louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03049605: Effects of Electromagnetic Therapy Versus Laser Therapy on Peripheral Diabetic Neuropathy
Official title: Effects of Electromagnetic Therapy Versus Laser Therapy on Peripheral Neuropathy in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Keywords: Neuropathies laser and magnetic therapy
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 65
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study are to:

* Evaluate effect of magnetic therapy on peripheral neuropathy in diabetic patients.
* Evaluate effect of laser therapy on peripheral neuropathy in diabetic patients.
* Compare effects of magnetic therapy with that of laser therapy on peripheral neuropathy in diabetic patients.

Detailed description: Sixty- five male and female diabetic patients with peripheral neuropathy will be selected to participate in this study. They will be equally divided into two groups Group-I: Twenty five patient with diabetic peripheral neuropathy will be exposed to low intensity pulsed magnetic therapy Group-II: Twenty five patients with diabetic peripheral neuropathy will be exposed for 24 treatment sessions of laser therapy Group-III 15 patient received only medical treatment

Eligibility criteria: Inclusion Criteria:

* All diabetic patients with peripheral neuropathy will be selected to participate in this study.
* Their age ranges from 35 to 65 years old.
* All patients under medical control (optimal blood glucose). such as analgesic medications (e.g. opiates, anti-depressants, anticonvulsants and diabetic drugs to control blood glucose).

Exclusion Criteria:

* Patients have DPN due to other causes than diabetes
* Ulcers in either foot
* Lack of blood sugar control
* Other nervous system impairments
* Visual problems
* Unstable medical conditions
* Pregnancy
* Metallic implants
* Alcohol or drug abuse.

Primary outcomes:
measure: Motor and sensory conduction velocity of the lower limb nerves
timeFrame: 30-45 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Associate professor university of Dammam
name: Enas F. Alananey, PhD
role: STUDY_DIRECTOR
References:
citation: Bosi E, Conti M, Vermigli C, Cazzetta G, Peretti E, Cordoni MC, Galimberti G, Scionti L. Effectiveness of frequency-modulated electromagnetic neural stimulation in the treatment of painful diabetic neuropathy. Diabetologia. 2005 May;48(5):817-23. doi: 10.1007/s00125-005-1734-2. Epub 2005 Apr 15.
Clinical trial NCT03617705: Alcohol Monitor Validation
Official title: Laboratory and Field Validation of a Wrist-Worn Alcohol Monitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus (HIV)
Keywords: alcohol consumption
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-08-06
Enrollment: 49
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will validate a wrist-worn alcohol monitor (BACtrack Skyn) in both laboratory and real-life settings.

Detailed description: The overarching goal of this research program is to improve alcohol intervention and eventually related clinical outcomes (e.g., liver function) among HIV+ drinkers through biosensor-assisted intervention. Research shows HIV infection can influence alcohol metabolism (i.e., higher blood alcohol levels), so it's necessary to validate the new alcohol biosensor in HIV+ drinkers rather than in general population. The primary goal of this project, as a step toward the development and evaluation of a biosensor-assisted alcohol intervention, is to validate the newly available wrist worn transdermal alcohol biosensor (BACtrack Skyn). The two specific aims are: (1) To assess validity and reliability of the Skyn biosensor using fixed-dose lab administration of alcohol through comparison with laboratory grade breathalyzer, and (2) To validate Skyn biosensor in daily life using a 2-week ecological momentary assessment (EMA) to compare self-reported drinking and the Skyn derived transdermal alcohol concentration (TAC) readings.

Eligibility criteria: Inclusion Criteria:

* HIV+ consumers of alcohol; self-reported ≥ 5 days with at least 1 alcoholic drink, and ≥1days with at least 3 drinks
* HIV- consumers of alcohol; self-reported ≥ 5 days with at least 1 alcoholic drink, and ≥1days with at least 3 drinks

Exclusion Criteria:

* non-drinkers
* recent addiction treatment or treatment seeking
* urine positive for illegal drugs except THC (not applicable to those who are only invited to do field test);
* past \& current alcohol withdrawal
* severe alcohol use disorder (DSM-5)
* meeting criteria for current nicotine dependence (not applicable to field only participants) or current substance use disorder (excluding mild cannabis use disorder and mild/moderate alcohol use disorder)
* medical conditions (other than HIV) contraindicating alcohol
* pregnancy/breastfeeding in women
* psychosis or other severe psychiatric conditions.

Primary outcomes:
measure: Transdermal Alcohol Concentration (TAC)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: HealthStreet
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Yan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05765305: Combined Chromium With Letrozole Versus Letrozole Only in Induction of Ovulation in Patients With Polycystic Ovary Syndrome
Official title: Letrozole and Chromium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients aged from 18 to 35 years

Brief summary: Combined letrozole with chromium versus letrozole only in induction of ovulation in polycystic ovary syndrome

Detailed description: Randomized controlled trial

Eligibility criteria: Inclusion Criteria:

* female patients aged from 18 to 35 years Anovulatory cycles Pcos

Exclusion Criteria:

* female patients aged more than 35years Male factor of infertility Other factors of infertility than pcos

Primary outcomes:
measure: Efficacy of letrozole
timeFrame: 12 months
Secondary outcomes:
measure: Miscarriage rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine
state: القاهره
Study officials:
References:
Clinical trial NCT06884605: Problem-Based Learning and Mind Mapping Method
Official title: The Effect of Problem-Based Learning and Mind Mapping Method on Identifying Nursing Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nursing Education
Keywords: problem-based learning
mind mapping
nursing intervention
nursing students
Lead sponsor: Bilecik Seyh Edebali Universitesi
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 102
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Nursing students

Brief summary: Problem-based learning and mind mapping methods contribute positively to the learning of nursing students and also improve their critical thinking skills.

Detailed description: This study focuses on determining nursing interventions, which is an important stage of the nursing process. It is aimed to evaluate the effect of problem-based learning and mind mapping method on determining nursing interventions in nursing students. The research is original in its field in terms of using problem-based learning and mind mapping method simultaneously and focusing on nursing interventions. Therefore, the study is expected to be guiding for teaching staff as well as measuring the effect of nursing students on planning knowledge and nursing interventions.

Eligibility criteria: Inclusion Criteria:

* Not having received training on determining the nursing process and nursing interventions before
* Attending classes, attending post-test and follow-up tests

Exclusion Criteria:

* Having previously received training to determine the nursing process and nursing interventions
* Being absent from class, not attending the post-test and follow-up test

Primary outcomes:
measure: The effect of learning method on students' knowledge level
timeFrame: 03/10/2025-05/07/2025
measure: The effect of learning method on students' skill level
timeFrame: 03/10/2025-05/07/2025
Secondary outcomes:
Other outcomes:
Locations:
city: Bilecik
country: Turkey
facility: Bilecik Şeyh Edebali University
Study officials:
affiliation: Bilecik Seyh Edebali Universitesi
name: Aysun Acun, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05782205: Surgeons' Mental Distress and Risks After Severe Complications Following Radical Gastrectomy
Official title: Surgeons' Mental Distress and Risks After Severe Complications Following Radical Gastrectomy in China: a Nationwide Cross-Sectional Questionnaire
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mental Health
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 1000
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: Enrolled as many surgeons as possible within the research time

Brief summary: Surgeons experience higher levels of work stress, even under normal circumstances. Many can suffer from substantial levels of mental health issues, especially when faced with severe complications. However, due to a variety of reasons, many surgeons are reluctant to disclose mental health issues or seek psychological help.

Gastric cancer is the fifth most common malignancy globally and accounts for the fourth leading cause of death from cancer. In China specifically, gastric cancer is a major public health issue, with some 400,000 new cases diagnosed every year. Of those cases, more than 80% patients are at advanced stages when diagnosed. At present, radical gastrectomy is considered the standard approach for patients with resectable advanced gastric cancer. Severe complications following radical gastrectomy ranged from 2.7% to 9.4% worldwide. In addition to delaying patients' recovery courses, severe complications also place enormous pressure on chief surgeons who performed the operations. Such pressures may bring great risks of psychological distress.

Surgeons are also the victims when they encounter severe complications following radical gastrectomy. Their mental distress should not be minimized. Until now, little has been known about the effects of surgical complications on surgeons. In the current study, based on a large-scale questionnaire survey in China, the investigators aimed to investigate incidences of surgeons' mental distress following severe complications after radical gastrectomy. The investigators also aimed to identify independent risk factors which could help develop strategies to improve the mental well-being of these surgeons after such incidences.


Eligibility criteria: Inclusion Criteria:

* General and/or gastrointestinal surgeons who experienced severe complications after radical gastrectomy.

Exclusion Criteria:

* Other conditions that do not meet the inclusion criteria.

Primary outcomes:
measure: Surgeons' mental health
timeFrame: June 01, 2023 to August 31, 2024.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT02862405: Perception of Objects and Natural Scenes in People With Vision Loss (ACTIVIS)
Official title: Evaluation of the Perception of Objects and Natural Scenes in People With Vision Loss (Loss of Central or Peripheral Vision)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vision Loss
Keywords: Vision loss
Object recognition
Space recognition
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
First posted: 2016-08-11
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with eye disease causing loss of central or peripheral vision

Brief summary: The loss of central vision causes difficulty not only in reading but also in faces recognition, and in particular in the identification of facial expression, objects or spaces. These visual deficits have been mainly studied in relation with reading, which is the main complaint of these kind of patients. However, there are not enough data regarding perception of objects and spaces in this population. Then, the objectives are to study the visual-spatial abilities in individuals with vision loss, and altered cognitive processes, (2) to develop clinics tools for early detection and quantification of visual-spatial deficits and (3)to understand the capacities of normal peripheral vision in order to test the possibility of potential training for use of peripheral vision when central vision is impaired by an ophthalmic pathology.


Eligibility criteria: Inclusion Criteria cases:

* Patients with eye disease causing loss of central or peripheral vision
* French speakers
* Age between 18 and 90 years old
* Written consent
* Health insurance

Inclusion Criteria controls:

* Sex and age matched controls (+/- 5 years)
* French speakers
* Normal visual examination with visual acuity of min 9/10

Exclusion Criteria:

* Psychiatric disease or neurological pathologies
* Communication difficulties (deafness / mutism)
* Drug treatment altering concentration
* Mental deterioration with MMS \<24
* Alcoholism or addiction to drugs
* Persons under guardianship

Primary outcomes:
measure: Comparison of performances in visual tests between different groups according to error rate
timeFrame: at inclusion
measure: Comparison of performances in visual tests between different groups according to answer time
timeFrame: at inclusion
Secondary outcomes:
measure: Estimation of the score of visual acuity by the logMAR chart
timeFrame: at inclusion
measure: Measure of lesion size
timeFrame: at inclusion
measure: Pearson correlation coefficient to determine the correlation between the performance parameters during visual tests (error rate and answer time) and clinical parameters (visual acuity and lesion size)
timeFrame: at inclusion
Other outcomes:
Locations:
Study officials:
affiliation: Hospital of the Lille Catholic Institute
name: Thi Ha Chau Tran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02878005: A Comparison Between the Intubating Laryngeal Tube Suction and the Ambu AuraGain
Official title: A Prospective and Randomized Study Comparing the New Intubating Laryngeal Tube Suction and the Ambu AuraGain in Adult Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation; Difficult
Keywords: Intubating Laryngeal Tube
blind intubation
fiberoptic
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The intubating Laryngeal Tube Suction-Disposable is a new version of the Laryngeal Tube-Suction. It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube either blindly or with fiberoptic guidance.This study was designed to assess the success rate of blind and fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients.

Detailed description: The intubating Laryngeal Tube Suction-Disposable (iLTS-D) (VBM Medizintechnik GmbH, Sulz, Germany) is a new updated version of the Laryngeal Tube-Suction Disposable (LTS-D) It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube (ETT) either blindly or with fiberoptic guidance. Similarly As in to the LTS-D, the iLTS-D also has a separate channel for the purpose of placement of gastric tubes placement up to a size of 18 Fr.

The iLTS-D comes in one size. According to the depth of insertion, this device is equivalent to size 4 for patients 175patients 175 to 190 cm tall, or size 5 for patients taller than 190 cm. The iLTS-D is provided by the manufacturer with a compatible 7.5mm ETT and with a plastic stabilizer for removal of the device.

The current randomized study was designed to assess the success rate of blind and fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients under general anesthesia

Eligibility criteria: Inclusion Criteria:

American Society Anesthesiology I and II

Exclusion Criteria:

Difficult intubation, Cervical pathology

Primary outcomes:
measure: Time to performe blind intubation measure in second
timeFrame: 30 seconds
Secondary outcomes:
measure: Time to performe fiberoptic intubation in second
timeFrame: 60 seconds
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04443205: Relevance of Ultrasound Screening for Foetal Macrosomia
Official title: Relevance of Ultrasound Screening for Foetal Macrosomia and Description of Its Management in Champagne-Ardenne
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: Fetal Macrosomia
Ultrasound
Shoulder Dystocia
induction of labour
Cesarean
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 3000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: Management of fetal macrosomia is based on a suspicion of macrosomia (no certainty before birth). This management is an artificial induction of labour for an earlier delivery and therefore a lower fetal weight gain. Several studies have already shown that ultrasound performed during the third trimester of pregnancy was not a perfect tool for this screening.

Detailed description: The aim of the study is to describe management of women whose child is macrosomal but has not been screened g using ultrasound during the third trimester of pregnancy.

Eligibility criteria: Inclusion criteria : Patients (consecutive inclusions) :

Women pregnant Women followed in the gynaecology and obstetrics department of the CHU of Reims, the CHG of Charleville Mézières or the CHG of Chalons en Champagne.

Women for which the delivery is planned in the gynaecology and obstetrics department of the Reims University Hospital, the Charleville Mézières General Hospital or the Chalons en Champagne General Hospital.

Non-inclusion criteria Women without ultrasound dating scan in the first trimester. Women having a contraindication to labour or vaginal delivery Women with a scarred uterus Women having a history of shoulder dystocia or obstetric trauma Women having a history of urinary or fecal incontinence Women having a history of bad birth experience with high psychological impact Women with maternal pathologies (excluding gestational diabetes) Women whose fetus is breech Women with twin pregnancy

Primary outcomes:
measure: Foetal macrosomia
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT06489405: Horticultural Practices for Children
Official title: The Effect of Hortıcultural Practices on Internet Addiction, Social Skills and Stress Levels in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Internet Addiction Level
Perceived Stres Level
Social Skill Level
Keywords: horticultural practices
internet addiction
perceived stres
social skill
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study was conducted with a parallel group randomized controlled experimental design to determine the effect of horticultural practices on internet addiction, social skills and stress levels in children. The children underwent horticultural practices for 6 weeks. Children were given a post-test at the end of the intervention program (week 6), a first follow-up three months after the intervention and a second follow-up six months later.


Eligibility criteria: Inclusion Criteria:

* studying in the 6th and 7th grade of secondary school
* volunteering to participate in the research
* consent by the family for participation in the study

Exclusion Criteria:

- the presence of a disease against the materials to be used in horticultural practices (pollen, plant, seed and fertilizer allergy, etc.)

Primary outcomes:
measure: Internet Addiction Scale (Internet Addiction Scale for Adolescents)
timeFrame: Baseline (before the intervention)
measure: Internet Addiction Scale (Internet Addiction Scale for Adolescents)
timeFrame: 6th week after the intervention
measure: Internet Addiction Scale (Internet Addiction Scale for Adolescents)
timeFrame: three months after completion of the intervention
measure: Internet Addiction Scale (Internet Addiction Scale for Adolescents)
timeFrame: six months after completion of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
state: Emek/Çankaya
Study officials:
References:
Clinical trial NCT00244205: Identifying Methylation Biomarkers for Monitoring Bladder Tumors
Official title: Using PCR Technology (Polymerase Chain Reaction Technology) for Monitoring Patients With Bladder Tumors - Optimizing Genanalyses for Clinical Use.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2005-10-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: To investigate the methylation status of 4-6 genes in Urine and matching bladder tissue biopsies, in order to find methylation markers for use in a noninvasive test in monitoring patients with bladder tumors.


Eligibility criteria: Inclusion Criteria:

* Patients with bladder tumors and patients with benign urinary tract conditions with no clinical suspicion of bladder cancer.

Exclusion Criteria:

* Patients with competing urinary and systemic diseases, pregnant and patients under 18 years of age.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Copenhagen University Hospital at Herlev
state: Copenhagen
Study officials:
affiliation: Copenhagen University Hospital at Herlev
name: Reza R Serizawa, MD
role: PRINCIPAL_INVESTIGATOR
References: