louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03923985: Clinical Trial to Evaluate the Effect of an Oral Probiotic on the Vaginal Flora
Official title: Clinical Trial to Evaluate the Effect of an Oral Probiotic (Food Supplement) Containing Lactobacillus Crispatus on the Vaginal Flora
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Flora
Keywords: Vaginal Flora
Oral Probiotics
Lead sponsor: Instituto Palacios
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Clinical trial to evaluate the effect of a probiotic containing Lactobacillus Crispatus on the vaginal flora


Eligibility criteria: Inclusion Criteria:

* Healthy women between 18 and 45 years old
* Women without current symptoms of vaginal infection
* Negative bacteriological and clinical examination

Exclusion Criteria:

* Women with vaginal infection
* Women with undiagnosed vaginal bleeding
* Patients with endometrial hyperplasia
* Suspicion of neoplasia or active neoplasia
* Women with intolerance, allergy or hypersensitivity to the components of the probiotic
* Women with immunosuppressive disorders or with HIV
* Women who are currently using probiotics by any route of administration
* Women who are using some treatment for vaginal sepsis
* Chronic decompensated noncommunicable diseases (diabetes mellitus, heart disease ...)
* Pregnant women or those with precocious menopause

Primary outcomes:
measure: Changes in the number of Lactobacillus Crispatus on the vaginal flora
timeFrame: Screening, month 2
Secondary outcomes:
measure: Changes in vaginal PH
timeFrame: Screening, month 2
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Palacios
Study officials:
affiliation: Instituto Palacios
name: Santiago Palacios, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05606185: Amount of Root Resorption of Maxillary Anteriors After en Masse Versus Two Step Space Closure
Official title: Amount of Root Resorption of Maxillary Anteriors After en Masse Versus Two Step Space Closure Using Cone Beam Computed Tomography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Root Resorption
Keywords: Two step retraction
En masse retraction
Cone Beam Computed Tomography
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to compare the three dimensional root resorption after extraction space closure in two groups: two step retraction and en masse retraction. Th main aim of this study is to conclude which method is less damaging to the roots.

Participants will be divided into two groups:

1. En masse retraction (experimental)
2. Two step retraction (control) Pre retraction and post retraction CBCT scans will be compared for both groups.


Eligibility criteria: Inclusion Criteria:

* Patients who signed the informed consent to be part of this study.
* Patients with Class I or Class II malocclusion.
* Patients requiring extractions of maxillary first premolars with absolute anchorage.
* Good periodontal status.

Exclusion Criteria:

* Patients who are syndromic or have cleft lip and/or palate.
* Patients with severe root dilacerations or root canal treated incisors.
* Patients receiving drugs that alter tooth movement.
* Patients with systemic disease like endocrinological disorders, vit D excess or deficiency, thyroid or parathyroid problems.
* Patients with history of trauma to dentition or impacted teeth in anterior maxilla.
* Patients who have undergone previous orthodontic treatment.

Primary outcomes:
measure: Root resorption
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: HIBA Tabassum, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05365685: Energy Turnover and Appetite
Official title: Effect of the Degree of Energy Turnover on Appetitive Responses in Adolescents With Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 18
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to compare the effect of a low versus moderate versus high energy turnover on energy intake, appetite and food reward, in adolescents with obesity. 18 adolescents with obesity will then complete three experimental sessions in a randomized order: low, high and moderate Energy turnover.

Detailed description: A total of 18 adolescents with obesity, aged 12-16 years olds will complete three experimental sessions in a randomized order: i) low energy turnover; ii) Moderate energy turnover and ; iii) High energy turnover. Their ad libitum energy intake at dinner will be assessed through an ad libitum buffet-type meal, their food reward assessed right before the dinner meal and their appetite sensation at regular intervals during the day.

Eligibility criteria: Inclusion Criteria:

* BMI percentile \> 97th percentile according to the french curves.
* ages 12-16 years old
* Signed consent form
* being registered in the national social security system
* no contraindication to physical activity

Exclusion Criteria:

Previous surgical interventions that is considered as non-compatible with the study.

* Diabetes
* weight loss during the last 6 months
* cardiovascular disease or risks

Primary outcomes:
measure: Energy intake measured during an ad libitum buffet meal (in kcal).
timeFrame: it will be assessed at dinner baseline
Secondary outcomes:
measure: Hunger feelings
timeFrame: immediately after breakfast/lunch/dinner on day 1
measure: Food reward
timeFrame: it will be assessed at dinner baseline
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Yves BOIRIE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02243085: Predictors of de Novo Urge Urinary Incontinence After Photoselective Vaporization of the Prostate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatic Hyperplasia
Urgency
Urinary Incontinence
Lead sponsor: DongGuk University
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 126
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men who underwent photoselective vaporization of the prostate using 80 watt potassium-titanyl-phosphate (KTP) laser or 120 watt high-power-system (HPS) laser for benign prostatic hyperplasia refractory to medical treatment

Brief summary: The aim of this study was to investigate the incidence of de novo urge urinary incontinence after the photoselective vaporization of the prostate for benign prostatic hyperplasia using the validated overactive bladder symptom score, and to determine the predictors of de novo urge urinary incontinence following the photoselective vaporization of the prostate.


Eligibility criteria: Inclusion Criteria:

* men in whom 6-months follow-up data were available
* men who did not complain of urge urinary incontinence based on the OABSS (overactive symptom score): OABSS question 4 score of ≤ 1

Exclusion Criteria:

* previous prostate or bladder surgery
* a previous diagnosis of urethral stricture or prostate carcinoma or bladder cancer or neurogenic bladder disease

Primary outcomes:
measure: de novo urge urinary incontinence at 6 months after surgery
timeFrame: 6 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Dongguk University ilsan Hospital
state: Gyeonggi-do
Study officials:
affiliation: DongGuk University
name: Min Chul Cho, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04714385: Medtronic PSR TDD PMCF
Official title: Product Surveillance Registry (PSR) - Targeted Drug Delivery (TDD) - SynchroMed II European Post-Market Clinical Follow-up (PMCF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Spasticity, Muscle
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2021-01-19
Enrollment: 209
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with SynchroMed II Model 8637 Programmable Pump who meet approved indications (Chronic pain and severe spasticity)

Brief summary: The purpose of this study is to provide continuing evaluation and reporting of safety and performance of the SynchroMed II Infusion System within its intended use. Data will support post-market surveillance obligations.

Detailed description: This study was originally posted under NCT01524276 and now posted alone to adapt to new ISO regulation.

Eligibility criteria: Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive or be treated with an eligible Medtronic product
* Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment
* The indication for implant meets approved indications
* The patient can reasonably be expected to remain fully on label for a 48-month time period after implant

Exclusion Criteria:

* Patient who is, or will be, inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
* There is no indication at enrollment (e.g., medical conditions, anticipated relocation, etc.) that the patient will be unable to complete 48 months of follow-up after implant

Primary outcomes:
measure: Pump accuracy
timeFrame: 4 years
Secondary outcomes:
measure: Pump survival
timeFrame: 4 years
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Brugge
city: Leuven
country: Belgium
facility: Leuven
city: Roeselare
country: Belgium
facility: Roeselare
city: Sint-Niklaas
country: Belgium
facility: Sint-Niklaas
city: Wilrijk
country: Belgium
facility: Wilrijk
city: Praha
country: Czechia
facility: Praha
city: Marseille
country: France
facility: Marseille
city: Enschede
country: Netherlands
facility: Enschede
city: Maastricht
country: Netherlands
facility: Maastricht
city: Ljubljana
country: Slovenia
facility: Ljubljana
city: Badalona
country: Spain
facility: Badalona
city: Madrid
country: Spain
facility: Madrid
city: Morges
country: Switzerland
facility: Morges
city: Nottwil
country: Switzerland
facility: Nottwil
city: Middlesbrough
country: United Kingdom
facility: Middlesbrough
Study officials:
References:
Clinical trial NCT01084785: Biobank Carcinoma: Storing Blood and Protein of Patients With Cancer
Official title: Storing Blood for Analysis of DNA and Protein of Patients With Cancer in MAASTRO Clinic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Cancer
genomics
proteomics
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
First posted: 2010-03-11
Enrollment: 10000
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: primary care clinic

Brief summary: The purpose of this study is to determine, by means of DNA and protein analysis, the relationship between DNA and protein profiles and a number of endpoints, which are important for the patient such as overall survival and side effects.

Detailed description: It has already been known for a long time that cancer is a genetic disorder and that the development of the illness is a very complex interaction between genetic and surrounding factors. Also the response on therapy and the development and seriousness of side effects is stipulated by this complicated collaboration of genetic and surrounding factors. Moreover it is not only the DNA that plays an important role but also the systems of control at protein level. At this moment a lot of questions remain to be answered because up till now the studies were of rather restricted statistic strength with frequently inconsistent dates and moreover retrospective. Major retrospective studies are necessary to distinguish the relationship between DNA/protein patterns and clinical relevant endpoints like prognosis and toxicity in which an as broad as possible patient group is being monitored. For this reason we want to take blood samples in MAASTRO clinic of all patients with lung cancer and to store it encrypted so that we can perform DNA and protein analyses in future and to correlate the results with survival and toxicity of the treatment.

Eligibility criteria: Inclusion Criteria:

* cancer

Exclusion Criteria:

* not able to comply with follow-up

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht Radiation Oncology
state: Limburg
Study officials:
affiliation: CCMO
name: Dirk De Ruysscher, Prof PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dehing-Oberije C, Aerts H, Yu S, De Ruysscher D, Menheere P, Hilvo M, van der Weide H, Rao B, Lambin P. Development and validation of a prognostic model using blood biomarker information for prediction of survival of non-small-cell lung cancer patients treated with combined chemotherapy and radiation or radiotherapy alone (NCT00181519, NCT00573040, and NCT00572325). Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):360-8. doi: 10.1016/j.ijrobp.2010.06.011. Epub 2010 Oct 1.
Clinical trial NCT00086385: Maintaining Nonsmoking: Older Smokers - 1
Official title: Maintaining Nonsmoking: Older Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tobacco Use Disorder
Keywords: Smoking cessation
Tobacco
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2004-07-07
Enrollment: 403
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to examine pharmacological and psychological interventions for smokers over 50.

Detailed description: The overall goals of this line of research were to prevent relapse to cigarette smoking, and to understand the processes related to smoking and relapse. The specific aims of the current study were to test a series of hypotheses about the efficacy and cost-effectiveness of long-term, tailored interventions in chronic, older smokers and the interaction of these interventions with gender and depression. Participants were 50 years or older and smoker 10 or more cigarettes per day. Baseline assessments includes measures of smoking behavior, nicotine dependence, depression diagnosis, demographics and life circumstances and measures of anger, depression and mood disturbance, stress, social support, health status, motivation for changed and drug and alcohol use.

Eligibility criteria: smokers of at least 10 cigarettes per day

Inclusion Criteria:

MULTIPLE

Exclusion Criteria:

MULTIPLE

Primary outcomes:
measure: Participants Abstinent From Cigarettes
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sharon M Hall, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnett PG, Wong W, Jeffers A, Munoz R, Humfleet G, Hall S. Cost-effectiveness of extended cessation treatment for older smokers. Addiction. 2014 Feb;109(2):314-22. doi: 10.1111/add.12404. Epub 2013 Dec 13.
citation: Hall SM, Humfleet GL, Munoz RF, Reus VI, Robbins JA, Prochaska JJ. Extended treatment of older cigarette smokers. Addiction. 2009 Jun;104(6):1043-52. doi: 10.1111/j.1360-0443.2009.02548.x. Epub 2009 Apr 9.
Clinical trial NCT01230385: Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects
Official title: Randomized, Open-Label, Parallel Group Study To Investigate The Safety And Tolerability Of Multiple Dose Lersivirine (Proposed Phase 3 Formulation) For 21 Days In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: lersivirine
UK-453
061
safety
tolerability
pharmacokinetics
HIV
non-nucleoside reverse transcriptase inhibitor
NNRTI
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: ViiV Healthcare
First posted: 2010-10-29
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate the safety and toleration of 2 different doses of lersivirine administered either fed or fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD (Phase 2b formulation). The pharmacokinetics of lersivirine in each group will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability of multiple doses of lersivirine administered to healthy subjects over 21 days.
timeFrame: 21 days
Secondary outcomes:
measure: Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7
timeFrame: 21 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01885585: Eliquis Regulatory Post Marketing Surveillance (rPMS)
Official title: Eliquis (Apixaban) Regulatory Post Marketing Surveillance in Clinical Practice for Venous Thromboembolism (VTE) Prevention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic Patients must be ≥19 years of age, at risk for venous thrombosis, and have elected to undergo total hip replacement arthroplasty or total knee replacement arthroplasty will be included in this study

Brief summary: The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Eliquis through collecting, reviewing, identifying and verifying the safety and effectiveness information about Eliquis in general practice


Eligibility criteria: Inclusion Criteria:

* Signed data release
* Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty

Exclusion Criteria:

* Being treated for an indication not approved for the use of Eliquis® in Korea
* Is contraindicated for the use of Eliquis® as described in the Korean label

Primary outcomes:
measure: Number of Adverse Events (AEs) and serious AEs
timeFrame: Up to 30 days after last study drug dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00069485: Resistance to HIV Infection
Official title: Evaluation of HIV-Specific Immunological and Virological Responses of HIV-1 Multiply-Exposed Seronegative Individuals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Keywords: HIV Seronegativity
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2003-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The immune systems of some individuals may be capable of resisting HIV infection. These individuals do not appear to be infected with HIV despite multiple sexual encounters with HIV infected partners. This study will examine the immune systems of these individuals to determine what factors are responsible for their ability to resist HIV infection.

Study hypothesis: Some long-term, multiply-exposed seronegative persons have relative resistance to HIV infection maintained by T cell responses.

Detailed description: Rare individuals appear naturally resistant to overt HIV-1 infection despite repeated sexual exposures. These individuals, referred to as exposed seronegatives (ES), represent a unique population in which to evaluate mechanisms by which HIV-1 replication is either controlled or aborted. The purpose of the study is to analyze HIV-specific immune responses, both cellular and humoral, that exist in seronegative individuals who have experienced multiple exposures to HIV by sexual contact.

This study will follow participants for 2 years. Participants will have 25 study visits during the study. Assessments will include HIV tests, viral load measurements, CD4 counts, pregnancy tests, and physical exams.

Eligibility criteria: Inclusion Criteria:

* Good general health
* HIV uninfected
* Repeated exposures to HIV through unprotected sexual intercourse within the 2 years prior to study entry
* Live in the greater Seattle area
* Plan to stay in the greater Seattle area for the 2 years after study entry

Exclusion Criteria:

* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center / University of Washington HIV Vaccine Trials Unit
state: Washington
Study officials:
affiliation: University of Washington
name: Julie McElrath, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: