louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06167252: Map of Unwanted Loneliness
Official title: Map of Unwanted Loneliness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Loneliness
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
Collaborators: name: Centro Internacional para la Investigación del Envejecimiento
First posted: 2023-12-12
Enrollment: 992
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population aged 65 or older who attend one of the 10 primary care centers participating in the provinces of Alicante and Valencia between March 1, 2022, and December 31, 2023.

Brief summary: Creating a map of the magnitude of the problem and the response of primary care to unwanted loneliness among the elderly, stratifying different needs based on place of residence and proximity to available assistance programs to address this issue, which, due to its scale, calls for collaboration among various institutions, disciplines, and experiences.


Eligibility criteria: Inclusion Criteria:

* Population aged 65 or older.
* Registration of medical records related to unanticipated loneliness.
* Patients with diagnoses of anxiety disorders (CIE-10 F41.1, F41.2, F41.8, F41.9, F43.2, F45, F48) or insomnia (CIE-10 F51) or affective disorders (CIE-10 F34.1) or somatization (CIE-10 F45.0) or pathological grief (CIE-10 Z63.4) or those referred to mental health or social worker services.

Exclusion Criteria:

* None

Primary outcomes:
measure: NH
timeFrame: 21 months
Secondary outcomes:
measure: NFMV
timeFrame: 21 months
measure: NPCNV
timeFrame: 21 months
measure: NPSWV
timeFrame: 21 months
measure: NFPV
timeFrame: 21 months
measure: NCPHV
timeFrame: 21 months
measure: NCEPV
timeFrame: 21 months
measure: NHD
timeFrame: 21 months
measure: NTDMGE
timeFrame: 21 months
measure: NTEM
timeFrame: 21 months
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: FISABIO
Study officials:
References:
Clinical trial NCT00600652: FCM Analysis GR in Steroid-Treatment Patients
Official title: Flow Cytometric Analysis of Glucocorticoid Receptor Using Monoclonal Antibody and Fluoresceinated Ligand Probes in Glucocorticoid-Resistant and -Sensitive Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: glucocorticoid-receptor
flow cytometry
glucocorticoid-resistant
prediction
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2008-01-25
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: one hundred patients, including 50 SLE and 50 NS, who will receive GC therapy, were studied. Of them, fifty were GC-resistant patients (25 male and 25 female; 20 without treatment and 30 relapse) and fifty were GC-sensitive ones( 25 male and 25 female; 20 without treatment and 30 relapse ). Controls were 50 healthy volunteers (25 male and 25 female). All participants gave their informed consent, and this investigation was approved by Changhai hoapital ethics committee.

Brief summary: Monitoring the GR with a GR-MoAb and FITC-Dex probes by FCM would be useful and convenient in determination GR before the steroid treatment in clinical, especially in steroid resistant states, in order to design more efficient clinical treatment protocols.

Detailed description: In order to assess the efficacy of this method, 100 patients with nephrotic syndrome and systemic lupus erythematosus receiving sufficient prednisolone thereafter and 50 age- and sex-matched normal controls will be studied.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of SLE and NS

Exclusion Criteria:

* Receiving hormone replacement therapy or had received hormone replacement therapy in three months before start of the study
* Received drugs or drinks containing alcohol within one month
* Having symptom such as infection
* Supersensitivity and endocrine disturbance.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Changhai Hospital
name: Jing Li, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Du J, Li M, Zhang D, Zhu X, Zhang W, Gu W, Feng Y, Zhai X, Ling C. Flow cytometry analysis of glucocorticoid receptor expression and binding in steroid-sensitive and steroid-resistant patients with systemic lupus erythematosus. Arthritis Res Ther. 2009;11(4):R108. doi: 10.1186/ar2763. Epub 2009 Jul 14.
Clinical trial NCT05804552: The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure
Official title: The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Electrical Stimulation
Urethral pressure
Neuromodulation
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: InnoCon Medical
First posted: 2023-04-07
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate the effect of electrical stimulation of the dorsal genital nerve on the urethral pressure in healthy women.


Eligibility criteria: Inclusion Criteria:

* Normal weight (Body weight 50 kg or more, Body Mass Index 18-5-30 kg/m2)
* Signed an informed consent

Exclusion Criteria:

Any history of clinically significant diseases, unless regarded irrelevant and/or stable by the investigator

* Any history or evidence of clinically significant urinary incontinence, urinary retention, overactive bladder, or other voiding dysfunction
* Known or suspected nerve injuries or paraesthesia in the pelvic area
* Pregnancy within six months before enrolment
* Breastfeeding within three months before enrolment
* Smoking or other regular use of any form of nicotine product during the study period and the previous 3 months
* Current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator)
* Any systemic drug use within 2 weeks before the first study day (prescription drugs, over-the-counter drugs, herbal drugs, and/or illicit drugs), except for occasional use of paracetamol (up to 4 g/day), ibuprofen, or antihistamine, hormonal contraceptives and hormone replacement therapy.

Primary outcomes:
measure: Effect of burst dorsal genital nerve stimulation compared to baseline
timeFrame: Baseline and during dorsal genital nerve stimulation
Secondary outcomes:
measure: Effect of continuous dorsal genital nerve stimulation on resting pressure compared to baseline
timeFrame: Baseline and during dorsal genital nerve stimulation
measure: Effect of continuous dorsal genital nerve stimulation on squeezing pressure compared to baseline
timeFrame: Baseline and during dorsal genital nerve stimulation
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Zelo Phase 1 unit
Study officials:
References:
Clinical trial NCT05878652: Playmaker 3D Printed Knee Extender
Official title: Utilization of a 3D Printed Customized Knee Extender on Patient Outcomes Following ACL Injuries
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ACL
ACL Injury
Keywords: Desktop 3D Printing
Knee Extender
Pre-habilitation
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 36
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the development of, and patient outcomes associated with, the use of individually printed knee extender in conjunction with a video-based home pre-habilitation program for patients who have suffered an ACL rupture before surgery.

Detailed description: The proposed study will assess the efficacy of utilizing desktop 3DP for patient-specific knee extenders paired with a video-based home pre-habilitation program to address the aforementioned barriers. If the novel device and home program is found to be a viable treatment option, this may improve or replace current treatments for knee pre-habilitation, increase accessibility to proper treatment, and reduce cost and time burden on patients, PTs, and providers. The study will offer a greater understanding of potential improvements to clinical workflows and efficiencies through using 3DP. This technology is an under- utilized resource; further research into the applications of 3DP in the field of orthopaedics will provide opportunities to improve patient care and outcomes.

Eligibility criteria: Inclusion Criteria:

* 14-60 years old patients who have suffered an isolated primary ACL rupture

Exclusion Criteria:

* Patients who have already attained full knee extension
* Open skin wounds that would come into contact with the device
* Pregnant women

Primary outcomes:
measure: Knee Extension Range of Motion
timeFrame: Change from baseline range of motion to day of ACL reconstruction.
measure: Time to Achieve Full Knee Extension
timeFrame: Through study completion, an average of 4 weeks.
Secondary outcomes:
measure: Knee Swelling
timeFrame: Through study completion, an average of 4 weeks.
measure: Average Daily Pain Level
timeFrame: From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.
measure: Water Bottles Used with Knee Sling
timeFrame: From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.
measure: Minutes Spent Using Knee Sling
timeFrame: Through study completion, an average of 4 weeks.
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Sanford Orthopedics and Sports Medicine
state: North Dakota
city: Sioux Falls
country: United States
facility: Sanford Orthopedics and Sports Medicine
state: South Dakota
Study officials:
affiliation: Sanford Health
name: Nathan Skelley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01557452: Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis
Official title: An Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Polyarticular Course Juvenile Idiopathic Arthritis (Poly JIA)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Keywords: JIA
Lead sponsor: Italfarmaco
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2012-03-19
Enrollment: 1
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective of the study:

the purpose of this extension study was to determine the safety of Givinostat in a long term treatment of patients who participated in DSC/08/2357/36 study with good results (clinical benefit at least pediACR30 response);

Detailed description: Givinostat is expected to exert a clinically relevant therapeutic effect on polyarticular JIA through the inhibition of the production/release of pro-inflammatory cytokines, such as IL-1β, IL-6 and TNFα, which are involved in the pathogenesis of the arthritic process.

Eligibility criteria: Inclusion Criteria:

* subjects who had successfully completed the previous Dose Finding Study and were fully compliant to the inclusion/exclusion criteria described in the previous DSC/08/2357/36

Exclusion Criteria:

* patients with fever related to JIA or other systemic features of JIA during 12 months before entering the study
* active bacterial or mycotic infection requiring antimicrobial treatment
* episode of macrophage activation syndrome over the last 6 months
* baseline prolongation of QT/QTc interval, use of concomitant medications that prolong the QT/QTc interval or history of additional risk factors for TdP.
* clinically significant cardiovascular disease
* clinically significant illness i.e. any condition that in the opinion of the Investigator places the patient to unacceptable risk for adverse outcome if he/she were to participate in the study
* psychiatric illness/social situation that would limit compliance with study medication and protocol requirements
* inherited metabolic diseases
* presence of malignancy
* pregnancy or lactation
* positive blood test for HIV
* active EBV infection, active B and/or C hepatitis
* platelet count \<100x10(9)/L

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAE) and Adverse Events (AE) of Interest
timeFrame: Through end of treatment, up to 108 weeks.
Secondary outcomes:
measure: Number of Patients Who Maintained PedACR30 Response
timeFrame: At weeks 48, 60 and 108
measure: Number of Patients Who Reached PedACR70 Response
timeFrame: At weeks 48, 60 and 108
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: 1st Faculty of Medicine and General Faculty Hospital
Study officials:
affiliation: General Faculty Hospital Department of Pediatrics and Adolescent Medicine, Praha, Czech Republic
name: Pavla Dolezalova, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06663852: ML Decision Model for G-NEC Adjuvant Therapy
Official title: Machine Learning-Based Decision Model for Optimal Adjuvant Therapy in Primary Gastric Neuroendocrine Carcinoma: a National Real-World Evidence Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Neuroendocrine Carcinoma (G-NEC)
Postoperative Adjuvant Therapy for G-NEC
Survival Outcomes
Machine Learning
Keywords: Gastric Neuroendocrine Carcinoma (G-NEC)
Adjuvant Chemotherapy
Machine Learning
Decision Support Model
Random Survival Forest
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 1505
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes adult patients diagnosed with gastric neuroendocrine carcinoma (G-NEC) or mixed adenoneuroendocrine carcinoma (MANEC) who underwent radical surgery at 38 tertiary hospitals in China between January 2006 and December 2020. The study population consists of patients who received either no adjuvant chemotherapy, etoposide and platinum derivatives-based chemotherapy, or fluorouracil-based chemotherapy following surgery.

Brief summary: Gastric neuroendocrine carcinoma (G-NEC) is a rare and aggressive tumor originating from neuroendocrine cells in the stomach lining. It is characterized by a high propensity for recurrence and a generally poor prognosis. Due to its rarity, there is limited data and no established consensus on the optimal postoperative adjuvant therapy, making treatment decisions challenging for healthcare providers.

This study is a retrospective analysis focusing on evaluating survival rates, identifying prognostic factors, and formulating treatment recommendations for patients with G-NEC. By analyzing real-world clinical data, we aim to better understand the factors that influence patient outcomes and to develop evidence-based strategies for improving survival. Our goal is to provide clinicians with valuable insights and tools to make more informed treatment decisions, ultimately enhancing the quality of care and outcomes for patients with this challenging disease.


Eligibility criteria: Inclusion Criteria:

* (1) patients who underwent radical surgery without any neoadjuvant therapy;
* (2) pathology confirmed NEC or mixed adenoneuroendocrine carcinoma (MANEC).

Exclusion Criteria:

* (1) history of other malignant neoplasms;
* (2) treatment with endoscopic submucosal dissection or endoscopic mucosal resection or thoracotomy;
* (3) incomplete clinical data (including pathological, adjuvant chemotherapy, and follow-up information);
* (4) receipt of alternative adjuvant treatment regimens;
* (5) death within 30 days postoperatively.

Primary outcomes:
measure: Disease-Free Survival (DFS)
timeFrame: From date of surgery up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT06081452: Public Survey on Breath Testing for Health and Disease
Official title: Public Survey on Breath Testing for Health and Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Disease
Health Behavior
Health Attitude
Health-Related Behavior
Health Knowledge, Attitudes, Practice
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our aim is to acquire a wide breadth of information from all members of the public, irrespective of the demographics, socioeconomic status and ethnicity. All member of the public, above the age of 18 are welcome to participate

Brief summary: A brief survey for the public to determine interest in health surveillance and disease detection

Detailed description: There are numerous barriers and favourable conditions that affect the acceptability of a screening test for cancer. Such factors have been investigated in the context of some of the current screening programs. Through this survey the investigators want to increase researcher awareness of these factors with the hope that this information will aid policy makers and guide future research.

There has been widening public interest in general health-surveillance in addition to disease detection. Breath testing has the potential to be a one-for-all non-invasive test to detect health domains. Through this survey, the investigators wish to understand public opinions about breath testing for health.

This survey consists of questions aiming to gather views on non-invasive testing for health and disease.

Eligibility criteria: Inclusion Criteria:

* Member of the public above the age of 18

Exclusion Criteria:

* Member of the public below the age of 18

Primary outcomes:
measure: Acceptability of breath testing
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Imperial College London
name: George Hanna, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02475252: Construct Validity of a Diagnostic Hysteroscopy Training Model
Official title: Prospective Case-control Study to Assess the Construct Validity of a Diagnostic Hysteroscopy in a Pelvic Training Model Using an Objective Structured Assessment of Technical Skills (OSATS) Assessment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Menorrhagia
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2015-06-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a prospective case-control study, the investigators compare the Objective Structured Assessment of Technical Skills (OSATS) scores in medical students and gynecologic experts performing a hysteroscopy on a training model for diagnostic hysteroscopy. The investigators hypothesize that OSATS on a hysteroscopy training model has construct validity to discriminate between experts and novices.

Detailed description: In a prospective case-control study, 140 medical students (,novices') and 10 senior gynecologists (,experts') will watch a demonstration detailing how to perform a hysteroscopy on a training model. All probands will perform a hysteroscopy themselves within 1 hour after the demonstration. Their performance will be judged using an Objective Structured Assessment of Technical Skills (OSATS) assessment. Using metrical and non-metrical measurements, construct validity of the hysteroscopy training model to distinguish between experts and novices will be assessed. Secondary endpoints are differences in OSATS scores within the group of novices based on gender and handyness, as well as satisfaction of the novices with the learning experience.

Eligibility criteria: Inclusion Criteria:

* medical Student
* no previous experience in gynecologic surgery
* no previous gynecologic surgery Training
* gynecologist with a personal history of at least 50 hysteroscopies)

Exclusion Criteria:

* language barrier
* unwillingness to participate

Primary outcomes:
measure: Construct validity
timeFrame: within 1 hour after demonstration
Secondary outcomes:
measure: OSATS scores according to gender
timeFrame: within 1 hour after demonstration
measure: OSATS scores according to handyness
timeFrame: within 1 hour after demonstration
Other outcomes:
Locations:
city: Herne
country: Germany
facility: Dept. OBGYN Ruhr University Bochum
Study officials:
affiliation: Ruhr University Bochum
name: Clemens B Tempfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05133752: Oral Nemonoxacin in Treating Elderly Patients With CAP
Official title: A Multi-Center, Open-Label, Single-Arm, Phase IV Study to Evaluate the Safety and Clinical Efficacy of Oral Administration With Nemonoxacin in Treating Elderly Patients With Community-Acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Community-acquired Pneumonia
Lead sponsor: TaiGen Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-24
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was to evaluate the safety and efficacy of oral nemonoxacin in treating elderly patients (aged ≥ 65 years) with community-acquired pneumonia (CAP).


Eligibility criteria: Inclusion Criteria:

* Age ≥65 years
* Clinical diagnosis of CAP
* Evidence of inflammatory exudates or infiltrates on chest X-ray

Exclusion Criteria:

* Suspect viral pneumonia, aspiration pneumonia, ventilator-associated pneumonia or hospital-acquired pneumonia
* History of hypersensitivity to quinolone or fluoroquinolone

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after treatment with oral nemonoxacin once daily for 7-10 days
timeFrame: From Visit 1 (Baseline) till Visit 3 (within 24 hr after last dose)
Secondary outcomes:
measure: Number of participants with clinical success in the modified intention-to-treat (mITT) population, intention-to-treat (ITT), and clinically evaluable (CE) populations.
timeFrame: Visit 3 (within 24 hr after last dose)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References: