louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03144258: Evaluation of the Microcirculation During the Corrective Surgery of Congenital Heart Defects in Children
Official title: Evaluation of the Systemic Microcirculation in the Course of Cardiopulmonary Bypass Used in the Surgery for Repair of Congenital Heart Defects in Infants and Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: congenital heart defects
systemic microcirculation
laser Doppler perfusion imaging
cardiac corrective surgery
Lead sponsor: National Institute of Cardiology, Laranjeiras, Brazil
Sponsor class: OTHER_GOV
First posted: 2017-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants and children with congenital heart defects scheduled to corrective cardiac surgery

Brief summary: General objective of the research project: To evaluate the alterations of systemic microvascular reactivity during cardiopulmonary bypass (CPB), in children submitted to cardiac surgery for repair of congenital heart defects.

Detailed description: • Specific objectives:

* To test the usefulness of skin laser Doppler flowmetry monitoring (LDPM) in the non-invasive evaluation of endothelium-dependent microvascular reactivity during CPB in children.
* To investigate whether skin LDPM could be proposed as a clinical monitoring of tissue perfusion during CPB in pediatric cardiac surgery.
* To investigate the effects of different anesthetic agents on microvascular reactivity during CPB.
* To investigate the effects of cardiovascular and vasoactive drugs used during CPB on microvascular reactivity.
* To evaluate the correlation of microcirculatory alterations observed during CPB with classical markers of tissue perfusion and oxygenation, including plasma lactate levels.
* To evaluate the correlation of microcirculatory alterations observed during CPB with markers of systemic inflammation, including pro- and anti-inflammatory cytokines.
* To evaluate the correlation of microcirculatory alterations observed during CPB with the plasma bioavailability of nitric oxide.

Eligibility criteria: Inclusion Criteria:

* infants and children with congenital heart defects scheduled to corrective cardiac surgery

Exclusion Criteria:

* age inferior to 3 months and superior to 6 years

Primary outcomes:
measure: Microcirculatory alterations during cardiopulmonary bypass
timeFrame: december 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: National Institute of Cardiology, Ministry of Health, Brazil
Study officials:
affiliation: National Institute of Cardiology
name: Eduardo Tibirica, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06429358: The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women
Official title: The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Lead sponsor: Frontier Medical and Dental College, Abbotabad
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial
Primary purpose: TREATMENT

Brief summary: Urinary tract infections (UTIs) are a significant public health problem affecting more than 150 million people worldwide and causing a significant economic impact of approximately US$ 6 billion annually. It is one of the most common infectious diseases after upper respiratory tract infections. More than 50% of women and at least 12% of men will be affected by urinary tract infections in their lifetime. The probiotic supplement was delivered as easy-to-swallow capsules specifically prepared to maintain the viability and stability of the Lactobacillus rhamnosus GG strain throughout the research period. Participants were told to take the probiotic supplement with water to maximise absorption and efficiency, ideally after meals.


Eligibility criteria: Inclusion Criteria:

* Pregnant women aged 18-40 year
* History of recurrent urinary tract infections (two or more episodes in the past year).
* Singleton pregnancy.

Exclusion Criteria:

* Multiple gestations.
* History of preterm labor.
* Chronic medical conditions (e.g., diabetes mellitus, immunodeficiency disorders).
* Use of antibiotics or probiotics within the past month.

Primary outcomes:
measure: Urinary Detailed Report Values
timeFrame: second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.
measure: Urine Culture
timeFrame: second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.
measure: Leukocytes:
timeFrame: second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.
measure: Nitrites:
timeFrame: second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.
measure: pH
timeFrame: second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottābād
country: Pakistan
facility: Frontier Medical and Dental College
state: KPK
Study officials:
References:
Clinical trial NCT00126958: Cost-Effectiveness in Bladder Cancer
Official title: Cost-Effectiveness of Follow-up of Patients With Superficial Bladder Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Keywords: superficial urothelial cell carcinoma
urinary analysis
Loss of heterozygosity
FGFR3 mutation
follow-up
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Reinier de Graaf Groep
name: Sint Franciscus Gasthuis
name: Vlietland Ziekenhuis
name: Medisch Centrum Rijnmond-Zuid, Netherlands
name: Havenziekenhuis
name: Albert Schweitzer Hospital, Netherlands
name: Ikazia Hospital, Rotterdam
name: Leiden University Medical Center
First posted: 2005-08-05
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This randomized clinical multicentre trial aims to evaluate the efficacy of microsatellite analysis on voided urine to detect tumour recurrences in the follow-up of patients with superficial urothelialcell carcinoma (UCC). Further, this study aims to identify subgroups of patients with a low risk of tumour recurrence using clinico-pathologic tumour characteristics in combination with a genetic marker (FGFR3 gene), such that the frequency of follow-up contact can be reduced. The overall objective is to reduce the frequency of cystoscopy during follow-up in patients with superficial UCC, leading to an improvement in quality of life at equal or lower costs. This study evaluates the cost-effectiveness of follow-up in bladder cancer.

Detailed description: The randomized clinical study consists of two intervention arms. The control arm consists of a conventional follow-up based on regular monitoring for urinary bladder UCC recurrences by cystoscopy. In the test arm a proportion of the cystoscopies is replaced by microsatellite analysis on voided urine. Both arms will be stratified for clinical and pathological tumour parameters as well as for the mutation status of the prognostic FGFR3 gene mutation.

Eligibility criteria: Inclusion Criteria:

* All patients with resectable pT1 or pTa, grade G1-G2 transitional cell carcinoma of the bladder which is biopsy proven

Exclusion Criteria:

* Patients who present or presented with a transitional cell carcinoma of the bladder, stage pT2 or more invasive, or carcinoma in situ (CIS) and/or G3 diagnosed in history

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Erasmus MC, JNI
name: Th. van der Kwast, Prof PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus MC, JNI
name: E.C. Zwarthoff, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00606658: Usefulness of Shirodhara for Insomnia
Official title: Usefulness of Shirodhara (Oil Dripping Treatment in Ayurveda) for Insomnia - A Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Insomnia
Keywords: Insomnia
Ayurveda
Shirodhara
Quality of Life
Lead sponsor: Southern California University of Health Sciences
Sponsor class: OTHER
First posted: 2008-02-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study will attempt to test the effects of this non-invasive procedure on a small sample of insomnia patients and also determine the feasibility of recruiting and retaining participants during the trial for such treatments in the United States.

Detailed description: A prospective case series design will be adopted. Due to the small sample size and the preliminary nature of the study, a single case study or case series are classified under Observational Descriptive Studies. The investigators will seek local Institutional Review Board (IRB) approval. Ten volunteers who respond to the recruitment efforts will be enrolled into the study. Successful enrollment is based on strict inclusion and exclusion criteria. Brahmi oil (sesame oil processed with Bacopa monieri and other herbs) will be used to perform Shirodhara. Each participant will be treated for 40 minutes for five consecutive days. Outcome measures data will be collected at baseline, third day and fifth day and a week after the treatment is over. Additionally, demographic data will be collected at baseline as well. Participants will be asked to record any adverse events or side effects they observe during the study period.

Eligibility criteria: Inclusion Criteria:

* Age 18-75 of either sex
* Duration of insomnia at least one year
* Willing to sign an informed consent
* A score of minimum 14 on the Insomnia severity index

Exclusion Criteria:

* Comorbidities such as Depression or any other psychological conditions that require medications
* Currently on prescription medication for insomnia
* Serious medical conditions such as uncontrolled hypertension, uncontrolled diabetes, or any other acute condition that disturbs sleep and requires waking up in the middle of the night
* Participants unwilling to comply with the protocol
* Anyone who is in litigation or receiving disability, workers' compensation benefits

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Baseline, end of five days and end of 14 days
Secondary outcomes:
measure: HD-16 Quality of Life Scale
timeFrame: Baseline, end of 5 days and 14 days
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Southern California University of Health Sciences
state: California
Study officials:
affiliation: Southern California University of Health Sciences
name: Sivarama P Vinjamury, MAOM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05061758: A Trial of LY3056480 in Patients With SNLH
Official title: A Phase 2 Double Blind, Randomized, Placebo Controlled Trial inVEstigating the Effect and Safety of Several Dosing Regimens of LY3056480 in Patients With STAble Sensorineural Hearing Loss
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Sensorineural Hearing Loss
Lead sponsor: Audion Therapeutics BV
Sponsor class: INDUSTRY
First posted: 2021-09-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blinded, randomized, placebo controlled, multi center efficacy phase 2 study
Primary purpose: TREATMENT

Brief summary: A phase 2 trial with LY3056480 in patients with stable SNHL

Detailed description: VESTA is a double blinded, randomized, placebo controlled, multi center efficacy phase 2 study comparing three dosing regimens of 250 µg LY3056480. Adult volunteers with stable mild to moderately-severe SNHL will be recruited through Adult Otolaryngology - Head \& Neck Surgery Services in the US. Four injections of 250µg LY3056480 or placebo administered trans-tympanically into one ear (worse hearing ear).

Eligibility criteria: Inclusion Criteria:

1. Male or female between 18 - 65 years of age;
2. Minimum of six months of documented stable hearing loss (+/- 5dB);
3. A documented stable word recognition test (stable for \~ 6 months +/- 6%/3 words)

Exclusion Criteria:

1. Presenting with a primary complaint of tinnitus
2. Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10 dB at two or more contiguous octave frequencies in the study ear
3. History of suspected or diagnosed genetic cause of hearing loss;
4. Partial deafness as defined as hearing loss in any frequency (up to 8 kHz) greater than 80dB
5. Suspected or known diagnosis of the following inner ear pathology, congenital hearing loss, fluctuating hearing loss, Ménière's disease, or secondary endolymphatic hydrops, perilymph fistula, cochlear barotrauma, autoimmune hearing loss, radiation-induced hearing loss, retro-cochlear lesion, ototoxicity
6. Evidence of acute or chronic otitis media or otitis externa on examination; or a history of middle ear pathology and/or surgery (except for ear tubes as a child)
7. Any therapy known as ototoxic
8. Participant in a previous trial of LY3056480

Primary outcomes:
measure: the efficacy of local treatment with LY3056480 in terms of hearing function
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: New York
country: United States
facility: New York Eye and Ear Infirmary ICAHN school of Medicine Mount Sinai
state: New York
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
References:
Clinical trial NCT04727658: Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL)
Official title: Linac FRACtionated Radiosurgical THALamotomy in Tremors : a Phase II Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Essential Tremor
Parkinsonian Disorders
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will be carried out according to a design by Simon in two stages (Simon, 1989).

First step: 14 patients will be included in the study. When the 14th patient has been treated, the inclusions will be suspended for 1 year until analysis of the primary endpoint.

• Second stage: 34 additional patients will be recruited for a total of 48 patients.
Primary purpose: TREATMENT

Brief summary: Radiosurgical thalamotomy on GammaKnife has been shown to be effective in the management of tremors. However, several teams describe a significant risk of severe neurological complications. In addition, fitting the invasive frame and the need to travel to GammKnife centers often limit access to treatment in this population of elderly patients.

Linear accelerators have greatly improved their precision, now reaching that of GammaKnife. A possible alternative is therefore to treat patients on linear accelerators, without an invasive frame.

The objective of the FRACTHAL study is to assess the feasibility and safety of treatment of essential and / or parkinsonian tremor by fractional radiosurgical thalamotomy on a linear accelerator.

The main hypothesis of the FRACTHAL study is based on the fact that dividing the dose into 3 sessions will both protect healthy tissue around the target while maintaining therapeutic efficacy on the treatment target.


Eligibility criteria: Inclusion Criteria:

* patient with disabling essential tremor, dystonic and / or parkinsonian in one or more limbs superiors ;
* patient contraindicated or refusing deep brain stimulation ;
* patient ≥ 18 years old,
* women of childbearing potential must take effective contraception ;
* signature of informed consent ; p- atients who benefited from contralateral thalami c stimulation can be included in the study

Exclusion Criteria:

* brain irradiation history ;
* contraindication or inability to perform injected MRI ;
* life expectancy \<12 months ;
* claustrophobic patient who cannot stand the radiotherapy mask ;
* abnormal anatomy of the thalamic region ;
* treatment with a trial drug within 30 days of entering the study ;
* presence of medical, psychological, social or geographic factors likely to modify the patient's compliance with the protocol under study or the monitoring or signing of the consent

Primary outcomes:
measure: Treatment toxicity
timeFrame: 12 months
Secondary outcomes:
measure: Treatment accuracy
timeFrame: At 6 and 12 months
measure: Tremor improvement
timeFrame: At 3, 6 and 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06433258: Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved and Rural Populations in South Texas
Official title: Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved and Rural Populations in South Texas: Tu Salud ¡Si Cuenta (TSSC)!
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Prevention
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Cancer Prevention Research Institute of Texas
First posted: 2024-05-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to enhance the current TSSC multilevel intervention delivered in Cameron and Hidalgo counties by adding additional components including an educational module on the risks of alcohol intake and its connection to cancer, as well as developing training and referral systems to address social determinants of health (SDOH) that negatively impact uptake of cancer prevention behaviors.


Eligibility criteria: Inclusion Criteria:

* residents of partnering municipalities throughout Cameron and Hidalgo

Exclusion Criteria:

* participated in TSSC before

Primary outcomes:
measure: Change in percentage of participants that show an increase in moderate and vigorous physical activity minutes as assessed by the Physical Activity Questionnaire
timeFrame: Baseline , 6 month follow up , 9 month month follow up
measure: Change in percentage of participants that report increase in fruit and vegetable intake as assessed by the Nutritious Eating Questionnaire
timeFrame: Baseline , 6 month follow up , 9 month month follow up
measure: Change in percentage of participants that report a reduced quantity of alcohol intake as assessed by a questionnaire
timeFrame: Baseline , 6 month follow up , 9 month month follow up
measure: Change in percentage of participants that report a reduced frequency of alcohol intake as assessed by a questionnaire
timeFrame: Baseline , 6 month follow up , 9 month month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Belinda Reininger, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01309958: DPBRN Development of a Patient Based Provider Intervention for Early Caries Management
Official title: Development of a Patient Based Provider Intervention for Early Caries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Keywords: Dental Caries
Intervention
Non-invasive treatment for early caries
Lead sponsor: Dental Practice-Based Research Network
Sponsor class: NETWORK
Collaborators: name: HealthPartners Institute
name: Kaiser Permanente
name: Permanente Dental Associates Group, Oregon
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2011-03-07
Enrollment: 334
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ghg@uab.edu

Brief summary: This study focused on improving the quality of dental care by fostering movement of the latest scientific advances into daily clinical practice.

Detailed description: Phase 1 - development of two instruments (a patient brochure that described non-invasive caries treatment and a patient questionnaire of satisfaction with non-invasive caries treatment).

Phase 2 - field tested the patient brochure

Phase 3 - pilot tested the patient brochure, quantifying patient satisfaction with non-invasive caries treatments and a feasibility study that will inform the design of a clinical trial in dental practices envisioned for a later study.

Eligibility criteria: Inclusion Criteria:

* dentists enrolled in the Dental Practice-Based Research Network (DPBRN) who participated in DPBRN Assessment of Caries Diagnosis \& Caries Treatment and DBPRN Reasons for placing the First Restoration on Permanent Tooth Surfaces

Exclusion Criteria:

* patients under 19 years of age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Gainesville
country: United States
facility: University of Florida College of Dentistry
state: Florida
city: Minneapolis
country: United States
facility: Health Partners Dental Group
state: Minnesota
city: Minneapolis
country: United States
facility: Health Partners Research Foundation
state: Minnesota
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
city: Portland
country: United States
facility: Permanente Denrtal Associates
state: Oregon
city: Copenhagen
country: Denmark
facility: University of Copenhagen Royal Dental College
Study officials:
affiliation: National Dental PBRN
name: Gregg H Gilbert, DDS, MBA
role: PRINCIPAL_INVESTIGATOR
References: