louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05567692: Subjects With T2D or at Risk of T2D Cohort Follow-up
Official title: Descendance Cohort: Follow-up of Subjects With Type 2 Diabetes or at Risk of Type 2 Diabetes Defined by the Existence of the Disease in the Family in Two Successive Generations
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes ; Risk Prediction ; Prevention
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
Collaborators: name: Institut Pasteur de Lille
First posted: 2022-10-05
Enrollment: 837
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects included in the DESCENDANCE clinical trial (Id: NCT01727349) between 20011 and 2020, will be re-invited to participate in the Descendance cohort follow-up.

Brief summary: The main objective of this study is to prospectively follow the subjects included in "Descendance" cohort and to describe the occurrence of type 2 diabetes in non-diabetic subjects, which will allow us to iteratively update the "Descendance" Type 2 Diabetes risk prediction model.

Detailed description: High risk families will be prospectively follow in order to better understand the risk of transmission of type 2 diabetes from one generation to another. The cohort will also allow us to collect additional data on diabetic patients.

The monitoring of the cohort will take place for at least 10 years with a follow-up of all participants every three years. To detect individuals who develop dysglycemia during the study, a glucose tolerance test (GTT) and HbA1c measurement will be conducted.

Eligibility criteria: Inclusion Criteria:

* Subjects have participated in the Descendance study
* Subjets who sign informed consent to participate in the study

Exclusion Criteria:

* Subjects not enrolled in Descendance study
* Subjects refusing to participate
* Pregnant or breastfeeding
* Subjects in emergency situations, under legal protection or unable to provide informed -consent
* Subjects lost to follow-up or died

Primary outcomes:
measure: Type 2 diabetes incidence in Descendance population
timeFrame: 9years
Secondary outcomes:
measure: Provide estimates of prevalence of diabetes and prediabetes in Descendance population
timeFrame: at baseline, 3-, 6- and 9-years follow-up
measure: Study of interactions between risk factors on type 2 diabetes incidence
timeFrame: at baseline, 3-, 6- and 9-years follow-up
Other outcomes:
Locations:
city: Évry
country: France
facility: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Study officials:
affiliation: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
name: Guillaume CHARPENTIER, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02534792: Early Revalvulation After Fallot Repair Improves Clinical Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tetralogy of Fallot
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 320
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tetralogy of Fallot patients repaired with transannulaire patch.

Brief summary: Aim With this retrospective study, the investigators would like to evaluate and, if possible confirm, whether earlier revalvulation of the right ventricular outflow tract is better than late revalvulation. Up to now, no analysis is done to validate this policy change.

Patient selection All patients registered in the database of paediatric and congenital cardiology of the University Hospitals in Leuven, with sufficient follow-up data, and who underwent transannular patching at repair will be included in the study.

Methodology and statistical analysis All files will be reviewed for demographic, electrocardiographic, echocardiographic, and outcome data. Besides descriptive statistics, Cox regression will be performed to detect whether the time period between repair and revalvulation influences clinical outcome (defined as death, heart failure hospitalization, redo-revalvulation, implantation of automatic defibrillator, endocarditis).


Eligibility criteria: Inclusion Criteria:

* Tetralogy of Fallot patients repaired with transannulaire patch.

Exclusion Criteria:

* None.

Primary outcomes:
measure: death
timeFrame: 10 years
Secondary outcomes:
measure: endocarditis
timeFrame: 10 years
measure: re-intervention
timeFrame: 10 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT00250692: A Study to Test the Pain-relieving Effect of Laughing Gas in Infants
Official title: Analgesic Effect of Nitrous Oxide in Neonates Undergoing Heel Stick
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Analgesic Affect
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2005-11-08
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Our proposal is to study infants in the Neonatal Intensive Care Unit (NICU) who are undergoing a heel stick for blood sampling, a standard procedure in patient care. Currently, these infants do not get any pain relief for this procedure. Several recent clinical studies have shown the usefulness of nitrous oxide (laughing gas) for treating pain for minor procedures in children 0 to 18 years, but these effects have not been exclusively studied in the newborn and infant populations. Animal studies have questioned the anti-nociceptive (pain-blocking) effect of nitrous oxide in very young animals. It is unclear if this also applies to humans. The reason for this difference may be due to an immaturity of the neural pathways that modulate pain in the very young. The purpose of this study is to investigate whether or not nitrous oxide has an analgesic (pain-relieving) effect in infants undergoing minor procedures in the neonatal period (less than 3 months).


Eligibility criteria: Inclusion Criteria:

- Full-term babies up to three months old scheduled for heel stick blood draw.

Exclusion Criteria:

* preterm, difficult airway (micrognathia, cranio-facial malformation, choanal atresia, Pierre Robin syndrome, or Treacher Collins syndrome), sedated, intubated (including tracheostomy), have an oxygen requirement (FiO2\>40%), anemia, bone marrow suppression, or cardiac defect

Primary outcomes:
measure: NIPS scale
measure: salivary cortisol level
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
Study officials:
affiliation: UCLA Department of Anesthesiology
name: Samuel Wald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00543192: Sexual Functioning in Endometrial Cancer
Official title: Sexual Functioning in Endometrial Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Sexual Function
Keywords: Endometrial Cancer
Sexual Function
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2007-10-12
Enrollment: 73
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University of Wisconsin Gynecologic Oncology and Radiation Oncology Clinics

Brief summary: The purpose of this study is estimate how sexual function in endometrial cancer survivors varies with severity of disease.


Eligibility criteria: Inclusion Criteria:

* History of Stage I-IIIA endometrial adenocarcinoma of any grade
* 1-5 years out from primary surgical treatment
* Adjuvant therapy may only have consisted of radiation or hormonal therapy
* No evidence of disease

Exclusion Criteria:

* Previous treatment for other malignancies
* Did not undergo surgery for primary treatment of endometrial cancer
* Inability to read, write and speak fluent English
* Major cognitive impairment affecting ability to provide consent

Primary outcomes:
measure: Female Sexual Function Index (FSFI).
timeFrame: at time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: David M Kushner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Onujiogu N, Johnson T, Seo S, Mijal K, Rash J, Seaborne L, Rose S, Kushner DM. Survivors of endometrial cancer: who is at risk for sexual dysfunction? Gynecol Oncol. 2011 Nov;123(2):356-9. doi: 10.1016/j.ygyno.2011.07.035.
Clinical trial NCT01740544: Computerised Assessment of Visual Neglect Symptoms in Peripersonal Space
Official title: Computerised Assessment of Visual Neglect Symptoms in Peripersonal Space
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Visual Neglect
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Median Klinik Berlin-Kladow
name: NeuroCure Clinical Research Center, Charite, Berlin
name: Center for Stroke Research Berlin
name: Free University of Berlin
name: Humboldt-Universität zu Berlin
First posted: 2012-12-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Healthy subjects will undergo cathodal stimulation of the right posterior parietal Cortex (PPC) and assessment of neglect-like symptoms in the encircling monitor system (EMS) as well as in a standard clinical test (Test Battery for Attention Performance, TAP, Zimmermann \& Fimm, 1993). The aim of this study is to investigate whether cathodal stimulation leads to poorer test performance.


Eligibility criteria: Inclusion Criteria:

* Younger subjects

  * aged between 18 and 35 years
  * ability to provide written informed consent
  * right-handedness
* Elderly subjects

  * aged between 50 and 85 years
  * ability to provide written informed consent
  * right-handedness

Exclusion Criteria:

- Exclusion criteria for both groups:

* serious psychiatric disorders (including depression, psychosis) in the past
* severe neurological disorders (such as epilepsy, dementia, stroke) in the past
* current severe medical disorder
* drugs, medication or alcohol abuse at the time of the study
* severe traumatic brain injury or tumor in the past
* operations on the brain, trepanations
* metallic implants in the head / neck area (except in the mouth), such as screws, splinter, artificial cochlea, electrodes
* severe skin diseases (like eczema) or very sensitive skin in the head region in the past
* epilepsy in the family
* current use of neuroleptics, antiepileptics, antidepressants, L-dopa, benzo-diazepines
* current pregnancy or lactation
* current claustrophobia

Primary outcomes:
measure: Test performance of young study participants in the encircling monitor system with/without cathodal stimulation
Secondary outcomes:
measure: Test performance of elderly study participants in the encircling monitor system with/without cathodal stimulation
measure: Test performance of study participants in the Test Battery for Attention Performance (TAP) with/without cathodal stimulation
measure: Comparison of visual search patterns between neglect patients and healthy subjects with cathodal stimulation
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Medicine
Study officials:
affiliation: Charite - Universitätsmedizin Berlin (NeuroCure Clinical Research Center)
name: Andreas Meisel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04574544: Zinc Supplementation and Nutrition Education Among Children in the Rural Community
Official title: Pilot Zinc Supplementation and Nutrition Education Among Children in the Rural Community, Cameroon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Effects of; Serum
Lead sponsor: University of Douala
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Evaluation of the anthropometric and biochemistry parameters of children before and after an intervention.
Primary purpose: TREATMENT

Brief summary: Malnutrition among children, especially stunting is a public health problem in Cameroon. This study assesses the impact of zinc supplementation of children and nutrition education of mothers on the nutritional status of the children in the rural community. Dietary surveys, nutritional status, zinc supplementation of children and nutrition education of mothers were carried out. After nutrition education and zinc supplementation, the study showed positive impact of both intervention on the nutritional status of children.

Detailed description: A questionnaire was developed, tested and adjusted prior the field survey. During the study, the knowledge of mothers on child nutrition, the eating habits of children, the estimated consumption of energy, nutrients of children and food availability on the market during harvesting and sowing seasons were evaluated. Moreover, data on zinc supplementation and nutrition education sessions conducted with mothers of these children were collected. The impact of zinc supplementation and maternal education was evaluated by measuring height/age, weight/age and weight/height indices, and levels of serum albumin, calcium, zinc, iron, magnesium and phosphorus before and after interventions.

Eligibility criteria: Inclusion Criteria:

* To have an age between 6 to 59 months
* To have signature of informed consent by the parents

Exclusion Criteria:

* To be illnes
* To have severe malnutrition

Primary outcomes:
measure: Zinc supplementation among children in the rural community
timeFrame: Zinc supplementation: 14 days
measure: Nutrition education of mothers and improvement of nutritionnal status of children
timeFrame: Impact of maternal education: 10 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01134744: Evaluating Validity of Clinical Criteria for Requesting Chest X-Rays in Trauma Patients
Official title: Study of Accuracy of Clinical Examination for Chest Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Trauma
Keywords: CXray
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-06-02
Enrollment: 385
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Three hundred and eighty six

Brief summary: The purpose of this study is to identify the clinical criteria for requesting a chest x-ray in a patient with blunt trauma and its findings such as clinical signs with a high sensitivity could be used in a larger study to codify the final criteria.

Detailed description: At present, a Chest x-ray is obtained from all trauma patients having suspicion to chest trauma. The indications for such radiographs are not well defined. This results in a large number of unnecessary chest radiographs being obtained. Our goal was to identify the clinical criteria for requesting a chest x-ray in a patient with blunt trauma and its findings such as clinical signs with a high sensitivity could be used in a larger study to codify the final criteria.

Eligibility criteria: Inclusion Criteria:

* Every patient with blunt trauma to chest

Exclusion Criteria:

* nothing

Primary outcomes:
measure: chest pain
timeFrame: 5 min after admision time
Secondary outcomes:
measure: tachypnea
timeFrame: 5 min after admision time
measure: abrasion
timeFrame: 5 min after admision time
measure: crepitation
timeFrame: 5 min after admision time
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-zahra university hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Emamkhomeini University Hospital
Study officials:
affiliation: MD,research comittee
name: hamidreza shemshaki, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01249144: Visual and Refractive Outcomes After Implantation of Aspheric IOLs With Different Dioptric Increments and Manufacturing
Official title: A Randomized Fellow-eye Controlled Clinical Trial to Compare the Visual and Refractive Outcomes Between Two Aspheric IOLs With Different Dioptric Increments and Manufacturing Tolerances in Patients Undergoing Bilateral Cataract Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cataract
Keywords: Intraocular Lens (IOL)
Quarter Diopter
Biaspheric
Lead sponsor: Lenstec Incorporated
Sponsor class: INDUSTRY
First posted: 2010-11-29
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares two intraocular lenses, the Softec HD and the Tecnis Z9002, used to replace the natural crystalline lens after cataract extraction. The variables compared include 1) the accuracy of targeted versus achieved refractive outcomes and 2) visual acuity outcomes three months after implantation.


Eligibility criteria: Inclusion Criteria:

* operable cataracts in both eyes
* require intraocular lenses (IOLs) in dioptric range from 18.0 diopters to 25.0 diopters in both eyes
* \</=1 diopter (D) of regular astigmatism in both eyes

Exclusion Criteria:

* Intraocular surgery or laser treatment prior to cataract surgery
* Severe dry eye
* Presence of ocular infection
* Uncontrolled intraocular pressure (IOP) or glaucoma preventing a postoperative best corrected visual acuity (BCVA) of 20/25 Snellen or better
* Retinal or macular pathology preventing a postoperative BCVA of 20/25 Snellen or better
* History of retinal detachment
* Corneal decompensation
* History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
* Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
* Amblyopia preventing a postoperative BCVA of 20/25 Snellen or better

Primary outcomes:
measure: Target versus Achieved Refraction
timeFrame: 3 Months Postoperative
Secondary outcomes:
measure: Uncorrected Visual Acuity
timeFrame: 3 Months Postoperative
Other outcomes:
Locations:
city: Tarpon Springs
country: United States
facility: St. Luke's Cataract & Laser Institute
state: Florida
Study officials:
affiliation: St. Luke's Cataract and Laser Institute
name: J. Pitzer Gills, III, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00434044: Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis
Official title: Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase III Study of Etanercept in the Treatment of Subjects With Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-02-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will represent the sponsor's first controlled study of etanercept in Chinese subjects with Ankylosing Spondytitis (AS). This trial is designed to assess the safety and efficacy of etanercept compared to placebo in the treatment of patients with AS.

Detailed description: Multicenter, double-blind, randomized, parallel and placebo-controlled outpatient study. The study consists of 2 parts: part A is a 6-week double-blind treatment period and part B is a 6-week open-label treatment period. During part A of the study, subjects will be randomly assigned to 1 of 2 treatment regimens: 2 etanercept 25 mg or placebo once weekly, administered subcutaneously (SC). After the completion of part A, all subjects will receive 2 etanercept 25 mg once weekly. The use of placebo as a control in part A is necessary to allow a valid comparison and to provide a quantitative assessment of effect.

Eligibility criteria: Inclusion Criteria:

1. Must be of Chinese ancestry and living in China.
2. Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
3. Active AS at time of enrollment, defined by average of visual analog scale (VAS) values for duration and intensity of morning stiffness 30 and two of the following: VAS for patient global assessment 30; average of VAS for nocturnal and total pain 30; BASFI greater than or equal to 30 (all scores on a scale of 0 to 100).

Exclusion Criteria:

1. Complete ankylosis (fusion) of spine.
2. Previous treatment with etanercept, antibody to Tumor Necrosis Factor a (TNFa), or other TNFa inhibitors or other biologic agents.
3. Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Subjects treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.

Primary outcomes:
measure: Assessment in Ankylosing Spondylitis (ASAS) response criteria 20% at week six.
Secondary outcomes:
measure: ASAS 20% response at all visits except week two. ASAS 50%, 70%, 40%, 5/6 responses at all visits.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: