on improving myocardial systolic and diastolic function and isolated reports of effects on regression of organ damage (heart, vessels). These drugs significantly improve the prognosis of patients with heart failure, reduce total and cardiovascular mortality, reduce the number of exacerbations and the need for hospitalization, and have a beneficial effect on improving quality of life regardless of coexisting diabetes. New properties demonstrating the pleiotropic effect of the flozins are constantly being discovered. Drugs in this group are highly potent, selective and reversible inhibitors of the sodium ion-dependent glucose cotransporter 2 (SGLT2). The flozins have a low risk of side effects.

Eligibility criteria: Inclusion Criteria:

* diagnosed heart failure NYHA class II and III
* consent to participate in the study
* patients should already be receiving treatment with an ACE inhibitor or sacubitril/valsartan or sartans, a beta-blocker, and an MRA, and should start on SGLT2i as part of therapy enhancement

Exclusion Criteria:

-

Primary outcomes:
measure: Identify factors that predict remodeling and enhancement of left ventricular (LV) systolic and diastolic function within 12 months.
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of the combined outcome including deaths from cardiovascular causes, defibrillator discharges, hospitalizations or episodes of atrial fibrillation.
timeFrame: Baseline ut to 12 months
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: University Clinical Hospital in Poznań, 49 Przybyszewskiego Street, 60-355 Poznań
state: Wielkopolska
Study officials:
affiliation: University Clinical Hospital in Poznań, 49 Przybyszewskiego Street, 60-355 Poznań
name: Arkadiusz Niklas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04261179: Study Comparing Lymphoseek® vs. Albumin Nanocolloid in Head and Neck, Melanoma and Breast Cancer
Official title: An Exploratory Prospective, Open-label, Unicentric Study With Cross-over Design, Comparing Lymphoseek® vs. Albumin Nanocolloid for Image- Guided Sentinel Lymph Node Mapping in Head and Neck, Melanoma and Breast Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Head Cancer
Neck Cancer
Melanoma
Breast Cancer
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Histologically confirmed diagnosis of melanoma, breast cancer or head and neck cancer and candidate for surgical resection with lymph node mapping being a part of the surgical plan.
* At least 18 years of age at the time of consent.
* The subject is clinically node negative (cN0) at the time of screening.
* In Melanoma Patients

  * Diagnosis of primary melanoma with sentinel node indication ( \>0.8 mm Breslow thickness; clinically negative lymph nodes)
* In Breast Cancer Patients

  * T1-T2 N0 breast cancer.
  * Patients with pure ductal carcinoma in situ (DCIS) if lymph node biopsy is part of the surgical plan.
* In Oral cavity tumors patients

  * T1-T2 N0 oral cavity squamous cell carcinoma

Exclusion Criteria:

* Pregnancy or lactation
* Clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
* Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy
* Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary tumor
* Patients who have undergone a wide excision for their tumor or complex reconstruction (rotation, free flap or skin graft of any type).

Primary outcomes:
measure: Nodal Concordance: proportion of lymph nodes identified by 99mTc-tilmanocept vs nanocolloidal human serum albumin by lymphoscintigraphies
timeFrame: for at least 48 consecutive hours
Secondary outcomes:
measure: Time frame to ascertain the sentinel nodes
timeFrame: 1 week
measure: Concordance among early and delayed images obtained withLymphoseek® or with albumianocolloid and the SPECT/CT images.
timeFrame: 1 week
measure: Number of sentinel nodes and secondary nodes depicted
timeFrame: 1 week
measure: Tracer retention in injection site
timeFrame: 1 week
measure: Safety and tolerability of 99mTctilmanocept (Lymphoseek®)
timeFrame: 1 week
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínico y provincial de Barcelona
Study officials:
References:
Clinical trial NCT06878079: ERAS and Postoperative Recovery in Gynecologic Patients: A QoR-15 Study
Official title: Assessing Enhanced Recovery After Surgery (ERAS) Intervention Impact on Postoperative Recovery in Gynecological Patients Using QoR-15 Questionnaire
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gynecologic
ERAS
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital Hsin-Chu Branch
First posted: 2025-03-14
Enrollment: 130
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who undergoing routine gynecological surgery, including total or subtotal hysterectomy, myomectomy, oophorectomy, gynecologic cancer staging surgery, cytoreductive surgery, and pelvic exenteration.

Brief summary: The Quality of Recovery-15 (QoR-15) questionnaire is a widely used Patient-Reported Outcome Measure (PROM) for evaluating postoperative recovery, including pain, physical function, and emotional well-being. Enhanced Recovery After Surgery (ERAS) is a multidisciplinary care model designed to optimize perioperative management through standardized protocols.

For gynecological surgery, ERAS emphasizes preoperative education, early interventions (e.g., smoking cessation, anemia management, nutrition optimization), intraoperative strategies (e.g., fluid balance, nausea prevention, temperature control), and postoperative care (e.g., early mobilization, pain control, ileus prevention). However, while ERAS is gaining acceptance, its effectiveness can vary due to workload, patient variability, and institutional resources, and its superiority over traditional care remains inconclusive.

This study aims to objectively compare ERAS and traditional perioperative care using the QoR-15 questionnaire to assess patient satisfaction, recovery speed, surgical risk reduction, and complication prevention. Rather than solely promoting ERAS, this research seeks to evaluate its applicability, enhance personalized care, and provide scientific evidence for perioperative management optimization.


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 80 years.
* Undergoing routine gynecological surgery, including total or subtotal hysterectomy, myomectomy, oophorectomy, gynecologic cancer staging surgery, cytoreductive surgery, and pelvic exenteration.
* Cancer patients with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
* Receiving either standard perioperative care or ERAS protocol-based care.

Exclusion Criteria:

* Age below 20 years.
* Lack of decision-making capacity.
* Undergoing emergency surgery.
* History of clinical depression.
* Undergoing palliative surgery.
* History of chronic pain.

Primary outcomes:
measure: Quality of Recovery-15 (QoR-15) questionnaire
timeFrame: 5 mins
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04088279: Novel Quantitative Magnetic Resonance Imaging (MRI) Measures in the Assessment and Follow-up of Patients With Pulmonary Hypertension (PH)
Official title: Novel Quantitative Magnetic Resonance Imaging (MRI) Measures in the Assessment and Follow-up of Patients With Pulmonary Hypertension (PH)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: MRI
oxygen enhanced
fourier decomposition
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A prospective study of the use of two novel MRI techniques (oxygen-enhanced and fourier decomposition MRI) in the initial diagnosis and follow-up of patients with Pulmonary Hypertension. The investigators believe these techniques may present a novel set of imaging biomarkers that may be used for risk stratification, prediction of treatment response and longitudinal disease monitoring. The reserach MRI is in addition to standard of care and will not affect treatment decisions.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Pulmonary Hypertension.
* Age 18 and over.

Exclusion Criteria:

* Standard contra-indications to MRI (as per NHS MRI safety questionnaire).
* Not medically fit for transfer to MRI.
* Patient judged inappropriate for involvement in study by clinical team e.g. secondary to emotional burden of recent diagnosis.

Primary outcomes:
measure: Delta pO2 max (mmHg)
timeFrame: Baseline and 3-6 months
measure: Wash in and wash out time constants (min)
timeFrame: Baseline and 3-6months
measure: Signal Intensity Change (%)
timeFrame: Baseline and 3-6months
measure: Fractions (% area of lung imaged)
timeFrame: Baseline and 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Simon Padley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03498079: Prevalence of Mullerian Anomalies in Infertile Women
Official title: Prevalence of Mullerian Anomalies and PCO in Egyptian Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mullerian Anomaly of Uterus
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
name: National Research Centre, Egypt
name: misr Infertility centre ,Alaqsor
First posted: 2018-04-13
Enrollment: 250
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - females with age between 20-42 years with primary infertility

Brief summary: * Mullerian anomalies are congenital structural anomalies in the uterus .
* Its prevalence is not uncommon .

Detailed description: * PCO is very common in gynecological practice
* Women with mullerian anomalies should be properly evaluated for other gynecological and urological problems

Eligibility criteria: Inclusion Criteria:

* females with age between 20-42 years with primary infertility

Exclusion Criteria:

* females with age above 42 years or below 20 years females with secondary infertility

Primary outcomes:
measure: the number of participants who will prove to have PCO
timeFrame: within 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05484479: Effect of Baduanjin Exercise on Chronic Periodontal Disease in Elderly
Official title: Baduanjin-exercise Efficacy on Chronic Periodontal Disease in Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Periodontal Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The metabolic syndrome (MetS) is a spectrum of conditions that increase the risk of cardiovascular disease and diabetes mellitus. The components of MetS include dysglycemia, visceral obesity, atherogenic dyslipidemia (elevated triglycerides and low levels of high-density lipoprotein) and hypertension. An association of periodontal disease and MetS has been suggested. This association is believed to be the result of systemic oxidative stress and an exuberant inflammatory response.

Physical activity is associated as a potential tool for reduction of periodontal disease prevalence. The frequency of physical activity is directly related to a low occurrence of periodontitis.

Detailed description: For 6 months, MeTS elderly (25 elderly) with chronic periodontal disease will be involved in sixty-minute Baduanjin physical training (5 session weekly). Also, for 6 months, another MeTS elderly (25 elderly) with chronic periodontal disease will serve as a control non-trained group.

Eligibility criteria: Inclusion Criteria:

* fifty elderly with metabolic syndrome and chronic periodontal disease will be included
* both sexes will be included

Exclusion Criteria:

* smokers
* elderly engaged in physical activity programs
* any cardiovascular/respiratory diseases that obstacle the conduction of Baduanjin
* elderly on drug therapies for chronic periodontal disease

Primary outcomes:
measure: Periodontal disease index
timeFrame: It will be assessed after 6-month intervention
Secondary outcomes:
measure: Simplified oral hygiene index
timeFrame: It will be assessed after 6-month intervention
measure: Interleukin 1 beta
timeFrame: It will be after 6-month intervention
measure: interleukin 6
timeFrame: It will be assessed after 6-month intervention
measure: superoxide dismutase
timeFrame: It will be assessed after 6-month intervention
measure: total antioxidant status
timeFrame: It will be assessed after 6-month intervention
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Dokki
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References: