louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04721093: Effects of Photobiomodulation on Changes in Cognitive Function and rCBF in MCI
Official title: Effects and Safety Evaluation of Changes in Cognitive Function of Photobiomodulation Treatment for Patients With Mild Cognitive Impairment (MCI): Single-institutional Prospective Clinical Trial, Single Group, Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Cerebral Blood Flow
Mild Cognitive Impairment
Cognitive Function
Keywords: Photobiomodulation
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 14
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with Mild Cognitive Impairment
Primary purpose: TREATMENT

Brief summary: This pilot study has two goals. The first is to see if the cognitive improves when VA and CA are stimulated in MCI patients, and the second is to do an explanatory data analysis to see if that improves cognitive in relation to the rCBF improvement.

Detailed description: After being informed about the study and potential risks, all patients giving written informed codsent sill undergo a 1 day screening period to determine eligibility for study entry. Subjects who pass the screening test will receive a registration number within 7 days and proceed with the pre-intervention test as follows.

Eligibility criteria: Inclusion Criteria:

* The patients with mild cognitive impairment(MCI). The MCI was diagnosed based on medical history and neurological examination
* A sufficient level of education to understand study procedures and be able to communicate with site personnel

Exclusion Criteria:

* Any psychiatric disorders such as schizophrenia that would compromise participation
* Those with central nervous system disease
* Serious cognitive problems(MoCA score 7 or less).

Primary outcomes:
measure: Korean Version of Montreal Cognitive Assessment(MoCA) score change
timeFrame: Baseline and week 8
measure: Single photon emission computed tomography(SPECT) z-score change
timeFrame: Baseline and week 8
measure: The verbal learning test(VLT) score change
timeFrame: Baseline and week 8
measure: The trail making test(TMT) score change
timeFrame: Baseline and week 8
measure: Boston naming test(BNT) score change
timeFrame: Baseline and week 8
measure: Rey complex figure test(RCFT)-'copy' score change
timeFrame: Baseline and week 8
measure: Rey complex figure test(RCFT)-'Immediate Recall' score change
timeFrame: Baseline and week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeongsang
country: Korea, Republic of
facility: Pusan national university Yangsan Hospital
state: Yangsan
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Yong-il Shin, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03190993: The DEB Pilot Study
Official title: The Diet Composition and Energy Balance Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Physiological Phenomena
Obesity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Martin, Corby, K., M.D.
name: Owen T. Carmichael
First posted: 2017-06-19
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized parallel arm design trial examining solid sugar vs. SSB treatments will be performed.
Primary purpose: PREVENTION

Brief summary: The purpose of the current study is to test if weight change is differentially affected by consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food form over 1 month.

Detailed description: Dose: Participants are to consume 1 unit per day of the study product.

Diet: Participants will receive no instructions for other dietary modifications; i.e., they will not be told to modify what or how much other food they consume.

Eligibility criteria: Inclusion Criteria:

* BMI 20 - 40

Exclusion Criteria:

* Diabetes (Type 1 or 2)
* Prediabetes
* Active cancer
* Serious digestive disorders
* Other conditions that affect metabolism or body weight
* Uncontrolled Thyroid disorder (controlled = 6 months of medication)
* Unable to consume study foods
* Non- weight stable (more than 10 lbs weight gain or loss in last 6 months)
* Pregnancy
* Intentions of becoming pregnant in the next 2 months
* Women who have undergone partial hysterectomy with intact ovary function
* Current or past alcohol or drug abuse problem
* Allergy or intolerance to study product ingredients.
* Any other medical, psychiatric or behavioral factors that in the judgment of the Principle Investigator that may interfere with study participation or the ability to follow the protocol

Primary outcomes:
measure: Change From Baseline in Body Weight
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT04808193: European Perioperative Brugada Survey
Official title: European Perioperative Brugada Survey
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brugada Syndrome
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this survey is to assess the current perception and clinical practice of Resident and Board-certified Anaesthesiologists and Intensivists regarding perioperative care of patients burdened with the Brugada Syndrome. It is intended to investigate this primarily on national and secondarily on European level.


Eligibility criteria: Inclusion Criteria:

* All participants must have received an invitation to participate in the survey through the online platform of the European Society of Anaesthesiology and Intensive Care.

Exclusion Criteria:

* Uninvited participation in the survey is not possible.

Primary outcomes:
measure: Questionnaire about treatments for Brugada patients
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussel
Study officials:
References:
Clinical trial NCT02873793: Analysis of Transposon Control Pathways in Germinal Cancers of the Testicle
Official title: Analysis of Transposon Control Pathways in Germinal Cancers of the Testicle
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Germinal Cancers of the Testicle
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men with germinal testicular cancer

Brief summary: By analogy with the mouse, the activity of control pathways for transposable elements (TE) in foetal primordial germinal cells could prove to be a determinant for fertility in adulthood in humans. Moreover, defects in the control of transposable elements (TE) could also contribute to the aetiology of germinal testicular cancer, by inducing chromosomal instability and tumorigenesis. In this context, the aim is to analyse a specific type of adult germinal testicular cancers, seminomas. Directly related to our research interest, the histological, transcriptomic and epigenetic features of theses adult tumours are reminiscent of germinal cells normally present in foetuses. The investigator postulates that these similarities could also extend to the biology of transposable elements (TE), and in particular to the initiation of the control of these elements. The management of seminomas requires surgery, orchiectomy, which consists of the total excision of the affected testicles. Using high-resolution high-throughput sequencing techniques, we propose to analyse the control pathways of transposable elements (TE) in tumour samples harvested from surgical pieces in comparison with adjacent healthy tissue. The results obtained in these tumour samples will be compared with those in normal foetal gonad samples.


Eligibility criteria: Inclusion Criteria:

* men who have provided oral consent
* men with germinal testicular cancer with negative or low serum markers (Alpha Foeto Protein AFP and Human Chorionic Gonadotrophin hCG), indicators of a seminomatous-type tumour
* men who have undergone orchiectomy (total excision of the affected testicle)
* confirmation of the diagnosis of seminomatous or non-seminomatous type by histology of the surgical piece
* absence of hepatitis B or C or infection with human immunodeficiency virus (HIV).

Exclusion Criteria:

* men without national health insurance cover
* Adults under guardianship

Primary outcomes:
measure: The role of Transposable Element in tumorigenesis seminomas adults
timeFrame: through the study completion up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT00138593: Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With Hemoglobin A1c (HbA1c) 9-11%
Official title: Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-30
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is not being conducted in the United States. This is a 52-week extension to a study to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range. The purpose of the extension study is to gather data on the long term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Only patients successfully completing study CLAF237A2329 are eligible
* Written informed consent
* HbA1c reduction from baseline to week 12 (visit 5) of the core study is greater than or equal to 0.3 absolute units
* Ability to comply with all study requirements

Exclusion Criteria:

* Premature discontinuation from study CLAF237A2329
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Safety in combination with pioglitizone after 52 weeks of treatment
measure: Change from baseline in HbA1c at 52 weeks
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose at 52 weeks
measure: Change from baseline in fasting lipids at 52 weeks
measure: Change from baseline in body weight at 52 weeks
measure: Change from baseline in HOMA B at 52 weeks
measure: Change from baseline in HOMA IR at 52 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Ligueros-Saylan M, Foley JE, Schweizer A, Couturier A, Kothny W. An assessment of adverse effects of vildagliptin versus comparators on the liver, the pancreas, the immune system, the skin and in patients with impaired renal function from a large pooled database of Phase II and III clinical trials. Diabetes Obes Metab. 2010 Jun;12(6):495-509. doi: 10.1111/j.1463-1326.2010.01214.x.
Clinical trial NCT05395793: In-person Focus Groups in the Management of Urinary Incontinence in Women
Official title: The Role of In-person Focus Groups in the Management of Urinary Incontinence in Women From a Mixed-methods, Randomized Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 10
Sex: FEMALE
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: Adult women with incontinence who are able to attend all three focus groups

Brief summary: The purpose of this study is to investigate how a support group with other individuals who share the condition urinary incontinence (UI) impacts patients experience with management of urinary incontinence.

Detailed description: Focus groups in various settings have demonstrated the ability to alleviate psychological and physiological distress in focus group participants. The exploration of focus groups is warranted to measure the potential benefit for patients with urinary incontinence. Researchers aimed to assess the feasibility and acceptability of in-person focus groups as a potential intervention for female patients with urinary incontinence from a mixed methods approach. A mixed methods pilot study will be conducted to investigate whether in-person focus group demonstrate meaningful significance in quantitative outcomes measured by validated questionnaires and qualitative outcomes analyzed from focus group transcripts and post-session surveys. This study was an initial assessment to determine whether in-person focus groups for females with UI is strong enough to warrant further research and clinical implementation.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* English-speaking
* Have the ability to commute to the meeting facility without institutional assistance

Exclusion Criteria:

• Those unable to attend all three focus group sessions

Primary outcomes:
measure: Change in mixed urinary incontinence symptoms
timeFrame: Baseline, 12 weeks
measure: Change in urinary distress
timeFrame: Baseline, 12 weeks
measure: Change in overactive bladder satisfaction with treatment
timeFrame: Baseline, 12 weeks
measure: Change in urinary tract condition severity
timeFrame: Baseline, 12 weeks
measure: Change in urinary tract condition improvement
timeFrame: Baseline, 12 weeks
measure: Change in sexual quality of life
timeFrame: Baseline, 12 weeks
measure: Change in Patient Health Questionnaire
timeFrame: Baseline, 12 weeks
measure: Change in physical activity
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Measure feasibility and acceptability of focus group
timeFrame: Baseline, 2 weeks, 4 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Aqsa Khan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05698693: Social Determinants of Sleep and Obesity
Official title: Social Determinants of Sleep and Obesity: Culturally Informing a Sleep Extension Intervention for African American Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Insufficient Sleep
Physical Inactivity
Sedentary Behavior
Obesity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The study uses qualitative interviews (Aim 1; n=10) to inform the adaptation of a sleep intervention for African American adults with overweight/obesity, short sleep, and physical inactivity. The feasibility, satisfaction, and preliminary efficacy will be tested (Aim 2) using a 2-armed randomized control trial (n=80).
Primary purpose: PREVENTION

Brief summary: African American adults sleep less and obtain worse quality sleep compared to the national average, and emerging evidence links inadequate sleep with greater morbidity and mortality from chronic diseases such as diabetes, obesity, and cancer. To address this public health concern, the proposed research seeks to use a multi-method approach to adapt a sleep intervention for African American adults with overweight/obesity not meeting national sleep duration or physical activity recommendations. The overall goal of the project is to reduce cancer and obesity-related health disparities among African Americans.


Eligibility criteria: Inclusion Criteria:

* Not meeting Physical Activity Guidelines
* age range: 21 to 65 years
* body mass index range: 25.0 to 40 kg/m2
* average self-reported habitual sleep duration of ≤6 hours
* self-identify as Black or African American.

Exclusion Criteria:

* Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)
* pregnant or less than 4 months postpartum
* infant living in household less than 1 year old

Primary outcomes:
measure: Feasibility
timeFrame: 4 weeks
measure: Satisfaction
timeFrame: 4 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ivan Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02726893: A Predictive Model for Inadequate Bowel Preparation Before Colonoscopy: Development and Validation
Official title: A Predictive Model for Inadequate Bowel Preparation Before Colonoscopy: Development and Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Cleansing Quality
Predictors
Colonoscopy
Boston Bowel Preparation Scale
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 1504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. patients undergoing colonoscopy.
2. patients older than 18 years.

Brief summary: About 30% of patients were reported to suffer inadequate bowel preparation.

Detailed description: Risk factors, such as diabetes, constipation, history of intra-abdominal or pelvic surgery, etc, have been demonstrated to be important predictors for inadequate bowel preparation. The aim of the study is to create and verify a predictive model for inadequate bowel preparation in Chinese.

Eligibility criteria: Inclusion Criteria:

* patients undergoing colonoscopy.
* patients older than 18 years.

Exclusion Criteria:

* patients referred for emergency colonoscopy.

Primary outcomes:
measure: inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) score.
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Li Yanqing, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02317393: Contribution of the Imaging to the Expression of intégrines αvβ3 for the Characterization of Residual Masses of Non-seminoma Tumors at the End of Chemotherapy
Official title: A Prospective,Multicenter, Phase II Study to Evaluate the Contribution of the Imaging TEP to the Expression of intégrines αvβ3 for the Characterization of the Residual Masses of Non-seminoma Tumors at the End of Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-seminomatous Germ Cell Tumors
Metastasis
Keywords: Nuclear medicine
Positron emission tomography
avb3 integrin expression
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2014-12-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the contribution of the imaging to the expression of intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at the end of chemotherapy.

The investigators hope that the results of this first stage of the clinical trial come to consolidate the preclinical results obtained by the investigators team to characterizing the interest and the strong contribution of the use of a tracer resting on the expression of αvβ3 integrine for the diagnosis of simple necrosed mass at the end of the treatment of a non-seminoma tumor, so allowing to defer a surgery to about 40 % of the patients.


Eligibility criteria: Inclusion Criteria:

* Man or woman aged 18 years or more
* Patients with one or several ganglionic or visceral residual masses (\> to 1 cm) after chemotherapy for metastatic non-seminoma testicular tumor, and for which or which a surgery is planned;
* Affiliate to a social security system;
* Signed written Informed consent

Exclusion Criteria:

* Patient deprived of liberty as a result of a justice or administrative decision
* Any medical or psychological condition which could compromise the capacity of the patient to participate in the study;
* Previous or concomitant other cancer in 5 years except basal cell carcinomas

Primary outcomes:
measure: Proportion of teratoma
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Metabolic profile
timeFrame: up to 10 weeks
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU
city: Caen
country: France
facility: Centre François Baclesse
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Rouen
country: France
facility: CHU Rouen
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Centre François Baclesse, CAEN, France
name: Nicolas AIDE, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Côte de Nacre, CAEN, France
name: Arnaud DOERFLER, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Henri Becquerel, ROUEN, France
name: Pierre VERA, Dr
role: PRINCIPAL_INVESTIGATOR
References: