louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03289806: Effects of DHA on Post-operative Fibrosis of Trabulectomy Blebs in Glaucoma Surgery
Official title: Study of the Effects of Docosahexaneoic Acid (DHA) on Post-operative Fibrosis of Trabulectomy Blebs in Glaucoma Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trabulectomy
Deep Sclerectomy
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery for glaucoma or strabismus

Brief summary: Post-operative fibrosis of trabulectomy blebs is a major cause of surgical failure leading to a renewed increase in intraocular pressure. The use of anti-metabolites over many years has made it possible to improve success rates for this surgery but these drugs have numerous adverse effects as they are toxic. Alternative therapies are thus necessary, and we believe that DHA could have antifibrotic effects on fibroblasts and could thus improve success rates in this surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing trabulectomy or deep sclerectomy
* Patients informed about the study

Exclusion Criteria:

- Patients who refuse to take part in the study

Primary outcomes:
measure: Test of cell viability by MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide)
timeFrame: At baseline
measure: Test migration ability by video microscopy
timeFrame: At baseline
measure: Test proliferation with immunohistochemistry (Ki67 staining)
timeFrame: At baseline
measure: Analysis of cell cycle in flow cytometry
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT01870206: Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns
Official title: Phase III Immunogenicity, Safety, Poliovirus Excretion and Acceptance of Vaccination OPV (Vero Cells) in Newborns Mexicans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Poliomyelitis
Keywords: Immunogenicity
Safety
Efficacy
Poliomyelitis
Newborn
Lead sponsor: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 320
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Polio is a highly infectious disease caused by a virus. It invades the nervous system, and can cause total paralysis in a matter of hours. The virus enters the body through the mouth and multiplies in the intestine. Initial symptoms are fever, fatigue, headache, vomiting, stiffness in the neck and pain in the limbs. One in 200 infections leads to irreversible paralysis (usually in the legs). Among those paralysed, 5% to 10% die when their breathing muscles become immobilized. There is no cure for polio, it can only be prevented. Polio vaccine, given multiple times, can protect a child for life.

Compare in newborns the immunogenicity and safety of the vaccine OPV produced by Birmex compared with the vaccine OPV produced by Sanofi Pasteur, both produced in Vero cells.

Detailed description: This is a randomized clinical trial, which includes 320 newborns of both sexes and residents of the state of México, 160 newborns receive the vaccine OPV Birmex and 160 newborns receive the vaccine OPV Sanofi Pasteur

Eligibility criteria: Inclusion Criteria:

* Newborns babies
* Weight ≥ 2.5 kg
* Have not received any doses of Polio Vaccine
* Whose parents or guardians reside in the work area
* Whose parent or guardian accept to sign written informed consent (by the other, father or guardian).

Exclusion Criteria:

* Born of a high-risk pregnancy.
* Weight ≤ 2.5 kg
* Presence of fever, diarrhea, known immunosuppression, respiratory infections.
* Treatment with immunosuppressants.
* Having neurological diseases.
* Require or received surgery in oropharynx.

Primary outcomes:
measure: Change seroconversion after one dose of trivalent vaccine OPV
timeFrame: after the first dose is taken blood samples (baseline, 30 and 60 days)
Secondary outcomes:
measure: Evaluate the adverse events in newborns babies
timeFrame: inmediately after treatment and during 60 days
Other outcomes:
measure: Poliovirus Excretion
timeFrame: Evaluate viral excretion rate, basal 7, 14, 21 and 28 days after vaccination of two vaccines against polio OPV in newborns Mexicans
Locations:
city: Valle de Chalco
country: Mexico
facility: Hospital General de Chalco Dr. Fernando Quiroz Gutierrez
state: Estado de México
Study officials:
affiliation: Laboratorios de Biológicos y Reactivos de México S.A de C.V
name: Mauricio Rodríguez Álvarez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00718406: Pain Relief of Metoprolol Versus Metoprolol Plus Morphine in Acute Chest Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndromes
Keywords: Acute coronary syndrome
Chest pain
Betablockers
Morphine
Prehospital phase
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2008-07-18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The primary aim was to evaluate the relief of chest pain during the first 30 minutes among patients who received metoprolol alone as compared with metoprolol plus morphine


Eligibility criteria: Inclusion Criteria:

* Acute chest pain
* ECG-signs indicating myocardial ischemia

Exclusion Criteria:

* Heart rate \< 60 beats/min
* Systolic blood pressure \< 110 mmHg
* High degree AV-block
* Signs of obstructive pulmonary disease
* Signs of pulmonary oedema
* Unwillingness
* Participation in other studies
* Long delay between arrival of ambulance and randomisation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Medical Institution, Dept of Molecular and Clinical Medicine, Sahlgrenska University Hospital
Study officials:
References:
Clinical trial NCT02521506: Clinical Efficacy of OneTouch® Verio™IQ Meter
Official title: Clinical Efficacy of OneTouch® Verio™IQ Meter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 90
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: SUPPORTIVE_CARE

Brief summary: Diabetes mellitus is one of the most prevalent disease in the western world. The control of glucose levels has a big impact in the prevention of diabetes complications. The measure of glucose levels in capillary blood with glucometers is the gold standard to measure and control the glucose levels. Nowadays the glucometers become to more precise and sophisticated devices. One of the most notables advance is the inclusion of software that cam predicts glucose trends. This software has not be tested in routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with diabetes mellitus 1 or 2
* Treatment with insulin regimen during at least 12 months
* Capability of performed 3 glucose measurement per day
* Levels of glycated hemoglobin (A1C) less than 10%

Exclusion Criteria:

* Patients diagnosed of mental disorders
* Patients included in structured therapeutic health 6 months before the inclusion
* Patients included in any clinical trial in the 4 months before the inclusion

Primary outcomes:
measure: number of hypoglycemic events
timeFrame: 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Almería
country: Spain
facility: Hospital Universitario Torrecárdenas
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
Study officials:
References:
Clinical trial NCT06273306: Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC)
Official title: Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Telemedicine
Telehealth
eHealth
Rheumatic Diseases
Arthritis, Rheumatoid
Spondylarthritis
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up.

This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and Spondylarthritis (SpA) from five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis with Rheumatoid Arthritis or Spondylarthritis
* Treatment with biologic or targeted disease modifying antirheumatic drugs.
* Ability to use smartphone.

Exclusion Criteria:

* only patients with conditions that hinder or prevent the use of a mobile application (blindness, mental retardation, dementia, digitalfilliteracy).

Primary outcomes:
measure: To assess the primary objective, composite endpoints that consider the viability, adherence and degree of satisfaction of the MAM are included
timeFrame: 24 months
Secondary outcomes:
measure: To identify features associated with adherence to follow-up through the MAM.
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario La Paz
name: Chamaida Plasencia-Rodríguez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00217906: A+ Asthma Early Intervention in Asthma Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2005-09-22
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This project will evaluate the effectiveness of a Head Start-based early intervention for designed to improve asthma management skill and practices of parents, pre-school children and Head Start staff.

Detailed description: BACKGROUND:

While increased asthma morbidity and mortality have been observed across all ethnicities, results from several studies have found that asthma morbidity has increased disproportionately in low-income African American children. Elementary school-based asthma education programs have shown promise in improving asthma management, and reducing asthma morbidity in this high-risk population, however, the fastest growing asthma risk is associated with children young than six. By elementary age many parents and children with asthma have well-established patterns of inappropriate asthma management that may be difficult to change. To date, no research has examined the impact of early intervention for asthma management in low-income, high-risk children.

DESIGN NARRATIVE:

Head Start sites will be randomized to either a minimal intervention control group or the A+ Asthma early intervention program designed to educate and assist Head Start teachers and family service coordinators to: optimize classroom management of asthma, educate, facilitate and reinforce appropriate parental medical and behavioral management of asthma, and instruct, model and reinforce early asthma knowledge and age-appropriate skills for preschool age children.

The primary outcome that the study was designed to evaluate Head Start absences/days enrolled, determined by review of Head Start attendance records.

The secondary outcomes specified in the protocol are health care utilization (emergency department visits, hospitalizations, primary care visits), asthma symptoms (restricted activity, symptom-free days, day and nighttime symptoms), asthma medications, parents' asthma-related quality of life, and parent, child and teacher asthma knowledge and management practices.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: Children aged 3 and 4 years who have asthma that is currently active

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Cynthia Rand
References:
citation: Paasche-Orlow MK, Riekert KA, Bilderback A, Chanmugam A, Hill P, Rand CS, Brancati FL, Krishnan JA. Tailored education may reduce health literacy disparities in asthma self-management. Am J Respir Crit Care Med. 2005 Oct 15;172(8):980-6. doi: 10.1164/rccm.200409-1291OC. Epub 2005 Aug 4.
Clinical trial NCT00233506: A Dose Finding Study of CpG in Patients With Chronic Lymphocytic Leukemia Who Have Been Previously Treated
Official title: A Dose-Finding Study of CpG 7909 in Previously Treated Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia
Keywords: CpG 7909
CLL
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Pfizer
name: National Cancer Institute (NCI)
First posted: 2005-10-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * CpG has the potential to stimulate the immune system
* this study will evaluate the safety of CpG given sub-q or IV
* purpose is to measure biological changes in CLL cells after receiving CpG


Eligibility criteria: Inclusion Criteria:

* Diagnosis of CLL
* CLL previously treated
* Hemoglobin \>/= 10
* Platelets \>/= 50,000
* Neutrophils \>= 1,000 -

Exclusion Criteria:

* patients with brain mets
* patients with autoimmune disease
* patients on corticosteroids or immunosuppressants
* patients with uncontrolled intercurrent illness
* pregnant women
* HIV patients receiving combination anti-retroviral therapy

Primary outcomes:
measure: maximum tolerated dose
timeFrame: at study completion
Secondary outcomes:
measure: response
timeFrame: at end of treatment
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: UIHC
name: Brian Link, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Clive Zent, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03053206: A Prospective, Interventional Study Assessing Response to Cytarabine, Daunorubicin and Etoposide (ADE) for First Relapse of Paediatric Acute Myeloid Leukemia
Official title: RESPONSE TO CYTARABINE, DAUNORUBICIN AND ETOPOSIDE (ADE) AT FIRST RELASPE IN CHILDHOOD AML
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Myeloid Leukemia, in Relapse
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 84
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: One-third to one-half of patients with AML relapse and in general relapsed AML patients have a poor prognosis. The treatment of relapsed AML consists of induction chemotherapy followed by Allogenic Stem Cell Transplant (ASCT). However, at present there is no standard salvage chemotherapy regimen for relapsed AML, as no study has shown any one regimen to be significantly superior. Anthracyclines, Fludarabine, Etoposide and cytarabineare active agents in AMLand have been used as monotherapy and in combination in refractory and relapsed AML patients. According to previous studies the present CR rate of different regimens ranges from 50-70%. A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR rates of approximately 70%. Therefore, we have planned this study to test the efficacy and toxicity of ADE induction chemotherapy in relapsed AML patients in a prospective manner.


Eligibility criteria: Inclusion Criteria:

1. Either gender with age ≤18 years at initial diagnosis
2. AML(non-M3) patients at first relapse (medullary)

Exclusion Criteria:

1. Primary refractory AML \&secondary AML
2. More than or equal to 2 relapses of AML
3. Symptomatic cardiac dysfunction (CTCAE Grade 3 or 4)
4. Active infection(pneumonia etc.)
5. Any other organ dysfunction (CTCAE Grade 4)
6. Patients not willing to consent for the study

Primary outcomes:
measure: complete remission (CR) rate
timeFrame: Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier
Secondary outcomes:
measure: Event free survival (EFS) and overall survival(OS)
timeFrame: 2 year
measure: toxicity of chemotherapy
timeFrame: Day 28 ± 7 of treatment
measure: clonal evolution
timeFrame: Day 28 ± 7 of treatment
measure: minimal residual disease (MRD)
timeFrame: Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier
measure: cardiac function
timeFrame: Day 28 ± 7 of treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01022606: Intra-arterial Measurement of pO2 in Walking Induced Transient Hack Profiles
Official title: Intra-arterial Measurement of pO2 in Walking Induced Transient Hack ("WITH") Profiles
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Claudication
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2009-12-01
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Confirm with invasive measurement the presence of a Walking-Induced Transient Hack (WITH) profile

Detailed description: Arterial PO2 and body temperature measurements during exercise

Eligibility criteria: Inclusion Criteria:

* walking induced transient Hack (WITH) tcpO2 profile

Exclusion Criteria:

* rejection by patient

Primary outcomes:
measure: arterial pO2
timeFrame: 2 months (time required to organise the test)
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital
name: P Abraham, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06806306: Assessment of the Preoperative Risk Factors for the Development of Post-LASIK Ectasia
Official title: Assessment of the Preoperative Risk Factors for the Development of Post-LASIK Ectasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lasik Eye Surgery
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: LASIK patients

Brief summary: : Laser-assisted in situ keratomileusis (LASIK) is one of the most widely performed refractive surgeries, offering effective and long-lasting correction for visual refractive errors. While LASIK has a high success rate and is generally safe, post-LASIK ectasia remains a rare but serious complication that compromises visual outcomes. Several risk factors for post-LASIK ectasia have been identified. The aim of the present study is to determine the preoperative risk factors for the development of post-LASIK ectasia.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of corneal ectasia was made by progressive central or inferior corneal steepening, increased myopia and/or astigmatism, and decreased visual acuity

Exclusion Criteria:

* Subjects who had glaucoma diagnosis, other corneal surgeries (other than LASIK), and central corneal opacity

Primary outcomes:
measure: Randleman ectasia score
timeFrame: At the baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03907306: Cold Argon Plasma (CAP) Application in the Wound Treatment After Open Hemorrhoidectomy
Official title: Cold Argon Plasma Application in the Wound Treatment After Open Hemorrhoidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cold Argon Plasma
Keywords: Cold argon plasma
hemorrhoidectomy
wound healing
hemorrhoids
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2019-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is single-center, prospective, randomized study

Detailed description: This study will include patients with 3-4 stage hemorrhoids. They will undergo an operation of open hemorrhoidectomy. Patients will be divided into a study group and a control group. Study group patients during a post-operation period except a standard treatment (antiseptic solutions and antibacterial and wound healing ointments) of a post-operation wound will be treated with cold argon plasma. Control group patients will be treated with a standard treatment. Wound healing speed will be researched.

Eligibility criteria: Inclusion Criteria:

* 3-4 stage hemorrhoids
* 3 hemorrhoids

Exclusion Criteria:

* patients underwent anal canals intervention
* acute hemorrhoids
* inflammatory bowel disease
* co-morbidity diseases of anal canal and perianal area
* concurrent conditions in the stage of decompensation

Primary outcomes:
measure: Wound healing
timeFrame: 30 days
Secondary outcomes:
measure: Pain Intensity Measure
timeFrame: 2, 3, 4, 5, 6, 7, 8, 14, 21, 30 days
measure: Life quality
timeFrame: before operation, 8 days, 30 days
measure: Microbiological contamination of wound area
timeFrame: 2, 8, 14, 21, 30 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Scientific Centre of Coloproctology
Study officials:
References: