louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01339936: Evaluation of the Effect of Repeated Usage on the Tear Film Characteristics of an Investigational Eye Drop in Dry Eye Sufferers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dry Eye Syndrome
Lead sponsor: Optometric Technology Group Ltd
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2011-04-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main objectives of the investigation will be to assess the effect of the repeated usage of an investigational eye drop on the tear film characteristics of dry eye sufferers and demonstrate the benefit of this eye drops for dry eye sufferers.


Eligibility criteria: Inclusion Criteria:

* Mild or greater dry eye symptoms.
* Evidence of evaporative dry eye

Exclusion Criteria:

* Known allergy or sensitivity to the study product(s) or its components
* Current contact lens wearer
* Systemic or ocular allergies
* Use of systemic medication which might have ocular side effects.
* Any ocular infection.
* Use of ocular medication.

Primary outcomes:
measure: Tear Film Evaporation Rate
timeFrame: after 30 days of eyedrop usage
Secondary outcomes:
measure: Tear Break Up Time
timeFrame: after 30 days of eyedrop usage
measure: Ocular Surface Disease Index Score
timeFrame: after 30 days of eye drop usage
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: OTG Research & Consultancy
state: England
Study officials:
References:
Clinical trial NCT00380536: Medical Self-Management for Improving Health Behavior Among Individuals in Community Mental Health Settings
Official title: Adapting a Medical Self-Management Program for a Community Mental Health Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Mental Illness
Keywords: Peer-led Education
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-09-26
Enrollment: 111
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: This study will evaluate the effectiveness of a medical illness self-management program in improving the health and health behavior of people who are receiving care at a community mental health center.

Detailed description: People with serious mental disorders tend to have shorter life expectancies and elevated rates of unhealthy behaviors and chronic illnesses. Peer-led medical illness self-management programs have been shown to be effective in improving the health and health behaviors of people with chronic medical conditions. This type of intervention, however, has yet to be systematically tested in individuals with mental disorders. Community mental health centers provide care to many people of low socioeconomic status who lack medical insurance. This study will evaluate the effectiveness of a medical illness self-management program in improving the health and health behaviors of people who are receiving care at a community mental health center.

Participants in this study will be randomly assigned to either partake in peer-led medical illness self-management group sessions or receive care as usual. Participants assigned to care as usual will continue to receive any services they would have otherwise been offered, but will not receive any additional services through the study. Participants assigned to the medical illness self-management program will attend group sessions once a week for 6 weeks. Sessions will focus on medical self-management, healthy behaviors, and effective use of the general medical system.

Eligibility criteria: Inclusion Criteria:

* Currently receiving treatment at Dekalb Community Service Board
* Chronic disease

Exclusion Criteria:

* History of more than two psychiatric or medical hospitalizations within the year prior to study entry

Primary outcomes:
measure: Patient activation
timeFrame: Measured at Months 6 and 12
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Measured at Months 6 and 12
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Winn Way Mental Health Center
state: Georgia
city: Decatur
country: United States
facility: Clifton Springs Mental Health Center
state: Georgia
Study officials:
affiliation: Emory University
name: Benjamin Druss, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01397136: Cell-free DNA: a Non-invasive Test for Assessing Embryo Quality
Official title: Cell-free DNA: a Non-invasive Test for Assessing Embryo Quality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Culture Media
DNA
Keywords: Human embryo
Culture media
Cell-free DNA
In vitro fertilization
Infertility
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor class: OTHER
Collaborators: name: Merck Serono S.A., Geneva
First posted: 2011-07-19
Enrollment: 600
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Culture media from human embryos collected at day 2-7 after in-vitro fertilization.

Brief summary: In the present project we propose to deeply characterize nuclear and/or mitochondrial DNA in embryo culture medium, in order to investigate whether both cell-free nucleic acid types may provide additional, reliable, predictive parameters for embryo viability and implantation potential.


Eligibility criteria: Inclusion Criteria:

* We will enroll in the study only embryos obtained from fresh gametes. It is to note that we currently transfer more than one embryo (with a maximum of 3, according to patient's age) and we will follow such criteria alongside the project. Consequently, we will take into consideration this aspect in correlating DNA parameters with embryo's outcome.

Exclusion Criteria:

* We will exclude cryopreserved embryos, in order to avoid potential biases due to cooling/defrosting procedures.

Primary outcomes:
measure: Isolation and characterization of nuclear and/or mitocondrial DNA into embryo culture medium
timeFrame: Month 6 of the project
Secondary outcomes:
measure: Prediction of high quality embryos according to molecular profiling of cell-free DNA released into culture medium.
timeFrame: Month 12 of the project
measure: Publication of scientific reports.
timeFrame: Month 12 of the project
measure: Dissemination of results by participating at national and international meetings, workshops and specific courses.
timeFrame: Months 3-12 of the project
Other outcomes:
Locations:
city: Genova
country: Italy
facility: IRCCS AOU San Martino-IST
state: GE
Study officials:
affiliation: UOS Physiopathology of Human Reproduction, IRCCS AOU San Martino-IST, Genoa, Italy
name: Paola Scaruffi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stigliani S, Anserini P, Venturini PL, Scaruffi P. Mitochondrial DNA content in embryo culture medium is significantly associated with human embryo fragmentation. Hum Reprod. 2013 Oct;28(10):2652-60. doi: 10.1093/humrep/det314. Epub 2013 Jul 25.
citation: Stigliani S, Persico L, Lagazio C, Anserini P, Venturini PL, Scaruffi P. Mitochondrial DNA in Day 3 embryo culture medium is a novel, non-invasive biomarker of blastocyst potential and implantation outcome. Mol Hum Reprod. 2014 Dec;20(12):1238-46. doi: 10.1093/molehr/gau086. Epub 2014 Sep 17.
Clinical trial NCT03035136: Retrospective Study on Epidemiology of Colorectal Lesions
Official title: Retrospective Study on Epidemiology of Colorectal Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ColoRectal Cancer
Colonic Polyp
Colonic Neoplasms
Keywords: polyps
Lead sponsor: Lyell McEwin Hospital
Sponsor class: OTHER_GOV
First posted: 2017-01-27
Enrollment: 2658
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All colonoscopies performed in Lyell McEwin Hospital between 2010 and 2016.

Brief summary: Retrospective analysis on colonoscopies in the endoscopy unit of the Lyell McEwin Hospital.

Detailed description: Colonoscopy reports will be manually searched by the investigator to evaluate epidemiology on colorectal lesions.

Eligibility criteria: Inclusion Criteria:

* Colonoscopies performed in Lyell McEwin Hospital between 2010-2016

Exclusion Criteria:

* Sigmoidoscopies

Primary outcomes:
measure: Adenoma detection rate
timeFrame: Day 1
Secondary outcomes:
measure: SSA/P detection rate
timeFrame: Day 1
measure: Polyp detection rate
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05051436: The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
Official title: The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pre-diabetes
Obesity
Keywords: Tadalafil
Mirabegron
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-09-21
Enrollment: 96
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigator hypothesizes that treatment with the ß3 agonist mirabegron results in improved glucose metabolism, including a reversal of prediabetes in obese, insulin-resistant human research participants, and this is further improved by combination therapy with tadalafil. The investigator will comprehensively analyze glucose homeostasis in prediabetic patients treated for 14 weeks with mirabegron, tadalafil or both drugs as compared to a placebo.


Eligibility criteria: Inclusion Criteria:

* Hemoglobin A1C between 5.7 and 6.4
* Body mass index between 27 and 45

Exclusion Criteria:

* Diabetes
* Chronic use of any antidiabetic medications
* Any unstable medical condition
* Use of steroids or daily use of NSAIDS
* History of chronic inflammatory conditions
* Use of anticoagulants
* Contraindications to the use of mirabegron or tadalafil
* Any condition deemed risky by the study physician

Primary outcomes:
measure: Oral glucose tolerance test
timeFrame: Baseline
measure: Oral glucose tolerance test
timeFrame: 14 weeks
Secondary outcomes:
measure: Hemoglobin A1C
timeFrame: Baseline
measure: Hemoglobin A1C
timeFrame: 14 weeks
Other outcomes:
measure: Fat biopsy
timeFrame: Baseline
measure: Fat biopsy
timeFrame: 14 weeks
measure: Muscle biopsy
timeFrame: Baseline
measure: Muscle biopsy
timeFrame: 14 weeks
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Philip Kern, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00767936: Viral & Host Factors Associated With Hepatitis B Virus-related Hepatocellular Carcinoma
Official title: Viral and Host Factors Associated With Development of Hepatitis B Virus-related Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Cancer
Hepatitis B
Hepatitis C
Hepatobiliary Cancers Liver
Hepatobiliary Cancers
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-10-07
Enrollment: 135
Sex: MALE
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: liver cancer and non-cancer liver conditions

Brief summary: Adult liver cancer is the third leading cause of cancer deaths worldwide. The major risk factor for liver cancer is hepatitis B virus (HBV) infection. The purpose of the study is to sequence the HBV genome in patients with chronic HBV infection, and in patients with liver cancer resulting from chronic HBV infection. The goal is to identify mutations in the HBV genome that predisposes these high risk individuals to the development of liver cancer.


Eligibility criteria: Inclusion Criteria:1. Patients diagnosed with liver cancer based on biopsy or serum AFP level, associated with characteristic hypervascular liver tumors on triphasic spiral CT scan or MRI.

2. Patients with non-cancer liver conditions such as cirrhosis, adenoma, cholangioma, or nodular hyperplasia.

3. Patients with hepatitis B or hepatitis C viral infections not associated with liver cancer. Exclusion Criteria:No other patients except those listed above will be recruited. Additionally, patients will be excluded if, upon looking through their medical records, information required for data analysis are missing.

Primary outcomes:
measure: identify mutations in the hepatitis B virus genome that predisposes these high risk individuals to the development of liver cancer
timeFrame: one time
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Samuel So
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01707836: Neurofibromatosis Type 1 Brain Tumor Genetic Risk
Official title: Genetic Variation and Risk of Pediatric Brain Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurofibromatosis Type 1
Pediatric Brain Tumor
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 176
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Families will be recruited from the Washingington University Neurofibromatosis-1 (NF1) Patient Registry Initiative (NPRI) and NF Center Clinic.

Brief summary: This study will analyze DNA samples to determine associations between maternal and offspring genetic factors and pediatric brain tumor development in children with Neurofibromatosis Type 1. Participating families (mother, father, child) will be asked to complete a short questionnaire and provide DNA samples (either saliva or blood). The information gained from your participation may one day help doctors develop strategies to reduce brain tumor risk in individuals with NF1. Please note: there is no therapy associated with this study.

Detailed description: The prenatal period is a developmentally vulnerable time point during which environmental conditions, including nutrition, can have life-long impacts on health.1,2 This is particularly relevant to many childhood cancers that are thought to initiate during pregnancy.3 As a consequence, there has been intense interest in whether prenatal exposures can modulate childhood cancer risk.4-6 It is important to recognize that both maternal and offspring genetic factors including those in nutritional pathways may play an important role in pediatric cancer risk through their effect on the child's exposure to nutrients important in development during the prenatal period. The purpose of this research study is to evaluate whether there are any maternal or offspring genetic factors in the folate pathway that may contribute to the development of brain tumors in children with Neurofibromatosis Type 1 through analysis of DNA samples collected from families.

Eligibility criteria: Inclusion Criteria:

* Pediatric participant (born during 1994-2012) with NF1 and diagnosed with a brain tumor
* Biological mother or father (or full sibling if mother or father is unable to participate) able to participate
* All family members (pediatric participant, biological mother, and biological father or full sibling) must be willing to contribute a blood or saliva sample
* ability to understand consent forms

Exclusion Criteria:

-those who do not meet inclusion criteria

Primary outcomes:
measure: Brain Tumor
timeFrame: September 1, 2012-February 1, 2014
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Kimberly J Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05125536: The Effect of Music in Alzheimer's Patients
Official title: The Effect of Music on Decreasing of Adaptation Difficulty in Alzheimer's Patients: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer's disease
Music
Adaptation difficulty
Nursing care
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was randomized controlled study conducted to determine the effect of Nihavent theme on reducing adjustment difficulties in Alzheimer's patients.

The study was carried out with 30 patients.15 patients constituted the experimental group and 15 patients formed the control group. Before the application, the scale was administered to both groups through face-to-face interviews. The patients in the experimental group were informed about the music session in advance.Instrumental songs in nihavent theme were played with the sound system to the experimental group. The sessions were lasted 12 weeks in total and there were two sessions per week, and each session took approximately 50 minutes to complete. While no intervention was performed for the patients in the control group. One week after the last music session, the the scale was re-administered to both groups.

Detailed description: Adaptation levels of Alzheimer's patients should be determined before planning nursing interventions. Institutions should support healthcare personnel in organizing music sessions for patients. It is believed that further studies examining the effect of the Nihavent theme in decreasing adaptation difficulty in Alzheimer's patients should be conducted with larger sample groups. The effects of verbal and non-verbal music on Alzheimer's patients should also be evaluated and compared to gain further insight on this important matter.

Eligibility criteria: Inclusion Criteria:

* 18-90 age range
* Were conscious able to communicate and active

Exclusion Criteria:

* Change in their diagnosis, medications, consciousness, and/or drug dose
* During the study period they a regression in emotional state (crying, sadness)
* Those with complex diseases such as cancer

Primary outcomes:
measure: Assessment Scale of Adaptation Difficulty for Elderly
timeFrame: 24 days
Secondary outcomes:
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University
state: Odunpazarı
Study officials:
References:
Clinical trial NCT06637436: PrEP Readiness Interventions for Sustained Motivation (PRISM)
Official title: Optimizing HIV Prevention for Highly Vulnerable Methamphetamine-using Sexual Minority Men
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: HIV
Methamphetamine Disorders
Keywords: HIV prevention
Methamphetamine
Motivational Interviewing
Contingency Management
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This is a hybrid type I, factorial randomized controlled trial to test the comparative and combined effectiveness of contingency management (CM), motivational interviewing (MI), and MI+CM for optimizing entry or re-entry into the PrEP care continuum. A total of 840 participants will be randomized to CM (n = 280), MI (n = 280), or MI+CM (n = 280), all delivered via Telehealth. Monthly follow-up assessments will be completed over 12 months to examine differential effectiveness for the primary outcome - filling a PrEP prescription (verified using a digital photo or detectable tenofovir diphosphate). Secondary outcomes will include: self-reported PrEP clinical evaluation by a PrEP provider; self-reported meth and other substance use severity (ASSIST), and self-reported receptive and insertive condomless anal sex (CAS).


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Assigned male a birth
* Assigned male at birth
* Self-reported methamphetamine use (past 3 months)
* Not on PrEP

Exclusion Criteria:

* Unwilling or unable to provide informed consent

Primary outcomes:
measure: Proportion of Participants with Verified PrEP Use
timeFrame: 12 Months
Secondary outcomes:
measure: Median Time to Verified PrEP Use
timeFrame: 12 Months
measure: Clinical Cut Points for Self-Reported Methamphetamine Use Severity
timeFrame: 12 Months
measure: Proportion of Participants Reporting Insertive Condomless Anal Sex (CAS)
timeFrame: 12 Months
measure: Proportion of Participants Reporting Receptive Condomless Anal Sex (CAS)
timeFrame: 12 Months
measure: Proportion of Participants with Prevention Effective PrEP Use
timeFrame: 12 Months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University Stempel College of Public Health and Social Work
state: Florida
Study officials:
References: