louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06126016: A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.
Official title: A Multi-center, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.(Paricalcitol) for Secondary Hyperparathyroidism With Stage 5D Chronic Kidney Disease (CKD 5D) Receiving Hemodialysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease 5D
Secondary Hyperparathyroidism
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis patients with secondary hyperparathyroidism due to chronic kidney disease(CKD 5D)

Brief summary: The purpose of this study is to evaluate the efficacy and safety of pacitol Inj.(paricalcitol) for secondary hyperparathyroidism with stage 5D chronic kidney disease (CKD 5D) receiving hemodialysis


Eligibility criteria: Inclusion Criteria:

* Among hemodialysis patients with secondary hyperparathyroidism due to chronic kidney disease (CKD 5D), those who are scheduled to administer Pacitol Inj. according to the product information.
* Those who voluntarily signed a written personal information collection and usage agreement to participate in this clinical study after receiving an explanation about the objective and methods of the study.
* Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion.

Exclusion Criteria:

* Those with a history of hypersensitivity reactions to this drug or its components
* Those with evidence of vitamin D toxicity
* Those with hypercalcemia at enrollment
* Pregnant or lactating women
* Those with evidence of parathyroid adenoma who is scheduled to undergo parathyroidectomy.
* Those who have been administered with investigational drugs of other clinical trials within 12 weeks from the baseline(Visit 1).
* Those who are judged by the principle Investigator or sub-Investigator to be ineligible to participate in the study.

Primary outcomes:
measure: Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D)
timeFrame: 12 weeks after administration
Secondary outcomes:
measure: Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D)
timeFrame: 24 weeks after administration
measure: Proportion of subjects whose intact parathyroid hormone level decreased by more than 30%
timeFrame: 12, 24 weeks compared to pre-dose
measure: Incidence of anemia
timeFrame: From baseline to 12 weeks or 24 weeks
measure: Change in intact parathyroid hormone
timeFrame: 12, 24 weeks compared to pre-dose
measure: Change in Calcium X Phosphorus
timeFrame: 12, 24 weeks after administration
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: DongGuk university Ilsan hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT05778916: 5 Year Radiological and Clinical Results From Patients Operated for Hallux Valgus Deformity.
Official title: Radiological Outcome vs.Patient Reported Clinical Outcome 5 Years Post Hallux Valgus Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hallux Valgus
Keywords: Radiological outcome
Clinical outcome
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Norwegian speaking men and women operated for hallux valgus deformity at Ostfold hospital trust in the years 2016-2018.

Brief summary: Retrospective study of patients operated for hallux valgus deformity at our hospital (ostfold hospital trust) 5 years ago. Patients will be clinically examined, a weighted radiograph of the foot (traditional and newer parameters will be evaluated) and patient reported outcome measures (PROM) scores will be collected.


Eligibility criteria: Inclusion Criteria:

* All patients (18-80 years at time of surgery) operated for hallux valgus deformity at ostfold hospital trust 2016-2018

Exclusion Criteria:

* Not able to speak/write/read norwegian language

Primary outcomes:
measure: Clinical 5 year outcome
timeFrame: Data collection during 2023, completion during 2024
Secondary outcomes:
measure: Clinical VAS 5 year outcome
timeFrame: Data collection during 2023, completion during 2024
measure: Clinical Likert scale 5 year outcome
timeFrame: Data collection during 2023, completion during 2024
measure: Radiological outcomes
timeFrame: Until 2024
Other outcomes:
Locations:
city: Sarpsborg
country: Norway
facility: Østfold Hospital Trust
state: Østfold
Study officials:
affiliation: Ostfold Hospital Trust
name: Marius Molund, MD, phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT02096016: HPV-test, Cervical Cancer and Follow-up
Official title: Recurrence After Surgery for Cervical Cancer - an Evaluation of the Follow-up Program.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Human Papilloma Virus
Uterine Cervical Neoplasms
Recurrence
Keywords: Surveillance
Follow up
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated for cervical cancer.

Brief summary: The investigators have planned this project to evaluate the follow-up program after surgery due to cervical cancer and to explore the possibilities for different tests of Human Papilloma Virus (HPV) in contributing to the customization of the follow-up program.

Purpose:

The investigators effort is to provide the background for an evidence-based update of the follow-up program after surgery due to cervical cancer with the purpose of early diagnosis of recurrence affecting quality of life for as few women as possible.


Eligibility criteria: Inclusion Criteria:

* Surgery. FIGO stage IA-IB. \> 18 years

Exclusion Criteria:

* Ajuvant oncologic treatment

Primary outcomes:
measure: Prevalence of HPV Genotypes in Vagina (Type 16, 18 and Other)
timeFrame: 2 years
Secondary outcomes:
measure: HPV Clearance From Vagina in Between the Two Planned Follow-up Visits.
timeFrame: 2 years
Other outcomes:
measure: Evaluate 1-year, 2-year and 5-year Recurrence
timeFrame: 5 years
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Katrine Fuglsang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02162316: A Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia
Official title: A Multicenter, Randomized, Double-blind Comparative Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Dyspepsia
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 136
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia

Detailed description: This is a multicenter, randomized, double-blind comparative clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia

Eligibility criteria: Inclusion Criteria:

* Roman III criteria
* One or more conditions are applied: epigastric pain, epigastric burning, bothersome, postprandial fullness or early satiety
* No organic lesion
* Helicobacter pylori infection

Exclusion Criteria:

* has taken prokinetics, H2 antagonists, PPIs, NSAIDs, anticholinergics, antibiotics, antidepressants, anticoagulants within a month
* had a surgery that might affect gastrointestinal motility

Primary outcomes:
measure: Volunteer global assessment of improvement rate of functional dyspepsia by using 5-Likert scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Volunteer global assessment by using 5-Likert scale
timeFrame: 6 weeks
measure: The improvement rate of 4 types of dyspepsia symptoms
timeFrame: 12 weeks
measure: The change of each score and total score of dyspeptic symptoms
timeFrame: 6, 12 weeks
measure: Assessment of NDI-K Quality of Life
timeFrame: 6,12 weeks
measure: The proportion of the patients who answered "yes for the question about symptom improvement
timeFrame: 6, 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
affiliation: Soonchunhyang University Hospital
name: Su Jin Hong, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Busan National University Hospital
name: Gwang Ha Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Sang Gyun Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Hyun Soo Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook National University Hospital
name: Seong-Woo Jeon, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04304716: Regional Anesthesia for Head and Neck Reconstruction
Official title: Regional Anesthesia for the Management of Perioperative Pain for Free Flap Reconstruction of the Head and Neck: A Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: By utilizing regional anesthesia blocks at the surgery tissue donor sites, it can potentially reduce post-operative pain while also reducing the use of opioids. It can aim to measure the reduction in opioid use, reduction in pain scores, patient satisfaction, and because there is not a current protocol established for regional anesthesia use for free flap reconstruction, and we aim to standardize the procedure.


Eligibility criteria: Inclusion Criteria:

* Subjects undergoing microvascular fibula free flap reconstruction of the head and neck
* Subjects undergoing primary reconstruction for both benign and malignant etiology

Exclusion Criteria:

* Pregnant women
* Subjects with true allergies to the study drugs, reporting anaphylaxis in the past
* Subjects undergoing reconstruction with more than 1 free flap
* Subjects undergoing secondary reconstructions
* Subjects undergoing surgery for osteonecrosis
* History of enrollment in a pain management program
* Any subject currently enrolled in pain management, or currently taking long acting opioids such as methadone or oxycontin

Primary outcomes:
measure: Opioid consumption
timeFrame: 72 hours (3 days) post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Rui Fernandes, MD, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00575016: Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Overactive Bladder
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-12-17
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.


Eligibility criteria: Inclusion Criteria:

* Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury
* Inadequate response to anticholinergic medication used to treat overactive bladder

Exclusion Criteria:

* History or evidence of pelvic or urologic abnormality
* Previous or current diagnosis of bladder or prostate cancer
* Urinary tract infection at time of enrollment

Primary outcomes:
measure: Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change From Baseline in Maximum Cystometric Capacity (MCC)
timeFrame: Baseline, Week 6
measure: Change From Baseline in Maximum Detrusor Pressure (MDP)
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Cairo
country: Egypt
city: Thessaloniki
country: Greece
city: Ahmadabad
country: India
city: Beirut
country: Lebanon
city: Belgrade
country: Serbia
city: Ankara
country: Turkey
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04793516: Development of a Virtual Reality Spatial Retraining Therapy to Improve Neglect in Stroke Survivors
Official title: Development of a Virtual Reality Spatial Retraining Therapy to Improve Neglect in Stroke Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Spatial Neglect
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Participants in this study will help test and develop a virtual reality (VR) system that is being designed to help people with spatial neglect after stroke.

Detailed description: Participants in this study will be tested to see if they have spatial neglect after their stroke, and the severity of such. Spatial neglect is a disorder that may occur after a stroke that leads to a person paying more attention to one side of their body over the other. Each testing session, they will perform paper and pencil neglect tests before and after playing a VR video game that is being designed as a potential future treatment. They will also give feedback on the game after the session is over. People who have spatial neglect after stroke are encouraged to apply.

Eligibility criteria: Inclusion Criteria:

* Read and speak English fluently
* Have a history of one stroke event that injured one cerebral hemisphere
* Presence of moderate to severe spatial neglect

Exclusion Criteria:

* History of progressive neurological disorders
* History of significant psychiatric disorders
* History of vestibular disorders
* Living outside a 50-mile radius of Kessler Foundation (located in West Orange, NJ)

Primary outcomes:
measure: Behavioral Inattention Test
timeFrame: At baseline, after intervention, and two weeks after intervention
Secondary outcomes:
measure: Simulator Sickness Questionnaire
timeFrame: After intervention
measure: Semi-structured interview
timeFrame: Two weeks after intervention
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Peii Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00628316: Effects of Caffeine in Tinnitus
Official title: Effects of Caffeine Consumption on Tinnitus Perception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: tinnitus
caffeine
Lead sponsor: Faculdade de Medicina de Valenca
Sponsor class: OTHER
First posted: 2008-03-05
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: TREATMENT

Brief summary: Caffeine intake is reported by many authors to enhance the perception of tinnitus. The aim of this study is to determine the effects of 1 month caffeine intake reduction in the scores of validated questionnaire Tinnitus Handicap Inventory (THI) and in a visual-analog scale (VAS).

Detailed description: A group of 50 patients who takes more than 3 small cups (50 ml) of caffeine daily and have tinnitus will be asked to reduce caffeine intake for 1 month. Scores of THI and VAS will be taken before and after this period.

Eligibility criteria: Inclusion Criteria:

* tinnitus for more than 6 months
* THI \> 38
* no central acting drugs in the last 6 months
* tympanogram type A-n
* daily intake of caffeine greater than 150 ml

Exclusion Criteria:

* vascular and muscular tinnitus
* concomitant TMJ disorders
* abnormal otoscopy
* mixed and conductive hearing losses
* Ménière disease

Primary outcomes:
measure: Tinnitus Handicap Inventory
timeFrame: 30 days
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 30 days
Other outcomes:
Locations:
city: Valença
country: Brazil
facility: Faculdade de Medicina de Valença
state: RJ
city: Volta Redonda
country: Brazil
facility: OTOSUL Otorrinolaringologia Sul-Fluminense
state: RJ
Study officials:
affiliation: Faculdade de Medicina de Valença
name: Ricardo R Figueiredo, MD,MSc
role: STUDY_CHAIR
References:
Clinical trial NCT05182216: Social Media Use in Sickle Cell Patients
Official title: Social Media Use in Sickle Cell Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Survey, Family Life
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with diagnosis of sickle cell disease

Brief summary: Surveys of patients to identify primary social media sources for health news.


Eligibility criteria: Inclusion Criteria:

* sickle cell disease diagnosis

Exclusion Criteria:

* negative sickle cell disease diagnosis

Primary outcomes:
measure: Social Media Use in Sickle Cell Patients
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04228016: Efficacy of an Intranasal Stent on Nasal Obstruction at Night
Official title: Efficacy of an Intranasal Stent on Nasal Obstruction at Night: A Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasal Obstruction
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Seven Dreamers Europe SAS
First posted: 2020-01-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to demonstrate a decrease with normalization of nasal resistance in the forward decubital position and with an intra-nasal stent in patients with nasal obstruction.

Detailed description: All patients consulting for nasal obstruction at night and who have functional nasal test with pathological resistance in decubitus position are included.

Functional nasal test (non invasive tests) will be performed before and after intranasal introduction of a stent: anterior rhinomanometry to measure nasal function by the measure of resistance and acoustic rhinometry to measure the geometry of nasal fossa by the measure of minimal sectional cross area sitting, after 30 minutes of decubitus then new measurements with a stent in decubitus position in each nostril .

Eligibility criteria: Inclusion Criteria:

1. Volontary patient
2. Over 18 years old or more.
3. Complain of a nasal obstruction more important (or only) at night (in decubitus position)

Exclusion Criteria:

1. Unability to sign the consent form
2. Allergy of stent component
3. Perforation of nasal septum
4. Haemostasis disorder or anticoagulant therapy
5. Bilateral obstructive septal deviation ou polyposis induce inability to introduce the stent in the nasal cavities

Primary outcomes:
measure: Nasal resistance in anterior rhinomanometry (sPa/ml/sec)
timeFrame: Day 15
Secondary outcomes:
measure: Nasal Obstruction and Septoplasty Effectiveness (NOSE)
timeFrame: Day 15
measure: Analog visual scale (EVA) of nocturnal nasal obstruction
timeFrame: Day 15
measure: Sino-Nasal Outcome Test 22 (SNOT-22) questionary
timeFrame: Day 15
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Day 15
measure: Compliance
timeFrame: Day 15
measure: Stent satisfaction
timeFrame: Day 15
measure: Stent tolerance
timeFrame: Day 15
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal
state: Ile De France
city: Créteil
country: France
facility: Hôpital Henri Mondor
Study officials:
References:
Clinical trial NCT01330524: Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo
Official title: Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo in Acute Nonarteritic Anterior Ischemic Optic Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Nonarteritic Anterior Ischemic Optic Neuropathy
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-04-07
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study 16 Patients diagnosed with Nonarteritic Anterior Ischemic Optic Neuropathy(NSION) who had a sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn in less than 30 days without exclusion criteria are randomly divided in two groups 1) control 2) case. In case group Avastin and Triamcinolone will be injected trough vitreal and placebo will be injected in control group. BCVA and Visual field will be then measured in these two groups.


Eligibility criteria: Inclusion criteria:

* Sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn (\<30 days)

Exclusion criteria:

* Any eye disease except NAION(Nonarteritic Anterior Ischemic Optic Neuropathy)
* Neurologic defect
* Abnormal ESR, CRP, any history of retina or vitreal surgery
* Severe corneal opacity which makes retina examination impossible

Primary outcomes:
measure: Changes of Best corrected visual acuity(BCVA)
timeFrame: 6 month
Secondary outcomes:
measure: Changes of Visual Field
timeFrame: 6 month
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Labbafinejad medical center
Study officials:
References: