louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06326567: Comprehensive Connected Cancer Care (C4): Intervention Evaluation
Official title: Comprehensive Connected Cancer Care (C4): Intervention Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Health Care Utilization
Keywords: Community Programs
Health Equity
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2024-03-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The C4 program aims to provide a multi-level intervention program (Patient Level, Healthcare Team and Healthcare System Level) that improves the coordination of care with supportive/ancillary care providers and community services through the use of patient navigation and a digital needs assessment and a closed-loop referral system and improves patient-centered communication and engagement in care through skills training for the healthcare team and provision of culturally appropriate patient educational tools and resources. The program components incorporate three areas that are critical to improving patient-centered care: coordination of care, patient-centered communication and engagement, and psychosocial care and other supportive services.


Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed or recurrent cancer who have not initiated treatment of any kind, including surgery, medical management, and/or radiation
* Patients with one reported social determinants of health (SDOH) need OR patients at high-risk for SDOH needs based on demographic information (racial \& ethnic minorities, medicaid/uninsured populations).
* Willingness to provide informed consent to participate

Exclusion Criteria:

* Not able to understand and communicate in English
* Unable and/or unwilling to access the internet on a phone, tablet, or computer

Primary outcomes:
measure: Change in Health Related Quality of Life (FACT-G7)
timeFrame: baseline (enrollment) and 4 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Timothy Mullett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06300567: Assessment of Patients Not Concluded After Neonatal Screening of Cystic Fibrosis.
Official title: Assessment of Patients Not Concluded After Neonatal Screening of Cystic Fibrosis, CFTR-RD Misdiagnosis.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: CFTR-RD
Lead sponsor: Hôpital Necker-Enfants Malades
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 400
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: children of adults not concluded for the diagnosis of Cystic fibrosis

Brief summary: Assessment of the outcome of patients not concluded fir cystic fibrosis, either symptomatic patients or asymptomatic children detected by newborn screening for cystic fibrosis. The aim is to identify patients potentially at risk of progressing to the clinical spectrum of cystic fibrosis

Detailed description: Among patients not concluded for the diagnosis of cystic fibrosis, some are carriers of CFTR-RD mutations, therefore at risk of progressing to a symptomatic form, and may already have a subclinical involvement that it is important to identify. Among patients who do not carry the CFTR-RD genotype, other patients may be at risk of developing symptoms, if they are carriers of an undetected variant or wrongly classified as non-pathogenic. It is important to detect them to prevent the onset of symptoms

Eligibility criteria: Inclusion Criteria:

patients not concluded for the diagnosis of Cystic fibrosis either because of intermediate sweat test or because extensive genetic study has identified 2 vrainats at least 1 being not CF causing

-

Exclusion Criteria:

* patients carrying 2 CF causing variants of the CFTR gene
* patients carrying only 1 or no variants of CFTR

Primary outcomes:
measure: lung Imaging
timeFrame: within 3 months after visit
Secondary outcomes:
measure: lung infection
timeFrame: within 2 weeks after visit
measure: pancreatic function
timeFrame: within 2 weeks after visit
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00498667: The Prognostic Value of Interim PET/CT After 2 Cycles of Chemotherapy in Predicting Progression of Non Hodgkins Lymphoma
Official title: Evaluation of the Prognostic Value of Early Interim PET/CT for Prediction of Progression Free Survival of Patients With Aggressive B Cells Non Hodgkin Lymphoma
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lymphoma; Large Cell (Diffuse) With Small Cell, Diffuse
Keywords: PET/CT
Aggressive non-Hodgkin Lymphoma
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2007-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients with agressive non hodgkin lymphoma who had interim pet/ct during therapy

Brief summary: A retrospective analysis will be performed regarding the usefulness of PET/CT performed following 2 cycle of chemotherapy in evaluation of progression, free survival and overall survival of patients with aggressive non Hodgkin Lymphoma.

Detailed description: Patients who were treated for aggressive non-Hodgkin lymphoma with adriamycin containing regimen, CHOP and High dose CHOP with or without rituximab were evaluated post 2 cycles of chemotherapy to rule out disease progression . Currently a retrospective evaluation of PET/CT as a predictive value for progression free survival and overall survival is evaluated

Eligibility criteria: Inclusion Criteria:

* aggressive non-Hodgkin lymphoma b cells
* age 18-70
* bilirubin less then 2
* creatinine less then 2
* Pet/CT performed post 2 cycles

Exclusion Criteria:

* no PET/CT post 2 cycles performed
* bilirubin \>2
* creatinine more then 2
* HIV positivity

Primary outcomes:
measure: progression free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: RAMBAM health care Campus
Study officials:
affiliation: RAMBAM health care campus,Rappaport faculty of medicine Technion Israel Technical institute
name: Eldad J Dann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01533467: A Device Designed to Protect the Perineum During Labor
Official title: Study of Perineal Protection Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Perineal Tear
Keywords: Delivery rupture
perineal protection device
reduce perineal tears
Lead sponsor: Helsingborgs Hospital
Sponsor class: OTHER
Collaborators: name: Lund University Hospital
name: Skane University Hospital
First posted: 2012-02-15
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective:

To investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth.

Design:

A multicenter randomized control trial performed at three hospitals in Sweden, in Helsingborg, Lund and Malmö. Participants recruited are women with vaginal delivery (N=1200), cephalic presentation. They will be randomized to an intervention group, with a perineal protection device, and a control group deliver as normal.

Main outcome measures:

The effect on the frequency and extension of perineal ruptures grade I, II and anal sphincter rupture are measured.

Detailed description: Perineal rupture shall be measured with a ruler. Anal sphincter ruptures be examined by physicians. Drawing be made of the tears by the midwife.

Eligibility criteria: Inclusion Criteria:

* Vaginal delivery

Exclusion Criteria:

* Age below 18 years and no understanding of written and oral information.

Primary outcomes:
measure: Grade I and II rupture during delivery
timeFrame: time at the delivery department (up to 12 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Knut Haadem
Study officials:
affiliation: Dept Obstet & Gynecol, Helsingborg Hospital, Helsingborg, Sweden
name: Knut Haadem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lavesson T, Griph ID, Skarvad A, Karlsson AS, Nilsson HB, Steinvall M, Haadem K. A perineal protection device designed to protect the perineum during labor: a multicenter randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:10-4. doi: 10.1016/j.ejogrb.2014.07.006. Epub 2014 Jul 30.
Clinical trial NCT05455567: OCTA Study of Choroidal Vasculature in Open Angle Glaucoma Patients
Official title: OCTA as a New Biomarker in the Pathogenesis of Primary Open Angle Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma Open-Angle Primary
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 57
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 40 years with diagnosis of open angle glaucoma. They did not present any other ophthalmological disease, diabetes, heart diseases and hypertension.

Brief summary: The aim of the present study was to examine and measure SFCT and CCVD using respectively EDI-OCT and OCTA in preperimetric and advanced glaucomatous eyes, in order to shed light on the vascular pathogenesis of glaucoma disease.


Eligibility criteria: Inclusion Criteria:• age older than 40 years

* diagnosis of glaucoma
* absence of diabetes, heart diseases, hypertension
* absence of drug intake
* absence of vitreoretinal, vascular retinal diseases
* absence of previous ocular surgery and congenital eye diseases.
* absence of errors of refraction
* absence of lens opacities
* absence of low-quality OCT and OCTA images

Exclusion Criteria:

* age younger than 40 years
* presence of diabetes, heart diseases, hypertension
* vitreoretinal and vascular retinal diseases
* previous ocular surgery and congenital eye diseases
* errors of refraction
* lens opacities
* low-quality OCT and OCTA images

Primary outcomes:
measure: The measurements of choroidal thickness and choriocapillary vessel density in patients with open angle glaucoma.
timeFrame: up to 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
References:
Clinical trial NCT00397267: Treatment of Acute Asthma in ER With Combination of Systemic Steroids and Inhaled Steroids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asthma Exacerbation
Keywords: Dyspnea
Cough
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2006-11-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We assume that the combination of systemic steroids and inhaled steroid in the first hour of treatment in the ER will decrease the admission rate and improve faster the pulmonary function.

120 patients refferd to the ER due to asthma attack aged 18-60 with PFR \< 60% 0o predicted will participate in the study after giving informed consent.

The usual treatment in the ER is inhalation of Beta 2 short acting and I.V solumedrol 120 mg . The study group will recieve in addition 3 inhalation of Budesonide 1000 microgram each during the first hour.

The controlled group will recieve Nacl 0.9% PFR will be followed 0 30 60 120 min.

Detailed description: Primary end points- PFT improvment and admission rate.

Eligibility criteria: Inclusion Criteria:

* Asthmatic patients aged 18-60 with PFR \< 60% of predicted

Exclusion Criteria:

* Patients with other chronic diseases
* cardiac renal hepatic etc will be excluded

Primary outcomes:
measure: PFT improvment
measure: Admission rate
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: ER Soroka Med Center
Study officials:
affiliation: BGU Soroka medical center
name: Dov Heimer, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04818567: Frequency and Causes of Failed Endoscopic Retrograde Cholangio-Pancreatography in AL-Rajhi Endoscopy Unit
Official title: Frequency and Causes of Failed Endoscopic Retrograde Cholangio-Pancreatography in AL-Rajhi Endoscopy Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ERCP, Failure, Complications, Cannulation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 196
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All cases underwent ERCP in our center

Brief summary: The failure can be traced backed to operator causes, technical causes and patient causes.

the most common etiology is cannulation failure. ERCP complications includes post-ERCP pancreatitis, perforation, bleeding, cholangitis and cholecystitis.


Eligibility criteria: Inclusion Criteria:

* All cases underwent ERCP in our center from 1st of January, 2013 to 1st of January. 2021 with any causes of jaundice or any indication for which ERCP was done.

Exclusion Criteria:

* incomplete data or missing files were excluded from this study

Primary outcomes:
measure: Frequency and causes of failed Endoscopic Retrograde Cholangio-Pancreatography in AL-Rajhi endoscopy unit
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05790967: The Effect of Sex Education on Sexuality of Pregnant Women
Official title: The Effect of Sex Education on the Sexual Response and Attitudes Towards Sexuality of Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: In this study, it is aimed to determine the effect of sexual education given to pregnant women on attitudes towards sexuality and sexual response during pregnancy.

The study will be carried out in two different groups. After the women are evaluated in terms of eligibility criteria for the research, the eligible pregnant women will be informed about the research and written informed consent will be obtained from those who accept. Random distribution of pregnant women to study groups will be made using the Block Randomization method. The following applications will be made to the groups.

Education Group: Women in the experimental group will be given education on sexual life during pregnancy. Before the training, preliminary data will be collected and then the participants will be given two hours of individual and face-to-face training.

At the end of the training, homework will be given to pregnant women to practice at home, including "sharing their sexual feelings and thoughts with their spouse, sharing problems and concerns about sexuality during pregnancy, and using alternative ways other than sexual intercourse. In addition, a "Sexual Life in Pregnancy Information Booklet" will be given, and they will be asked to read the information in the booklet and share it with their spouses. After 4 weeks, the data sheets will be applied again.

Control Group: Patients in the control group of the study will not be subjected to any treatment other than the routine procedure. Data collection forms will be applied to the patients in the control group at the beginning of the study and after 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Primigravida
* Having a singleton pregnancy
* Being between 14 -22 weeks of pregnancy
* Living with their partner

Exclusion Criteria:

* Pregnant woman or her partner has a previous diagnosis of sexual dysfunction
* Having a risky situation where sexual intercourse is prohibited during pregnancy by the physician
* Use of psychiatric drugs
* Pregnant woman or her partner has a previous diagnosis of sexual dysfunction
* Having a risky situation where sexual intercourse is prohibited during pregnancy by the physician
* Use of psychiatric drugs such as antidepressants

Primary outcomes:
measure: Change in sexual response
timeFrame: baseline, four weeks later
measure: Attitude Scale toward Sexuality during Pregnancy Change:
timeFrame: baseline, four weeks later
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Cebeci Hospital
state: Mamak
Study officials:
References:
Clinical trial NCT06301867: Preventing Failed Extubations
Official title: Preventing Failed Extubations Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation Complication
Weaning Failure
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All mechanically ventilated patients in participating intensive care units.

Brief summary: More than 300,00 people in the United States experience acute respiratory failure and require mechanical ventilation every year. Of those that recover and are extubated, the most common reason for reintubation is recurrent respiratory failure. Our study proposes a novel methodology for identifying those patients most at risk for recurrent respiratory failure.

Detailed description: Spontaneous breathing trials (SBTs) with pressure-support ventilation are commonly used to determine if mechanically ventilated patients are ready for extubation. However, 10-25% of all patients who pass a spontaneous breathing trial and are extubated will require re-intubation . Extubation failure is associated with an up to 50% increased risk of death independent of other risk factors and patient characteristics . Currently proposed methods for identifying patients who pass an SBT but are at high risk of reintubation perform poorly when applied in a real-world setting . Thus, there is a critical need to develop new methodologies for identifying patients at high risk for extubation failure.

Respiratory system mechanics, such as compliance, driving pressure, and plateau pressure, can identify patients at risk of poor outcomes, including prolonged mechanical ventilation and death. However, respiratory system mechanics are not commonly measured during spontaneous breathing trials, and the relationship between respiratory mechanics during an SBT and extubation failure is not known. This is due in part to long-standing concerns that accurate measurements of plateau pressures, and thus driving pressures and compliance, cannot be made in spontaneously breathing patients.

The objective of this study is to determine if respiratory compliance measured during a spontaneous breathing trial is a feasible method for identifying patients at increased risk of extubation failure.

Eligibility criteria: Inclusion Criteria:

* Extubated in participating ICU during study period

Exclusion Criteria:

* Previously extubated during hospitaliztion
* Extubation as part of transitioning to comfort measures

Primary outcomes:
measure: Percentage of patients who had a plateau pressure measured prior to extubation as a measure of feasibility
timeFrame: Day 0
Secondary outcomes:
measure: Percentage of patients who were reintubated prior to hospital discharge
timeFrame: Day 0 to Day 90
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT00379067: A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding.
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Tamsulosin OCAS 0.4 mg Tablets, Once Daily on Nocturia, Compared to Placebo, in Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia
Nocturia
Actigraphy
Tamsulosin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Europe Ltd.
name: Boehringer Ingelheim
First posted: 2006-09-21
Enrollment: 882
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, double-blind, placebo-controlled study with two treatment arms (Tamsulosin OCAS 0.4 mg \& placebo). The study comprises a 2-week placebo run-in followed by a 12-week treatment period.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as having LUTS associated with BPH
* On average, at least 2 voids per night over the last week
* A maximum of 4 hours of undisturbed sleep expected per night (night time is defined as the time from going to bed with the purpose of sleeping until waking up with the purpose of getting up)

Exclusion Criteria:

* Subject is currently taking diuretics
* Subjects who work shift hours and whose hours of work include any time between 23.00 and 06.00h

Primary outcomes:
measure: The change from baseline to week 12 in mean number of nocturnal voids
timeFrame: 12 weeks
Secondary outcomes:
measure: The change from baseline to week 12 in mean hours of undisturbed sleep, defined as the time from falling asleep to first awakening to void
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Medical Affairs Europe, Astellas Pharma Europe Limited, Lovett House, Lovett Road, Staines Middlesex TW 18 3AZ
name: Use Central Contact
role: STUDY_DIRECTOR
References: