louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05162807: Intervention to Improve Caregiver Palliative Care Knowledge and Attitudes
Official title: Improving Caregiver Palliative Care Knowledge and Attitudes: Evaluating the Impact of a Psychoeducational Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Palliative care
Caregiver
Lead sponsor: Tulane University
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between groups, randomized design. Participants are randomized to either intervention or control conditions.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized clinical trial will assess whether a psychoeducational intervention will improve palliative care knowledge and attitudes among close friends and family members of individuals with cancer. The psychoeducational intervention entails viewing a video introducing palliative care and its purpose, structure, benefits, and efficacy.

Detailed description: The primary aims of this randomized clinical trial are to examine the impact of a psychoeducational intervention on (1) palliative care knowledge, and (2) palliative care attitudes among close friends and family members of individuals with cancer. Participants will complete a baseline survey including measures of palliative care knowledge and experience. Participants will be randomized to then view either a psychoeducational video introducing palliative care (intervention) or an educational video on nutrition throughout cancer survivorship (attention control). All participants will then complete outcome measures, including primary outcomes of palliative care knowledge and attitudes.

Eligibility criteria: Inclusion criteria:

* Provide informed consent
* 18 years of age or older
* Have ever had a close friend or family member diagnosed with cancer

Primary outcomes:
measure: Palliative Care Knowledge Scale (PaCKS)
timeFrame: Immediately post-intervention
measure: Palliative Care Attitudes Scale - Caregiver (PCAS-9C)
timeFrame: Immediately post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
Study officials:
affiliation: Tulane University
name: Brenna K Mossman, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05942807: Observational Monocentric Study on Biliary Tract Cancer (BABEL)
Official title: The Prognostic and Predictive Role of Clinical, Biochemical, Pathological and Molecular Characteristics of Patients With Biliary Tract Cancer: an Observational Monocentric Study. (BABEL)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biliary Tract Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population is consituited by patients with BTC treated at Medical Oncology Unit of the FPUAG - IRCCS. The study involves a historical cohort and a prospective cohort.

Brief summary: BABEL is an observational, single-center, prospective study about patients affected by biliary tract cancers (BTC) treated at the Medical Oncology Unit of the FPUAG - IRCCS.

Detailed description: BABEL is an observational, single-center, prospective study with an historical cohort. Study population is represented by patients affected by biliary tract cancers (BTC) treated at the Medical Oncology Unit of the FPUAG - IRCCS. The study involves an historical cohort and a prospective cohort. Primary aim of the study is to associate BTC patients' overall survival with IDH1/2 mutations, in order to confirm the prognostic role of these genes both metastatic and resectable disease setting. The secondary aims are to correlate FGFR mutations and overall survival of BTC patients and to find new clinical and molecular characteristics linked with survival and response to treatment.

Eligibility criteria: Inclusion Criteria:

* Patients with biliary tract cancer;
* Patients with radiological evident disease;
* Patients \>18 anni;
* Written informed consent;
* Patients with at least one oncological visit.

Exclusion Criteria:

* Patients without available clinical data;
* Patients without histological diagnosis of BTC;
* Patients without written informed consent.

Primary outcomes:
measure: Overall survival
timeFrame: The expected OS for BTC patients is 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli/IRCSS - UOC di Oncologia Medica
state: Rome
Study officials:
References:
Clinical trial NCT03449407: Multi-dimensional Investigations of Negative Emotions and Drug-resistant Auditory Verbal Hallucinations in Psychosis
Official title: Multi-dimensional Investigations of Negative Emotions and Drug-resistant Auditory Verbal Hallucinations in Psychosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia Spectrum and Other Psychotic Disorders
Hallucinations, Auditory
Keywords: Auditory hallucinations
Psychosis
Mood
Brain imaging
Experience sampling method
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, including in-patients, out-patients and day hospital patients, will be recruited from psychiatric units of multiple hospital sites.

Brief summary: Auditory verbal hallucinations (AVH) are commonly reported as source of distress, disability and mortality in schizophrenia. Despite proven efficacy of antipsychotics, many patients still experience drug-refractory AVH. It has been postulated that AVH is maintained by negative emotions. Yet, little is known about the temporal relationship and underlying mechanisms between negative affect and AVH. Utilizing both an ecologically-validated method and brain imaging technique, this study aims to uncover the role of emotions in the maintenance of psychotic symptoms.


Eligibility criteria: Inclusion Criteria:

* Aged 18 to 65 years
* Clinical diagnosis of schizophrenia spectrum disorder
* Present hallucinations

Exclusion Criteria:

* Left-handedness
* Intellectual disability
* Organic psychosis

Primary outcomes:
measure: Psychotic symptomatology as measured by Positive and Negative Syndrome Scale (PANSS), Scale of Assessment for Positive Symptoms (SAPS), and the Psychotic Symptom Rating Scales (PSYRATS)
timeFrame: Baseline
measure: Depressive symptomatology as measured by Calgary Depression Scale (CDS)
timeFrame: Baseline
measure: Beliefs about voices as measured by Beliefs about Voices Questionnaire - Revised (BAVQ-R)
timeFrame: Baseline
measure: Anxiety severity as measured by Beck anxiety inventory (BAI)
timeFrame: 1 week
measure: Mood states as measured by Visual analogue scale (VAS)
timeFrame: 1 week
Secondary outcomes:
measure: Cognitive capacity as measured by the Wechsler Adult Intelligence Scale - IV (HK) short form (WAIS-IV)
timeFrame: Baseline
measure: Handedness as measured by Edinburgh Handedness Inventory (EHI)
timeFrame: Baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT04390607: Leukocyte Esterase Sensor Test
Official title: A Research Study to Determine if a Leukocyte Esterase Electrochemical Assay Can be Used as a Marker for Periprosthetic Joint Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prosthetic Joint Infection
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This will be a prospective study with consecutive revision joint surgery patients determined to be in one of three groups: 1) patients undergoing revision joint replacement for presumed aseptic loosening, 2) patients undergoing irrigation and debridement with implant retention, and 3) patients undergoing two stage revision for infection. We will also recruit a small number of patients undergoing primary joint replacement (Jefferson hospital only).

Brief summary: The primary objective of this study is to assess the diagnostic efficacy of the quantitative electrochemical LE biosensor for periprosthetic joint infection (PJI). The secondary objective of this study is to assess the utility of d-lactase as adjunct biomarker to LE in making a diagnosis of PJI.


Eligibility criteria: Inclusion Criteria:

1: consecutive patients undergoing at least one of the following procedures: presumed aseptic revision arthroplasty, irrigation and debridement, radical resection for periprosthetic joint infection

Exclusion Criteria:

1. known active gout flare
2. existing corrosion or metallosis
3. inflammatory arthritis
4. preexisting diagnosis of infection in the same joint
5. patients undergoing second-stage procedure for infection.

Primary outcomes:
measure: Receiver Operating Curve (ROC) analysis
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
References:
Clinical trial NCT01326507: Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism
Official title: Performances de l'h-FABP Pour Identifier dès Les Urgences Les Embolies Pulmonaires d'évolution défavorable
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Keywords: pulmonary embolism
Heart-type fatty acid-binding protein
cardiac biomarkers
risk stratification
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2011-03-31
Enrollment: 165
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: The patients presenting with acute pulmonary embolism and right ventricular dysfunction are at high risk for life-threatening events and must be identified in the emergency department for adequate care and hospital admission. Echocardiography can identify right ventricular dysfunction, but this test is not always available, and echocardiographic criteria of right ventricular dysfunction vary among published studies. The primary purpose of this protocol is to study the prognostic value of a cardiac biomarker, h-FABP (heart-type Fatty Acid-Binding Protein) , to identify in the emergency department the patients presenting with high risk pulmonary embolism. As secondary outcomes, H-FABP results will be compared to other cardiac biomarkers (BNP, troponin) and clinical score performances that have been previously studied to stratify the prognosis of patients with pulmonary embolism in the emergency department.


Eligibility criteria: Inclusion Criteria:

* patients with acute pulmonary embolism diagnosed in the emergency departement

Exclusion Criteria:

* patient under guardianship
* patient without social insurance
* pregnant women
* refusal to sign the consent
* myocardial infarction in the 10 days before pulmonary embolism

Primary outcomes:
measure: number of death by pulmonary embolism
timeFrame: 1 month
measure: life-threatening pulmonary embolism (cardiopulmonary arrest, shock, mechanical ventilation)
timeFrame: 1 month
measure: recurrent episode of pulmonary embolism
timeFrame: 1 month
Secondary outcomes:
measure: prognostic value of a clinical score (PESI), BNP and troponin in acute pulmonary embolism
timeFrame: 1 month
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hôpital Rangueil Service des urgences
Study officials:
affiliation: University Hospital, Toulouse
name: Dominique LAUQUE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lauque D, Maupas-Schwalm F, Bounes V, Juchet H, Bongard V, Roshdy A, Botella JM, Charpentier S. Predictive value of the heart-type fatty acid-binding protein and the Pulmonary Embolism Severity Index in patients with acute pulmonary embolism in the emergency department. Acad Emerg Med. 2014 Oct;21(10):1143-50. doi: 10.1111/acem.12484.
Clinical trial NCT05937607: The Effect of the Hand Massage A Women Undergoing Brachytherapy
Official title: The Effect of the Hand Massage Application on the Procedural Pain and State Anxiety of Women Undergoing Brachytherapy: A Parallel-Group Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hand Massage
Keywords: Hand Massage
Pain
State Anxiety
Brachytherapy
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background Gynecologic cancers are among the ten most common cancers among women. During brachytherapy, women can have pain and situational anxiety due to the treatment.

Methods This parallel-group randomized controlled study evaluated the effect of the hand massage practiced using baby oil, with lavender oil, on reducing operational pain and situational anxiety in women with brachytherapy. The study was completed with 36 patients. The treatment group included 18 patients, and the control group had 18. The data were collected through patient information form, visual analog scale, and state anxiety inventory. Before the brachytherapy, three sessions of hand massages, each lasting 10 minutes (5 minutes for each hand), were performed using baby oil with lavender. Data collection forms were repeated after each session. The control group received routine treatment. p\<0.05 was accepted as significant.

Detailed description: Therefore, the impact of hand massage applied with lavender baby oil on women with gynecologic cancer having brachytherapy for three sessions on the pain and state anxiety experienced during the intervention was evaluated in this study.

Eligibility criteria: Inclusion Criteria:

* verbal communication
* to be at the age of 18 and above
* to be diagnosed with gynecologic cancer and receive BT three days a week regularly
* to be aware that she has a gynecologic cancer disease and to be a volunteer to participate in the study

Exclusion Criteria:

* the patients who had metastasis, bleeding or coagulation disorder
* received complementary and integrated treatment
* had edema or lesion on hand, had a psychiatric disease
* had communication problems
* did not want to have a massage
* were under general anesthesia during the intervention

Primary outcomes:
measure: Visual Analog Scale
timeFrame: The scale was filled in the baseline
Secondary outcomes:
measure: State Anxiety Scale
timeFrame: The scale was filled in the baseline
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Dilek Efe Arslan
state: Talas
Study officials:
affiliation: ERCİYES UNİVERSİTY
name: DİLEK EFE ARSLAN, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03900507: Postoperative Results of Incisional Endometriosis
Official title: Postoperative Results of Patients Who Received Medical Treatment for Incisional Endometriosis and Did Not Respond to Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Pain
Keywords: incisional endometriosis
scar endometriosis
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone surgery previously and who have an incision in the abdominal region and who applied with a complaint of mass in the incision and who were primarily considered endometrial focus in the diagnosis,

-Patients who were diagnosed with endometriotic foci in the incision line and used medical treatment for a while, but who did not benefit because of surgical excision.

Brief summary: The primary aim is to determine the endometriotic foci formed in the incision line after surgical operations, and the medical treatment approach is the primary objective. Medical treatment was initiated and the patients who did not benefit from the treatment would be operated and postoperative pain scores would be compared with the medical treatment. It will be tried to determine which treatment is more effective in pain control.

In addition to removing the symptoms and providing therapeutic methods in patients, it is aimed to help in differential diagnosis of dermatological diseases and malignancy and thus to prevent anxiety in patients. It is also aimed to evaluate the pathology results in the most appropriate way to eliminate the symptoms (severe pain, bleeding, etc.) that occur in accordance with the menstrual cycle every month.


Eligibility criteria: Inclusion Criteria:

* Patients who have undergone surgery previously and who have an incision in the abdominal region and who applied with a complaint of mass in the incision and who were primarily considered endometrial focus in the diagnosis,
* Patients who were diagnosed with endometriotic foci in the incision line and used medical treatment for a while, but who did not benefit because of surgical excision.

Exclusion Criteria:

* Dermatologically diagnosed patients
* Follow-up patients with malignancy diagnosis
* Patients who have responded to medical treatment

Primary outcomes:
measure: preoperative pain scores
timeFrame: 1 week
measure: postoperative pain scores
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT06330207: An Emergency Department (ED) Provider Centered Intervention for Non-Traumatic Dental Condition Management (NTDC)
Official title: An Emergency Department (ED) Provider Centered Intervention for Non-Traumatic Dental Condition Management (NTDC)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emergency Department Visit
Odontalgia
Keywords: non-traumatic dental conditions
emergency department
opioid
antibiotic
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2024-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall objective of this proposal is to understand the barriers and facilitators to non-traumatic dental condition (NTDC) management in the emergency department (ED) through quantitative and qualitative methods. The first aim will determine the national variation in NTDC prescribing in the ED and subsequent ED/urgent care revisits and hospitalizations within 30-days of an index ED visit. Using national electronic health records and integrated claims datasets and a random effects model, we will identify factors associated with prescribing for NTDC and variation at the patient, provider, hospital and state levels. The second aim identifies ED providers' perceived barriers and facilitators to the management of NTDC in the ED. Using individual in depth interviews, ED providers (physicians, advanced practice providers) will identify the facilitators and barriers to management and prescribing for NTDC in the ED.


Eligibility criteria: Inclusion Criteria:

* ED providers (physicians, nurse practitioners, physician assistants)
* Working full-time in the ED

Exclusion Criteria:

* Part-time ED providers

Primary outcomes:
measure: Acceptability and feasibility
timeFrame: at baseline, and up to 6 months
Secondary outcomes:
measure: Prescribing behavior
timeFrame: at baseline, and up to 6 months
Other outcomes:
measure: Pilot trial outcomes
timeFrame: up to 6 months post intervention
Locations:
Study officials:
References:
Clinical trial NCT00965107: Onset Time of Thiopental Versus Propofol in the Elderly
Official title: Onset Time of Thiopental Versus Propofol in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Induction of Anaesthesia
Age
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
First posted: 2009-08-25
Enrollment: 78
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed at increasing the safety of the use of anaesthesia in an elderly population (\> 60 years). Patients with decreased physiological reserve, including all elderly patients, have an increased risk of getting an erroneous induction bolus. This project will investigate how fast elderly patients (\> 60 years) fall asleep during bolus induction of anaesthesia with two of the most used hypnotics, thiopental and propofol, evaluated with BIS-monitoring and clinical signs of anaesthetic depth. The hemodynamic response will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Elective surgical patients above 60 years of age, with an indication of general anaesthesia during surgery.
* Informed consent.
* The patient must be legally competent.
* The patient must be able to read and understand Danish.

Exclusion Criteria:

* Known allergic reactions to thiopental, propofol, lidocaine or alfentanil
* "Body Mass Index" (BMI) \<18 and \> 35.
* NYHA-class \> 2.

Primary outcomes:
measure: "Onset-time" defined as the time from started induction bolus to: - Time to BIS-value <50.
timeFrame: 120 seconds
Secondary outcomes:
measure: Hemodynamical effect (bloodpressure/pulse) every 60 seconds.
timeFrame: 120 seconds
measure: "Onset-time" defined as the time from started induction bolus to: - Time to loss of grip.
timeFrame: 120 seconds
measure: "Onset-time" defined as the time from started induction bolus to: - Time to eye closure.
timeFrame: 120 seconds
measure: "Onset-time" defined as the time from started induction bolus to: - Time to ciliary reflex cessation.
timeFrame: 120 seconds
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet
city: Copenhagen
country: Denmark
facility: Department of Anesthesia, Juliane Marie Center, Copenhagen University Hospital Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lars Rasmussen, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Martin K Soerensen, MD
role: PRINCIPAL_INVESTIGATOR
References: