louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05414565: Post-Market Study of Alcon Intraocular Lenses
Official title: Clinical and Functional Performance of Acrysof IQ Vivity Versus Aspheric Monofocal IOLs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Acuity
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: Queensland University of Technology
First posted: 2022-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from ophthalmology practices who implant the Alcon Vivity and Alcon aspheric monofocal IOLs.

Brief summary: The purpose of the study is to evaluate clinical and functional performance in real-world conditions in participants who have been implanted with Acrysof IQ Vivity (Extended Vision) IOLs compared with Alcon Aspheric Monofocal IOLs.

Detailed description: This observational study will enroll subjects who have been implanted with an Alcon aspheric monofocal or monofocal toric IOL no less than 4 months prior to study procedures. This study will be conducted in Australia.

Eligibility criteria: Key Inclusion Criteria:

* In good general health at the screening visit;
* Implanted in both eyes at least 4 months ago with either Vivity/Vivity toric IOL or an Alcon aspheric monofocal/monofocal toric IOL (Acrysof IQ/Clareon);
* Best Corrected Distance Visual Acuity (BCDVA) of 20/25 or better with both eyes together;
* BCDVA of 20/40 or better in each eye;

Key Exclusion Criteria:

* Clinically significant Posterior Capsular Opacity (PCO) as assessed via slit-lamp exam per investigator opinion;
* History of ocular surgery other than cataract surgery and Nd:YAG laser surgery;
* History of amblyopia.

Primary outcomes:
measure: Binocular photopic best-corrected distance visual acuity (BCDVA)
timeFrame: At least 4 months post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Kelvin Grove
country: Australia
facility: School of Optometry and Vision Science, Queensland University of Technology
state: Queensland
Study officials:
affiliation: Alcon Research, LLC
name: Director of Clinical Projects, Surgical
role: STUDY_DIRECTOR
References:
Clinical trial NCT06181565: The Impact of Pericardial Closure on the Grafts, in the Context of Coronary Artery Bypass Grafting
Official title: The Impact of Pericardial Closure on the Grafts, in the Context of Coronary Artery Bypass Grafting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bypass Graft Stenosis
Keywords: Cardiac surgery
pericardial closure
grafts
bypass
aortocoronary bypass
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who will have isolated aortocoronary bypass grafting surgery will be included.

Brief summary: Once the pericardium is closed, there is no information on the hemodynamics of the grafts after coronary artery bypass grafting. This would be the reason for different opinions on pericardial closure: some teams do not close the pericardium and others close it.

In the department Cardiovascular Surgery of the University Hospital of Saint-Etienne, the Medistim machine is used in routine and the hemodynamic properties of the grafts are recorded immediately after the bypass surgery, before the closure of the pericardium.

Detailed description: The aim of the study is to have hemodynamic information immediately after the closure of the pericardium using the Medistim machine. The prospective study will be conducted on 50 patients, who will be selected consecutively without randomization. The inclusion and exclusion criteria are determined.

Eligibility criteria: Inclusion Criteria:

* All patients who will have isolated aortocoronary bypass grafting surgery

Exclusion Criteria:

* History of thoracic trauma
* Severe cyphosis
* Severe thoracic deformity (Pectus excavatum)
* Pericardial disease
* History of radiotherapy
* Severe pulmonary disease (emphysema)
* Right heart failure
* Redo surgery

Primary outcomes:
measure: Flow through the grafts
timeFrame: Minute : 1, 15
Secondary outcomes:
measure: Resistance on grafts
timeFrame: Minute : 1, 15
measure: Pulsatility of the grafts
timeFrame: Minute : 1, 15
measure: Systolic curves
timeFrame: Minute : 1, 15
measure: Diastolic curves
timeFrame: Minute : 1, 15
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Andranik PETROSYAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06020365: Investigation of Fecal Microbiota Transplant in Chronic Intestinal Pseudo-obstruction Patients
Official title: Investigation of Fecal Microbiota Transplant Treatment in Chronic Intestinal Pseudo-obstruction Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Pseudo-Obstruction
Fecal Microbiota Transplantation
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic Intestinal Pseudo-Obstruction (CIPO) is a rare gastrointestinal disorder that primarily affects the movement of the intestines, leading to symptoms that resemble a true bowel obstruction but without a physical blockage. This condition is characterized by impaired motility of the gastrointestinal tract, which can result in severe symptoms and complications. In previous studies, the investigator found that sequential microbiota transplantation therapy can improve clinical symptoms of chronic pseudo-obstruction. Building on this foundation, the current study further investigates the effects of sequential interventions involving intestinal cleansing, small intestine bacterial treatment, fecal microbiota transplantation, and nutritional therapy on the short-term and long-term clinical symptom improvement in patients. Additionally, the investigator aim to elucidate the changes in gut microbiota phenotypes before and after treatment.


Eligibility criteria: Inclusion Criteria:

1. aged over 18 years old;
2. met the current diagnosis criteria for Chronic Intestinal Pseudo-obstruction;
3. can tolerate nasojejunal tube and complete full course of FMT treatment;
4. the clinical data are relatively complete and there is follow-up available for evaluation

Exclusion Criteria:

1. accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism;
2. associated with gastrointestinal organic diseases such as short bowel syndrome, intestinal fistula, and inflammatory bowel disease; c) severe destruction of the intestinal mucosa, severe immunosuppression, combined with severe systemic infection; d) Intervention with antibiotics during treatment

Primary outcomes:
measure: Enteral Nutrition Tolerance
timeFrame: 8 weeks
Secondary outcomes:
measure: Nutrition Status
timeFrame: 52 weeks
Other outcomes:
measure: Need for surgery
timeFrame: 52 weeks
measure: Changes of both colerectal and small intestinal microbiota profile
timeFrame: 8 weeks
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
Study officials:
References:
Clinical trial NCT04193865: Hemofilter Life Span, ECLS And/or CRRT
Official title: Hemofilter Life Span and Filtration of Inflammatory Markers in Patients Receiving Extracorporeal Life Support And/or Continuous Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Diseases
Acute Injury of Kidney
Renal Failure
Renal Insufficiency
Neonatal Renal Disorder (Disorder)
Keywords: Extracorporeal life support
Extracorporeal membrane oxygenation
Acute Kidney Injury
Renal replacement therapy
Renal Support therapy
Kidney support therapy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2019-12-10
Enrollment: 10
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both male and female neonatal (aged 0-28 days of life) and pediatric (children aged 29 days-17 years) patients receiving ECLS will be eligible. The study team will also enroll neonatal and pediatric patients receiving CRRT alone (no ECLS).

Brief summary: The goal of this project to better understand the immune-modulatory effects of continuous renal replacement therapy (CRRT) in neonatal and pediatric patients, particularly those receiving extracorporeal life support (ECLS). Little is known about the effects of CRRT in this particular population and improved knowledge will be useful clinically and may lead to novel therapeutic approaches and improved outcomes for these critically ill patients.

Detailed description: Via collection of serum and ultrafiltrate samples, the invesitgators will examine how hemofilter lifespan alters the filtration of pro- and anti-inflammatory cytokines.

Eligibility criteria: Inclusion Criteria:

* Neonatal or pediatric patients receiving ECLS (\>2 kilograms and \>34 weeks gestation)
* CRRT utilized during ECLS course
* For the secondary endpoints comparing CRRT-mediated cytokine filtration in patients receiving ECLS with concurrent CRRT to patients receiving CRRT alone (no ECLS), the investigators will also enroll neonatal and pediatric patients receiving CRRT alone (no ECLS). Patients will be eligible for entry into this study if they meet all of the following criteria:
* Neonatal or pediatric patients receiving CRRT

Exclusion criteria:

-Those patients with inability or unwillingness of legal guardian/representative to give informed consent

Primary outcomes:
measure: Cytokine concentrations over time (every 12 hours for the entire course of CRRT)
timeFrame: Cytokine concentrations over time every 12 hours for the entire course of CRRT through study completion, up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical Univeristy of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Heidi Murphy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02343965: The Impact of the Practice of Touch-massage on the Anxiety of Patients With Hematological Disorders Hospitalized in a Protective Environment, a Randomized, Controlled Study
Official title: The Impact of the Practice of Touch-massage on the Anxiety of Patients With Hematological Disorders Hospitalized in a Protective Environment, a Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Diseases
Keywords: Touch-massage
anxiety
leukemia
haematology
cancerology
supportive care
complementary therapy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 62
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: SUPPORTIVE_CARE

Brief summary: Each year, 17000 cases of severe hematological diseases are diagnosed in France, with more than 6,000 of these requiring hospitalization in a protective, sterile environment. New methods, such as touch massage, have emerged in response to anxiety symptoms observed in patients in such sterile and isolated surroundings. We hypothesize that during the period of isolation, touch massage becomes a nursing care which can help the patient.

Detailed description: Patients with hematologic diseases (leukaemia, myeloma, lymphoma) hospitalized in a sterile area of a hematology unit for at least 3 weeks 18 to 65 years female or male Not having met the nurse, who is providing the touch-massage

Eligibility criteria: Inclusion Criteria:

* Patients with hematologic diseases (leukaemia, Myeloma, lymphoma) hospitalized in a sterile area of a hematology unit for at least 3 weeks
* 18 to 65 years
* Female or male
* Not having met the nurse, who is providing the touch-massage

Exclusion Criteria:

* Allergy to sweet almond oil
* Injury to the skin, at the back and / or arms and / or hands
* Cognitive impairment and / or preventing psychiatric responses to interviews and / or questionnaires
* Physical inability to take sitting in an ergonomic chair for the conduct of touch massage.

Primary outcomes:
measure: Impact of touch-massage practice on patients' anxiety state, as measured by the anxiety-state questionnaire (Spielberger, CD et al, 1983) to assess the predisposition to anxiety.
timeFrame: 3 weeks
Secondary outcomes:
measure: Evolution of Self Esteem, as measured by the self-esteem questionnaire
timeFrame: 3 weeks
measure: Evolution of anxiety, measured by the the anxiety-state questionnaire (Spielberger, CD et al, 1983)
timeFrame: 3 weeks
measure: Evolution of anxiety
timeFrame: 3 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01167465: Determination of Safety and Consumers' Satisfaction of Moussik Versus Desitin Creamy Ointment in Diaper Rash Prophylaxis
Official title: A Clinical Observation to Assess the Safety and Consumers' Satisfaction of Moussik vs Desitin Creamy Ointment in Prophylaxis of Diaper Rash. A Single Blind, Multicenter, Randomized, Cross-over Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Diaper Rash
Keywords: Diaper Dermatitis
Diaper Rash
Erythema
Lead sponsor: Trima, Israel Pharmaceutical Products
Sponsor class: INDUSTRY
First posted: 2010-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this clinical observation is to evaluate the safety and consumers' satisfaction of Moussik vs Desitin Creamy ointment as a diaper rash protection product.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female infants aged between 3-18 months who are routine users of disposable diapers

Exclusion Criteria:

* Children with symptoms of systemic disease or skin lesions.
* Children diagnosed as having diaper dermatitis at baseline
* Known hypersensitivity to any of the components of the trial preparations.
* Children suffering from atopic diseases.
* Children who have participated during the last month in another clinical trial.

Primary outcomes:
measure: Six point erythema skin grade
timeFrame: After two weeks
Secondary outcomes:
measure: Visual analogue scale (VAS) from 0 to 10
timeFrame: After two weeks
Other outcomes:
Locations:
Study officials:
name: Kobi Shiff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02798965: Prevalence of Circulating Parvovirus Genome in Recently Diagnosed Graves' Disease: a Case-control Study
Official title: Prevalence of Circulating Parvovirus Genome in Recently Diagnosed Graves' Disease: a Case-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Graves Disease
Keywords: parvovirus genome
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Lymphocytic thyroiditis is the most common autoimmune disease, usually affecting young women. Although the aetiology and pathogenesis remain obscure, the most widely accepted hypothesis is an interaction between a genetic predisposition and an environmental trigger factor such as viral infection. Parvovirus infections have been proposed as trigger factors for Hashimoto's thyroiditis and Graves' disease.


Eligibility criteria: Inclusion Criteria:

* Graves' disease :patients treated for Graves' disease, the diagnosis date less than 4 months
* Control : patients cared for nodules or goiter

Exclusion Criteria:

* Patients undergoing immunosuppressive therapy including corticosteroids

Primary outcomes:
measure: prevalence of circulating parvovirus genome
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Rachel DESAILLOUD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03853265: The Effect Of Virtual Reality Glasses On The Behavior Of Children With Autism Spectrum Disorder
Official title: The Effect Of Virtual Reality Glasses On The Behavior Of Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 5
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Study is parallel design with control group having the option of receiving treatment after study data is collected from initial treatment group
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine whether the use of virtual reality glasses showing an immersive video simulation of the dental visit will help decrease anxiety at future appointments by decreasing the element of surprise and increasing the patient's familiarity and comfort level with a specific dental practice environment.

Detailed description: After an initial baseline data collection visit to the dental clinic, patients will be placed in the virtual reality (VR) group or the no VR group. Caregivers in the VR group will be given VR glasses. They will be instructed how to access the video and use the glasses. The child/wearer of the glasses will feel immersed in the three-dimensional environment and be able to look around the room as they move down the hallways in the video. The caregiver will be encouraged to have the child wear the VR glasses as often as possible and record the number of times the video is watched. The caregiver will fill out a "records form" which will include the date and time the video was watched. Both groups will then return to the clinic for follow up data collection visit.

Eligibility criteria: Inclusion Criteria:

* Autism Spectrum Disorder (ASD)

Exclusion Criteria:

* No specific diagnosis of Autism Spectrum Disorder (ASD)
* Limited English Proficiency
* Existing patient of VCU Department of Pediatric Dentistry
* Parent/guardian determination that child would not be avle to tolerate immersive simulation with VR glasses

Primary outcomes:
measure: Change in heart rate
timeFrame: Baseline to 2 week follow up
measure: Change in 5-point Venham Anxiety Scores
timeFrame: Baseline to 2 week follow up
measure: Change in 5-point Venham Uncooperative Behavior Scores
timeFrame: Baseline to 2 week follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Tegwyn Brickhouse, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06913465: The Impact of Hypothyroidism on Tear Production and Dry Eye Symptoms: Implications for Optometric Care
Official title: The Impact of Hypothyroidism on Tear Production and Dry Eye Symptoms: Implications for Optometric Care
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dry Eye Syndromes
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 64
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This observational cross-sectional study will assess the impact of hypothyroidism on tear production and tear film stability. Conducted at DHQ Hospital dera ghazi khan over six months, the study will recruit 71 participants aged 20-60 years using a non-probability convenience sampling method. Patients with confirmed hypothyroidism will undergo tear assessment through the Schirmer I test, Tear Breakup Time (TBUT) test, and Ocular Surface Disease Index (OSDI)

Brief summary: This observational cross-sectional study will assess the impact of hypothyroidism on tear production and tear film stability. Conducted at DHQ Hospital dera ghazi khan over six months, the study will recruit 71 participants aged 20-60 years using a non-probability convenience sampling method. Patients with confirmed hypothyroidism will undergo tear assessment through the Schirmer I test, Tear Breakup Time (TBUT) test, and Ocular Surface Disease Index (OSDI) questionnaire. The Schirmer test will measure tear production, while TBUT will assess tear film stability.

Detailed description: Ocular surface staining and tear osmolarity will further evaluate ocular health. Patients with systemic conditions affecting tear production, such as diabetes or rheumatoid arthritis, will be excluded. The collected data will be analyzed to determine the relationship between hypothyroidism and dry eye symptoms, aiding in better management of ocular health in hypothyroid patients. The study aims to provide valuable insights into the association between thyroid dysfunction and tear film abnormalities.

Eligibility criteria: Inclusion Criteria:

* Age between 20-60 years.
* Confirmed diagnosis of hypothyroidism with thyroid function tests.
* No prior history of ocular surgery or significant ocular pathology.

Exclusion Criteria:

* Use of systemic medications affecting tear production (e.g., antihistamines, diuretics).
* Other systemic conditions (e.g., diabetes, rheumatoid arthritis).
* Pregnancy or lactation

Primary outcomes:
measure: The Ocular Surface Disease Index (OSDI)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Dera Ghazi Khan
country: Pakistan
facility: DHQ Hospital
state: Punjab
city: Lahore
country: Pakistan
facility: CENUM Center Mayo Hospital Rd, Anarkali Bazaar
state: Punjab
Study officials:
References: