louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02700750: Relation Between Macular and RNFL Thickness Measurement and Quality Grading in OCT
Official title: Relation Between Macular and RNFL Thickness Measurement and Quality Grading in OCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nerve Fiber Bundle Defect
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators will enroll and scan normal eyes of healthy individuals using the Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest quality and 40 the best possible one. Each of the participants will be scanned numerous times using this noninvasive imaging tool, while trying to get as many scans as possible of different quality. The differences in the parameters between the scans will then be recoded.

Collected data will include age, sex, subjects' refractive status, visual acuity, full slit lamp exam and the participants' OCT characteristics and measurements.

Detailed description: The investigators will enroll and scan 200 normal eyes of 100 healthy individuals using the Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest quality and 40 the best possible one. Each of the subjects will be scanned numerous times using this noninvasive imaging tool, while trying to get as many scans as possible of different quality. The differences in the parameters between the scans will then be recoded.

Collected data will include age, sex, subjects' refractive status, visual acuity, full slit lamp exam and the participants' OCT characteristics and measurements.

Eligibility criteria: Inclusion Criteria: At least 20/30 visual acuity (BCVA), refractive error less than ±6 diopters (D) spherical equivalent or 3 D of astigmatism, and normal-appearing optic nerve head and retina on dilated fundus examination.

Exclusion Criteria:

* Any history or evidence of eye disease or surgery.
* Intraocular pressure (IOP) more than 22 mm Hg.

Primary outcomes:
measure: correlation between quality grading and retinal and RNFL thickness
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05766150: Oral Microbioma and Oral Malignant Disease
Official title: Association Between Oral Microbioma With Developing of Oral (Pre)Malignant Disease.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Cancer
Oral Squamous Cell Carcinoma
Premalignant Lesion
Lead sponsor: Academisch Ziekenhuis Maastricht
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2023-03-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Persons visiting oral and maxillofacial surgery department in Maastricht UMC or Radboud UMC who meet the inclusion criteria can be included.

Brief summary: This case-control study aims to investigate if oral microbioma is associated with developing oral (pre)malignant disease.


Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years in case of oral malignancy or premalignant disease, ≥40 years in case of no malignant disease
* Patients are (partially) dentate (≥20 teeth)
* Patients who have given written informed consent to participate in this study

Exclusion Criteria:

* Patients with a history of radiotherapy in head and neck region
* Patients with a history of chemotherapy, immunotherapy or immunomodulating drugs
* Patients with a previous malginancy in head and neck region
* Edentulous patients (with or without implants)
* Patients with removable (partial) dentures

Primary outcomes:
measure: Association between oral microbioma and (pre)malignant disease.
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: To describe the difference in oral microbioma between young (>40 years) patients with oral SCC and older (>40 years) patients with oral squamous cell carcinoma.
timeFrame: Through study completion, an average of 3 years
measure: To desribe the difference in oral microbioma and stage of disease upon presentation.
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Deptartment of Oral and Maxillofacial Surgery, Maastricht UMC+
city: Nijmegen
country: Netherlands
facility: Department of Cranio- & Maxillofacial surgery, Radboud UMC
Study officials:
References:
Clinical trial NCT02116855: Individualized Prophylaxis for Severe Hemophilia A Children
Official title: Individualized Tertiary Low Dose Prophylaxis for Severe Hemophilia A Children With Arthropathy in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemophilia
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 50
Sex: MALE
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A multi centre two year long term escalating dose tertiary prophylaxis study on the efficacy and cost saving of individualized low dose prophylaxis regimens for boys with severe hemophilia A in China staring with a low dose regimen in step I, an escalated low dose regimen in step II and a tailored dose regimen based on individual PK profiles in step III. The dose escalation criteria are adjusted according to patterns and frequencies of joint bleeding and assessed in each subject every 3 months. Efficacy of the 3 different dose regimens are measured by the Annualized Joint Bleeding rate (AJBR) as a primary end point and the Hemophilia Joint Health Score (HJHS ) and QoL scores (CHO-KLAT and PedsQoL) , image studies of target joints by Ultrasound, X-ray and MRI examinations, consumption of factor VIII and inhibitor rates as secondary end points.


Eligibility criteria: Inclusion Criteria:

1. Severe hemophilia A with FVIII \<1 %
2. Age from 6 to 10 years
3. Patients with more than 50 exposure day (ED)
4. Patients with one or more target joints (a target joint is defined as a joint with 3 or more bleeds in a consecutive 3 months) or disease joints (defined as presence of visible joint swelling and /or limitation of movements and/or joint deformities in the absent of an acute joint bleed )
5. on-demand treatment more than 12months before the study

Exclusion Criteria:

1. A history of FVIII inhibitor (titer greater than 0.6 BU) and detectable FVIII inhibitor at screening (titer greater than 0.6 BU)
2. Chronic renal failure (serum creatinine greater than 2.0 mg /dL)
3. Chronic Liver disease (ALT greater than 200 U/L))
4. Patients with clinically documented immunodeficiencies
5. Patients anticipated to require Major surgery
6. Patients with competing high risks such as symptomatic HIV infection, Juvenile rheumatoid arthritis, metabolic bone diseases, or other diseases known to mimic or cause joint diseases
7. Patients live too far from the comprehensive care centre at BCH and had demonstrated previous non compliance to therapies or clinical studies

Primary outcomes:
measure: AJBRs (annualized Joint bleeding rates)
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Children's Hospital
name: hui R Wu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05240755: Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery
Official title: Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Post-operative Pain
Lead sponsor: Foundation for Orthopaedic Research and Education
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Requiring shoulder arthroscopic surgery for soft tissue pathology
* Able to complete surveys and follow-up visits

Exclusion Criteria:

* Younger than 18 years of age
* Shoulder dislocation, fracture, previous surgery, coexisting extremity pathology, pregnancy.

Primary outcomes:
measure: Post-operative pain
timeFrame: 30 days post-operatively
Secondary outcomes:
measure: Sleep Quality
timeFrame: 30 days preoperatively leading up to surgery then 30 days postoperatively as well. Outcomes will be collected from surgery to 6 weeks postoperatively.
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
Study officials:
References:
Clinical trial NCT03488550: Single-dose Study of ANX007 in Participants With Primary Open-angle Glaucoma
Official title: A Phase 1, Open-label, Single-dose, Dose-escalation, Safety, Tolerability, and PK Study of Intravitreal ANX007 in Participants With Primary Open-angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Open-angle Glaucoma
Lead sponsor: Annexon, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a multi center, open-label, single dose, safety study. Approximately 9 to 15 participants with open-angle glaucoma are assigned into 3 sequential dose-levels and will receive ANX007 administered as single, IVT injections.

Detailed description: This is a phase 1, open-label, dose-escalation, safety study evaluating up to 3 dose levels of ANX007 administered as single IVT injections. Approximately 9 to 15 eligible participants are enrolled into one cohort each. All participants receive ANX007 in an open-label manner. The primary objective is to evaluate the safety and tolerability of a single intravitreal (IVT) injection of ANX007 in participants with primary open-angle glaucoma. Secondary objectives are to evaluate the serum pharmacokinetics (PK) and immunogenicity. An exploratory objective will evaluate the pharmacodynamic (PD) effect of ANX007 on serum C1q activity.

Eligibility criteria: Inclusion Criteria:

* Male or female age 18 years and older
* Diagnosis of primary open-angle glaucoma
* Intraocular pressure \<21 mm Hg on a stable IOP treatment regimen
* Reliable visual field testing

Exclusion Criteria:

* BCVA worse than 20/80 in either eye
* Extensive glaucomatous visual-field damage
* History of intraocular inflammatory or infectious eye disease in study eye
* Ocular trauma in study eye within the preceding 6 months
* History of uncomplicated cataract surgery less than 6 mos prior
* Any abnormality preventing reliable Tonopen tonometry in study eye
* Active malignancy within past 5 yrs
* Previous tx with another humanized monoclonal antibody
* History of any autoimmune or neurologic disease
* Concurrent use of glucocorticoid medications
* Receiving monoamine oxidase inhibitor therapy

Primary outcomes:
measure: Safety and tolerability as measured by the occurrence of adverse events
timeFrame: Day 56
Secondary outcomes:
measure: Serum plasma concentration of ANX007 after a single IVT injection.
timeFrame: Day 15
measure: Immunogenicity of ANX007 after a single IVT injection.
timeFrame: Day 56
Other outcomes:
measure: Effect of a single IVT injection of ANX007 on serum C1q
timeFrame: Day 15
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
Study officials:
affiliation: Annexon Vice President of Clinical Operations
name: Eric Humphriss
role: STUDY_DIRECTOR
References:
Clinical trial NCT03475550: Managing Side Effects in Clinical Practice
Official title: Managing Side Effects in Clinical Practice: A Quality Assurance Study in Functional Gastrointestinal Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a quality improvement health services study in the Division of Gastroenterology at Beth Israel Deaconess Medical Center (BIDMC).

Detailed description: The purpose of this study is to evaluate patients' reported experiences with regularly prescribed medications. No medications are prescribed as part of this study. Rather, if a patient are prescribed a new medication during their regularly scheduled clinic visit, he/she may be eligible to participate.

Patients who agree to participate and who are prescribed a medication in clinic will be contacted by telephone or email 3 weeks after their appointment to evaluate positive and negative experiences with the medication.

Eligibility criteria: Inclusion Criteria:

* Patient is seen in the Division of Gastroenterology at BIDMC
* Patient is prescribed a medication for the treatment of functional gastrointestinal disorders that has not previously been tried by the patient

Exclusion Criteria:

* Patient is not seen in the Division of Gastroenterology at BIDMC
* Patient has previously taken the drug that is prescribed

Primary outcomes:
measure: Patient-reported benefit from the drug
timeFrame: 3 weeks after the physician visit
measure: Number of side effects reported from the drug
timeFrame: 3 weeks after the physician visit
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT02885350: Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour
Official title: Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labor Pain
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the analgesic effect of two different opioids (fentanyl and sufentanil) will be compared when given either intrathecally or epidurally in primiparous parturients during early phase of the labour.


Eligibility criteria: Inclusion Criteria:

* Primiparous parturients
* In early phase of labour (cervical dilatation at or under 5 cm)
* No prior opioids by any route of administration within past 120 min
* Pain at or over 80 mm on 0-100 mm visual analog scale during contraction

Exclusion Criteria:

* Allergy for any of the medications used
* Contraindications for epidural/spinal analgesia
* BMI at the time of delivery under 20 or over 35 kg/m2

Primary outcomes:
measure: Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery
timeFrame: 20 minutes
Secondary outcomes:
measure: The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid
timeFrame: The data below report an average duration of time that is typically less than three hours
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Maternity Hospital, Helsinki University Central Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital (Katiloopiston sairaala)
name: Antti J Vaananen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaananen A, Kuukasjarvi M, Tekay A, Ahonen J. Spinal and epidural sufentanil and fentanyl in early labour. Acta Anaesthesiol Scand. 2019 Nov;63(10):1413-1418. doi: 10.1111/aas.13450. Epub 2019 Jul 23.
Clinical trial NCT06386250: Comparison of Regional Block, Caudal Block and Wound Infiltration in Inguinal Hernitomy
Official title: Comparison of Regional Block, Caudal Block and Wound Infiltration for Post-operative Pain Management in Children Undergoing Inguinal Herniotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative pain
inguinal herniotomy
children
regional block
caudal block
wound infilteration
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C)
Primary purpose: PREVENTION

Brief summary: Background: Although Inguinal herniotomy in children is taken as a day care procedure, post-operative pain management still remain controversial in these cases and superiority of wound infiltration, caudal block or regional block over each isn't known.

Objective: The objective of the study was compare regional block, caudal block and wound infiltration for post-operative pain management in children undergoing inguinal herniotomy

Detailed description: Three hundred patients rom the department of pediatric surgery, KEMU/Mayo Hospital, were randomized in three study groups by a computer generated table. Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C). . Patients were assessed for postoperative pain intensity using FLACC pain scale at 0, 1, 2, 4, 8, 24 hours after surgery in children less than 8 years of age. Wong-Baker Faces pain Scale at 0, 1, 2, 4, 8, 24 hours after surgery in children more than 8 years of age. Patients were discharged after 24 hours. If pain score ≥ 4 was given intravenously, Ketoralac. Urinary retention was observed after 24 hours, wound infection was observed after 7 days.

Eligibility criteria: Inclusion Criteria:

* Both Male and female inguinal hernia patients
* Patients from 3-12 years age Exclusion Criteria
* History of allergy to any drugs used in study documented on history .Infection at the site of regional, caudal or local infiltration, documented on clinical examination.

.Irreducible, obstructed or strangulated hernia, documented on clinical examination.

Primary outcomes:
measure: Postoperative pain intensity
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
measure: postoperative pain intesity
timeFrame: 24 hours
Locations:
city: Lahore
country: Pakistan
facility: Muhammad Sharif
state: Punjab
Study officials:
affiliation: King edward Medical University/Mayo Hospital Lahore
name: Muhammad Sharif, FCPS
role: STUDY_CHAIR
References:
Clinical trial NCT06774950: Value-based Care in Type 2 Diabetes (Enhancing T2D Care)
Official title: Améliorer La Prise En Soins Et La Qualité De Vie Des Patients Diabétiques De Type 2 (Alliance DT2)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Réseau de soins Delta
Sponsor class: OTHER
Collaborators: name: University of St. Gallen - School of Medicine
First posted: 2025-01-14
Enrollment: 154
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The clinical trial has a complex trial design. The clinical trial is not a Decentralized Clinical Trials-DCT, nor has decentralized elements
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to obtain a better glycemic index score (decrease) by improving the care and quality of life of type 2 diabetic patients for a possible remission of diabetes.

This will be achieved through an intervention that includes a strategy for training primary care physicians and other healthcare professionals in patient therapeutic education (TPE), as well as group and/or individual TPE-related activities/tools made available to patients, funded and encouraged for individualized planning. Intervention follow-up will be carried out by means of quality-of-life questionnaires for patients who have undergone the new method, compared with patients who have received the usual care.


Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed type 2 diabetes (less than 10 years)
* Age (between 40 and 65)

Exclusion Criteria:

* Significant comorbidities linked to worsening diabetes (such as renal failure, previous myocardial infarction, retinopathy, signs or symptoms of severe diabetic neuropathy or diabetic foot ulcers), severe osteoarthritis or as judged by the attending physician.
* Pregnant or breast-feeding women
* Persons who are unable to give signed informed consent

Primary outcomes:
measure: Glycated haemoglobin HbA1c (∆HbA1c)
timeFrame: During 18 month
Secondary outcomes:
measure: Health-related quality of life (∆ EQ-5D-5L)
timeFrame: During 18 months
measure: Diabetes self-care behaviours measured by the Diabetes Intention, Attitude, and Behavior Questionnaire (∆ DIAB-Q)
timeFrame: During 18 months
measure: Fat/lean body mass (∆ body composition)
timeFrame: During 18 months
measure: Cost-effectiveness analysis
timeFrame: At 12 and 18 months
Other outcomes:
Locations:
Study officials:
affiliation: University of St. Gallen - School of Medicine
name: Alexander Geissler, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00489450: Phase I Study to Investigate the Alcohol Interaction of SK3530
Official title: Clinical Trial to Investigate the Influence of Alcohol on the Pharmacokinetics and Safety of SK3530 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Erectile Dysfunction
Keywords: SK3530
alcohol
pharmacokinetics
safety
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2007-06-21
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was designed to investigate the alcohol effect of SK3530 on the pharmacokinetics (PKs) and safety.

Detailed description: This study was a randomized, open, single-dose, three-treatment, three-period, three-sequence, crossover study in which subjects were received, in random order, SK3530 100mg alone, 0.5g/Kg of alcohol alone, and SK3530 plus alcohol together. There was a minimum of a 7 day washout period between treatments. The alcohol was diluted to 240 mL with water. The contents were drunk in 1 minutes or less. For SK3530 and metabolite measurement, plasma samples were collected at pre-scheduled time and the safety was monitored all through the study.

Eligibility criteria: Inclusion Criteria:

* ages 20 to 50
* body weight of IBM ± 20%

Exclusion Criteria:

* cardiovascular disease
* color-blindness or weakness
* no availability to intake 0.5 g/Kg alcohol
* abnormal supine blood preesure

Primary outcomes:
measure: PK parameters - AUC, Cmax
timeFrame: 24hr after administration
Secondary outcomes:
measure: Safety (Vital signs, Adverse events)
timeFrame: until post-study visit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In-Jin Jang, MD
role: PRINCIPAL_INVESTIGATOR
References: