louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05528601: Influence of an App on Quality of Life of Women With Endometriosis
Official title: Observational Study on the Influence of an App-based Self-management Program on the Quality of Life of Women With Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Quality of Life
Keywords: endometriosis
quality of life
smartphone application
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two arm study
Primary purpose: TREATMENT

Brief summary: Comparison of quality of life before and after 14 days of use of Endo App® in endometriosis patients compared to non-users

Detailed description: Introduction: Endometriosis can significantly impair the quality of life of those affected. Multimodal self-help measures are recommended but often difficult to access. Smartphone apps have been shown to improve quality of life for other conditions with chronic pain. The aim of this study was to examine whether there is evidence of beneficial effects of the Endo-App and whether a multicenter randomized controlled trial should be planned to substantiate these effects.

Methods: In a sample of N=106 women affected by endometriosis the present study determined the influence of the use of a smartphone app (Endo-App ®) on their quality of life. Among others, the validated questionnaire Endometriosis Health Profile from Oxford University was used for this purpose.

Eligibility criteria: Inclusion Criteria:

* suffering from endometriosis
* 18 years or older
* willing and capable of using a smartphone

Exclusion Criteria:

* minor under 18 years
* endometriosis excluded
* not capable of using a smartphone

Primary outcomes:
measure: quality of life of endometriosis patients
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Münster
country: Germany
facility: University Hospital Münster Germany
state: NRW
Study officials:
References:
Clinical trial NCT07005401: Factors Determine the Feasibility and Surgical Margin Quality of Sublobar Resection for Non-small Cell Lung Cancer?
Official title: What Determines the Feasibility and Surgical Margin Quality of Sublobar Resection for Small-sized Non-small Cell Lung Cancer?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-small cell lung cancer
Segmentectomy
Wedge resection
Margin quality
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 1064
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: Patients with small-sized pulmonary nodules who underwent lobectomy or sublobar resection between 2020 and 2023 in a single surgical team were retrospectively screened.

Brief summary: Sublobar resection (SR) has been recognized as non-inferior to lobectomy for small-sized non-small cell lung cancer (NSCLC). This study aimed to systematically identify the potential factors influencing the feasibility and surgical margin quality of SR for small-sized NSCLC.

Patients with small-sized NSCLC (≤2 cm) who underwent SR or lobectomy between 2020 and 2023 were screened. Surgical procedures were determined by discussion under the guidance of 3D-CTBA. A surgical margin ≥ the maximum tumor diameter was considered sufficient. SR with a sufficient surgical margin was considered eligible. Univariate and multivariate logistic regression analyses were performed to identify factors affecting the feasibility and margin quality of SR.

Detailed description: Patients with small-sized pulmonary nodules who underwent lobectomy or SR between 2020 and 2023 in a single surgical team were retrospectively screened. All the surgical approach was jointly determined by three experienced surgeons (at least 15 years, Doctor Liang Chen, Weibing Wu and Zhicheng He). Patients satisfied with the following criteria were initially reserved: (1) the maximum nodule diameter ≤ 2 cm; (2) single malignant nodule; (3) intentional resection; (4) histopathological confirmed primary NSCLC. Further, patients with (1) interlobar lesions; (2) nodules in the right middle lobe; (3) receiving neoadjuvant before surgery; (4) poor CT quality were excluded.

Eligibility criteria: Inclusion Criteria:

* the maximum nodule diameter ≤ 2 cm
* single malignant nodule
* intentional resection
* histopathological confirmed primary non-small cell lung cancer

Exclusion Criteria:

* interlobar lesions
* nodules located in the right middle lobe
* receiving neoadjuvant before surgery
* poor CT quality were excluded

Primary outcomes:
measure: surgical margin quality
timeFrame: Perioperative
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Liang Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06348901: Clinical Utility of Oxford Cognitive Screen Test to Screen Cognitive Impairment in Post Stroke Patients
Official title: Clinical Utility of Oxford Cognitive Screen Test to Screen Cognitive Impairment in Post Stroke Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients and healthy voluteers

Brief summary: The goal of this type of study: clinical trial is to assess K-OCS clinical utility in participant population. The main aims:

validate the reliability and validity of the Korean version of the Oxford Cognitive Screen (K-OCS) analyze its sensitivity, specificity, and diagnostic accuracy, and compare its examination participation rates with existing assessment tools to determine the effectiveness of K-OCS in detecting post-stroke cognitive impairment.


Eligibility criteria: For stroke patients

1. Inclusion Criteria:

   * Adults over 20 years of age
   * More than 72 hours elapsed since the onset of stroke symptoms.
   * After hearing a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to observe the precautions
   * Involved individuals diagnosed with stroke by neurology and rehabilitation medicine specialists based on data acquired from 3T GE Signa System (General Electric, Milwaukee, WI), brain magnetic resonance imaging (MRI), and computed tomography (CT).
2. Exclusion Criteria:

   * Who cannot meet the inclusion criteria

For healthy voluteers

1. Inclusion Criteria:

   * Over 20 years of age
   * A person who is performing an independent daily life
   * A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing a detailed explanation of this study and fully understanding it
2. Exclusion Criteria:

   * Who cannot meet the inclusion criteria

Primary outcomes:
measure: Measurement of K-OCS
timeFrame: Between November 2020 and April 2022
Secondary outcomes:
measure: Measurement of Korean version of mini-mental state examination (K-MMSE)
timeFrame: Between November 2020 and April 2022
measure: Measurement Korean Version of the Oxford cognitive screen (K-OCS)
timeFrame: Between November 2020 and April 2022
measure: Measurement of national institute of health care stroke scale (NIHSS)
timeFrame: Between November 2020 and April 2022
measure: Measurement of fuctional independence meausure (FIM)
timeFrame: Between November 2020 and April 2022
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, CHA Bundang Medical Center
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT05529901: Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder
Official title: Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke
PFO - Patent Foramen Ovale
Cryptogenic Stroke
TIA
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2022-09-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have had a cryptogenic stroke (including transient ischemic attack with positive head imaging findings) with possible involvement of patent foramen ovale (PFO) due to a presumed paradoxical embolism.

Brief summary: The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with cryptogenic stroke (including transient ischemic attack with positive head imaging findings)
* Diagnosed with a PFO
* Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

* N/A

Primary outcomes:
measure: PFO Closure Rate
timeFrame: 12 months
measure: Rate of Conversion to surgical procedure
timeFrame: Discharge
measure: Incidence rate of post-procedure ischemic stroke events
timeFrame: 36 months
measure: Device success
timeFrame: 36 months
measure: Incidence rate of post-procedure adverse events and/or device issues
timeFrame: 36 months
measure: Incidence rate of device- and procedure-related events within 30 days post procedure
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
measure: Incidence rate of post-procedure Atrial fibrillation
timeFrame: 36 months
Locations:
city: Okayama
country: Japan
facility: Okayama University Hospital
Study officials:
References:
Clinical trial NCT06728501: Diabetes Education for Patients With Type 2 Diabetes in Turkmenistan
Official title: Diabetes Education for Patients With Type 2 Diabetes in Turkmenistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate whether structured diabetes mellitus education leads to improved blood glucose control in Turkmenistan.

Detailed description: Diabetes education is not routinely carried out in Turkmenistan. The aim of the study is to investigate whether patients with type 2 diabetes benefit from an International Diabetes Federation (IDF) based education program. Patients will be randomized into a education group and a control group. The education group will receive 4 - 5 hours of education and the control group will only receive general information about diabetes mellitus. After 6 months, it is checked whether the change in the HbA1c value differs between the two groups. Additinal paremeters such as blood pressure, diabetes knowledge and lipids will also be evaluated (secondary parameters).

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes

Exclusion Criteria:

* type 1 diabetes
* diabetes duration \< 1 year
* severe comorbidities
* abuse of alcohol or drugs
* pregnancy

Primary outcomes:
measure: Change in HbA1c
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ashgabat
country: Turkmenistan
facility: International Center of Surgery and Endocrinology, Ashgabat, Turkmenistan
Study officials:
References:
Clinical trial NCT06302101: Telerehabilitation Exercise in Older Adults
Official title: Efficacy of Synchronous Telerehabilitation Chair-Based Exercises and Cognitive Exercises in Elderly Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Elderly
Balance
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 27
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effectiveness of chair-based exercises and cognitive exercises through synchronous telerehabilitation in older adults.

Older adults will be divided into two groups (intervention group n=16; control group n=11) .


Eligibility criteria: Inclusion Criteria:

* Getting a score of 6 or above on the Hodkinson Mental Test

Exclusion Criteria:

* -Having another chronic disease that can cause pain Having a neurological disease Being blind Having an orthopedic, neurological or mental disability

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 15 minutes
measure: Timed Up and Go Test During Dual Tasking
timeFrame: 5 minutes
measure: Geriatric Pain Measure
timeFrame: 15 minutes
measure: Older people's quality of life-brief (OPQOL-brief)
timeFrame: 8 minutes
Secondary outcomes:
measure: Hodkinson Mental Test
timeFrame: 5 minutes
measure: Dominant Side One Leg Stand Test
timeFrame: 30 seconds
measure: Timed Up and Go Test
timeFrame: 3 minutes
measure: chair sit and stand test
timeFrame: 30 seconds
measure: Geriatric Depression Scale
timeFrame: 15 minutes
measure: Successful Aging Scale
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Elif Gur Kabul
state: Center
Study officials:
References:
Clinical trial NCT05382767: Safety and Efficacy of CKDB-501A in Subjects With Post-stroke Upper Limb Spasticity
Official title: A Randomized, Double-blind, Active-controlled, Multicenter Phase I Trial to Investigate the Safety and Efficacy of CKDB-501A in Subjects With Post-stroke Upper Limb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Post-stroke Upper Limb Spasticity
Lead sponsor: CKD Bio Corporation
Sponsor class: INDUSTRY
First posted: 2022-05-19
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multicenter, randomized, double-blind, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501A in Subjects with Post-stroke Upper Limb Spasticity


Eligibility criteria: Inclusion Criteria:

* Male or female patients ≥ 19 years
* History of stroke more than 24 weeks prior to screening
* ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of finger flexor and elbow flexor as measured on MAS(0 to 4)
* ≥ 2 points in one of the targeted functional disability item (i.e. hand hygiene, clothing, upper extremity, or pain for evaluation on DAS

Exclusion Criteria:

* Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
* Fixed joint/muscle contracture in the target limb
* History(within 24 weeks of screening visit) or planned(during study period) treatment with phenol or alcohol injection(chemodenervation) or surgery in the target limb
* History(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb
* History(within 12 weeks of screening visit) treatment with Botulinum Toxin
* Concurrent treatment with an intrathecal baclofen
* Known allergy or sensitivity to the study medication or its components (Clostridium botulinum toxin type A, albumin, Sodium chloride, etc.)
* Male and Female who are not willing to take any appropriate means of contraception during the study period
* Patients who are not eligible for this study at the discretion of the investigator.

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: up to week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
References:
Clinical trial NCT05707767: A Prospective Study of Surgical Treatment Strategies for Chordoma
Official title: A Prospective Study of Surgical Treatment Strategies for Chordoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chordoma of Spine
Surgery
Keywords: chordoma
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chordoma is a rare but locally invasive cancer that arises from the embryonic notochord. Total resection is challenging in mobile spine because of the complex anatomy and bone invasion.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 70 ys,
* With a diagnosis of chordoma confirmed by pathology,
* Undergone surgical treatment in our hospital,
* Available for clinical follow-up and agree to long-term clinical follow-up and sign informed consent.

Exclusion Criteria:

* Suffer from other tumors,
* Suffer from cardiovascular disease, cerebrovascular disease, or immune system disease.

Primary outcomes:
measure: Excision Extension
timeFrame: 1 week after surgery.
Secondary outcomes:
measure: OS (Overall Survival)
timeFrame: 2 years
measure: PFS (Progression-Free Survival)
timeFrame: 2 years
measure: DFS (Disease Free Survival)
timeFrame: 2 years
measure: ORR (Objective Response Rate)
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References:
citation: Walcott BP, Nahed BV, Mohyeldin A, Coumans JV, Kahle KT, Ferreira MJ. Chordoma: current concepts, management, and future directions. Lancet Oncol. 2012 Feb;13(2):e69-76. doi: 10.1016/S1470-2045(11)70337-0.
citation: Wedekind MF, Widemann BC, Cote G. Chordoma: Current status, problems, and future directions. Curr Probl Cancer. 2021 Aug;45(4):100771. doi: 10.1016/j.currproblcancer.2021.100771. Epub 2021 Jul 1.
citation: Yeter HG, Kosemehmetoglu K, Soylemezoglu F. Poorly differentiated chordoma: review of 53 cases. APMIS. 2019 Sep;127(9):607-615. doi: 10.1111/apm.12978.
citation: Kolz JM, Wellings EP, Houdek MT, Clarke MJ, Yaszemski MJ, Rose PS. Surgical treatment of primary mobile spine chordoma. J Surg Oncol. 2021 Apr;123(5):1284-1291. doi: 10.1002/jso.26423. Epub 2021 Feb 10.
citation: Williams BJ, Raper DM, Godbout E, Bourne TD, Prevedello DM, Kassam AB, Park DM. Diagnosis and treatment of chordoma. J Natl Compr Canc Netw. 2013 Jun 1;11(6):726-31. doi: 10.6004/jnccn.2013.0089.
Clinical trial NCT01166867: A Pilot Study Using Photo-plethysmographic (PPG) Camera
Official title: Photo-plethysmographic (PPG) Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant Development
Keywords: assessment
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Orange County
First posted: 2010-07-21
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infant

Brief summary: The researcher want to use video signals to monitor heart rate, respiration rate and oxygen saturation using Photo-plethysmography (PPG) as the underlying mechanism for the method: periodic changes in skin reflectance, induced by the cardio-vascular wave, are measured using light.

Detailed description: The Researcher want to use ambient light to monitor heart rate, respiration rate and oxygen saturation (SpO2) in infant patients in a hospital setting. The plethysmographic signal is typically strong on children. This provides a reliable heart rate monitor. However, to measure oxygen saturation, a quantitative value of the strength at two wavelength regions (green and red) is required. It is also not known if the normal ambient light is spectrally appropriate to analyze the video signals for oxygenation. With the current prototype of our system, we can monitor heart rate reliably and estimate oxygen saturation in adults, using normal artificial light or daylight, entering through a window.

Eligibility criteria: Inclusion Criteria:

* infant and toddler

Exclusion Criteria:

* non-infant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: Stuart Nelson, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References: