louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06725238: Acute-to-chronic Glycemic Ratio (ACGR) is a Marker of DFUs .
Official title: The Interplay of Acute-to-Chronic Glycemic Ratio With Other Biomarkers in Diabetic Foot Ulcers: An Effect is Not Related to the Therapeutic Remedies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Ulcer (DFU)
Keywords: Diabetes foot ulcers
Acute-to-chronic glycemic index
Leucocyte-glucose index
Triglyceride-glucose index
Lead sponsor: University of Diyala
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetic participants with or without diabetic foot ulcer who were referred to the consultant clinics at the Shar hospital in Sulaymaniyah, Iraq were recruited

Brief summary: Diabetic foot ulcers (DFUs) have resulted from peripheral arterial ischemia and peripheral neuropathy that are complicated with infections and amputation of the lower extremities. Uncontrolled glycemic status and significantly higher glycosylated hemoglobin (HbA1c) are associated with DFUs. This study aimed to assess the acute-to-chronic glycemic ratio (ACGR) in type 2 diabetes (T2D) with DFUs and compare it with those without DFUs, considering the relationships of this ratio with other indices that characterized the pathogenesis of T2D. This cross-sectional study was conducted on T2D with DFUs and non-DFUs. The primary outcome is ACGR. The secondary outcomes are indices related to the anthropometric, metabolic, and hematological variables.

Detailed description: DFUs are a macrovascular complication of diabetes mellitus resulting from peripheral artery disease and peripheral neuropathy that commonly affects the lower extremities. The DFUs are usually classified and scored according to the clinical findings. The ACGR is computed by dividing the acute (or current, or on admission in hospital) plasma glucose level by the chronic plasma glucose level calculated using the current (or on admission) HbA1c value.

Eligibility criteria: Inclusion Criteria:

Type 2 Diabetes Clinical and laboratory diagnosis of diabetic foot ulcers Treatment with oral anti-diabetes +/- insulin

Exclusion Criteria:

History of recent systemic infections Alcohol consumption Surgical procedures within 4 weeks Pregnant or breast-feeding women; Terminal illnesses.

-

Primary outcomes:
measure: Acute-to-chronic glycemic ratio
timeFrame: The measurement is done at the time of recruitment
Secondary outcomes:
measure: Leucocyte-glucose index
timeFrame: at the time of recruitment
Other outcomes:
Locations:
city: Baqubah
country: Iraq
facility: College of Medicine, University of Diyala
state: Diyala
Study officials:
affiliation: College of Pharmacy, University of Sulaimani, Sulaymaniyah
name: Rawa A Ratha, M.Sc., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023 Jul 3;330(1):62-75. doi: 10.1001/jama.2023.10578.
Clinical trial NCT01544738: Sensory Stimulation Effect on Movement Speed in Patients With Parkinson Disease
Official title: Aponeurotic Stimulation Effect on Parkinson Bradykinesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
sensory stimulation
Bradykinesia
Lead sponsor: Université Libre de Bruxelles
Sponsor class: OTHER
Collaborators: name: Fonds National de la Recherche Scientifique
name: Belgium: Belgian Federal Science Policy Office (BELSPO)
First posted: 2012-03-06
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Movement slowness (bradykinesia) is one of the main motor symptoms in Parkinson Disease (PD). Several studies have shown that patients with PD exhibit slowness because they are unable to modulate, in an optimal way, the velocity of voluntary motor acts not induced by external stimulation. Indeed, these patients have difficulties to integrate multi-sensorial information, mainly proprioception.

The investigators investigated changes in shoulder velocity during pointing movements by patients with PD after stimulation of soft tissues (aponeurosis) of upper limb muscles. The stimulation consisted of manipulating, with a hook (the diacutaneous fibrolysis method), the aponeurotic tissues enrobing the heads of the upper limb muscles. This technique has previously been shown to decrease passive tension and the tendon reflex response of the manipulated muscle group. The investigators hypothesis is that aponeurotic manipulation of shoulder muscles therefore creates a modification in the proprioceptive information, which in return temporarily decreases the bradykinesia of shoulder movements.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson Disease

Exclusion Criteria:

* Patients with a limitation in the shoulder range of motion necessary to perform pointing movements

Primary outcomes:
measure: 3D kinematic movement parameters and upper limb muscles electromyographic activation
timeFrame: Participants will be followed for the duration of the clinical test (2 weeks)
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Participants will be followed for the duration of the clinical test (2 weeks)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: ULB-FSM Laboratory of neurophysiology and movement biomechanics
Study officials:
affiliation: Université Libre de Bruxelles
name: Ana Bengoetxea, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université Libre de Bruxelles
name: Françoise Leurs, PhD Student
role: STUDY_CHAIR
affiliation: Université Libre de Bruxelles
name: Leslie Rigal, Master Student
role: STUDY_CHAIR
affiliation: Université Libre de Bruxelles
name: Guy Cheron, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06554938: Efficacy of Dental Hygiene Aids in Reducing Gingival Bleeding and Plaque Among Orthodontic Patients.
Official title: Efficacy of Dental Hygiene Aids in Reducing Gingival Bleeding and Plaque Among Orthodontic Patients. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Bleeding
Dental Plaque
Keywords: Dental plaque
Gingival Bleeding
Oral irrigator
waterpik
super floss
Lead sponsor: Ajman University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study comprised 18-35-year-old girls and boys planning orthodontic treatment. Participants had upper right tooth to lower left molar braces, a pocket depth of 3 mm, and had not flossed in 24 hours. Smoking, periodontal disease, missing teeth, voids between teeth in the arch, and systemic disorders disqualified participants.
Primary purpose: PREVENTION

Brief summary: Adult orthodontic patients aged 18-30 were included in a randomised, single-blind clinical research using a split-mouth design at a dental clinic. Both the Waterpik® and the Super-Floss® water flossers are manufactured by Oral-B.

Detailed description: In order to reduce gingival inflammation and remove subgingival plaque, oral hygiene therapy is necessary. The available evidence indicates that mechanical plaque control, which patients administer themselves daily, is the most important factor in managing and reducing plaque accumulation.

Aim: This research aimed to determine whether Waterpik or Superfloss was more effective in lowering the gingival bleeding score and plaque.

Methods: Adult orthodontic patients aged 18-30 were included in a randomised, single-blind clinical research using a split-mouth design at a dental clinic. Both the Waterpik® and the Super-Floss® water flossers are manufactured by Oral-B.

Eligibility criteria: Inclusion Criteria:

* Participants aged 18-35 years undergoing orthodontic treatment and
* systemically healthy without habits

Exclusion Criteria:

* Participants not undergoing orthodontic treatment and participants undergoing orthodontic treatment in the included age category but with systemic conditions prevalent
* missing teeth and
* treated previously for periodontal conditions

Primary outcomes:
measure: Gingival bleeding
timeFrame: 24 to 72 hours; 24 hours means at baseline and 72 hours is post intervention
measure: Dental plaque
timeFrame: 24 to 72 hours; 24 hours means at baseline and 72 hours is post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ajman
country: United Arab Emirates
facility: Ajman University
Study officials:
References:
Clinical trial NCT03142438: The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea
Official title: The Evaluation of a Full Face and Nasal Mask for the Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
Collaborators: name: North Texas Lung & Sleep Clinic
First posted: 2017-05-05
Enrollment: 57
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F\&P trial full face and nasal mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 70 OSA patients will be recruited from the North Texas Lung and Sleep Clinic (NTLSC) database

Detailed description: Visit 1 will involve the participants being fitted with the F\&P trial full face or nasal mask for use in-home.

The participant will then come in to return the mask (Visit Two) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit one.

The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within three weeks of the beginning of the study.

Eligibility criteria: Inclusion Criteria:

* Adult (22+ years of age)
* Able to give informed consent
* Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
* Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
* Fluent in spoken and written English
* Existing oronasal and nasal mask user

Exclusion Criteria:

* Inability to give informed consent
* Participant intolerant to PAP
* Anatomical or physiological conditions making PAP therapy inappropriate
* Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
* Pregnant or may think they are pregnant.

Primary outcomes:
measure: Number of Participants Subjective Usability Reporting
timeFrame: 14 ± 4 days in-Home
measure: Number or Participants Comparative Subjective Reported Comfort
timeFrame: 14 ± 4 days in-Home
Secondary outcomes:
measure: Objective Performance Reporting
timeFrame: 14 ± 4 days in-Home
measure: Number of Participants Reported Mask Acceptability
timeFrame: 14 ± 4 days in-Home
measure: Number of Participants Subjective Comfort Reporting
timeFrame: 14 ± 4 days in-Home
measure: Number or Participants Subjective Reporting of Seal Performance
timeFrame: 14 ± 4 days in-Home
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: North texas Lung and Sleep Clinic
state: Texas
Study officials:
affiliation: Board Certified Sleep Specialist
name: David Ostransky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00337038: Endothelial Function as a Marker for Blood Pressure Control Among Hypertensive Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hypertension
Diabetes Mellitus Type 2
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2006-06-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Our aim is to examine the influence of blood pressure and glycemic control together with N-acetylcystein utilization on the endothelia function of hypertensive diabetic patient.The study population will include 50 diabetic patient with uncontrolled hypertention that will be recruited from the Hypertension Clinic of Soroka University Medical Center.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients with uncontrolled hypertension that will be recruited from the Hypertension Clinic of Soroka University Medical Center

Exclusion Criteria:

* Pregnancy,secondary hypertention,malignancy or other serious illness

Primary outcomes:
measure: endothelial function
timeFrame: half of year
Secondary outcomes:
measure: blood pressure and glycemic control
timeFrame: half of year
Other outcomes:
Locations:
Study officials:
affiliation: Hypertension Clinic of Soroka University Medical Center
name: Ester Paran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Soroka University Medical Center
name: Ester Paran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06009250: Prevalence of Non-alcoholic Fatty Liver Disease in Patients With Chronic Kidney Disease in Assiut
Official title: Prevalence of Non-alcoholic Fatty Liver Disease in Patients With Chronic Kidney Disease in Assiut
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: CKD
NAFLD
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CKD patients

Brief summary: The goal of this observational study is to detect the prevalence of NAFLD in CKD patients

The main question\[s\] it aims to answer are:

* \[question 1\] prevalence of NAFLD in CKD patients.
* \[question 2\] the relationship between NAFLD and CKD.

Detailed description: The goal of this observational study is to detect the prevalence of NAFLD in CKD patients

The main question\[s\] it aims to answer are:

* \[question 1\] prevalence of NAFLD in CKD patients.
* \[question 2\] the relationship between NAFLD and CKD.

Eligibility criteria: Inclusion Criteria:

* CKD patients

Exclusion Criteria:

* HCV and HBV Positive patients
* Alcoholics
* patient on Hemodialysis
* patients with wilson disease
* patients with alpha one antitrypsin deficiency

Primary outcomes:
measure: abdominal ultrasound
timeFrame: 1 year
measure: liver enzymes
timeFrame: 1 year
measure: Fibroscan
timeFrame: 1 year
measure: BUN, Cr level and estimated GFR
timeFrame: 1 year
measure: Lipid Profile
timeFrame: 1 year
measure: Complete Blood Picture (WBCs, HB, Patelets
timeFrame: 1 year
measure: serum Uric Acid
timeFrame: 1 year
Secondary outcomes:
measure: Waist Circumference
timeFrame: 1 year
measure: Body Mass Index
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06595550: The Effect of Whey Protein Consumption on Hypoglycemia in Adults with Type 1 Diabetes During Fasting Ramadan.
Official title: The Effect of Whey Protein Consumption on Hypoglycemia in Adults with Type 1 Diabetes During the Fasting Holy Month of Ramadan: a Randomized, Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1 Diabetes
Fasting
Nutrition, Healthy
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 44
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Cross over randomized design for adding whey protein to Suhoor meal for patients with T1DM during fasting Ramadan

Detailed description: Patients with type1 diabetes who intend to fast will be supplied with dietary supplement "Whey protein" to be taken with Suhoor (predawn meal) for one week during Ramadan. They will be then crossed over to not taking the whey protein for another week. the order of taking whey protein will be randomized.

During both weeks patients will be monitored through flash continuous glucose monitoring and data will be compared in regards to incidence and timing of hypoglycemia, hyperglycemia, and time in target range.

After Ramadan data will be collected on number of days they had to brake fast due to low blood sugar during both weeks and overall satisfaction with using whey protein during Ramadan.

Eligibility criteria: Inclusion Criteria:

1. Type 1 Diabetes Mellitus
2. Age \>14 years
3. Committed to do Regular SMBG or on CGM
4. On Multiple Daily Injections or insulin pumps
5. On carbohydrate counting for meal dosing
6. Have previously fasted Ramadan
7. willing to fast Ramadan this year
8. Well-educated about requirements for fasting Ramadan

Exclusion Criteria:

1. Hypoglycemia unawareness
2. Cognitive impairment or learning disability
3. Renal and hepatic impairment
4. Adrenal insufficiency
5. Pregnancy
6. Alcohol consumption
7. Any diagnosed psychiatric disease
8. Sensor-augmented insulin pumps
9. HbA1c \>12%
10. Already on protein supplements

Primary outcomes:
measure: Hypoglycemia incidence rate
timeFrame: 1 month
Secondary outcomes:
measure: Percentage Time-below-range (TBR), time-above-range (TAR), and time-in-range (TIR) prior to and following whey protein consumption 2.
timeFrame: 1 month
measure: Glycemic control (HbA1c) and GMI during protein consumption
timeFrame: 1 month
measure: number of days they needed to brake the fast during each week
timeFrame: 1 month
measure: Patient preferences through questionnaire
timeFrame: 1 month
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdullah International Research Centre
Study officials:
affiliation: Ministry of National Guard Health Affairs
name: Reem Alamoudi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01877850: Utility of a Weaning Protocol in ICU
Official title: Non Pharmacological Randomized Clinical Trial Designed to Evaluate the Difference of the Duration of Weaning Process From the Ventilator Between Protocol-driven Weaned Patients and Clinical-driven Weaned Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weaning Failure
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2013-06-14
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: difficult to wean patients

Brief summary: The purpose of this study is to evaluate the difference of the duration of weaning process from the ventilator between protocol-driven weaned patients and clinical judgment driven weaned patients.

Detailed description: All patients with prolonged weaning and who required tracheostomy are enrolled in the study. These patients are randomized as "Case or Control" by a computer program.

Patients can start the weaning process when the acute phase of the respiratory failure has been resolved and pressure support ventilation was setted.

For all this patients are calculated modified-BWAP(BWAP-M) and TOBIN indexes. The "Case" patients started the weaning protocol process only if BWAP-M value is more than 15 or BWAP-M 10-15 with Tobin index \< 100.

If not, the BWAP-M and Tobin will be calculated every day. The Control patients will start weaning by clinical judgement even if the BWAP-M value is less than 10.

For all patients are calculated: the duration of weaning process, the ICU length of stay and the duration of the mechanical ventilation.

Eligibility criteria: Inclusion Criteria:

1. all patients that are clinically identified as prolonged to wean (failed 3 spontaneous breathing trials or 7 days or more of mechanical ventilation after the initial unsuccessful trial) and tracheostomized in ICU
2. improvement or resolution of the underlying causes of acute respiratory failure ratio between pressure partial artery of oxygen and fraction inspired oxygen (PaO2/FiO2) \>200 with fraction inspired oxygen (FiO2)\< 0,45.
3. pressure supported ventilation at the time of enrollment.

Exclusion Criteria:

1. patients assessed as easy weaning and not tracheostomized;
2. patients already tracheostomized on admission to ICU.

Primary outcomes:
measure: duration of weaning
timeFrame: within the first 15 days (plus or minus 5 days) after start of weaning
Secondary outcomes:
measure: duration of mechanical ventilation
timeFrame: within the first 12 days (plus or minus 10 days) after start of mechanical ventilation
Other outcomes:
measure: ICU length of stay
timeFrame: within the first 26 days (plus or minus 22 days) after ICU recovery
measure: success of weaning
timeFrame: spontaneous breathing for 48 hours
Locations:
city: Brescia
country: Italy
facility: Institute of Anesthesiology and Intensive Care of the University of Brescia, Spedali Civili, Italy,
Study officials:
name: Elena Peli
role: PRINCIPAL_INVESTIGATOR
References: