louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06546189: Oral Lactobacillus Supplementation as Treatment for Overactive Bladder Syndrome: A Randomised Controlled Trial
Official title: Oral Lactobacillus Supplementation as Treatment for Overactive Bladder Syndrome: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overactive Bladder Syndrome
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Overactive bladder describes a syndrome characterized by frequent urges to urinate and increased urination with or without nocturia and with or without urinary incontinence. Overactive bladder affects approximately 13% of older women and thus represents a condition with high prevalence. Affected women report significant limitations in daily life, as well as social isolation. Despite the high occurrence of this condition, therapeutic options are limited, partly because the etiology of this condition is not fully understood. Increasingly, studies suggest an imbalance in the urogenital microbiome as a possible cause of the development of the condition. Therefore, the aim of this study is to test, whether the oral administration of a lactobacillus preparation can lead to a reduction in symptoms.

Design: Randomized controlled study

Methods: Intake of OMNi BiOTiC® 41167 or placebo twice daily for 6 months; swabs (vaginal and urethral) and urine samples from a single-use catheter for microbiome determination at 0, 3, and 7 months.

Outcome: Reduction of subjective symptoms (yes/no) after 3 and 7 months; reduction of Overactive Bladder Symptom Score after 3 and 7 months; change in the urogenital microbiome after 3 and 7 months (comparison of intervention vs. placebo).


Eligibility criteria: Inclusion Criteria:

* diagnosis of overactive bladder syndrome or mixed urinary incontinence with predominance of overactive bladder symptoms

Exclusion Criteria:

* under age 18
* neurogenic overactive bladder

Primary outcomes:
measure: symptom reduction
timeFrame: 6 months
measure: ICIQ-OAB symptom score reduction
timeFrame: 6 months
Secondary outcomes:
measure: change in vaginal/urethral/bladder microbiom
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02526589: Does Bloody Urine Predict Urethrovesical Anastomosis Leakage After Radical Prostatectomy
Official title: Does Bloody Urine Predict Urethrovesical Anastomosis Leakage After Radical Prostatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasm
Anastomosis
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 226
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Robotic assisted laparoscopic radical prostatectomy patients. Catheter removal visit.

Brief summary: Traditionally the watertightness of urethrovesical anastomosis after robotic radical prostatectomy is controlled by cystogram. However, clinical observations and one previous study showed that patients with anastomotic leakage have red coloured urine. If the investigators can verify this finding, the most of the cystograms can be avoided. In this study the investigators estimate urine colour after cystogram and take a picture from urine collecting pag. Later on the pictures are digitally analyzed and compared to cystogram finding.


Eligibility criteria: Inclusion Criteria:

* Previous robotic radical prostatectomy
* Catheter removal visit

Exclusion Criteria:

* No urine in urinary collecting bag

Primary outcomes:
measure: Urine colour
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Jarno Riikonen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01871389: Impact of Monthly High Dose Oral Cholecalciferol on Serum 25 Hydroxy Vitamin D Levels in Bariatric Surgery Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: bariatric surgery

Brief summary: Vitamin D deficiency is common after bariatric surgery. This study is designed to determine if a high dose monthly supplement of vitamin D 3 will be effective in helping improve vitamin D status after surgery such as gastric bypass. Bariatric surgery subjects taking monthly high dose cholecalciferol supplements in addition to the standard vitamin D protocol will have a significant rise in serum vitamin D levels compared to the subjects taking only the usual vitamin D protocol.


Eligibility criteria: Inclusion Criteria:

* morbidly obese meeting criteria for gastric bypass over age 18

Exclusion Criteria:

* taking medications that affect vitamin D status, elevated serum hydroxy vit D or calcium

Primary outcomes:
measure: Serum 25(OH)D3
timeFrame: Change at 3 and 6 mos
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Advanced Bariatric Surgery Center
state: Texas
Study officials:
References:
Clinical trial NCT00546689: Correlation Between Intestinal Parasites and Serum Level of Eosinophils and IgE in Individuals With HIV or AIDS
Official title: Phase 1 Correlation Between Intestinal Parasites and Serum Level of Eosinophils and IgE in Individuals With HIV or AIDS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
aids
intestinal parasites
eosinophils
immunoglobulins
HIV/aids
Treatment Experienced
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
First posted: 2007-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: Correlation between intestinal parasites and serum level of eosinophils and IgE in individuals with HIV or aids attended at clinical hospital of the Botucatu Medical School-UNESP

Detailed description: The present study correlates intestinal parasitism and levels of eosonophils and of serum IgEs in patients attended at the C.H. of the School of Medicine - Botucatu/UNESP. Thirty adult patients with AIDS were analyzed in the use of HAART, aged 42 ±11 years, 14 (46.7%) male, excluding those that had used anthelminthics 30 days prior to collection. Socioeconomic questionaires were applied and 3 samples of feces were taken for parasitological exams (TF-test® method) and 5 ml of blood for counting eosinophils (automated hematological counter, Pentra 80, ABX) and IgE doses (equipment BN-100, Dade-Behring). The index of parasites was 10%, with E.nana (3.3%), E.coli (3.3%) and B.hominis (3.3%). Parasitized individuals were from an urban region with complete basic sanitation and good socioeconomic level. Normal eosinphil values were found in all samples and increased IgE values in 1 (33.3%) sample. The index of parasites was low due to good socioeconomic level and disease control. Augmented IgE levels corroborate the literature, which reports an increase characteristic of immune response in the face of parasitic infections in individuals with HIV or AIDS. In conclusion, new studies should be undertaken to evaluate the level of eosinophils associated with cytokines to obtain a better understanding of this correlation.

Eligibility criteria: Inclusion Criteria:

* HIV or AIDS
* age same or superior to 18 years,
* both sexes
* assisted by the Hospital of the Clinics of Botucatu Medical School-UNESP

Exclusion Criteria:

* use of anthelminthic in the period of 30 days antecedents the it dates from collection
* individuals that don't have all of the necessary evaluations to the objectives of the study
* individuals that abandon the attendance, or that you/they are to death during the study

Primary outcomes:
measure: all
timeFrame: one year
Secondary outcomes:
measure: all
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Botucatu Medical School - UNESP
name: Paulo C Pereira, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT01932489: The Jules Bordet Institute Molecular Profiling Program Feasibility Trial
Official title: THE JULES BORDET INSTITUTE PROGRAM FOR MOLECULAR PROFILING OF METASTATIC LESIONS: FEASIBILITY. PRECISION - Feasibility.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Metastatic
Metastatic Melanoma
Metastatic Non-Small Cell Lung Carcinoma
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Prior to the use of genomic tests for patient inclusion in clinical trials, it is essential for the Jules Bordet Institute (JBI) to pilot the logistical and technical aspects by examining the feasibility and turnaround time of performing and obtaining data from a few key molecular assays.

Patients with metastatic colorectal cancer, non-small cell lung cancer or melanoma will be enrolled. Biopsie from metastatic lesions will be performed. A targeted cancer gene screen assay will be performed using DNA sequencing.

Results will be discussed during a molecular screening tumor board.


Eligibility criteria: Inclusion Criteria:

* Written informed consent for all study procedures according to local regulatory requirements prior to enrollment into the study.
* Age ≥ 18 years.
* Histologically proven metastatic or locally recurrent CRC, NSCLC or melanoma.
* Tumor tissue (FFPE and frozen) from recurrent or metastatic lesions available for research purposes.

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status \>2.
* The biopsy procedure is estimated to be too risky for the patient.
* Any anti-VEGF or anti-VEGFR treatment administered less than 3 weeks before new biopsy procedure.
* No appropriate washout period for patients on anticoagulation therapy.

Primary outcomes:
measure: Quality of the biopsies
timeFrame: 1 month
measure: Technical failure rate.
timeFrame: 1 month
measure: Percentage of patients with results within the specified turnaround time
timeFrame: 1 month
Secondary outcomes:
measure: Feasibility of a tumor sequencing board.
timeFrame: 2 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Jules Bordet Institute
Study officials:
affiliation: Jules Bordet Insitute
name: Philippe Aftimos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05997329: Nutrition Throughout the Treatment Course - Expanding Care From Hospital to Home
Official title: Nutrition Throughout the Treatment Course - Expanding Care From Hospital to Home
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: University of South-Eastern Norway
First posted: 2023-08-18
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with cancer have increased risk of malnutrition due to the disease itself and the treatment regimen they undergo. This is particularly relevant for patients with head and neck cancer (HNC), where 74%-95% are malnourished. HNC is a heterogenous group of cancers, including oral cavity, larynx, pharynx and salivary glands. The present project will study the effectiveness and implementation of remote patient monitoring of nutrition and tailored nutrition support throughout the treatment course in patients with head and neck cancer. The implementation will be evaluated in a randomized controlled trial (RCT), and the aim of the project is to reduce the prevalence of malnutrition and increase the quality of life among patients with HNC.


Eligibility criteria: Inclusion Criteria:

* Head and neck cancer
* Older than 18 years

Exclusion Criteria:

* Patients admitted with the classification of malignant tumors (TNM) stage 4
* Terminal condition (life expectancy \< 6 months)
* Patients who do not understand the Norwegian language.

Primary outcomes:
measure: Malnutrition
timeFrame: 17 weeks
Secondary outcomes:
measure: Weight change
timeFrame: During the 17 weeks
measure: Nutrition intake
timeFrame: Monthly up to three months
measure: Body composition
timeFrame: Monthly up to three months
measure: Health-related quality of life
timeFrame: Monthly up to three months
measure: Number of Participants compliant to the intervention
timeFrame: At 17 weeks
measure: Number of patients with non-elective readmissions
timeFrame: At 17 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
Clinical trial NCT04839029: Bipolar Versus Mono-polar Needlescopic En Bloc TUR-BT
Official title: Bipolar Versus Monopolar Needlescopic En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Cancer
Bladder Neoplasm
Keywords: NMIBC
TURBT
En bloc resection
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 200
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: Non-muscle invasive bladder cancers (NMIBC) compose about 80% of bladder tumors. the stranded treatment of these tumors is TURBT.

en bloc resection of NMIBC yields better mascularis propria with better oncological outcomes


Eligibility criteria: Inclusion Criteria:

* confirmed primary NMIBC (Ta, Tis, T1)
* Age \> 18 years

Exclusion Criteria:

* MIBC
* anterior located mass ( difficult or non visualized)

Primary outcomes:
measure: Quality of tumor Resection
timeFrame: immediatly post operative
measure: adequacy of tumor Resection
timeFrame: 2 to 6 weeks postoprative
Secondary outcomes:
measure: Complications
timeFrame: within 30 days post-operative
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Banha university hospital
state: Qalubia
Study officials:
affiliation: Faculty of medicine, Banha university
name: Waleed El-Shaer, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03126929: Further Psychometric Data for the Reliability and the Diagnostic Validity of CRS-R
Official title: Further Psychometric Data for the Reliability and the Diagnostic Validity of the Coma Recovery Scale-Revised
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Minimally Conscious State
Vegetative State
Keywords: disorders of consciousness
Vegetative state
Minimally conscious state
Emergence from MCS
Coma Recovery Scale-Revised
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators chosen patients with VS, MCS, EMCS

Brief summary: This study aims to provide, in a large sample, further psychometric data as regards the internal consistency, the test-retest reliability and the diagnostic validity of the Coma Recovery Scale-Revised (CRS-R).

Detailed description: Recently, a report of the American Congress of Rehabilitation Medicine aiming to provide a systematic review of behavioral assessment scales for DOC has indicated that, when compared to other scales, the CRS-R meets the highest psychometric standards for the evaluation of severely brain-injured patients and may be used to assess DOC with minor reservations. However, that report mentions few evidences or studies with small sample sizes for some aspects of its reliability and validity such as its internal consistency and its test-retest reliability.The report also states that the diagnostic validity of the CRS-R remains unproven. In this study, the investigators will therefore aim to provide further psychometric data as regards those variables in a large sample of patients with DOC

Eligibility criteria: Inclusion Criteria:

* age above 18 years old
* any etiology
* pre-screening performed by the referent physician comforting the presence of a disorder of consciousness in accordance with international diagnostic criteria for VS, MCS or emergence from MCS (EMCS)

Exclusion Criteria:

* neuromuscular blocking agents or sedative drugs administered within the prior 24 hours
* no documented history of a prior coma
* critical illness or unstable medical condition

Primary outcomes:
measure: Coma Recovery Scale-Revised for assess the level of consciousness
timeFrame: 24 hours(1 day)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01686529: Bevacizumab for Primary Pterygium Treatment
Official title: Conjunctival Autografting Alone or Combined With Subconjunctival Bevacizumab for Primary Pterygium Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pterygium
Keywords: Pterygium
bevacizumab
autoconjunctival graft
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study was to investigate the efficacy and safety of subconjunctival bevacizumab application as an adjuvant therapy for primary pterygium.


Eligibility criteria: Inclusion Criteria:

* Patients with primary pterygium

Exclusion Criteria:

* Patients with diabetes mellitus
* collagenopathies,
* previous ocular surgeries,
* pregnant or lactating patients

Primary outcomes:
measure: Pterygium recurrence
timeFrame: One point.
Secondary outcomes:
measure: Conjunctival ischemia
timeFrame: Ischemia is measured at 24 h, 1 week, 15 days, six months and one year postoperative
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto de Oftalmología
Study officials:
affiliation: Instituto de Oftalmología
name: Yonathan Garfias, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nava-Castaneda A, Olvera-Morales O, Ramos-Castellon C, Garnica-Hayashi L, Garfias Y. Randomized, controlled trial of conjunctival autografting combined with subconjunctival bevacizumab for primary pterygium treatment: 1-year follow-up. Clin Exp Ophthalmol. 2014 Apr;42(3):235-41. doi: 10.1111/ceo.12140. Epub 2013 Jul 5.
Clinical trial NCT06668129: Effects of a Postural Education Multicomponent Intervention in Primary School Children.
Official title: Effects of a Postural Education Multicomponent Intervention in Primary School Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Back Pain Lower Back
Lead sponsor: University of the Balearic Islands
Sponsor class: OTHER
Collaborators: name: State Research Agency, Spain
name: European Regional Development Fund
name: Ministry of Science and Innovation, Spain
First posted: 2024-10-31
Enrollment: 849
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study, named PEPE project, aims to study the effects of a 9-month postural educational multicomponent intervention on back health in schoolchildren. As well as, this project aims to examine the effectiveness of the intervention on teachers. Total of 2000 children aged 10 to 12 and 20 schools will be randomized into an intervention group (N=1000 children, N=10 schools) and a control group (N=1000 children, N=10 schools). A 9-months intervention program will be implemented. Participants will be evaluated three times: before the intervention (baseline, Month 0), after the intervention (post-test, Month 9) and 6 months after the intervention finished (follow-up, Month 15). The intervention will consist on: (1) nine oral presentations delivered at school, (2) multisubject teaching unit, (3) information campaign widespread by the school (i.e. posters, triptychs, school website, social networks, etc.), and (4) The Back-Care Day at school. The effectiveness of the intervention will be evaluated by means of primary outcomes which include the back-care knowledge of schoolchildren. As well as, a set of secondary outcomes such as daily postural habits, use of a backpack, and LBP prevalence in schoolchildren and among teachers involved will be studied. This intervention will provide new insights into the prevention of childhood LBP which may lead to a better management of this health problem throughout an individuals lifetime.


Eligibility criteria: Inclusion Criteria:

* Children aged between 10 and 12 years, who belonged to the fifth and sixth grades of primary school.

Exclusion Criteria:

* Children with some type of medical condition that may affect the results of the measurements or that present some limitation of their abilities that prevents the intervention program from developing normally.

Primary outcomes:
measure: Knowledge of back health
timeFrame: 16 weeks
Secondary outcomes:
measure: Daily postural habits
timeFrame: 16 weeks
measure: Backpack use
timeFrame: 16 weeks
measure: LBP prevalence
timeFrame: 16 weeks
measure: Back care knowledge
timeFrame: 16 weeks
measure: LBP prevalence and daily postural habits
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Palma
country: Spain
facility: University of the Balearic Islands
state: Illes Balears
Study officials:
References: