louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05875519: Healing Process and Blood Sugar Level Following Local Anesthetic Infiltration With and Without Vasoconstrictor
Official title: Evaluation of Healing Process and Blood Sugar Level Following Local Anesthetic Infiltration With and Without Vasoconstrictor for Extraction of Maxillary Teeth in Diabetic Patients Double Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Anesthesia, Local
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluating the healing of the extraction socket and the glycemic levels before, and after injection of local anesthesia with and without vasoconstrictor in diabetic patients


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria patients over 20 years and under 60 years of age
* DM controlled by medication
* Requiring a tooth extraction in the maxilla, with an indication of the intra-alveolar technique for periodontal reasons.
* Only participants that are willing to control and record blood glucose level throughout the study period.

Exclusion Criteria:

* Patients with any significant medical condition (besides DM)
* Alcoholic individuals
* Patients on drugs that affect the central nervous systems
* Patients who reported the use of drugs that might interfere with pain sensitivity
* Pregnant and lactating women
* Patients with hypersensitivity to local anesthetics or non-steroidal anti-inflammatory drugs (NSAIDs).

Primary outcomes:
measure: Glycemic level recorded before local anesthesia administration and 30 minutes following local anesthesia injection using glucometer
timeFrame: 30 minutes
Secondary outcomes:
measure: Healing score of the extraction socket
timeFrame: 21 days
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Dentistry, Minia University
Study officials:
References:
Clinical trial NCT00964119: Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population
Official title: An Interdisciplinary Study of Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acne
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2009-08-24
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects will be recruited from the UW-Madison, Department of Dermatology located at 1 South Park Street, Madison, Wisconsin. Study flyers and brochures will be posted in the waiting areas and clinic rooms at the UW Dermatology clinics. UW Dermatologist will identify patients that meet study criteria and ask if they are interested in research participation, then they will be referred to study personnel for more information.

Brief summary: This is a prospective study, that will follow participants over their course of treatment on Isotretinoin. All patients who are prescribed Isotretinoin for their acne treatment are registered in iPLEDGE. The iPLEDGE program involves a set of steps that the patient, physician and pharmacist must follow for the patient to take Isotretinoin. Patients will be asked if they are willing to participate in this research study to determine musculoskeletal changes in adolescents and young adults on systemic therapy using the highly sensitive magnetic resonance (MR) imaging modality. In addition to the MRI, participants will be asked if they are willing to give an extra sample of blood when their routine blood work is being done for iPLEDGE. This blood sample will be used to determine if there are any effects of isotretinoin on bone turnover markers.


Eligibility criteria: Inclusion Criteria:

1. Registered in I-Pledge and has not started the Isotretinoin medication
2. Females and males ages 12-21 years old
3. Able to undergo 3 MRI scan

Exclusion Criteria:

1. Participants taking additional vitamin A, D or Calcium supplements
2. Previous musculoskeletal injuries (from incidental trauma, sports related injury or motorvehicle accidents, etc)
3. Clinical diagnosis of psoriasis, rheumatoid arthritis and/or Reiter's disease
4. relocation within the next 6 months
5. participation on a research study involving drug medication within the past 30 days

Primary outcomes:
measure: Skeletal Toxicities Related to the Use of Isotretinoin
timeFrame: Baseline to 5 months post therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin, Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Joyce Teng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02999919: Body Mass Index and Post-dural Puncture Headache
Official title: The Relationship Between Body Mass Index and Post-dural Puncture Headache in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: This Study Investigated the Influence of Body Mass Index (BMI) on PDPH in Elective Caesarean Section Patients in Whom 27G Spinal Needles Were Used
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 420
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Post-dural puncture headache (PDPH) is seen more frequently in pregnant women due to stress, dehydration, intra-abdominal pressure, and insufficient fluid replacement after delivery. Obesity protects against PDPH in pregnant women; increased intra-abdominal fat tissue reduced cerebrospinal fluid leakage by increasing the pressure in the epidural space. Therefore, this study investigated the influence of body mass index (BMI) on PDPH in elective caesarean section patients in whom 27G spinal needles were used.

Detailed description: The study included 420 women with American Society of Anesthesiology physical status I-II who underwent elective caesarean section under spinal anesthesia. The patients with a BMI less than 30 were accepted as normal weight (Group I) and those with a BMI above 30 were accepted as obese (Group II). Dural puncture performed with a 27G Quincke spinal needle at the L3-4 or L4-5 intervertebral space and given 12.5 mg hyperbaric bupivacaine intrathecally. The patients were questioned regarding headache and low back pain 6, 12, 24, and 48 hours after the procedure, and by phone calls on days 3 and 7.

Eligibility criteria: Inclusion Criteria:

(ASA) physical status I-II who underwent elective caesarean section under SA. Women age 18-40 years.

Exclusion Criteria:

* Who had undergone lumbar disc or vertebra surgery, had chronic low back pain or headache, had contraindications for neuro-axial block, and emergency patients.

Primary outcomes:
measure: influence of body mass index (BMI) on PDPH in elective caesarean section patients
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00289419: Intraarticular Analgesia After Total Hip Arthroplasty, a Randomised Study
Official title: Postoperative Analgesia After Total Hip Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Intraarticular Bolus Injection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthroplasty, Replacement, Hip
Keywords: Arthroplasty, Replacement, Hip
Anesthetics, Local
Pain, Postoperative
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2006-02-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether wound infiltration with following single-shot bolus injection with local anesthetic and NASIDs are effective in the treatment of postoperative pain after total hip replacement compared to continuous epidural infusion.

Detailed description: Sufficient postoperative pain relief after total hip replacement is necessary to achieve normal mobilisation and a reduction of the surgical stress response. After total hip replacement epidural treatment has proven superior, with regards to pain relief, than treatment with parenteral infusions and periphery nerve blocks. Even though epidural treatment gives excellent pain relief adverse effect as motor block, urine retention, hypotension and itching occurs regularly which delays rehabilitation.

Treatment with the administration of local anesthetic in the operating field has shown its efficiency in reducing postoperative pain with a low incidence of adverse effects after various surgical procedures.

This study compares continuous epidural infusion of ropivacaine added morphine to a new technique, where ropivacaine, ketorolac and adrenaline is used to infiltrate the tissue around the hip joint during surgery, and is injected by an intraarticular catheter 8 hours postoperative.

Data of pain scores, analgesia consumption, adverse effects and mobilisation is collected for the first 4 postoperative days.

Eligibility criteria: Inclusion Criteria:

* Patients admitted consecutively to primary total hip arthroplasty due to arthrosis

Exclusion Criteria:

* Patients unable to provide informed consent
* Patients with contraindications for spinal anesthesia
* Patients with known hypersensitivity towards the used drugs
* Patients with severe chronic neurogenic pain
* Patients with Rheumatoid arthritis
* Patients with a daily opioid consumption

Primary outcomes:
measure: Consumption af analgesics
timeFrame: 96 h
Secondary outcomes:
measure: Side effects
timeFrame: 96 h
measure: Mobilization level
timeFrame: 8 h
measure: Pain scores VAS
timeFrame: 96 h
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Orthopedic Center, Aarhus University Hospital
Study officials:
affiliation: Orthopedic Center, Aarhus University Hospital, Aarhus, Denmark
name: Kjeld Søballe, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02781519: Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans
Official title: Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cannabis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.


Eligibility criteria: Inclusion Criteria:

* at least one lifetime exposure to cannabis
* good physical and mental health

Exclusion Criteria:

* cannabis naive individuals
* major current or recent stressors
* taking estrogen supplements or oral contraceptive pills (for women)

Primary outcomes:
measure: Rewarding Effects measured by Visual Analog Scale (VAS)
timeFrame: changes in "high" assessed over the following timepoints: baseline, +10, +80, and +200 minutes after THC infusion begins
measure: Verbal Learning: measured by Rey Auditory Verbal Learning Test (AVLT)
timeFrame: 25 minutes after THC infusion begins
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
state: Connecticut
Study officials:
References:
Clinical trial NCT06963619: AQT90 FLEX NTproBNP (N-terminal Pro-brain Natriuretic Peptide) 2 Test Kit - Reference Interval Study Protocol - China
Official title: NTproBNP2 Test Kit (Time-Resolved Immunofluorescence Method) Reference Interval Establishment Study Protocol
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diagnostic Tests
Lead sponsor: Radiometer Medical ApS
Sponsor class: INDUSTRY
First posted: 2025-05-09
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To establish the reference range of the NTproBNP2 Test Kit (time-resolved immunofluorescence method) in apparently healthy Chinese population.

Brief summary: To establish the reference range of the NTproBNP2 Test Kit (time-resolved immunofluorescence method) in apparently healthy Chinese population.


Eligibility criteria: Inclusion Criteria:

Subjects who meet all the following criteria are eligible for inclusion:

1. Voluntarily participate in this study and sign informed consent;
2. Body Mass Index (BMI) ≥18.5 and \<28kg/ m2;
3. Age ≥18 years old;
4. Through the investigator's consultation with the subjects, evaluate the subjects who meet the requirements of the reference individual of this study (refer to the "reference individual questionnaire").

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded:

1. Physical examination, laboratory test/examination results meet any of the following:

   * eGFR(estimated glomerular filtration rate) (formula: CKD-EPI, chronic kidney disease epidemiology collaboration) \< 60 mL/min/1.732
   * Systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥80 mmHg
   * Glycated hemoglobin A1c (HbA1c) ≥ 6.0%; or fasting blood glucose ≥ 7.0 mmol/L
   * Total cholesterol ≥ 6.22 mmol/L and/or triglycerides ≥ 2.26 mmol/L
   * High-sensitivity troponin: Female: ≥15.6 pg/mL (ng/L), Male: ≥34.2 pg/mL (ng/L)
   * Electrocardiogram, with obvious abnormalities such as those that may cause cardiac structural changes or risk factors for arrhythmia as assessed by the investigator
2. Subjects who are unable to provide a sufficient volume (≈2 mL) of EDTAanticoagulated whole blood sample;
3. Subjects who withdraw informed consent;
4. Subjects assessed by the investigator as unsuitable for inclusion in this study.

Primary outcomes:
measure: AQT90 FLEX NTproBNP2 Test Kit - Reference Interval Establishment - China
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01788319: Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm)
Official title: Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm) in Open Angle Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Angle Glaucoma
Keywords: laser trabeculoplasty
glaucoma
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate if micropulse laser trabeculoplasty (532nm) is as effecttive as or better than the conventional laser trabeculoplasty (532nm), it might be a new treatment strategy for glaucoma patients. It is done with a laser device that can also be used for many other ophthalmic applications, thus reducing the economic burden of treatment.


Eligibility criteria: Inclusion Criteria:

* individuals over 18 years old
* willing to sign an informed consent and able to comply the requirements of the study
* having no other ocular diseases besides glaucoma

Exclusion Criteria:

* history of ocular trauma
* intraocular surgery (except for phaco)
* pigment dispersion and exfoliation glaucoma

Primary outcomes:
measure: to compare the intraocular pressure reduction with the micropulse laser trabeculoplasty (532nm) versus the conventional laser trabeculoplasty (532nm)
timeFrame: one year of follow-up
Secondary outcomes:
measure: Secondary the complication rate between the two techniques will be compared
timeFrame: one year of follow up
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Ophthalmology, UZLeuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Evelien Vandewalle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06396819: Collagen-povidone for Diabetic Seniors' Tenosynovitis
Official title: Topical Collagen-povidone Injection as an Alternative Treatment for Stenosing Tenosynovitis in Older Adults With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Complications
Keywords: intervention
Stenosing Tenosynovitis
Collagen-Povidone
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2024-05-02
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A therapeutic intervention using povidone collagen vs. placebo was carried out, and the patients were recruited after meeting the inclusion criteria and divided into two randomized groups (Case vs Control). Application of collagen-povidone solution at a dose of 0.2 cc, compared with the application of physiological solution in the control group.
Primary purpose: TREATMENT

Brief summary: Diabetes affects 415 million adults globally, leading to hand issues. Povidone collagen shows promise in managing tenosynovitis. A clinical trial was conduced to compared its efficacy in adults over 60. It is shown that the intervention reduces pain, improves functionality, and grip strength with no complications. Collagen povidone holds potential for treating diabetic hand issues.

Detailed description: A randomized clinical trial from January 2022 to January 2023 compared povidone collagen intervention with a placebo in adults aged 60 and above suffering from stenosing tenosynovitis. Participants were randomized into Case (collagen-povidone) and Control (physiological solution) groups. The study evaluated parameters like tenosynovitis, diabetes, pain, functionality, and grip strength.

Eligibility criteria: Inclusion Criteria:

* Diagnostic of stenosing tenosynovitis
* Diagnostic of diabetes
* Adults aged 60 or older

Exclusion Criteria:

* Adults aged 60 or older

Primary outcomes:
measure: Mean evolution time of tenosynovitis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, Mexico
state: Jalisco
Study officials:
References:
Clinical trial NCT06844019: Birth & Breastfeeding Support Study
Official title: Birth & Breastfeeding Support Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breastfeeding
Breastfeeding Initiation
Breastfeeding Duration
Birth
Birth Practices
Gestational Diabetes Mellitus (GDM)
Preeclampsia
Keywords: Birth, birth practices, gestational diabetes, preeclampsia
breastfeeding
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 1628
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women and women who have given birth \> 18 years old

Brief summary: The goal of this observational study is to learn about the effects of birth practices such as cesarean section and vacuum assisted birth and diseases such as gestational diabetes and preeclampsia on exclusive breastfeeding. The main question it aims to answer is:

• Does cesarean section, vacuum assisted birth, gestational diabetes and preeclampsia affect exclusive breastfeeding three months after birth? Participants answer eight online survey questions. One survey is distributed before birth and the remaining seven surveys are distributed after birth at three, seven and four-teen days, as well as one, three, six and twelve months after birth.


Eligibility criteria: Inclusion Criteria: 18 years, intention to breastfeed, single gestation, reads and understands Danish -

Exclusion Criteria: Twin gestation, less than 18 years, no intention to breastfeed, does not read and understand Danish

-

Primary outcomes:
measure: Exclusive Breastfeeding
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev & Gentofte University Hospital
Study officials:
affiliation: Herlev & Gentofte Hospital
name: Thomas Bergholt, Professor, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05997719: Exploring Cancer Evolution, Prognostic and Predictive Biomarkers in EGFR-mutant NSCLC
Official title: Exploring Cancer Evolution, Prognostic and Predictive Biomarkers in EGFR-mutant NSCLC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Keywords: EGFR mutation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically or cytologically confirmed EGFR-mutant NSCLC

Brief summary: To investigate genomic architecture, cancer evolution and their relationship with clinical outcomes in EGFR-mutant NSCLC.

Detailed description: EGFR mutations are detected in about 50% of East Asian NSCLC and 10% of Western NSCLC. EGFR-mutant NSCLC harbors distinct genomic architecture including high ITH, early diversification, genome instability, low background mutation rates. But despite its high ITH, EGFR-mutant NSCLC usually have better prognosis than NSCLC with other driver mutations even without the application of targeted therapies, indicating that EGFR mutations may have distinct impacts on cancer evolution. This study intends to investigate the genomic architecture, cancer evolution trajectories and their relationship with clinical outcomes in EGFR-mutant NSCLC, and to identify prognostic and predictive biomarkers for this population that could potentially guide therapeutic decisions and improved clinical outcomes.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or older
2. Histologically or cytologically confirmed non-small-cell lung cancer
3. ECOG PS=0-2
4. EGFR mutations confirmed by tissue or peripheral blood
5. Can provide tumor tissue samples (fresh or archived)
6. The subject should have good compliance, who would participate in the research voluntarily, and sign the informed consent

Exclusion Criteria:

1. History of other malignancies within 5 years (excluding basal cell carcinoma of the skin or other carcinoma in situ that has been resected).
2. Unable to provide sufficient tumor tissue for analysis.
3. Subjects with active, unstable systemic diseases, such as active infection, uncontrolled hypertension, heart failure (NYHA class \>= II), unstable angina pectoris, acute coronary syndrome, severe arrythmia, severe liver, kidney or metabolic diseases, HIV infection.
4. Subjects who are deemed unable to comply with the study requirements or complete the study.

Primary outcomes:
measure: Intratumor heterogeneity (ITH)
timeFrame: 5 years
Secondary outcomes:
measure: Clinical utility of ctDNA in EGFR-mutant NSCLC
timeFrame: 5 years
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Sun Yat-sen University Cancer Center
Study officials:
References: