louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01194518: Exploring Life Experience and Lifestyle Intervention Program Among Patients With Chronic Kidney Disease: A Longitudinal Study
Official title: Exploring Life Experience and Lifestyle Intervention Program Among Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Life experience
Life style
Health behavior
Mixed method
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
Collaborators: name: National Cheng-Kung University Hospital
name: E-DA Hospital
First posted: 2010-09-03
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Primary purpose: PREVENTION

Brief summary: The lifestyle consulting program through one year follow-up could effective increase the scores of health responsibility and nutrition according to the past three-year study. Behavior change is a dynamic and complex process. Using a long-term follow up approach will be able to understand the trajectory of behavior change. The purpose of this study is to explore life experience and lifestyle intervention program for patients with chronic kidney disease using mixed methods with a longitudinal approach. The first year of this study will include a qualitative study with in depth interview of the subjects who attend previous study in the research team and have the scores of health promoting lifestyle among the highest 27% and lowest 27%. The life experience will be explored. The quantitative study will be an experimental design. Qualified subjects will be randomly assigned to intervention or control group. The intervention protocol is based on trans-theoretical model. Each subject will be followed every six months. The second and third year of studies will continue to use the qualitative and quantitative approach to understand the life experience and meaning among patients with chronic kidney diseases. The trajectory of life experience and life style changes will be explored. The method may strengthen the effectiveness of lifestyle program and may provide comprehensive understanding of the trajectory of behavior changes among patient with chronic kidney disease.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Early Stages of Chronic Kidney Disease (GFR≧30ml/min/1.73㎡)
* Must be able to commmunicate in Chinese or Taiwanese
* Muse be voluntarily to attend
* Patient who does not exercise regularly
* Patient whose blood pressure higher than 140/90 mmHg
* Patient who is overweight or BMI\>25kg/㎡

Exclusion Criteria:

* Patient who limited to exercise

Primary outcomes:
measure: Body weight
timeFrame: six months
measure: Waist to hip ratio
timeFrame: six months
measure: Overall knowledge of renal protection
timeFrame: six months
measure: Health promotion lifestyle
timeFrame: six months
measure: Quality of Life
timeFrame: six months
measure: Physical activity
timeFrame: six months
measure: General Health Perceptions
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: National Cheng Kung University
Study officials:
References:
Clinical trial NCT06875518: Comparative Study of Blood Loss in Total Laparoscopic Hysterectomy by Ligation the Uterine Arteries in Different Techniques.
Official title: Comparative Study of Blood Loss in Total Laparoscopic Hysterectomy by Ligation the Uterine Arteries in Different Techniques.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Disease
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Following Caesarean section, hysterectomy is the second most common major gynecological surgery, with approximately 600,000 procedures performed annually in the USA. Since Reich et al. first reported a total laparoscopic hysterectomy (TLH) in 1989, numerous studies have confirmed its feasibility and reproducibility. Evidence increasingly supports TLH over vaginal hysterectomy (VH) and total abdominal hysterectomy (TAH) for benign gynecological conditions. The development and rapid advancement of laparoscopic instruments and techniques have enabled the safe and successful completion of complex procedures using minimally invasive approaches. Women with a higher BMI or requiring complex surgeries benefit from reduced postoperative complications with laparoscopic operations.


Eligibility criteria: Inclusion Criteria:

* Patients aged between 35-60 years Patients presented with menometrorrhagia unresponsive to medical treatment, and uterine pathology such as adenomyosis or multiple fibroids.

Exclusion Criteria:

* Patients were excluded if they had: medical conditions preventing pneumo-peritoneum
* Patients with medical conditions hindering proper ventilation during general anesthesia.
* Patients diagnosed with endometrial carcinoma and patients with uterine size larger than 24 weeks were excluded.
* Patients with excessive adhesions precluding access to the uterine arteries were not enrolled in the study.

Primary outcomes:
measure: Intra operative blood loss
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Mostafa Bahaa
state: New Damietta
Study officials:
References:
Clinical trial NCT03395418: Evaluation of the Right Use of Inhaled Therapeutics
Official title: Evaluation of the Right Use of Inhaled Therapeutics Prescribed in Asthma and COPD in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD Asthma
Keywords: COPD
Asthma
Inhaled Therapeutics
Lead sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Sponsor class: OTHER
First posted: 2018-01-10
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: NON_PROBABILITY_SAMPLE
Study population: Patients followed in pneumology for asthma or COPD who have:

* a prescription for long-term inhaled therapeutics
* also a home health provider (either for long-term oxygen or for a CPAP, NIV ...)

Brief summary: Asthma and COPD have a significant impact on public health, affecting about 8 million people in France and generating health care costs of 5.5 billion euros, almost 50% of which are dedicated to long-term treatments are essentially inhaled therapies.

The good control of the disease depends on the patient's compliance, but also on the proper use of the devices used for the administration of inhaled drugs under penalty of the degradation of the control of the disease with major medical and medico-economic consequences.

Thus, education of these patients in the use of devices must be an integral part of medical care. It comes up against the complexity of the therapeutic arsenal on the one hand and on the other hand with its time-consuming nature: this makes it incompatible with a realization in consultation.

The "ARGOS" process is a telemonitoring project for the support of therapeutic education, consisting in setting up a concrete and real-time relay between prescribers and patients for the education of inhaled therapeutics.

Its objective is to provide the answer to what is currently an "unmet need" in the management of asthma and COPD, with the prospect of a positive impact on the observance of these treatments and by consequently their clinical and economic efficiency.


Eligibility criteria: Inclusion Criteria:

* Patient followed in Pneumology for asthma or COPD with a prescription for long-term inhaled therapies AND a home health provider (who monitors either home oxygen and / or respiratory equipment)
* The patient must have a means of telephone communication in order to be able to be contacted by a provider, an H2AD permanence or a doctor
* Patient having given his agreement after having been informed in writing of the purpose and the data collected during this study
* Age ≥ 18 years
* Beneficiary of a social security scheme

Exclusion Criteria:

* Refusal of the patient
* Patient not understanding French
* Absence of home health provider
* Absence of means of telephone communication

Primary outcomes:
measure: Percentage of exploitable films
timeFrame: Day 1 to day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: ANTADIR
Study officials:
References:
Clinical trial NCT02632318: Dawn Simulation and Postural Hypotension
Official title: Dawn Simulation as a Passive Countermeasure to Postural Hypotension in Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Orthostatic Hypotension
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
Collaborators: name: Velux Fonden
name: Palo Alto Veterans Institute for Research
First posted: 2015-12-16
Enrollment: 35
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: One of the most physiologically demanding things that older people do every day is to get up in the morning. After spending a night laying flat, where the blood distributes evenly across the body, when they stand in the morning (and the blood rushes to their feet), their cardiovascular system may not be able to compensate and maintain blood flow to the brain. This phenomenon is known as orthostatic or postural hypotension. The investigators have found in a group of young individuals that use of a dawn-simulation light that gradually wakes the brain is able to increase cardiovascular tone prior to arising. The goal of this experiment is to determine whether this dawn simulation light is able to increase cardiovascular tone in older adults such that they would have reduced or absent postural hypotension when they awaken in the morning. This would greatly reduce the risks of falls and their associated morbidities in older adults.


Eligibility criteria: Inclusion Criteria:

* History of falls or dizziness at exit from bed in the morning (at least two incidents in the past year)
* At least 20/200 corrected visual acuity
* Stable health
* Normal hearing

Exclusion Criteria:

* Regular cigarette smoker
* Alcohol abuse
* Drug abuse

Primary outcomes:
measure: Sympathovagal balance derived from blood pressure measurement
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
References:
citation: Gabel V, Miglis M, Zeitzer JM. Effect of artificial dawn light on cardiovascular function, alertness, and balance in middle-aged and older adults. Sleep. 2020 Oct 13;43(10):zsaa082. doi: 10.1093/sleep/zsaa082.
Clinical trial NCT02386618: Endoscopic Treatment for Local Residual Neoplasia
Official title: Endoscopic Treatment for Local Residual Neoplasia After Endoscopic Mucosal Resection of the Colorectal Lateral Spreading Tumors (LST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer
laterally spreading tumors
endoscopic mucosal resestion
local residual neoplasia
Lead sponsor: Vitkovice Hospital
Sponsor class: OTHER
First posted: 2015-03-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Endoscopic mucosal resection (EMR) is considered to be a gold standard of therapy of colorectal lateral spreading tumors (LST) without significant risk for lymphatic spread. According to the investigators previous study, local residual neoplasia (LRN) after conventional endoscopic mucosal resection (EMR)occurs in up to 21% of cases. Endoscopic therapy of LRN was not sufficient in 53 % and has not been standardized yet.


Eligibility criteria: Inclusion Criteria:

* patients older than 18 years
* patients with local residual neoplasia in scar in three months after endoscopic mucosal resection for laterally spreading tumor (0-IIa \> 10 mm)
* signed informed consent

Exclusion Criteria:

* incomplete endoscopic mucosal resection
* previous therapy for local residual neoplasia
* difficult or impossible localization of post-EMR scar

Primary outcomes:
measure: Efficacy of endoscopic treatment od local residual neoplasia (absence of neoplastic tissue in post-EMR scar proven by endoscopic and histologic examination)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
facility: Vitkovice Hospital
Study officials:
affiliation: Vitkovice Hospital, Ostrava
name: Premysl Falt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06718218: A Combination Mindfulness and Music Intervention for Acute Pain
Official title: A Combination Mindfulness and Music Intervention for Acute Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Acute Pain
Keywords: Mindfulness
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project is a single-site, four-arm, randomized controlled trial evaluating a combination mindfulness + music intervention on acute pain among patients in an orthopedic clinic waiting room. Participants will be randomized to one of four conditions: 1) a 5-minute mindfulness recording, 2) a 5-minute mindfulness recording with an accompanying sustained tone at 65.41 Hertz, 3) a 5-minute mindfulness recording with an accompanying binaural beat set at 65.41 Hertz in the left ear and 69.41 Hertz in the right ear, or 4) a 5-minute mindfulness recording with an accompanying binaural beat set at 65.41 Hertz in the left ear and 69.41 Hertz in the right ear as well as instrumental, theta wave music.


Eligibility criteria: Inclusion Criteria:

* Being 18 years of age or older
* Receiving pain treatment at Tallahassee Orthopedic Center
* Understanding English instructions fluently

Exclusion Criteria:

* Unable to consent because of physical or mental incapacity.

Primary outcomes:
measure: Change in Pain Unpleasantness Numeric Rating Scale
timeFrame: Immediately before and after 5-minute audio recording
Secondary outcomes:
measure: Change in Pain Intensity Numeric Rating Scale
timeFrame: Immediately before and after 5-minute audio recording
measure: Change in Anxiety Numeric Rating Scale
timeFrame: Immediately before and after 5-minute audio recording
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Orthopedic Clinic (TOC)
state: Florida
Study officials:
References:
Clinical trial NCT05923918: A Study to Evaluate Safety and Efficacy of PBK_M2101
Official title: A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2101
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Intestinal Disease
Colonic Diseases
Gastrointestinal Disease
Digestive System Disease
Lead sponsor: Pharmbio Korea Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-28
Enrollment: 246
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial was prospective, randomized, single-blind, 3-treatment arm, parallel treatment group, and active-controlled. , Multi-center, Phase 3 confirmatory clinical trial.


Eligibility criteria: Inclusion Criteria:

* Patients who is informed and give a consent in voluntary
* Patients who is scheduled a esophagogastroduodenoscopy and colonoscopy
* BMI 19≤and\<30

Exclusion Criteria:

* Patients who participate in other interventional study or had participated within 30 days before screening
* Pregnant or breast-feeding women who do not want to stop breast-feeding
* Uncontrolled hypertension
* Uncontrolled diabetes
* Fluid or electrolyte (Na, K, Ca, Mg, chloride, bicarbonate) disturbance
* HIV infection and/or chronic hepatitis B or C
* Patients who has a difficulty to participate because of severe nausea or vomiting
* History of colon surgery and abdominal surgery within 6 month; need an emergency surgery

Primary outcomes:
measure: Successful cleansing rate
timeFrame: From day of first dosing to day of colonoscopy
Secondary outcomes:
measure: Overall cleansing rate
timeFrame: From day of first dosing to day of colonoscopy
measure: Mean segmental cleansing score
timeFrame: From day of first dosing to day of colonoscopy
measure: Mean cecal intubation time
timeFrame: From day of first dosing to day of colonoscopy
measure: Mean colonoscopy withdrawal time
timeFrame: From day of first dosing to day of colonoscopy
measure: Treatment compliance
timeFrame: From day of first dosing to day of colonoscopy
measure: Patient satisfaction
timeFrame: From day of first dosing to day of colonoscopy
measure: Polyp detection rate
timeFrame: From day of first dosing to day of colonoscopy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical Center
Study officials:
affiliation: Seoul Asan Medical Center
name: Byeon, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05441618: Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®
Official title: Retrospective, Single Center, Single Arm Post Market Clinical Follow-Up (PMCF) Study on the Performance and Safety of Lyoplant® Used for the Replacement and Extension of Connective Tissue Structures in Neurosurgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tumor, Cerebral Ventricle
Tumor, Cerebellar
Aneurysm Cerebral
Trauma, Brain
Keywords: Lyoplant
Retrospective Study
Decompressive Craniectomy
Cerebral Dura Defect
Cerebellar Dura Defect
Spinal Dura Defects
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2022-07-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient files from adult patients with indication of surgical diagnosis (e.g. decompressive craniectomy, tumor, aneurysm, trauma etc.) in a single center are revisited and analysed for primary and secondary variables

Brief summary: Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Use of investigational device according to Instructions for Use (IfU)

Exclusion Criteria:

* none

Primary outcomes:
measure: Rate of Cerebrospinal Fluid Leakage
timeFrame: at one follow-up ≥ 3 months after surgery
Secondary outcomes:
measure: Incidence of re-operations with product relationship
timeFrame: at one follow-up ≥ 3 months after surgery
measure: Incidence of further (serious) adverse events in chronologic sequence
timeFrame: intra- and postoperative, until follow-up ≥ 3 months after surgery
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg AöR
state: Bayern
Study officials:
affiliation: Universitätsklinikum Augsburg AöR
name: Philipp E Krauss, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01310218: Length of Post Operative Dressing After Carpal Tunnel Release
Official title: Length of Postoperative Dressing After Mini-open Carpal Tunnel Release: A Randomized Prospective Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carpal Tunnel Syndrome
Keywords: orthopedics, carpal tunnel syndrome, postoperative care
Lead sponsor: UConn Health
Sponsor class: OTHER
First posted: 2011-03-08
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to prospectively compare the functional, satisfaction, and wound outcomes of patients treated with one of two accepted methods of postoperative dressing following carpal tunnel release. Hypothesis: There will be no difference between the short term (approximately 2 - 3 days)and longer term (9 to 14 days)bulky dressing groups in terms of outcomes.


Eligibility criteria: Inclusion Criteria:

* adults
* carpal tunnel syndrome

Exclusion Criteria:

* previous surgery for Carpal Tunnel Syndrome
* ipsilateral hand, arm, shoulder surgery with continued symptoms

Primary outcomes:
measure: Change from baseline in Levine-Katz Scale assessed at different time points.
timeFrame: Levine-Katz Scale at baseline (pre-operation)
measure: Change in the Levine-Katz Scale from baseline(pre-operation) at 2 weeks
timeFrame: Baseline and two weeks.
measure: Change in the Levine-Katz Scale from baseline(pre-operation) at 3 months
timeFrame: Baseline and three months.
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Craig Rodner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01024218: Preference Study Between NovoFine® Autocover™ and a NovoFine® 8 mm Needle
Official title: An Open-label, Multicenter, Handling Test and Prospective Cross-over Study on Nurse/Health Assistants Preference Between NovoFine® Autocover™ and 8 mm NovoFine® Needle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Healthcare Professionals
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 78
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this clinical trial is to assess the preference of 2 different needles used by nurses and health assistants. The trial consists of a handling test followed by a 12 week cross-over study.


Eligibility criteria: Inclusion Criteria:

* The participant must have been either a diabetes nurse or a diabetes health assistant with competence in subcutaneous injections of insulin for at least 4 weeks
* Participants must demonstrate proficiency with the injection device in the handling test prior to testing the NovoFine® Autocover™ Needle in patients

Primary outcomes:
measure: Device preference
timeFrame: after 12 weeks
Secondary outcomes:
measure: Comparison of the adverse device effects (occlusion/activation/locking problems/manufacturing defects)
measure: Comparison of the frequency of adverse device effects
measure: Comparison of the frequency of adverse events (needle stick injuries)
Other outcomes:
Locations:
city: København
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: