louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06997562: Greater Occipital Nerve Blockade and Sphenopalatine Ganglion Blockade in Patients With Episodic Migraine
Official title: Comparative Efficacy of Greater Occipital Nerve Blockade and Sphenopalatine Ganglion Blockade in Patients With Episodic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Greater Occipital Nerve Block
Sphenopalatine Ganglion Block
Episodic Migraine
Lead sponsor: New Valley University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the effectiveness of greater occipital nerve blockade and sphenopalatine ganglion blockade in reducing headache intensity, duration, frequency, and disability in patients with episodic migraine.

Detailed description: Migraine is a chronic neurological disorder characterized by recurrent headaches, affecting millions globally. Peripheral nerve blocks such as Greater Occipital Nerve (GON) and Sphenopalatine Ganglion (SPG) blockade have emerged as promising non-pharmacologic treatments.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18-65 years.
* Both sexes.
* Diagnosed with episodic migraine per the International Classification of Headache Disorders, 3rd edition (ICHD-3).
* Failure to achieve adequate relief with at least one prophylactic migraine treatment.

Exclusion Criteria:

* Chronic migraine (≥15 headache days per month).
* History of nerve blocks within the last 6 months.
* Known allergy to anesthetic agents.
* Pregnancy or lactation.
* Active psychiatric conditions affecting compliance.

Primary outcomes:
measure: Degree of headache intensity
timeFrame: 3 months post-procedure
Secondary outcomes:
measure: Migraine disability assessment score
timeFrame: 3 months post-procedure
measure: Headache duration
timeFrame: 3 months post-procedure
measure: Headache frequency
timeFrame: 3 months post-procedure
Other outcomes:
Locations:
city: New Valley
country: Egypt
facility: New Valley University
Study officials:
References:
Clinical trial NCT05978362: Value of Capsular Repair for Latarjet
Official title: Prospective, Multicenter, Randomized Single-blind Study on the Interest of Capsular Repair in the Latarjet Operation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2023-08-07
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, comparative, longitudinal, randomized single-blind study
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the occurrence of osteoarthritis (YES/NO) by radiography.

Detailed description: This is a prospective, comparative, longitudinal, randomized, single-blind, multicenter study.

This study will validate preliminary results on a technique associating capsular repair with abutment according to Latarjet in the treatment of shoulder instabilities. It may help reduce the risk of osteoarthritis and thus allow patients to maintain a healthy, stable and painless shoulder for longer.

Eligibility criteria: Inclusion Criteria:

* Patient, male or female, over the age of 18
* Patient with shoulder instability with risk factors for recurrence (ISIS score \> 3), requiring surgical stabilization by abutment
* Affiliated patient or beneficiary of a social security scheme
* Patient having been informed and having given his free, informed and written consent.

Exclusion Criteria:

* Patient with history of surgery for instability of the same shoulder
* Patient presenting contraindications to the realization of a postoperative scanner
* Patient whose physical and/or psychological health is severely impaired, which according to the investigator may affect the compliance of the study participant
* Patient participating in another clinical research or in a period of exclusion from another research still in progress at the time of inclusion
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman
* Patient hospitalized without consent.

Primary outcomes:
measure: occurrence of osteoarthritis
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Maussins-Nollet
Study officials:
References:
Clinical trial NCT06734962: Evaluation of Bone Regeneration After Apical Surgery Using Advanced Platelet-rich Fibrin: Utilization of Ultrasound for the Assessment of Periapical Lesions
Official title: Evaluation of Bone Regeneration After Apical Surgery Using Advanced Platelet-rich Fibrin: Utilization of Ultrasound for the Assessment of Periapical Lesions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Periapical Lesions
Keywords: Periapical healing
Apical Surgery
A-PRF
Ultrasound
Lead sponsor: Riga Stradins University
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 44
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 study examines the impact of advanced platelet-rich fibrin (A-PRF) on bone regeneration in apical surgery compared to standard methods. It highlights the effectiveness of ultrasound as a diagnostic tool for assessing periapical lesions. Eligible participants were adults with specific periapical lesions following root canal treatment failures. Exclusions included patients outside specific criteria, like those with advanced periodontal disease or undergoing orthodontic treatment. Participants were randomized into two groups: one receiving A-PRF to enhance bone regeneration and a control group without it. Both groups underwent apical surgery under magnification, with different postoperative protocols. The study involved radiological and ultrasonographic evaluations of lesion size and bone healing at baseline, 6 months, and 12 months, alongside blood analyses for Vitamin D and cholesterol level to assess their potential impact on healing.


Eligibility criteria: Inclusion Criteria:

1. Adult patients with precisely defined periapical lesions related to maxillary or mandibular incisors and premolar teeth as a sequel to persistent endodontic infection
2. Patients after root canal treatment/retreatment
3. Patients with or without the sinus tract
4. Patients with root perforations
5. Patients with clinical cases deemed unsuitable for non-surgical endodontic intervention
6. Patients with traumatic lesions clearly indicated for endodontic apical surgery.

Exclusion Criteria:

1. Patients younger than 18 years
2. Patients with lesions unrelated to the root apical area
3. Patients in possession of vital teeth with radiolucency in the apical region
4. Pregnant patients
5. Patients with non-restorable teeth
6. Patients with advanced periodontal disease
7. Patients with uncontrolled systemic health conditions
8. Patients receiving bisphosphonate therapy
9. Patients receiving orthodontic treatment.

Primary outcomes:
measure: Volumetric bone volume healing assessment
timeFrame: Baseline, 6 and 12 month
Secondary outcomes:
measure: Asessment of Ultrasound diagnostic accuracy for periapical lesion measurment
timeFrame: Baseline
Other outcomes:
Locations:
city: Riga
country: Latvia
facility: Riga Stradins University Institute of Stomatology
Study officials:
References:
Clinical trial NCT04144062: Primary Molars Restoration Using Different Pediatric Crowns.
Official title: CAD/CAM Crowns Versus Prefabricated Zirconia and Stainless Steel Crowns for Restoration of Primary Molars: A Prospective Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Restoration of Primary Molars With CAD/CAM Crowns
Keywords: Crowns
Zirconium
Computer-Aided Design
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: study aims to compare hybrid ceramic CAD/CAM and prefabricated zirconia ans stainless steel crowns restoring primary molars through In-vivo evaluation of the clinical outcomes in terms of; crown retention, stain resistance and periodontal and gingival health as well as parental/child satisfaction.


Eligibility criteria: Inclusion Criteria:

1. Age range of the patients from 5 to 8 years old.
2. Have no history of spontaneous pain or swelling.
3. Patients willing to return for follow-up examinations and evaluation.
4. Medically free patients or with controlled systemic disease ASA I or II.
5. No active periodontal diseases.
6. Patients with posterior pulpotomized tooth/teeth indicated for crown restoration (e.g. 2-3mm of teeth above cement-enamel junction).

Exclusion Criteria:

1. Children with intellectual, severe emotional or behavioral problems.
2. Presence of parafunctional habits such as clenching or bruxism.
3. Abnormal tooth mobility, gingival swelling, fistulous tract, or non-vital pulps.
4. Non-restorable teeth.
5. Radiographic positive signs of thickened or interrupted periodontal membrane space, internal root resorption, periapical or furcal radiolucency

Primary outcomes:
measure: clinical success
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Nehal Salman
Study officials:
References:
Clinical trial NCT01082562: Safety Study of BMS-844421 for Treatment of Hypercholesterolemia
Official title: Randomized, Double-blind, Placebo-Controlled, Ascending Single- and Multiple-Dose Study to Evaluate the Safety , Pharmacokinetics and Pharmacodynamics of BMS-844421 in Healthy Subjects and in Subjects With Elevated Cholesterol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Atherosclerosis
Hypercholesterolemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability, serum concentrations and pharmacodynamic effects on serum low-density lipoprotein (LDL) cholesterol of single and multiple subcutaneous and intravenous doses of BMS-844421 in healthy subjects (SAD) and in subjects with elevated cholesterol (MAD).


Eligibility criteria: Inclusion Criteria:

* Healthy Subjects (SAD)
* Healthy Subjects (MAD) with untreated elevated cholesterol
* Body Mass Index (BMI) of 18 to 30 kg/m² inclusive
* Women who are not of childbearing potential and men, ages 18 to 45

Exclusion Criteria:

* Any significant acute or chronic medical illness
* History of liver or renal disorders
* Prior use of any prescription or over-the-counter lipid lowering drugs, within 8 weeks prior to study drug administration

Primary outcomes:
measure: To asses safety, tolerability, pharmacodynamic effects of BMS-844421 on PCSK9 concentrations
timeFrame: At the conclusion of the MAD part of the study
Secondary outcomes:
measure: Assess single and multiple dose pharmacokinetics of BMS-844421
timeFrame: All outcomes will be assessed at the conclusion of the MAD part of the study
measure: Assess the absolute bioavailability of single BMS-844421 SC doses
timeFrame: All outcomes will be assessed at the conclusion of the MAD part of the study
measure: Assess the effects of multiple doses of BMS-844421on lipid components
timeFrame: All outcomes will be assessed at the conclusion of the MAD part of the study
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01826162: Short Chain Fatty Acid Metabolism and Energy Metabolism
Official title: The Effects of Differential Short Chain Fatty Acid Availability on Human Substrate and Energy Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Obesity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
First posted: 2013-04-08
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Gut microbiota is being increasingly recognized as an important factor in fat distribution, insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota could play an important role in the development of obesity and type 2 diabetes mellitus. The role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by microbial fermentation of fibre, is still controversial. At the present time, our understanding of the effects of SCFA on human metabolism (in gut or systemically) is still limited. The investigators hypothesize that the differential availability of SCFA impacts human metabolism differently.

In this placebo controlled, double-blind, randomized crossover pilot study the investigators will validate in overweight/obese healthy male volunteers whether rectal administration of SCFA is a good model for studying the acute metabolic effects of SCFA. For this, it will be investigated if site of administration (in distal or proximal colon) of SCFA differentially affects parameters of substrate and energy metabolism and to test the duration of short-term effects of SCFA administration.


Eligibility criteria: Inclusion Criteria:

* Overweight, obese men

Exclusion Criteria:

* athletes
* diabetes mellitus

Primary outcomes:
measure: Fat oxidation, energy expenditure
timeFrame: 1 study day for each administration
Secondary outcomes:
measure: Hormones that influence substrate and energy metabolism
timeFrame: 1 study day for each administration
measure: Inflammatory markers
timeFrame: 1 study day for each administration
measure: Plasma SCFA content
timeFrame: 1 study day for each administration
measure: Circulating metabolites
timeFrame: 1 study day for each administration
measure: Appetite VAS scoring
timeFrame: 1 study day for each administration
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: Ellen Blaak, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04430062: Short-term Outcome of Covid-19 Surgical Patients: Case-series of a High-risk Area Community Hospital
Official title: Short-term Outcome of Covid-19 Surgical Patients: Case-series of a High-risk Area Community Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Surgery
Disease Outbreaks
Keywords: Surgery
Covid-19
SARS-CoV-2
Surgical outcome
Lead sponsor: Azienda Socio Sanitaria Territoriale di Lodi
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population referring to a community hospital during the SARS-CoV-2 outbreak in the Northern Italy

Brief summary: The investigators retrospectively evaluated all the patients operated in a high-risk community hospital from the first Italian case of Covid-19 (February 21st) to the April 10th (in order to have at least a 30-days follow-up). The investigators selected those patients who had a preoperative or post-operative positive Real Time - Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2 and the clinical outcome of the participants was evaluated in term of need of Intensive Care Unit (ICU) post-operative recovery, medical and surgical complications, length of hospital stay and death.


Eligibility criteria: Inclusion Criteria:

* preoperative or post-operative positive Real Time - Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2
* surgical procedure in elective or acute care surgery performed under general anesthesia

Exclusion Criteria:

* patients operated without general anesthesia
* patients preoperatively intubated for Covid-19

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lodi
country: Italy
facility: Ospedale di Lodi - ASST Lodi
state: Lombardia
Study officials:
References:
Clinical trial NCT04796662: CT Lucia 601 IOL Implantation in the Sulcus
Official title: CT Lucia 601 IOL Implantation in the Sulcus
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cataract; Complicata
Posterior Capsule Tear
Lens Dislocation
Keywords: CT Lucia 601 lens
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had an implantation of the CT Lucia 601 lens

Brief summary: To perform a retrospective investigation of the CT Lucia 601 IOL implantation in the sulcus

Detailed description: The purpose of the study is to collect data that are parameters of post-IOL implantation safety:

* Questionnaire on subjective quality of vision
* Centration and anteroposterior position of the IOL (using biometry)
* Presence and quantification of any inflammation or pigment present in the anterior chamber (flare meter)
* Refractive outcome, with calculation of customized A-constant of the CT Lucia 601 IOL in-the-sulcus and quantification of higher-order aberrations (HOA)
* General safety-parameters:

  * Visual acuity
  * Intra-ocular pressure
  * Presence of macular edema or retinal nerve fiber layer (RNFL) thinning (SD-OCT)
  * Any adverse ophthalmic events

Eligibility criteria: Inclusion Criteria:

* Patients with an implantation of a CT Lucia 601 lens for different reasons:

  * During vitrectomy to treat a complicated cataract surgery and had the implantation of a CT Lucia 601 IOL in the sulcus or patients
  * During phaco surgery with a posterior capsule tear that necessitated the implantation of the implant lens in the sulcus
  * Explantation of an in-the-bag lens and implantation of a CT Lucia 601 as replacement lens (e.g. to treat opacification of the implant lens or intolerance of the implant lens).
* Age : \> 18 years
* Signed informed consent
* Preoperative myopia less than 10 diopters
* Implantation of the CT Lucia IOL at least six months earlier

Exclusion Criteria:

* History of uveitis
* Ocular pathology or history that could influence the biometry of the effective lens position, such as ocular trauma with zonulolysis, congenital iris- or lens defects etc.
* Any eye condition influencing the lens position (to be specified) according to the investigator

Primary outcomes:
measure: safety of the CT Lucia 601 IOL in the sulcus
timeFrame: 2019-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
Study officials:
affiliation: UZ Leuven
name: Peter Stalmans, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00784862: ATAC - Pharmacokinetics (PK) Sub-Protocol
Official title: A Randomised, Double Blind Trial to Assess the Pharmacokinetics of Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-04
Enrollment: 9358
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effect of ARIMIDEX on the pharmacokinetics of tamoxifen and the effects of tamoxifen on the pharmacokinetics of ARIMIDEX..


Eligibility criteria: Inclusion Criteria:

* Eligible for entry into the main ATAC trial 1033IL/0029
* Patients must have been taking ATAC trial medication for at least 3 months (i.e. patients must have reached at least visit 2 of the main ATAC study)
* Patients should be taking their medication in the mornings for at least 3 months
* Patients must be 100% compliant over the preceding fourteen days

Exclusion Criteria:

* Excluded from entry into the main ATAC trial (1033IL/0029)
* Patients whose concurrent treatment includes diazepam or drugs which might affect tamoxifen steady state levels or steroid hormone status. These include ketoconazole (antifungal) or related compounds

Primary outcomes:
measure: Steady state plasma trough concentrations of tamoxifen, desmethyltamoxifen and anastrozole
timeFrame: 24±4 hours after previous dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06138262: Preconception Nutrition Education Intervention for Prospective Brides
Official title: Effectiveness of Preconception Nutrition Education for Prospective Brides to Prevent Anemia and Chronic Energy Deficiency During Pregnancy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Education
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In this study there were 2 groups, namely the group that was given intervention and the group that was not given intervention / control group. The intervention group will be provided with education through a preconception nutrition education module and the leaflet, and the control group was given education using the leaflet.
Primary purpose: PREVENTION

Brief summary: This research focuses on the importance of preconception health care. In this research, an intervention was carried out providing health education regarding preconception nutritional preparation. Research methods used is a Quasi Experiment with the Non Equivalent Control Group method. Example used in this research were 100 prospective brides and grooms in Indonesia. The intervention group will be provided with education through a preconception nutrition education module and the brides health card, and the control group was given education using the brides health leaflet.


Eligibility criteria: Inclusion Criteria :

* Women aged 20 to 35 years old
* Have no history of disease that weakens anemia and nutritional intake
* Examination maximum 3 months before the wedding
* Prospective bridal couples do not delay the pregnancy program

Exclusion Criteria :

* Not complete premarital reproductive health examination

Primary outcomes:
measure: Haemoglobin Level
timeFrame: one day
measure: Body Mass Index
timeFrame: one day
measure: Midupper Arm Circumference (MUAC)
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Depok
country: Indonesia
facility: Puskesmas / Government First Level Health Facilities
state: West Java
Study officials:
References: