louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06197490: Renal Impact of KAFTRIO in Mucoviscidose Population
Official title: Renal Impact of KAFTRIO in Mucoviscidose Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
KAFTRIO
renal impact
lithiasis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with cystic fibrosis followed at Centre Hospitalier Lyon Sud (in the reference and competence center for cystic fibrosis)

Brief summary: The objective of this study is to describe the renal impact of Elexacaftor-Teacaftor-Ivacaftor, a triple modulator therapy of CFTR channel, in patients with cystic fibrosis. This new treatment acts on the CFTR channel, which is expressed at the level of the nephrons. The objective is to study the changes in plasma and urinary parameters, including metabolic explorations of urolithiasis, change in volemic parameters, renal function, urinary sediment and nutritional and glycemic parameters, in newly treated patients, through the data collected at introduction of the treatment and during the follow-up.


Eligibility criteria: Inclusion Criteria:

* Patient with cystic fibrosis
* More than 18 years old
* Eligible for KAFTRIO

Exclusion Criteria:

* KAFTRIO contraindication
* Patient less than 18 years old
* Dialysis patient
* Pregnant woman
* Greffed patient
* Patient opposition to data collection

Primary outcomes:
measure: Modification of the parameters of the lithiasis assessment
timeFrame: 1 month after initiation of KAFTRIO
measure: Modification of the parameters of the lithiasis assessment
timeFrame: 7 months after initiation of KAFTRIO
Secondary outcomes:
measure: Change in volemic parameter
timeFrame: 1 month after initiation of KAFTRIO
measure: Change in volemic parameter
timeFrame: 7 month after initiation of KAFTRIO
measure: Change in renal function
timeFrame: 1 month after initiation of KAFTRIO
measure: Change in renal function
timeFrame: 7 month after initiation of KAFTRIO
measure: Change in urinary sediment
timeFrame: 1 month after initiation of KAFTRIO
measure: Change in urinary sediment
timeFrame: 7 month after initiation of KAFTRIO
measure: Change in glycemic profile
timeFrame: 1 month after initiation of KAFTRIO
measure: Change in glycemic profile
timeFrame: 7 month after initiation of KAFTRIO
measure: Change in lung function
timeFrame: 1 month after initiation of KAFTRIO
measure: Change in lung function
timeFrame: 7 month after initiation of KAFTRIO
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Etienne NOVEL-CATIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04517890: Transdermal Lidocaine Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System
Official title: Clinical Outcomes of Transdermal Lidocaine Administration Prior to Levonorgestrel Releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IUCD Complication
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind randomized controlled trial
Primary purpose: PREVENTION

Brief summary: aims to investigate the effectiveness of Transdermal lidocaine patch for Pain Control During Levonorgestrel Releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section

Detailed description: Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility criteria: Inclusion Criteria:

* Non-pregnant women
* Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
* Women who delivered only by cesarean section

Exclusion Criteria:

* Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids.
* Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
* Allergy to lidocaine
* Women refuse to participate in the study

Primary outcomes:
measure: The difference in pain scores during intrauterine device insertion
timeFrame: 10 minutes
Secondary outcomes:
measure: duration of IUD insertion
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w Shady, md
role: STUDY_CHAIR
References:
Clinical trial NCT06198790: Postoperative Anemia After Bariatric Surgery
Official title: Postoperative Anemia After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anemia
Bariatric Surgery Candidate
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients without anemia at baseline who will undergo bariatric surgery will be included.

Brief summary: To investigate the real incidence of short and long-term anemia after bariatric surgery, and explore the risk factors.

Detailed description: This study aims to investigate the real incidence of short and long-term anemia after bariatric surgery and explore the risk factors.

Eligibility criteria: Inclusion Criteria:

* Patients who will undergo sleeve gastrectomy or Roux-en-Y gastric bypass
* Aged between 16 and 70 years
* Patients who is not diagnosed as anemia at baseline

Exclusion Criteria:

* Patients who have anemia at baseline

Primary outcomes:
measure: Incidence of anemia after 1, 3, 5, 10 years
timeFrame: 10 years
Secondary outcomes:
measure: Incidence of anemia-related nutrient deficiencies
timeFrame: 10 years
measure: Hazard ratios for the risk factors of postoperative anemia
timeFrame: 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yuntao Nie
Study officials:
affiliation: China-Japan Friendship Hospital
name: Yuntao Nie, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01894490: Randomized Clinical Trial: Nasoenteric Catheter or Jejunostomy
Official title: Randomized Clinical Trial: Nasoenteric Catheter or Jejunostomy as a Route For Nutrition After Major Upper Gastrointestinal Operations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications After Gastrointestinal Operations
Keywords: Gastrointestinal surgery, complications, length of hospital stay, mortality
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with gastrointestinal disorders undergoing major abdominal operations

Brief summary: Curative treatment of upper gastrointestinal tract neoplasms is complex and associated with high morbidity and mortality. In general, the patients are already malnourished, and early postoperative enteral nutrition is recommended. However, there is no consensus concerning the best enteral access route in these cases.

Detailed description: A prospective randomized trial with patients undergoing esophagectomy, total gastrectomy or pancreaticoduodenectomy to asses the outcomes of either jejunostomy placement or catheter placement

Eligibility criteria: Inclusion Criteria:

* age over 18,
* gastrointestinal resections

Exclusion Criteria:

* age under 18,
* no gastrointestinal procedure

Primary outcomes:
measure: Complications
timeFrame: 30 day
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 30 days
Other outcomes:
measure: Mortality
timeFrame: 30 day
Locations:
city: Belo Horizonte
country: Brazil
facility: Universidade Federal de Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Maria Isabel TD Correia, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03065790: Early FDG PET/CT Imaging as a Measure of Response in Patients With Non-Hodgkin Lymphoma on Lenalidomide
Official title: Early FDG PET/CT Imaging as a Measure of Response in Patients With Non-Hodgkin Lymphoma on Lenalidomide
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-Hodgkin Lymphoma
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non-Hodgkins Lymphoma

Brief summary: Adult patients with non-Hodgkin lymphoma who will be treated with lenalidomide will undergo FDG PET/CT scan as an early evaluation of response to therapy. Changes in FDG uptake will be correlated response and long term outcomes.


Eligibility criteria: Inclusion Criteria:

* Adult patients, at least 18 years of age
* History of histologically confirmed NHL as assessed per medical record review.
* At least one site of measurable disease (per RECIST 1.1) that is seen on CT, MRI, or FDG PET/CT.
* Recommended to start lenalidomide.
* Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

* Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine or serum pregnancy test at the time of the screening visit.
* Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
* Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.

Primary outcomes:
measure: Number of FDGmax SUV % change in FDG SUVmax
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Michael Farwell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01144390: Effect Study of Optimized Intervention to Heroin Addicts
Official title: Barriers and Effect of Optimizing Intervention Protocols for Heroin Dependence in Community-based Methadone Maintenance Treatment (MMT): a Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heroin Dependence
Keywords: heroin dependence
community-based
MMT
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2010-06-15
Enrollment: 240
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: TREATMENT

Brief summary: The purpose of this study is to explore barriers and determine whether optimizing protocol is effective in the treatment of heroin dependence in community-based MMT clinics.

Detailed description: Drug dependence is one of the most serious public health problems worldwide. In China, among more than 100, 0000 registered drug addicts mostly are heroin dependence. Drug dependence post great risks to physical condition, their family and society, and can lead to infectious disease transmission. Though almost 500 MMT clinics which can offer MMT service to heroin addicts have been set up, there are still some problems, for example, poor compliance, high rate of dropping out and relapse which affect the service delivery to them. The guideline developed by WHO focused on psychotherapy to opiate addicts with MMT. So delivery of a set of comprehensive, integrated psychotherapy to opiate addicts is very critical in such methadone clinics.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of heroin dependence
* must be able to take methadone

Exclusion Criteria:

* schizophrenia and mood disorder
* physical disabilities who could not come to take part in psychotherapy sessions.

Primary outcomes:
measure: treatment retention
timeFrame: 12 months
Secondary outcomes:
measure: in-treatment performance.
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Mental Health Center of Hongkou District
state: Shanghai
city: Shanghai
country: China
facility: Mental Health Center of Pudong District
state: Shanghai
city: Shanghai
country: China
facility: Mental Health Center of Xuhui District
state: Shanghai
city: Shanghai
country: China
facility: Mental Health Center of Yangpu District
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: min ZHAO, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pan S, Jiang H, Du J, Chen H, Li Z, Ling W, Zhao M. Efficacy of Cognitive Behavioral Therapy on Opiate Use and Retention in Methadone Maintenance Treatment in China: A Randomised Trial. PLoS One. 2015 Jun 24;10(6):e0127598. doi: 10.1371/journal.pone.0127598. eCollection 2015.
Clinical trial NCT02497690: Effectiveness of Therapy Via Telemedicine Following Cochlear Implants
Official title: Effectiveness of Therapy Via Telemedicine Following Cochlear Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congenital Sensorineural Deafness
Keywords: Cochlear Implant
Hearing Aid
Telemedicine
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: University of Colorado, Boulder
First posted: 2015-07-14
Enrollment: 77
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will assess the effectiveness of post-cochlear implant or hearing aid fitting Aural Rehabilitative Therapy (ART) delivered by means of telemedicine technology.

Detailed description: Children with congenital sensorineural deafness can acquire relatively normal language if they undergo cochlear implantation surgery or hearing aid fitting followed by aural rehabilitation therapy in the first three to four years of life. High quality therapy, however, may not be available in many areas. This study will assess the effectiveness of post-cochlear implant or hearing aid fitting ART delivered by means of telemedicine technology. This will be accomplished primarily by evaluating subjects' language abilities using the 5th Edition of the Preschool Language Scales.

Eligibility criteria: Inclusion Criteria:

* been fitted with bilateral or unilateral cochlear implants, or bilateral hearing aids.
* focus on recruiting families who are members of minority groups.
* therapy must be provided in English.

Exclusion Criteria:

* the presence of one or more significant co-morbidities

  * blindness,
  * severe motor impairment,
  * autism,
  * significant genetic/chromosomal syndrome.

Primary outcomes:
measure: Evaluation of subjects' language abilities.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: James Grigsby, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06795490: Families in Balance: Enhancing Household Routines and Reducing Early Childhood Obesity Among Families With Low-income
Official title: Families in Balance: Enhancing Household Routines and Reducing Early Childhood Obesity Among Families With Low-income
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Behavior
Keywords: Online program
Informational material
Surveys
Eating activity
Sleep
Health behaviors
Body mass index
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2025-01-28
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: About 150 adults and 150 children will take part in the study
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects of two different approaches to support healthy family mealtime, sleep, and screentime routines: A parent leader-guided online program that promotes parent and child self-regulation as a means to improve healthy family routines versus an asynchronous program that provides parents information about healthy family routines. Families will be randomly assigned to either of these programs and changes in parent and child outcomes will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Parents must be the legal and custodial guardian of a 2 through 5-year-old child
* Parents must report that their child is eligible for public health insurance
* Parents must be able to complete the study activities in English
* Parents must be able to complete study activities at a study location or at home, and online/via Zoom.

Exclusion Criteria:

- Children must not have serious medical problems that affect weight, sleep, activity, or eating.

Primary outcomes:
measure: Child age and sex-adjusted Body Mass Index (BMI)
timeFrame: Base line (pre-intervention) and approximately 5 months
Secondary outcomes:
measure: Child sleep duration
timeFrame: Base line (pre-intervention) and approximately 5 months
measure: Child daily screentime
timeFrame: Base line (pre-intervention) and approximately 5 months
measure: Child intake of key food groups
timeFrame: Base line (pre-intervention) and approximately 5 months
measure: Child sleep routines
timeFrame: Base line (pre-intervention) and approximately 5 months
measure: Child screentime limits
timeFrame: Base line (pre-intervention) and approximately 5 months
measure: Family meal frequency
timeFrame: Base line (pre-intervention) and approximately 5 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Katherine Bauer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00469690: Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients: Trough Drug Effects
Official title: Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients: Trough Drug Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2007-05-04
Enrollment: 58
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the ability of two different topical NSAIDs (non-steroidal anti-inflammatory medications used for pain relief) to reach the back of the eye and to stop inflammation. The study will conclude on the day of your cataract surgery.


Eligibility criteria: Inclusion Criteria:

1. Healthy Male/Female 21 years of age of older.
2. Patient understands and is willing to sign the written informed consent form
3. Likely to complete the entire course of the study.
4. Patient is scheduled to undergo cataract surgery
5. Female patients of childbearing potential must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation).
6. Patient is willing and able to administer eye drops and record the times the drops were instilled

Exclusion Criteria:

1. Patient has been using a topical NSAID within 1 week of study entry
2. Patient has a known sensitivity to any of the ingredients in the study medications
3. Patient has sight in only one eye
4. Patient has a history of previous intraocular surgery
5. Patient's doctor has determined they have a condition (i.e., UNCONTROLLED systemic disease) or are in a situation that may put them at significant risk, confound the study results or may interfere significantly with their participation in the study
6. Female patients who are pregnant, nursing an infant or planning a pregnancy
7. Patients who are currently involved in another investigational study or have participated in one within the 30 days prior to entering this study

Primary outcomes:
measure: Aqueous concentrations
timeFrame: 8 months
Secondary outcomes:
measure: PGE2 Inhibition
timeFrame: 8 months
Other outcomes:
Locations:
city: Wilkes Barre
country: United States
facility: Bucci Laser Vision Institute and Ambulatory Surgery Center
state: Pennsylvania
Study officials:
affiliation: Bucci Laser Vision Institute and Ambulatory Surgery Center
name: Frank Bucci, MD
role: PRINCIPAL_INVESTIGATOR
References: