louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05231252: The Effect of Direct Cyclophotocoagulation Using Endolaser in Silicon Induced Glaucoma: a Pilot Study.
Official title: The Effect of Direct Cyclophotocoagulation Using Endolaser in Silicon Induced Glaucoma: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: pilot
Primary purpose: TREATMENT

Brief summary: Transcleral cyclophotocoagulation has been used to treat glaucoma secondary to silicone oil


Eligibility criteria: Inclusion Criteria:

. Patients above 18 years of age. .Silicon filled for more than 2 months. .IOP more than 21 mmHg on triple topical antiglaucoma eye drops.

Exclusion Criteria: . History of glaucoma prior to the initial retinal surgery. . Immediate rise of IOP after SOI. . History of previous laser application to the ciliary body. . Any contraindications for silicone oil removal.

Primary outcomes:
measure: IOP lowering in patients with silicon induced glaucoma
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University,Faculty of medicine
name: Ahmed A.Mohamed, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03828552: Parents' Experience of Their Children Stay in a Pediatric Intensive Care Unit.
Official title: Parents' Experience of Their Children Stay in a Pediatric Intensive Care Unit.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit Syndrome
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parent (mother or /and father) of a recovered child in the PICU for at least 3 days, for a first stay, without limit of age, disease or admission mode.

Brief summary: Children recovered in pediatric intensive care unit (PICU) suffer from severe conditions, sometimes life-threatening. Thus, priority is given to urgent somatic care, children medicalization is strong, invasive technics have to be used, and medical monitoring is close.

A stay in PICU often leaves a painful memory to the child and family, and can lead to psychological morbidity such as post-traumatic stress disease.

This study aims to assess parents' experience during their child hospitalization in PICU, and the impact of this stay on the entire family in the following month.


Eligibility criteria: Inclusion Criteria:

* Parent (mother or /and father) of a recovered child in PICU.
* No limit of age, disease or admission mode.
* First stay in PICU, for at least a 3 days stay.
* Parents having been informed and having accepted the participation in the study.

Exclusion Criteria:

* Death of the child during the stay in PICU or during the month following the discharge from PICU
* Non-fluent french speakers/readers.

Primary outcomes:
measure: Analyse qualitatively the parents'experience during the PICU stay of their child
timeFrame: 1 month
measure: Assessment of the impact on the family of this PICU stay of their child
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Pediatric intensive care unit of Women-Mother-Children Hospital
Study officials:
References:
Clinical trial NCT05379452: Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection in Shanghai
Official title: Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection During the Outbreak of Omicron in Shanghai: a Cohort Study.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: SARS-CoV2 Infection
Neonatal Infection
Outcomes
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 236
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates born to mothers with SARS-CoV-2 infections will be recruited from all the designated hospital during the outbreak of Omicron in Shanghai.

Brief summary: Since March 2022, there are an outbreak of SARS-CoV-2 infection (Omicron) in Shanghai. This cohort study aims to analysis the clinical outcomes of neonates born to mothers with SARS-CoV-2 infection.


Eligibility criteria: Inclusion Criteria:

* Neonates born to mothers with SARS-CoV-2 infections.

Exclusion Criteria:

* Parents who rejected to participate in this study.

Primary outcomes:
measure: The death of newborns
timeFrame: The date of discharge，an average of 4 weeks after the admission
Secondary outcomes:
measure: The malformation rate of neonates born to mothers with SARS-CoV-2 infections
timeFrame: Birth
measure: The preterm delivery rate of neonates born to mothers with SARS-CoV-2 infections
timeFrame: Birth
measure: The brain injury rate of neonates born to mothers with SARS-CoV-2 infections
timeFrame: within 7days after the admission
measure: The development delay rate of neonates born to mothers with SARS-CoV-2 infections
timeFrame: within 1 year after the admission
measure: The Chinese standardized Denver Developmental Screening Test (DDST) in neonates born to mothers with SARS-CoV-2 infections
timeFrame: Infants ( ≥35 weeks）are at 1 year after birth;Infants（< 35weeks） are at a corrected age of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children Hospital of Fudan University
Study officials:
References:
Clinical trial NCT06029452: A Retrospective Validation Study To Identify Chart-Based Clinical Diagnosis Of Wild-Type Transthyretin Amyloid Cardiomyopathy (Attrwt-CM) And Non-Amyloid Heart Failure Among Patients With Heart Failure (HF).
Official title: A Retrospective Chart Validation Study Evaluating the Performance of Machine Learning Algorithm (ML) to Predict the Clinical Diagnosis of Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt-CM) and Non-amyloid Heart Failure Among Patients With Heart Failure (HF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ATTR-CM
Keywords: Chronic Heart Failure
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 558
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients with clinical diagnosis of ATTRwt-CM or non-amyloid HF

Brief summary: This is an observational, retrospective non-inferiority study with a study sample from a large national database.

A machine learning (ML) model will use a national database to predict the clinical diagnosis of ATTRwt-CM among HF patients. This study will include HF patients ≥50 years old.


Eligibility criteria: Inclusion Criteria:

* HF patients (defined as having ≥1 claim for HF or HF treatment) ≥50 years old with clinical diagnosis of ATTRwt-CM or non-amyloid HF ascertained by charts. Patients will be required to have ≥12 months of continuous activity in the EHR or claims prior to the Index Date.

Exclusion Criteria:

* Patients with any of the following diagnoses:

  * Light chain (AL) amyloidosis
  * Intracranial hemorrhage
  * Cerebral amyloid angiopathy
  * End stage renal disease
  * Blood cancer

Primary outcomes:
measure: Number of Participants According to Clinical Diagnosis Predicted Using the Machine Learning (ML) Algorithm
timeFrame: At diagnosis, anytime during retrospective data identification period of approximately 5.4 years; retrospective data observed in this study for approximately 2.5 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04752852: Use of Prophylactic Steroids in the Prevention of Post-thyroidectomy Hypocalcaemia and Voice Dysfunction
Official title: Randomised Control Trial on the Use of Prophylactic Steroids in the Prevention of Post-thyroidectomy Hypocalcaemia and Voice Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Diseases
Hypocalcemia
Vocal Cord Dysfunction
Keywords: Thyroidectomy
Postoperative Hypocalcaemia
Postoperative Vocal cord dysfunction
Dexamethasone
Lead sponsor: Holy Family Hospital, Pakistan
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Total thyroidectomy for benign surgical pathologies is associated with risks related to temporary hypocalcaemia and vocal quality dysfunction. Dexamethasone, as an anti-inflammatory steroid, has been proposed to have a physiological effect on hypocalcaemia and voice quality. Investigators conducted a double-blinded controlled trial to assess the effect of preoperative dexamethasone on the vocal dysfunction and hypocalcaemia following thyroidectomy


Eligibility criteria: Inclusion Criteria:

* Benign thyroid condition.
* Patients without any preoperative corrected hypocalcaemia and voice or vocal quality dysfunction.

Exclusion Criteria:

* Previous thyroid or neck surgery
* Known vocal cord dysfunction on laryngoscopy
* Hearing or voice problems
* History of gastroesophageal reflux and stomach ulcer disease
* Contraindications of steroids

Primary outcomes:
measure: Hypocalcaemia
timeFrame: 3 days
measure: Voice dysfunction
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Holy Family Hospital Rawalpindi Pakistan
name: Raheel Ahmad, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Worni M, Schudel HH, Seifert E, Inglin R, Hagemann M, Vorburger SA, Candinas D. Randomized controlled trial on single dose steroid before thyroidectomy for benign disease to improve postoperative nausea, pain, and vocal function. Ann Surg. 2008 Dec;248(6):1060-6. doi: 10.1097/SLA.0b013e31818c709a.
citation: Kolahdouzan M, Iraj B, Eslamian M, Harandizadeh M, Meamar R. Preventive Effect of Dexamethasone Therapy on the Transient Hypoparathyroidism through Total Thyroidectomy. Iran J Otorhinolaryngol. 2019 Mar;31(103):73-80.
citation: Dhahri AA, Ahmad R, Rao A, Bhatti D, Ahmad SH, Ghufran S, Kirmani N. Use of Prophylactic Steroids to Prevent Hypocalcemia and Voice Dysfunction in Patients Undergoing Thyroidectomy: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Oct 1;147(10):866-870. doi: 10.1001/jamaoto.2021.2190.
Clinical trial NCT03351452: tES Effects on Associative Memory Performance
Official title: Effects of Transcranial Electric Stimulation on Associative Memory Formation in Healthy Elderly Participants as Well as in Individuals With Memory Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Mild Cognitive Impairment
Alzheimer Disease
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 28
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Previous studies showed that transcranial electric stimulation (tES) applied over the prefrontal cortex improves cognitive performance in healthy elderly adults as well as in patients suffering from mild cognitive impairment or early Alzheimer's disease. Therefore, tES methods might be a useful intervention tool for patients suffering from memory impairment in early terms of the disease.

The present study aims at establishing a connection between the stimulation-induced changes on associative memory performance and its underlying neurophysiological parameters. tES effects and their underlying mechanisms will be compared between healthy elderly controls and clinical study populations receiving either real or sham tES over the left ventrolateral prefrontal cortex during an associative memory task.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Non-smokers
* Right-handedness
* Native German speakers or comparable level of fluency
* Normal or corrected-to-normal vision

Exclusion Criteria:

* Neurological or psychiatric condition (other than diagnosed cognitive impairment)
* Past head injuries
* Magnetizable implants
* History of seizures
* Current or life-time alcohol or drug abuse
* Skin diseases

Primary outcomes:
measure: Performance on immediate cued recall task
timeFrame: 20 min
measure: Performance on delayed cued recall task
timeFrame: 24 hours
Secondary outcomes:
measure: task-dependent BOLD activity
timeFrame: 20 min
measure: resting-state BOLD activity
timeFrame: 10 min
Other outcomes:
measure: Performance on cued recall task
timeFrame: follow-up after 24 hours
measure: Performance on recognition task
timeFrame: follow-up after 24 hours
Locations:
city: Bern
country: Switzerland
facility: University Hospital of Old Age Psychiatry and Psychotherapy
Study officials:
affiliation: University of Bern
name: Stefan Klöppel, Prof.Dr.med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00486252: Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN®
Official title: Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN® (Latanoprost) as First-Line Monotherapy and as Second-Line Monotherapy After Beta-Blockers Therapy Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma,Open-Angle
Ocular Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-14
Enrollment: 996
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatients with unilateral or bilateral open angle glaucoma or ocular hypertension

Brief summary: The primary objective is to evaluate the Intraocular pressure reducing effect of Xalatan over 3 months. The secondary objective is to study the other efficacy parameters during treatment for 3 months


Eligibility criteria: Inclusion Criteria:

* Unilateral or bilateral open angle glaucoma or ocular hypertension (IOP (Intraocular Pressure) ≥ 21 mmHg at diagnosis).
* Naive patients (no prior anti-glaucoma pharmacological or surgical treatment) and patients with beta-blockers therapy failure
* Visual acuity (best corrected) equal to or better than 6/6

Exclusion Criteria:

* closed/barely open anterior chamber angle or history of acute angle closure glaucoma.
* history of any antiglaucoma surgical treatment (Argon Laser Trabeculoplasty and/or any ocular filtering surgical intervention).
* ocular surgery (on the globe of the eye only), or inflammation/infection within 3 months prior to baseline visit. (Applies to both fellow and study eyes.)
* other abnormal ocular conditions or symptoms preventing the patient from entering the study, in the investigator's clinical judgement.

Primary outcomes:
measure: Change in Intraocular Pressure (IOP): Baseline to Month 3
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: Percentage Change in Intraocular Pressure (IOP)
timeFrame: Month 1, Month 3
measure: Categorized Percentage Change in Intraocular Pressure (IOP)
timeFrame: Month 1, Month 3
Other outcomes:
measure: Change in Intraocular Presssure (IOP): Baseline to Month 1
timeFrame: Baseline, Month 1
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06835452: Comparison of Current Subgingival Debridement Methods
Official title: Comparison of Current Subgingival Debridement Methods: Clinical Trial with 6 Months Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Treatment of Periodontitis
Guided Biofilm Therapy
Subgingival Plaque
Subgingival Debridement
Keywords: guided biofilm therapy
periodontitis
subgingival debridement
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Nigde Omer Halisdemir University
First posted: 2025-02-19
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 90 female patients with stage 1-2 periodontitis

Brief summary: Our study aimed to compare the effectiveness of current subgingival debridement methods used in the treatment of Stage 1 and Stage 2 periodontitis patients, the aesthetic condition achieved after these treatments, and the pain felt during treatment.

90 female patients who were diagnosed with chronic periodontitis (Stage 1-2) and required supra-subgingival scaling for treatment purposes, and who volunteered to participate in the study, were included in the study. Three treatment groups were determined. 30 people were included in each group. Periodontal examination was performed before and after the treatments in the 1st month, 3rd month and 6th month and the data on the collected periodontal parameters were analyzed.

Detailed description: Periodontal parametreler Gingival index, plaque index, periodontal pocket depth and bleeding index on probing.

It was evaluated with the visual analog scale for pain and aesthetics.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy patient (without known chronic disease)
* Periodontal diagnostic data (Gingival Index, Plaque Index, Periodontal pocket depths, Attachment loss, Radiological data-Bone loss data) are complete
* Treatments diagnosed with stage 1-2 periodontitis and those who have not had periodontal treatment in the last 6 months

Exclusion Criteria:

* Having a systemic disease
* Pregnant and lactating women
* smoker
* Those who do not want to participate in the study

Primary outcomes:
measure: Gingival index
timeFrame: baseline, 1st month, 3rd month and 6th month
Secondary outcomes:
Other outcomes:
Locations:
city: Niğde
country: Turkey
facility: Nigde Omer Halisdemir University
Study officials:
References:
Clinical trial NCT04340752: Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy
Official title: Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy: A Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Rotator Cuff Tears
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 30
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: Rotator cuff re-tear is a common delayed complication of arthroscopic rotator cuff repair. This process of re-tear is multifactorial and there has not been any readily identifiable perioperative measure that is predictive of subsequent rotator cuff failure. There have been no human studies looking at intraoperative assessment of rotator cuff vascularity, nor the predictive value that vascularity may have for rotator cuff re-tear. Indocyanine Green (ICG) has been safely used in patients for visualization purposes and has real potential for identifying vascularity in arthroscopic surgical patients. The aim of this study is to establish a standard dosing protocol for ICG in the arthroscopic visualization of rotator cuff vascularity.

Detailed description: The primary study objective is to determine optimal dosing of an intravenous fluorescence solution (IC-Green) for arthroscopic evaluation of rotator cuff vascularity. The primary endpoint is surgeon's ability to assess vascularity within the rotator cuff based on a 5-point likert scale. The likert values from each of the three doses will undergo an ANOVA test to compare means of the three doses.

Eligibility criteria: Inclusion Criteria:

* Patients has full or partial thickness rotator cuff tear and is scheduled to undergo arthroscopic rotator cuff repair
* Patient is at least 18 years of age and less than 80 years of age

Exclusion Criteria:

* Patient is less than 18 years of age or greater than 79 years of age
* Patient has a documented allergy to iodides
* Patients who have had iodide based radiology studies within the last seven (7) days prior to surgery
* Patient is pregnant

Primary outcomes:
measure: Optimal dosing of an intravenous fluorescence solution (ICG) for arthroscopic evaluation of rotator cuff vascularity
timeFrame: up to 6 months post operative visit
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Kirk Campbell
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03929952: Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients
Official title: Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Chronic Low Back Pain
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to evaluate neurofeedback-induced changes in brain function and the correlations between these changes and clinical scores by functional magnetic resonance imaging and electroencephalography in patients with low back pain.


Eligibility criteria: Inclusion Criteria:

* Patient with a wifi connexion at home
* Patient with the ability to modulate the height of the candle by thinking in the alpha synchrony test.
* Patient with chronic low back pain for more than six months with a visual analogue pain scale greater than 5 impacting activities of daily living, hobbies and work
* Patient having given free and informed consent and signed consent.
* Affected patient or beneficiary of a health insurance plan.
* Patient who is at least 18 years old (≥) and younger than 75 years old (\<).

Exclusion Criteria:

* Pregnant or breastfeeding patient
* Patient with a contraindication to performing a fMRI scan: ferromagnetic implant in the body, piercing, claustrophobia, unable to remain in the scanner stationary for 40 minutes
* Patient already included in another study
* Patient in a exclusion period determined by a previous study
* The subject is under the protection of justice, guardianship or curatorship.
* The subject refuses to sign the consent.
* It is not possible to give the subject informed information.

Primary outcomes:
measure: Description of the cortical zone activated by neurofeedback
timeFrame: Day 20
Secondary outcomes:
measure: Back Beliefs Questionnaire (BBQ)
timeFrame: Day 20
measure: Fear Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Day 20
measure: Oswestry Disability Index (ODI)
timeFrame: Day 20
measure: Coping Strategies Questionnaire (CSQ)
timeFrame: Day 20
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Day 20
measure: Scale of lumbar pain in Quebec
timeFrame: Day 20
measure: Tampa scale
timeFrame: Day 20
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Nimes University Hospital
Study officials:
affiliation: Nîmes University Hospital
name: Arnaud Dupeyron, MD
role: PRINCIPAL_INVESTIGATOR
References: