louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03055169: TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure
Official title: TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetic Predisposition to Disease
Hyperglycemia
Intensive Care Unit Syndrome
Multiple Organ Failure
Keywords: hyperglycemia
Multiple Organ Failure
biobank
diabetes
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 994
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted in ICU \> 48h with at least one organ dysfunction

Brief summary: This study evaluates the link between genetic polymorphisms as r7903146, rs12255372 of TCF7L2 gene and the risk of developing hyperglycemia during Intensive care unit stay


Eligibility criteria: Inclusion Criteria:

* admission in ICU\>48h
* at least one organ dysfunction

Exclusion Criteria:

* age\< 18 years
* pregnant women
* admission less than 48h

Primary outcomes:
measure: value of the odds ratio associated with the relationship between a polymorphism TCF7L2 gene and the occurrence of hyperglycemia
timeFrame: one year after inclusion
Secondary outcomes:
measure: Changes in inflammatory markers
timeFrame: one year after inclusion
measure: Changes in serum lipid profile
timeFrame: one year after inclusion
measure: Changes in liver enzymes
timeFrame: one year after inclusion
measure: Insulin Resistance (HOMA)
timeFrame: one year after inclusion
Other outcomes:
measure: Blood samples collection
timeFrame: 5 years
measure: Number of patients with genotype TCF7L2 by PCR
timeFrame: 5 years
Locations:
city: Caen
country: France
facility: CHU Cote de Nâcre
city: Lille
country: France
facility: Hôpital Roger Salengro, CHRU de Lille
city: Roubaix
country: France
facility: CH Victor Provot
city: Rouen
country: France
facility: CHU Charles Nicolle
city: Tourcoing
country: France
facility: CH Tourcoing
Study officials:
affiliation: University Hospital, Lille
name: Mercedes Jourdain, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ben Hamou A, Kipnis E, Elbaz A, Bignon A, Nseir S, Tamion F, Du Cheyron D, Jaillette E, Voisin B, Robriquet L, Vanbaelinghem C, Thellier D, Abi Rached H, Jannin A, Duhamel A, Behal H, Machuron F, Espiard S, Preiser JC, Preau S, Pattou F, Jourdain M. Association of transcription factor 7-like 2 gene (TCF7L2) polymorphisms with stress-related hyperglycaemia (SRH) in intensive care and resulting outcomes: The READIAB study. Diabetes Metab. 2020 Jun;46(3):243-247. doi: 10.1016/j.diabet.2019.05.001. Epub 2019 May 20.
Clinical trial NCT06973369: The Effect of Education Given With Creative Drama Method Based on Leininger's Theory on the Cultural Sensitivity and Effectiveness Levels of Nursing Students
Official title: The Effect of Education Given With Creative Drama Method Based on Leininger's Theory on the Cultural Sensitivity and Effectiveness Levels of Nursing Students
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nursing Education
Nursing Students
Creative Drama
Cultural Sensitivity
Keywords: Leininger
Nursing students
Creative drama
Cultural sensitivity
Cultural effectiveness
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to determine the effect of cultural care education given with creative drama method according to Leininger theory on the cultural sensitivity and effectiveness levels of nursing students. The study will be conducted as a pre-test and post-test randomized controlled experimental study. The universe of the study consists of fourth-year students (n=80) of "Agri Ibrahim Cecen University, Faculty of Health Sciences, Department of Nursing". In this study, students in the intervention and control groups will be determined by simple randomization method. After the theoretical course content is given based on Leininger theory, students in the intervention group will be given creative drama technique with cases and students in the control group will be given traditional case examples. A pre-test will be applied before the training program and a post-test will be applied after the training program.


Eligibility criteria: Inclusion Criteria:

* Want to participate in the study voluntarily,
* Have taken the Intercultural Nursing course,
* Have taken 75% of the practical nursing courses.

Exclusion Criteria:

* Being a nurse working in the clinic,
* Being a foreign national,
* Being in the initiative group and not participating in the creative drama application,
* The student wanting to leave the research at any stage,
* Not filling out the data collection forms or filling them incompletely.

Primary outcomes:
measure: Change in Cultural Sensitivity Score
timeFrame: At Baseline, Immediately after training
measure: Change in Intercultural Effectiveness Score
timeFrame: At Baseline, Immediately after training
Secondary outcomes:
Other outcomes:
Locations:
city: Agri
country: Turkey
facility: Agri Ibrahim Cecen University
Study officials:
References:
Clinical trial NCT04117269: External Shoe Lift to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers
Official title: Clinical Efficacy of an External Shoe Lift in the Contralateral Limb to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot Ulcer
Peripheral Neuropathy
Treatment Adherence and Compliance
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 42
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: Previous researches hipothesize that imposed limb-length discrepancies may discourage adherence in patients with active diabetic foot ulcer and using offloading devices. Our hipothesis is that the use of an external shoe lift contralaterally to the affected foot may improve adherence to offloading devices and improve healing.


Eligibility criteria: Inclusion Criteria:

* Plantar diabetic foot ulcer.
* Wagner I and II classification.
* Ulcer area between 1-30 cm square centimeters.
* HbA1c values in the last three months below 11%
* Ankle brachial Index (ABI) value \> 0.5.

Exclusion Criteria:

* Diagnosis of Critical Limb Ischaemia definid by TASCC II guideline.
* Presence of foot ulcer in both feet.
* Presence of soft tissue infection.
* Osteomyelitis suspicion.
* Peripheral neuropathy due to different causes than diabetes.

Primary outcomes:
measure: Percentage of diabetic foot ulcers healed
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of diabetic foot ulcers healed
timeFrame: 20 weeks
measure: Adherence to offloading device
timeFrame: 3 days
measure: Time to healing
timeFrame: 30 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Diabetic foot Unit Complutense University
Study officials:
References:
Clinical trial NCT05561569: Air Versus Gas Tamponade in Primary Retinal Detachment
Official title: Randomized Trial Comparing Air Versus Gas Tamponade in Primary Retinal Detachment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Detachment
Proliferative Vitreoretinopathy
Keywords: Vitrectomy
Retinal detachment
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Management of primary retinal detachment due to upper retinal break is one of controversial situation that may face ophthalmologists in vitreoretinal subspecialty.

Detailed description: There is no single surgical plan for management of primary retinal detachment due to upper retinal break, some surgeons prefer scleral buckling over vitrectomy in cases with no traction over the retinal break, others prefer to perform primary pars-plana vitrectomy with either air or gas tamponade.

In this study we aim to compare the results of air and non-expansile gas tamponade in cases with upper retinal detachment with grade a or b proliferative vitreoretinopathy.

Eligibility criteria: Inclusion Criteria:

* primary rhegmatogenous retinal detachment with upper break with proliferative vitreoretinopathy from grade a to b.

Exclusion Criteria:

* cases with combined tractional retinal detachment.
* cases with recurrent retinal detachment.
* cases that are eligible for scleral buckling that have no traction on retinal break.

Primary outcomes:
measure: Improvement in visual acuity
timeFrame: Change from baseline visual acuity at 6th month.
Secondary outcomes:
measure: Changes in metamorphopsia
timeFrame: Change from baseline metamorphopsia at 6th month.
Other outcomes:
measure: Recurrence of retinal detachment
timeFrame: Incidence of recurrent retinal detachment at 6th month.
Locations:
city: Banhā
country: Egypt
facility: Ahmed Abdelshafy
state: QA
Study officials:
affiliation: Benha University
name: Ahmed A Abdelshafy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06071169: The Effect of Progressive Relaxation Exercise on Nurses
Official title: The Effect of Progressive Relaxation Exercise on Nurses' Life Satisfaction, Comfort and Burnout Levels
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Progressive Relaxation Exercise
Comfort
Life Satisfaction
Burnout
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to examine the effect of progressive relaxation exercise on nurses' life satisfaction, comfort and burnout levels. Data will be collected by using Descriptive Characteristics Information Form, Satisfaction with Life Scale, Nurse Comfort Scale and Burnout Scale. The nurses in the intervention group will be asked to perform relaxation exercises. The nurses in the control group will not receive any intervention.

Detailed description: This study aims to examine the effect of progressive relaxation exercise on nurses' life satisfaction, comfort and burnout levels. This study will be conducted as a randomized controlled experimental study. Data will be collected by using Descriptive Characteristics Information Form, Satisfaction with Life Scale, Nurse Comfort Scale and Burnout Scale. The nurses in the intervention group will be asked to perform relaxation exercises 3 days a week for 5 weeks, 20 minutes in each practice. The nurses in the control group will not receive any intervention.

Eligibility criteria: Inclusion Criteria:

Working as a nurse in a tertiary treatment center for at least 3 years Have not participated in any relaxation exercise Absence of neurological/psychiatric disorders Not having an obstacle to exercise Nurses who volunteered to participate in the study will be included in the study.

Exclusion Criteria:

Individuals who have any exercise program and use any relaxation method (yoga, acupuncture, massage, music therapy, etc.) will not be included in the study.

Primary outcomes:
measure: Comfort
timeFrame: 5 weeks after first meeting
measure: Satisfaction with Life
timeFrame: 5 weeks after first meeting
measure: Burnout
timeFrame: 5 weeks after first meeting
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06974669: The Value of Using Mini-oral Pulse Steroid Therapy Along With Non Cultured Epidermal Cell Suspension (NCES) in Stable Resistant Vitiligo
Official title: The Value of Using Mini-oral Pulse Steroid Therapy Along With Non Cultured Epidermal Cell Suspension in Stable Resistant Vitiligo: An Interventional Prospective Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vitiligo
Keywords: vitiligo
surgery
mini-oral pulse steroid therapy
resistant
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 40
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: Assessing the additive value of mini-oral pulse steroid therapy in surgical treatment of acral and difficult to treat sites of vitiligo


Eligibility criteria: Inclusion Criteria:

* Patients with non-segmental vitiligo (NSV) with acral or resistant lesions over the elbows and knees, that has not responded to conventional treatment
* Stability for ≥ 1 year
* Age ≥18 years
* Lack of topical treatment for at least 1 month prior to surgery and systemic treatment for at least 3 months prior to surgery.

Exclusion Criteria:

* Non acral NSV responsive to conventional treatment modalities
* Active vitiligo; new lesions, expansion of old lesions, confetti like lesions, ill-defined edges or koebnerization in \< 1 year
* Age \< 18 years.
* Pregnant females.
* Patients with hypertension, diabetes or tuberculosis
* Topical treatment in the past month and systemic treatment in the past 3 months.

Primary outcomes:
measure: comparing percent change in pigmentation in both arms
timeFrame: 3 months
measure: comparing percent change in surface area in both arms
timeFrame: 3 months
Secondary outcomes:
measure: comparing physician global assessment in both arms
timeFrame: 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Dermatology Department, Cairo University Hospitals
Study officials:
affiliation: Dermatology Department, Cairo University Hopsitals
name: Dr. Mogawer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02775669: Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique
Official title: Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hydrocephalus
Keywords: noninvasive ICP monitoring
Lead sponsor: University Clinic Frankfurt
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study Population: Children with open fontanels and need of intracranial pressure monitoring

Brief summary: Investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation due to craniosynostosis.

Detailed description: The investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation and Implantation of an external ventricle drain or a subdural ICP Monitoring devise. The second ICP probe is fixed epicutaneously on the skin over the frontal fontanel. The hourly measured ICPs within 24 hours postoperatively were compared with the Bland-Altman two methods analysis.

Eligibility criteria: Inclusion Criteria:

Child with open fontanel Need of ICP monitoring

Exclusion Criteria:

closed fontanel No Need of ICP monitoring

Primary outcomes:
measure: Comparison of ICP values (mmHg), intracranial pressure obtained invasive and noninvasive in mmHg will be compared. Either there is a significant difference or not. The data will be collected hourly. Device: Spiegelberg ICP Probe.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00846469: Coronary Computed Tomography (CT) Angiography Versus Standard Therapy in the Emergency Room
Official title: 64 Slice Coronary CT Angiography vs. Standard Therapy in the Emergency Room: Determining Cost-effectiveness and Predicting Clinical Outcome in Patients With Low and Moderate Risk for Acute Coronary Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 43
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the usefulness of CCTA (Coronary Computed Tomography Angiography) in the emergency room setting to diagnose and predict the outcome of patients with chest pain who have a low to moderate risk of heart disease.

And to also determine if the use of CCTA(Coronary Computed Tomography Angiography) is more cost effective (cost less) than the current standards of care treatments. To determine if patients who present to the emergency room w/low to moderate probability of having an ACS (Acute Coronary Syndrome) prefer CCTA (coronary computed tomography angiography)-based care compared to standard algorithm based care.


Eligibility criteria: Inclusion Criteria:

* 25 years of age or older
* Experiencing chest pain

Exclusion Criteria:

* Pregnant
* At high risk for ACS (Acute Coronary Syndrome)

Primary outcomes:
measure: To assess the usefulness of CCTA (coronary computed tomography angiography)in the emergency room setting to diagnose/predict the outcome of patients w/chest pain who have low to moderate risk of heart disease.
timeFrame: one year
Secondary outcomes:
measure: To determine if the use of CCTA (coronary computed tomography angiography)is more cost effective than the current standard of care treatments being used.
timeFrame: one year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Suzanne Chong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03408769: Metastatic Breast Carcinoma and Women Sexual Quality of Life
Official title: Metastatic Breast Carcinoma: Evaluation of Women Sexual Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Carcinoma
Keywords: Cancer
Sexuality
Quality of life
Intimacy
BISF-WBrief Index of Sexual Functioning for Women questionnaire
Quality of life questionnaire (EORTC QLQ-BR23):
Partnership questionnaire (partnerschaftsfragebogen; PFB)
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be offered to women aged 50 to 70, with metastatic breast carcinoma and living in a couple and followed at the Lorraine Institute of Oncology.

Brief summary: Sexual health is one of the relevant parameters for assesing the quality of life.

Improvement sexual and emotional function improves quality of life scores and depression or anxiety in curative phase.

The purpose of the study is to assess the quality of sexual life of postmenopausal women with metastatic breast cancer in couples and to establish links with overall quality of life and the quality of the relationship.

Detailed description: We use a quantitative methodology to assess quality of female sexual life, quality of life and quality o relationship with validated scientific questionnaires.

The sexual and emotional intimacy will be explored by semi structured interview, not mandatory for patients.

Eligibility criteria: Inclusion Criteria:

* Women with metastatic breast cancer
* Age ≥ 50 and \< 70 years old
* Diagnosis of metastatic breast cancer at least 6 months prior to study participation
* Patient living with a partner
* Menopausal women (absence of menstruation for 1 year minimum)
* ECOG performance status ≤ 2
* Affiliated to public health system
* Informed and having expressed her non-opposition

Exclusion Criteria:

* Patient in exclusive palliative care
* Single or not living in a couple
* Non-menopausal patient

Primary outcomes:
measure: Quality of sexual life of postmenopausal women with metastatic breast carcinoma living in couples
timeFrame: 1 day
Secondary outcomes:
measure: Quality of life
timeFrame: 1 day
measure: Quality of Relationship of the couple
timeFrame: 1 day
measure: Sexual and emotional intimacy
timeFrame: 1 day
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: Dubuc Myriam
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05448469: Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia in Patients Undergoing Open Splenectomy
Official title: Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia, a Randomized Double Blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Analgesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are very few randomized controlled trials in open splenectomy surgery, which compare paravertebral block with ESP block. The purpose of this randomized controlled trial is to compare the efficacy of ultrasound-guided paravertebral block with ESP block for perioperative analgesia in open splenectomy .


Eligibility criteria: Inclusion Criteria:

* patients who will be scheduled for indicated open splenectomy surgery in the supine position via left subcostal ,midline or letf subcostal with midline extention incisions
* physical status American Society of Anesthesiologists (ASA) II or III.

Exclusion Criteria:

* Patients who refuse to participate
* patients with body mass index (BMI) \>35 kg/m2
* infection at the site of injection
* coagulopathy, severe thrombocytopenia \<50×103
* spine deformity
* history of opioid dependence
* polytrauma patients with dorsal spine fracture
* urgent abdominal exploration for splenectomy in heamodynamically unstable patients
* history of allergy to opioids or local anesthetics
* history of allergy to opioids, or local anaesthetics.

Primary outcomes:
measure: First time to analgesic requirement
timeFrame: 1st 24 hour
Secondary outcomes:
measure: total analgesic consumption
timeFrame: 1st 24 hour
measure: Numerical rating scale (NRS)
timeFrame: 1st 24 hour
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References: