louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06064058: Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain
Official title: Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain in Prediabetic Non-obese Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain Lower Back Chronic
Back Pain
Pre Diabetes
Diabetes
Back Pain, Low
Keywords: Back Pain
HBA1C
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three Groups:

* Case
* Palcebo
* No placebo, no intervention group
Primary purpose: TREATMENT

Brief summary: Prediabetes, characterized by elevated HbA1c levels, is a common precursor to type 2 diabetes mellitus. Recent studies have suggested a potential link between prediabetes and nonspecific back pain. This randomized controlled trial aimed to assess whether reducing HbA1c levels through lifestyle interventions and, along with the correction of vitamin D and magnesium, can alleviate nonspecific back pain in prediabetic patients.

Detailed description: The study included 40 patients from an outpatient clinic in Baghdad, evenly divided into intervention and control groups. The intervention group underwent a 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction. HbA1c levels were measured, and back pain severity was assessed (through what assessment method ?). The control group received standard care with NSAIDs and acetaminophen for pain management. Assessments were conducted at baseline and at various intervals over a total period of 6 months to evaluate changes in HbA1c levels and back pain intensity.

This randomized controlled trial provides evidence that reducing HbA1c levels through lifestyle modifications, along with the correction of vitamin D and magnesium, can lead to a reduction in nonspecific back pain intensity and improved functional outcomes in prediabetic patients.

Eligibility criteria: Inclusion Criteria:

* Poor sleep (less than 6 hours per day)
* chronic back pain
* Multiple joint pain
* non-specific back pain
* HBA1C more than 5.7
* ability to record the data

Exclusion Criteria:

* Not able to record data
* previous spine surgeries
* severe OA in knee
* Spinal stenosis
* Peripheral vascular diseases
* Rheumatological diseases
* Lumbar disc prolapse
* uncooperative patient

Primary outcomes:
measure: HBA1C
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Dr. Ghazwan A. Hasan Clinic
Study officials:
affiliation: University of Warith Al-Anbiyaa, College of Medicine
name: Hashim T Hashim, MBChB
role: STUDY_DIRECTOR
References:
Clinical trial NCT07023458: The Effects of Hypoxic Burden on Executive Function (EF) in Preschool Children With Obstructive Sleep Apnea
Official title: The Effects of Hypoxic Burden on Executive Function (EF) in Preschool Children With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 85
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Siriraj Hospital

Brief summary: The goal of this observational study is to study the effect of hypoxic burden on executive function in preschool children aged 2-6 years who have OSA.

The main question it aims to answer is Effect of hypoxic burden from OSA to executive function measured by BRIEF-P in preschool children..

Detailed description: There is no comparison group in this study Participants will performed full night polysomnography, Denver and BRIEF-P test within 3 months.

Eligibility criteria: Inclusion Criteria:

* Children aged 2-6 years old with OSA

Exclusion Criteria:

* Underlying diseases : hypoventilation, neuromuscular diseases, etc.

Primary outcomes:
measure: Executive function from BRIEF-P test
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06330558: Side-specific Factors for Conversion in Adrenalectomy for Pheochromocytoma.
Official title: Side-specific Factors for Conversion in Adrenalectomy for Pheochromocytoma. A Comparative Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Tumor
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-03-26
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An analysis of individuals who have undergone TLA and have unilateral PHEO of any size, aged over 18 years, and of both sexes.

Brief summary: Context: Adrenalectomy for pheochromocytoma (PHEO) poses difficulties due to the elevated chance of conversion. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of conversion in left-sided abdominal laparoscopic adrenalectomy (LLA) and right-sided abdominal laparoscopic adrenalectomy (RLA).

Methods: A retrospective analysis was conducted to include a total of 271 patients diagnosed with PHEO. These patients were separated into two groups: LRA (N=121) and LLA (N=150). The study period spanned from September 2016 to September 2023.

Detailed description: The process of performing an adrenalectomy for pheochromocytoma (PHEO) is difficult due to the significant risk of conversion. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of conversion in left-sided abdominal laparoscopic adrenalectomy (LLA) and right-sided abdominal laparoscopic adrenalectomy (RLA).

Methods: A retrospective analysis was conducted to include a total of 271 patients diagnosed with PHEO. These patients were separated into two groups: LRA (N=121) and LLA (N=150). The study period spanned from September 2016 to September 2023.

Eligibility criteria: Inclusion Criteria:

* Unilateral pheochromocytoma of any size, over 18 years old, both males and females

Exclusion Criteria:

* Patients undergoing initial open adrenalectomy, - Additional surgical interventions during total laparoscopic adrenalectomy, - Partial adrenalectomy,

Bilateral PHEOS. Hemorrhagic diathesis, Structural deformity Pregnancy,

- Prior unilateral abdominal surgery, data is absent. The preoperative diagnosis is ambiguous. Hereditary (PHEO), or recurrent PHEO

Primary outcomes:
measure: conversion
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06702358: Potential Therapeutic Implications of Laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women
Official title: Potential Therapeutic Implications of Laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-menopausal Women
Visceral Fat
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Laser pointer instruments Product Details Infrared laser diode made in Italy, it must be perpendicular with direct contact to each point.

Each point will stimulate bilaterally by a laser beam of the following parameters wave length 904 nm; strength, 24 mW; energy, 0.1 J; stimulation time, 30 s/point; and two sessions per week for 8 weeks.
Primary purpose: TREATMENT

Brief summary: Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women

Detailed description: All the patients fitted the inclusion criteria, will be given explanation of the treatment protocol in their understandable language.

Treatment procedures. Group (A): will receive laser acupuncture in addition to traditional treatment (low calorie-diet and physical activity) Group (B): will receive traditional treatment only

Laser acupuncture technique:

Application of laser acupuncture on 10 acupuncture procedure for each woman which will be detected by therapist according to Acupuncture points Will stimulate St 25 (Tianshu), St 36 (Zusanli), Liv 3 (Taichong); P 6 (Neiguan), H 7 (Shenmen) for the psychical aspect of the therapy and Auriculothera- py: 55 (Shenmen) and 87 (Stomach) Each point stimulating will be Stimulation time, 30 s/point two sessions per week for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Post-menopausal women
* Woman with visceral obesity
* with age ranges from 50-65years
* Body mass index (BMI) more than 30 kg/m2
* WHR more than 0.8

Exclusion Criteria:

* Endometrial cancer

  * Insulin resistance
  * Or metabolic disorders
* Diabetes
* Hypertensive •NOT receiving any medication of obesity

Primary outcomes:
measure: Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women
timeFrame: for 8 weeks
measure: Body Mass Index (BMI)
timeFrame: for 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nawal Reda Rashad Mohamed
state: US
Study officials:
References:
Clinical trial NCT00250458: Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Elimination of Migraine-Associated Nausea in Migraine Patients Treated With Rizatriptan Orally Disintegrating Tablet (ODT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-11-08
Enrollment: 346
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: Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.


Eligibility criteria: Inclusion Criteria:

* 6-month history of migraine, moderate to severe migraine attacks with nausea, 1-6 migraine attacks per month

Exclusion Criteria:

* Heart disease, high blood pressure

Primary outcomes:
measure: Participants With Elimination of Nausea at 2 Hours Postdose
timeFrame: At 2 hours after treatment
Secondary outcomes:
measure: Participants With Pain Relief at 2 Hours Postdose
timeFrame: 2 hours after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Freitag F, Taylor FR, Hamid MA, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Elimination of migraine-associated nausea in patients treated with rizatriptan orally disintegrating tablet (ODT): a randomized, double-blind, placebo-controlled study. Headache. 2008 Mar;48(3):368-77. doi: 10.1111/j.1526-4610.2007.00954.x. Epub 2007 Nov 28.
Clinical trial NCT05473858: Oraverse Versus Laser
Official title: Comparative Study of the Effect of Diode Laser and Oraverse on Reversing the Effect of Articaine 4% Soft Tissue Anasthesia in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Reversal of Local Anesthesia in Children
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: clinically assess the reversal of articaine 4% of two different concentration of vasoconcentration soft-tissue local anesthesia in pediatric dentistry using Diode Laser and Oraverse

Detailed description: Patients will be divided randomly into two groups (20 patients in each group) Group (1): Patients will be undergoing anesthesia revision by diode laser Group (2): Patients will be undergoing anesthesia revision by oraverse. Then each group will be subdivided into 2 subgroups (10 patients each) according to type of local anesthetic agent into:

subgroup 1: Articaine 4% with 1:100000 epinephrin \&Subgroup 2: Articaine 4% with 1:200000 epinephrin After 30 min of injection corresponding to approximate time of treatment, the patient in each group will be exposed to the reversal agent which may be diode laser or oraverse.

Eligibility criteria: Inclusion Criteria:

1. Patients who need to be treated under anesthesia by injecting mandibular first molar infiltration.
2. Cooperative children aged 6 to 10 years old with the ability to understand and respond to the sensation of soft tissue -

Primary outcomes:
measure: reversal of local anasthesia
timeFrame: 30 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dr.sara nabil
Study officials:
References:
Clinical trial NCT00929058: Bevacizumab and Vasoconstriction
Official title: Bevacizumab and Vasoconstriction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cancer
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2009-06-26
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Rationale: The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most common side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab hypertension had an overall incidence up to 32%. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear.

Objective: To study if arterial bevacizumab infusion causes acute vasoconstriction using plethysmography in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Male 18-50 years old
* normal results of glucose, lipids and creatinine
* informed consent

Exclusion Criteria:

* History of abuse of drugs or alcohol
* History of malignant disease
* First degree relatives with a history of cancer before the age of 50
* First degree relatives with a history of premature cardiovascular disease
* Current use of medication
* Clinical evidence of cardiac of pulmonary disease
* Hypertension ( systolic\>140mmHg, diastolic \>90mmHg)
* Diabetes mellitus
* smoking
* a history of thombosis or a family history of recurrent thrombosis
* abnormality on ECG

Primary outcomes:
measure: Fore-arm vasomotor response to administered bevacizumab, expressed as percentage change in forearm blood flow ratio
timeFrame: Infusion of bevacizumab during 6 minutes
Secondary outcomes:
measure: Correlation between VEGF concentrations in plasma and the vasoconstrictive response to bevacizumab
timeFrame: Infusion of bevacizumab during 6 minutes
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: UMCN
name: Gerard Rongen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03525158: A Brief Cognitive Intervention After Intrusive Memories of Trauma With Young Refugees
Official title: Intrusive Memories of Trauma Experienced by Young Refugees: Using Single Case Experimental Design to Investigate a Brief Cognitive Intervention Involving Computer Gameplay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrusive Memories of Trauma, Symptom of Post Traumatic Stress Disorder (Criterion B1)
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 4
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single case experimental AB design with or without optional replication (ABAB) (ie no random assignment)
Primary purpose: OTHER

Brief summary: This research study is designed to investigate the use of a simple cognitive task (a memory cue and 10 minute time gap, followed by playing the computer game "Tetris") for decreasing the number of intrusive memories of trauma among young refugees and asylum seekers. The design is a single case experimental AB design with or without optional replication (ABAB). Participants will aim to complete a no-intervention phase ('A': baseline phase) of one week followed by a one-week intervention phase ('B'), including a one-session intervention with a researcher comprising the simple cognitive task, followed by instructions to continue to use the technique self-guided in the subsequent week. Follow ups are conducted after each week to monitor the occurrence of intrusive memories of trauma in a pen-and-paper diary. It is predicted that participants will report fewer intrusive memories during the intervention phase than during the preceding baseline phase.


Eligibility criteria: Inclusion Criteria:

* Refugee or asylum seeker
* Experiencing intrusive memories of trauma
* Have access to a smartphone
* Able to speak or read the study material in Swedish, English or Arabic
* Able to attend three meetings with a researcher

Exclusion Criteria:

* Exhibit psychotic symptoms or other symptoms of severe mental illness

Primary outcomes:
measure: Change in the occurrence of intrusive memories of trauma from baseline week to intervention week
timeFrame: Baseline week 1 and Intervention week 1
Secondary outcomes:
measure: Feasibility and acceptability ratings for using a smartphone game-play intervention
timeFrame: Intervention week 1
measure: Self-guided intervention adherence - usage of the gameplay intervention in daily life
timeFrame: Intervention week 1
measure: Impact of intrusive memories on concentration, control, sleep and stress
timeFrame: Baseline week 1 and Intervention week 1
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Residental care home for young people
city: Stockholm
country: Sweden
facility: Swedish Language Classes for Refugees
Study officials:
affiliation: Karolinska Institutet
name: Emily Holmes, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01866358: Intraosseous Infusion for Neonatal Asphyxiated Resuscitation
Official title: Intraosseous Infusion for Neonatal Asphyxiated Resuscitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asphyxia Neonatorum
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 60
Sex: ALL
Minimum age (years): 28
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Intraosseous infusion is better than umbilical vein infusion for neonatal asphyxiated resuscitation


Eligibility criteria: Inclusion Criteria:

* newborns who need resucitation

Exclusion Criteria:

-

Primary outcomes:
measure: success rate of resuscitation
timeFrame: 24 hours
Secondary outcomes:
measure: Injury of brain and heart
timeFrame: 1 month
Other outcomes:
measure: Success rate of puncture
timeFrame: 24 hours
Locations:
city: Chongqing
country: China
facility: Pediatrics of Daping Hospital
state: Chongqing
Study officials:
affiliation: Professor, Chief of Pediatric Department
name: Shi Yuan, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04097158: Biomarkers in Different Types of Amyotrophic Lateral Sclerosis (ALS) Patients Being Treated With Edaravone
Official title: Oxidative Markers and Efficacy in Amyotrophic Lateral Sclerosis (ALS) Phenotypes Treated With Edaravone
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Temple University
name: Thomas Jefferson University
name: University of Southern California
name: Northwestern University
First posted: 2019-09-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Anyone who meets the Inclusion/Exclusion Criteria

Brief summary: This study is being conducted to help the investigators better understand how the new FDA approved medication Edaravone (also known as Radicava) works in subsets of patients with ALS. The investigators are also trying to understand if there are specific ALS patients, with different presentations of ALS, who might benefit most from this medication. Also, the investigators are following specific biomarkers to determine the optimal treatment duration in patients with different forms of ALS

There is no study medication being offered in this trial. Edaravone is prescribed as part of regular care. In this trial we are collecting blood, urine, and spinal fluid samples in ALS patients who are taking Edaravone and ALS patients who are not taking Edaravone to measure certain markers that could indicate why the drug may be working in a specific type of ALS.


Eligibility criteria: Inclusion Criteria:

1. Either possible, probable, or definite ALS, predominantly lower motor neuron disease, predominantly upper motor neuron disease, or bulbar
2. With or without cognitive involvement
3. Willing to participate
4. On no experimental treatment
5. Ages 18 - 85
6. No prior exposure to Edaravone (Radicava)
7. On a stable dose of Riluzole for 30 days or off Riluzole
8. Male or female
9. Females of childbearing age must use contraception

Exclusion Criteria:

1. Unstable medical illness
2. Abnormal liver function (\>2x ULN)
3. Unlikely to survive for 26 weeks

Primary outcomes:
measure: Define pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in different ALS/MND phenotypes.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Jeffrey Rosenfeld, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: