louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01554215: Mom Power is an Attachment Based Parenting Program for Families and Their Children
Official title: Phase 1 of Mom Power: Attachment Based Parenting and Self-Care Skills Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parenting
Keywords: parenting
child behavior
attachment
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 419
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mom Power is a weekly attachment based parenting program aimed to increase parenting and self-care skills for families.


Eligibility criteria: Inclusion Criteria:

* Participants ages 15+ years with at least one child , interested in learning about parenting and willing to attend weekly sessions in group setting.
* Participants must be willing to be both videotaped and audio taped for research purposes
* must speak English as their first language.

Exclusion Criteria:

* Participants with no children 0-6 or younger than 15. Participants not willing to attend weekly sessions or participate in group/at home control.

Primary outcomes:
measure: Psychopathology
timeFrame: 3 months
Secondary outcomes:
measure: Parenting
timeFrame: 3 months
measure: Maternal Mental Representations
timeFrame: 3 months
measure: Connection to Care
timeFrame: 3 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Department of Psychiatry
state: Michigan
Study officials:
affiliation: University of Michigan Department of Psychiatry
name: Maria Muzik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenblum KL, Muzik M, Morelen DM, Alfafara EA, Miller NM, Waddell RM, Schuster MM, Ribaudo J. A community-based randomized controlled trial of Mom Power parenting intervention for mothers with interpersonal trauma histories and their young children. Arch Womens Ment Health. 2017 Oct;20(5):673-686. doi: 10.1007/s00737-017-0734-9. Epub 2017 Jun 25.
Clinical trial NCT02093715: FeNO and Cytokines in Respiratory Syncytial Virus (RSV) and Non RSV Bronchiolitis in Relation to Future Asthma
Official title: FeNO and Cytokines in RSV and Non RSV Bronchiolitis in Relation to Future Asthma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Bronchiolitis
Keywords: Bronchiolitis
FeNO
Asthma
wheezing, RSV
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-03-21
Enrollment: 400
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children ages 2 weeks to 2 years who will arrive to Dana Children's hospital, Tel-Aviv Medical Center due to first episode of shortness of breath and working diagnosis of bronchiolitis.

Brief summary: The purpose of this study is to determine Fractional exhaled Nitric-Oxide (FeNO)levels and blood cytokines during acute bronchiolitis, and to seek for correlation between these markers and future development of asthma.


Eligibility criteria: Inclusion Criteria:

* First episode of shortness of breath
* Children in ages 2 weeks to 2 years

Exclusion Criteria:

* Any chronic disease
* Congenital anomalies

Primary outcomes:
measure: Physician diagnosed asthma
timeFrame: At the age of 4 years
Secondary outcomes:
measure: Fractional exhaled Nitric Oxide (FENO) level
timeFrame: During acute bronchiolitis, after 2 and 6 months
Other outcomes:
measure: Wheezing episode
timeFrame: From recruitment time till the age 4.
measure: PCR for respiratory viruses
timeFrame: At recruitment
Locations:
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
References:
Clinical trial NCT01395615: An Observational Study on The Health Related Quality of Life in Patients With Chronic Lymphocytic Leukaemia
Official title: Utility Measurement Study for Patients With Chronic Lymphocytic Leukaemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphocytic Leukemia, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-07-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic lymphocytic leukaemia

Brief summary: This observational study will assess the health related quality of life (HQRL) profiles of patients with chronic lymphocytic leukaemia. Using health assessment questionnaires, data will be collected from patients currently receiving therapy and from those who have finished therapy and have undergone an assessment of treatment.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Patients with chronic lymphocytic leukaemia
* Patients receiving 1st line therapy
* Patients receiving 2nd line therapy. This will include patients who previously have responded well to 1st line therapy (relapse was \>12 months after finishing the 1st line therapy) and are receiving the same therapy again
* Within the past three months, patients whose treatment has been stopped after 2-3 cycles of 1st or 2nd line therapy and who have not received any further therapies
* Patients receiving their 3rd, 4th, 5th or 6th cycle of 1st or 2nd line therapy
* Patients who have completed therapy, are considered stable and are between 3-12 months post therapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

* Clinically significant disorder (other than chronic lymphocytic leukaemia and chronic lymphocytic comorbidities) or any other condition, including alcohol or drug abuse, which may interfere with study participation or affect study conclusions
* Mental disability or significant mental illness, legal incapacity or limited legal capacity
* Current high degree of comorbid burden that might affect the accuracy of the quality of life data

Primary outcomes:
measure: Quality of life: EuroQol Group EQ-5D questionnaire
timeFrame: 18 months
measure: Quality of life: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire
timeFrame: 18 months
measure: Quality of life: EORTC QLQ-CLL16 (chronic lymphocytic leukaemia) questionnaire
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Taunton
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03060915: Actigraphy Sleep Parameters in Obstructive Sleep Apnea Patient's
Official title: Comparison of Actigraphy Sleep Parameters vs Polysomnography Sleep Parameters in OSA Patient's
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Actigraphy
Polysomnography
Obstructive Sleep Apnea
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Those patient's that come to the sleep unit and that accept to participate in the study will undergo a polysomnography with the extra of an actigraphy placed in their no dominant arm wrist. The outcomes that will be analyzed are:

Time in bed, assumed sleep time, wake time, sleep efficiency, sleep latency, light's on/light's off


Eligibility criteria: Inclusion Criteria:

* Patient's with OSA suspicion undergoing a PSG in the sleep unit

Exclusion Criteria:

* Neurologic disorders
* Severe comorbidities
* Other sleep disorders, such as insomnia
* No informed consent

Primary outcomes:
measure: Sleep time (min)
timeFrame: 3 months
Secondary outcomes:
measure: sleep efficiency
timeFrame: 3 months
measure: Wake time
timeFrame: 3 months
measure: sleep latency
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Hospital Clinic
name: Josep Maria Montserrat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03045315: LXR and Oocyte Meiosis Resumption
Official title: Are LXRs Involved in Regulation of Human Oocyte Meiosis Resumption?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Infertility
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Previous studies in animal model showed clearly that lipid homeostasis influence oocyte meiosis resumption. However Liver X Receptors pathway has never been investigated in human ovocyte

Detailed description: In mice deficient of Liver X Receptor (LXR) genes, the oocytes are unable to resume meiosis. Oxysterols are molecules derived from the cholesterol synthesis pathway. They are ligands of the liver X receptors (LXRs). In human, the LXR signalling pathway has never been investigated in this process. The Investigator propose to analyse in granulosa cells surrounding ovocyte the expression of LXR, their target genes and the enzymes involved in oxysterols synthesis. These granulosa cells are normally retrieved and destroyed 18 hours after sperm insemination of oocytes in a In Vitro Fertilization program. The oocyte meiosis resumption will be considered as positive (Granulosa cell positive, GC+) if a zygote is observed 18 hours after sperm insemination and negative (Granulosa cell negative, GC-) if none zygote appears. Moreover the investigator will analyse the quality of embryo development during 5 days after zygote is formed (normal process of In Vitro Fertilization) . The both populations of granulosa cells (GC+ and GC-) will be compared. The measurements of Liver X Receptor genes and the enzymes involved in oxysterols pathways xill be performed by Reverse Transcription-Polymerase Chain Reaction. The accumulation of lipid in granulosa cells will be measures by oil red staining. By this sudy the investigator will probably find new biological markers of resumption meiosis for women enrolled in In Vitro Fertilization programm. Moreover, data will help to better understand the physiopathology of oocyte meiosis failures.

Eligibility criteria: Inclusion Criteria:

* woman aged less 37 years
* included in a IVF program
* tubal infertility
* ovarian stimulation with recombinant FSH
* induced ovulation by recombinant chorionic gonaotrophin

Exclusion Criteria:

* dysovulation
* male infertility
* Ovarian insuficiency

Primary outcomes:
measure: Expression of RNAs of LXR pathways in granulosa cells surrounding oocyte
timeFrame: at day 1
Secondary outcomes:
measure: Accumulation of lipid in granulosa cells surrounding oocyte
timeFrame: at day 5
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Florence BRUGNON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06281015: Artificial Intelligence and Bone Tomoscintigraphies Achieved With CZT Camera
Official title: Ultra-Fast Whole-Body Bone Tomoscintigraphies Achieved With a High-Sensitivity 360° CZT Camera and a Dedicated Deep Learning Noise Reduction Algorithm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Lesion
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Nineteen cancer patients (8 women, 11 men) referred to fast whole-body bone single photon emission tomography for detection or follow-up of bone metastasis were retrospectively included in this study.

Brief summary: This study aimed to determine whether the whole-body bone Single Photon Emission Computed Tomography (SPECT) recording times of around 10 minutes, routinely provided by a high-sensitivity 360 degrees cadmium and zinc telluride (CZT) camera, can be further reduced by a deep learning noise reduction (DLNR) algorithm.

Detailed description: This study aimed to determine the extent to which fast whole-body bone-SPECT recording times, routinely obtained with a high-sensitivity 360 degrees CZT-camera and rather low injected activities, can be further reduced using the DLNR algorithm.

Eligibility criteria: Inclusion Criteria:

* patients referred to fast whole-body bone single photon emission tomography for detection or follow-up of bone metastasis

Primary outcomes:
measure: Assess a dedicated deep learning noise reduction algorithm
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre les Nancy cedex
country: France
facility: CHRU Nancy
Study officials:
References:
Clinical trial NCT06834815: Investigating the Bactericidal Effect of Probiotics on Chromogenic Bacteria in Children An In Vivo and In Vitro Study
Official title: Effect of Probiotics on Chromogenic Bacteria and Extrinsic Stains in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Black Stains
Keywords: probiotics
chromogenic bacteria
black stains
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 9
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: probiotics
Primary purpose: TREATMENT

Brief summary: To investigate the bactericidal effect of probiotics (Streptococcus salivarius M18 and Lactobacillus reuteri) on two types of bacteria (Aggregatibacter actinomycetemcomitans and Actinomyces naeslundii) causing black stains of teeth in vitro.

Detailed description: In vitro:

An unstimulated salivary sample will be taken from patients having black stains. The two types of bacteria of each condition will be cultured, amplified, and measured in the laboratory from the saliva of these patients. After that, one type of probiotics will be applied to these bacteria separately and the same bacterial measurement will be done to evaluate the bactericidal effect of the probiotics on these bacteria, aiming to find the minimal inhibitory concentration of the probiotics.

Eligibility criteria: Inclusion Criteria:

* Patients with black stains on teeth scored via modified Lobene index scores 1-3.
* Medically free patients

Exclusion Criteria:

* Stains other than black.
* Patients on antibiotic treatment or any other medication for the last 2 weeks.
* Patients allergic to prophylaxis powder.
* Parents refusing to participate

Primary outcomes:
measure: chromogenic bacterial count before and after probiotic application
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dentistry .Ain shams university
Study officials:
References:
Clinical trial NCT00505115: The Human Blastocyst Secretome and Implantome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blastocyst
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2007-07-23
Standard ages: CHILD
ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE

Brief summary: The aim of this study is to identify the protein secretion and consumption profile of the human blastocyst (secretome) and the implanted blastocyst (implantome) using the protein array technology.


Eligibility criteria: Inclusion Criteria:

* Conditioned medium of blastocytes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Fundación para la Investigación del Instituto Valenciano de Infertilidad (FIVI)
Study officials:
affiliation: Fundación para la Investigación del Instituto Valenciano de Infertilidad (FIVI)
name: Carlos Simon, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02070315: Quantitative Evaluation of the Progression of Liver Disease, Using ShearWaveTM
Official title: Quantitative Evaluation of Liver Disease With Liver and Kidney Elastography Using the Supersonic Imagine Aixplorer ShearWaveTM Elastography Ultrasound Machine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Disease
Heart Failure
Keywords: heart failure
liver failure
post liver transplant
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 1000
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: participants will be from Liver Consultants of Texas patient population

Brief summary: Liver biopsy for the assessment of fibrosis has multiple limitations. Liver ShearWaveTM Elastography may provide a non-invasive, fast, and reproducible alternative for the quantitative assessment of liver fibrosis.

Detailed description: To obtain a quantitative evaluation of the progression of liver disease, using ShearWaveTM Elastography measurements obtained with the Supersonic Imagine Aixplorer ultrasound machine.

To compare the glomerular filtration rate and the quantitative evaluation of the progression of renal disease, using ShearWaveTM Elastography measurements obtained with the Supersonic Imagine Aixplorer ultrasound machine in post-liver transplantation patients.

Eligibility criteria: Inclusion Criteria:

* Males and Females over the age of 18
* Patients of Liver Consultant's of Texas Dallas office, with chronic liver disease or liver transplant patient seen in Liver Transplant Clinic
* Patients diagnosed with heart failure

Exclusion Criteria:

- Any person unable to provide an informed consent

Primary outcomes:
measure: Shearwave Elastography Ultrasound
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: James Trotter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00138515: Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes
Official title: Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes
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: 418
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone. 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 CLAF237A2303 are eligible
* Written informed consent
* Ability to comply with all study requirements

Exclusion Criteria:

* Premature discontinuation from CLAF237A2303
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Safety of vildagliptin in combination with metformin during 52 weeks of treatment
measure: Change from baseline in HbA1c at 52 weeks
Secondary outcomes:
measure: Change in HbA1c between 24 weeks and 52 weeks
measure: Change from baseline in fasting plasma glucose at 52 weeks
measure: Change in fasting plasma glucose between 24 weeks and 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: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
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 NCT04904315: Subjects Through the Application of the Mindera Kit Part 2
Official title: An Exploratory, Multicenter, Observational Study to Examine RNA Biomarkers of Psoriasis Subjects Through the Application of the Mindera Kit Part 2 (STAMP-2).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psoriasis
Lead sponsor: Mindera Health
Sponsor class: INDUSTRY
First posted: 2021-05-27
Enrollment: 100
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: Male and female subjects who are 18 years of age or older with a diagnosis of psoriasis.

Brief summary: A 16 week study to examine if baseline or on-therapy transcriptomics can be used to help predict selection of medications and provide new therapeutic targets for drug development in psoriasis subjects.


Eligibility criteria: Inclusion Criteria

1. Subject must have the ability to understand and sign written informed consent.
2. Subject must be an adult male or female adult who is ≥ 18 years of age at the time of screening.
3. Subject must be diagnosed with psoriasis by either a dermatologist or a rheumatologist, with the affected area of ≥ 2 centimeters in diameter.
4. Subjects must be treated with anti-TNF-α (or biosimilar) therapy once enrolled in the study.A two-week period is required to washout of the previous biologic when switching therapies.

Exclusion Criteria

1. Subject is unable or unwilling to give written informed consent and/or to comply with study procedures.
2. Subject has had usage of topical psoriasis treatments on study lesion within 2 weeks prior to baseline studyvisit and unwilling to washout.
3. Subjects currently treated with Hydroxychloroquine (Plaquenil), unless otherwise approved by Sponsor

Primary outcomes:
measure: Observation of on therapy transcriptomics to potentially aid in new therapeutic targets
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CSO
name: Toby Dickerson
role: STUDY_CHAIR
References: