louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04308655: Obstetric Pain Management for Women With Opioid Use Disorder (QUEST)
Official title: Obstetric Pain Management for Women With Opioid Use Disorder: A Longitudinal, Qualitative Mixed-methods Evaluation of Patients and Provider Perspectives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-use Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 33
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: This study will enroll pregnant adults with opiate use disorder (on medication assisted therapy) who are currently in their third trimester.

Brief summary: This is a mixed methods longitudinal observational study to assess patient and provider perspectives on pain and pain management among pregnant women with opiate use disorder (OUD). The findings from this study will inform patient-centered approaches to pain management. Themes surrounding mothers' pain/recovery experiences that correlate with quantified pain and analgesia endpoints will be identified. Findings will also shape an appropriate patient-centered research agenda for obstetric pain management in patients with OUD.

Detailed description: A fine understanding of the attitudes and beliefs about pain and its management for patients with opioid use disorder is currently lacking. These psychological aspects of pain and analgesia are expected to have significant effects on nociception, pain experience, analgesic efficacy, and opioid requirements and its subsequent risks for relapse/treatment noncompliance. There is also have little understanding of provider-held attitudes and beliefs which can influence pain and its treatment for this population.

The findings from this study will inform patient-centered approaches to pain management for obstetric patients with OUD. They will also shape an appropriate patient-centered research agenda for obstetric pain management in patients with OUD. This work will find new patient-centered endpoints for this special population that may be currently overlooked with existing standard pain assessments.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who are 18 years of age or older
* History of opioid use disorder, on medication assisted therapy
* Currently in their third trimester

Exclusion Criteria:

* Unable to participate in informed consent discussions
* Unable to give informed consent for any reason
* Not fluent in English (surveys are validated in English language)
* Unable to participate fully in all study procedures for any reason

Primary outcomes:
measure: Themes surrounding mothers' pain/recover experience
timeFrame: Through study completion, an average of 6 weeks (from enrollment through labor and delivery)
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Magee Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Grace Lim, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00239655: A Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by Magnetic Resonance Imaging (MRI)(0812-003)(COMPLETED)
Official title: A Randomized, Double-Blind Placebo Controlled, Parallel Groups Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by MRI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Relapsing-Remitting Multiple Sclerosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test MK0812 on disease activity in patients with relapsing-remitting MS. Disease modifying activity will be assessed by measurement of brain lesions via MRI brain scans and an open label extension is offered.


Eligibility criteria: Inclusion Criteria:

* Patients must have clinically definite relapsing-remitting MS onset within last 10 years and have had at least 1 objective clinical exacerbation in the last year OR a recent clinically isolated syndrome suggestive of MS occurring 3-12 months before screening
* Patients must be relatively healthy

Exclusion Criteria:

* Patient has primary progressive MS

Primary outcomes:
measure: Accrual rate of new GD-enhancing lesions as assessed by MRI
timeFrame: 3 Months
Secondary outcomes:
measure: Volume and cumulative number of new persistent Gd-enhancing lesions
timeFrame: 3 Months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00207714: An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis
Official title: A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
CNTO 148
Methotrexate
Joint pain
Arthritis
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Centocor BV
First posted: 2005-09-21
Enrollment: 172
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: Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.

Detailed description: This is an experimental medical research study. The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis.

Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 20, 22, 28, 36, 44 for 48 weeks

Eligibility criteria: Inclusion Criteria:

* Diagnosis of RA according to the American College of Rheumatology criteria for at least 3 months prior to screening
* Have active Rheumatoid Arthritis at the time of screening and at baseline, as defined by 6 or more swollen joints and 6 or more tender joints and additional laboratory criteria

Exclusion Criteria:

* Have other inflammatory diseases, including but not limited to ankylosing spondylitis, systemic lupus erythematosus, Lyme disease
* Received disease-modifying antirheumatic drugs (\[DMARDs\] eg, D penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, interleukin \[IL\]-1 receptor antagonist \[anakinra\], azathioprine, sulphasalazine, agents other than MTX) within 4 weeks prior to the first study dose

Primary outcomes:
measure: Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Summary of ACR-N, Index of Improvement at Week 16
timeFrame: Week 16
Other outcomes:
Locations:
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Kay J, Matteson EL, Dasgupta B, Nash P, Durez P, Hall S, Hsia EC, Han J, Wagner C, Xu Z, Visvanathan S, Rahman MU. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study. Arthritis Rheum. 2008 Apr;58(4):964-75. doi: 10.1002/art.23383.
Clinical trial NCT01830114: A Web App for Patients With Alcohol and Drug Use Problems in Primary Care
Official title: A Web App for Patients With Alcohol and Drug Use Problems in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Drug Abuse
Keywords: alcohol abuse
drug abuse
hazardous alcohol use
hazardous drug use
Lead sponsor: Behavior Therapy Associates, LLP
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2013-04-12
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this pilot study is to evaluate the feasibility and technical merit of a web application for patients in primary care called Check-up and Choices (CC).

Detailed description: The overall objective of this project is to develop, evaluate, and disseminate a web application called Check-up and Choices (CC). CC will be developed for use in primary care. It would tightly integrate screening for heavy drinking and drug use, a brief motivational intervention for hazardous or heavy drinkers, a moderation training protocol for less dependent problem drinkers, and an abstinence-oriented protocol for more dependent drinkers and drug abusers. The brief motivational intervention will be tailored to the patient's age. Its purpose will be to motivate problem drinkers to change their drinking. The action-oriented moderation and abstinence protocols are cognitive-behavioral interventions (CBIs) that provide patients with the skills to maximize their chances of success with changing their drinking and/or drug use.

The investigators have already developed these elements but they are not integrated into a single program with appropriate branching between them. Nor has the content been tailored for use in primary care.

Eligibility criteria: Inclusion Criteria:

* physicians,
* nurses,
* nurse practitioners,
* physician's assistants,
* psychologists embedded in primary care settings, and
* other mental health counselors embedded in primary care settings.

Primary outcomes:
measure: Feasibility Questionnaire
timeFrame: Within 1 month of enrollment with an expected average of 1 week..
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Behavior Therapy Associates, LLC
state: New Mexico
Study officials:
References:
Clinical trial NCT05966714: Neonatal Electrical Activity at Different Altitude Levels
Official title: Neonatal Electrical Activity at Different Altitude Levels: A Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Altitude Hypoxia
Neonatal Encephalopathy
Keywords: altitude
neonate
Amplitude integrated electroencephalography
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 531
Sex: ALL
Minimum age (years): 0
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy neonates at different altitude levels

Brief summary: In this study, the objective is to compare neonatal cerebral electrical activity within 3 days after birth across different altitude areas using amplitude-integrated electroencephalography (aEEG), and establish reference value for each altitude level.


Eligibility criteria: Inclusion Criteria:

1. Singleton term infants (gestational age between 37 0/7 and 41 6/7 weeks) born in the participating hospital.
2. Infants appear well as defined by normal vital signs (heart rate ranging from 110 to 180 beats/min, respiratory rate ranging from 30 to 60 breaths/min, temperature ranging from 36.5°C to 37.5°C), absence of signs of illness such as cyanosis, respiratory distress and heart murmur.
3. The mother is permanent residence of the current altitude level and live in the study area for the entire duration of pregnancy.

Exclusion Criteria:

1. Need for supplemental oxygen or assisted ventilation.
2. Any evidence of intrauterine distress such as meconium-stained amniotic fluid, Apgar score \<7 at 1 or 5 min.
3. Referred to neonatal intensive care unit or neonatology department for any reason other than observation.
4. With major congenital anomaly.
5. Probes cannot be properly placed due to scalp lesions or hematomas.
6. Reject or withdraw from the study.

Primary outcomes:
measure: Differences in aEEG indicators in neonates within three days after birth at different altitudes
timeFrame: within three days after birth
Secondary outcomes:
measure: Establish reference values for each altitude level
timeFrame: within three days after birth
Other outcomes:
Locations:
city: Kunming
country: China
facility: Yangfang Li
state: Yunnan
city: Shanghai
country: China
facility: Children Hospital of Fudan University
Study officials:
References:
Clinical trial NCT03139214: Parenting Intervention and Metabolic Syndrome
Official title: Parenting Intervention and Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of Georgia
First posted: 2017-05-03
Enrollment: 391
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention involved 7 parenting sessions with mothers and their children that taught nurturant parenting techniques, effective communication skills, and about the importance of developing and following household rules.
Primary purpose: PREVENTION

Brief summary: This study aimed to test the effect of a parenting intervention on metabolic syndrome in African American youth. The investigators hypothesized that a parenting intervention would produce reductions in metabolic syndrome, particularly for those families that started out high in difficulties with parenting.

Detailed description: In this study, the investigators conducted a parenting intervention (Strong African American Families, or SAAF). Families (mothers with their 11 year old child) were randomized to either the parenting intervention or to a control group. Those in the intervention group received 7 group sessions with the parent and child aimed at promoting better family relationships. Those in the control group received 3 mailings about child development and stress management. At age 25, youth were assessed on metabolic syndrome. The investigators hypothesized that the parenting intervention would produce reductions in metabolic syndrome relative to the control group, particularly for those families that started out high in difficulties with parenting.

Eligibility criteria: Inclusion Criteria: 5th graders -

Exclusion Criteria: None

-

Primary outcomes:
measure: Metabolic syndrome diagnosis (based on International Diabetes Federation criteria using a clinical assessment of obesity, blood pressure, cholesterol, glucose)
timeFrame: 14 years post-intervention
measure: Metabolic syndrome components
timeFrame: 14 years post-intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00911014: Access to Healthcare, Patient Comprehension and Future Plans of Women Undergoing Surgery for a Vesicovaginal Fistula in Niamey, Niger
Official title: Access to Healthcare, Patient Comprehension and Future Plans of Women Undergoing Surgery for a Vesicovaginal Fistula in Niamey, Niger
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vesicovaginal Fistula
Delivery of Healthcare
Lead sponsor: Ascher-Walsh, Charles, M.D.
Sponsor class: INDIV
First posted: 2009-06-01
Enrollment: 58
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who underwent surgery for repair of vesciovaginal fistula in Niamey, Niger

Brief summary: Evaluate access to healthcare, comprehension of pre-operative counseling and post-operative goals of women treated for vesicovaginal fistula in Niger through use of a questionnaire.


Eligibility criteria: Inclusion Criteria:

* Women who underwent surgery for repair or vesicovaginal fistula

Exclusion Criteria:

* None

Primary outcomes:
measure: Access to healthcare
timeFrame: 1 year
Secondary outcomes:
measure: Comprehension of pre-operative counselling
timeFrame: 1 year
measure: Post-operative goals of women undergoing repair of vesicovaginal fistula
timeFrame: 1 yr
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount SInai School of Medicine
state: New York
Study officials:
affiliation: Mt Sinai School of Medicine, Dept Obstetrics and Gynecology
name: Charles Ascher-Walsh, MD, MS
role: STUDY_DIRECTOR
References:
citation: Meyer L, Ascher-Walsh CJ, Norman R, Idrissa A, Herbert H, Kimso O, Wilkinson J. Commonalities among women who experienced vesicovaginal fistulae as a result of obstetric trauma in Niger: results from a survey given at the National Hospital Fistula Center, Niamey, Niger. Am J Obstet Gynecol. 2007 Jul;197(1):90.e1-4. doi: 10.1016/j.ajog.2007.03.071.
Clinical trial NCT05679414: Prevalence of Thrombophilic Gene Polymorphism (MTHFR C677T) in COVID-19patients
Official title: Prevalence of Thrombophilic Gene Polymorphism (MTHFR C677T) in Egyptian Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID 19 Associated Coagulopathy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed as COVID -19 by RT-PCR

Brief summary: Aim of the study is to find the prevalence of thrombophilic gene methylene tetrahydrofolate reductase (MTHFR) gene polymorphism in a sample of COVID-19 patients, aiming at early detection of MTHFR mutant patients and guiding preventive therapy.

Detailed description: The inflammatory component of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) creates a prothrombotic state that necessitates a thrombophylactic strategy for hospitalized patients. Such strategies are difficult to be standardized because certain individuals can have prothrombotic conditions, such as inherited thrombophilia, which predispose them to an additional coagulative risk. Whether outside the hospital or when admitted, patients with inherited thrombophilia need special anticoagulant attention. Identifying such patients, especially in susceptible populations like the Egyptian people, will aid primary providers in risk stratification for choosing the optimal anticoagulation plan. Case-control study which will be conducted on 33 patients who had been diagnosed as COVID-19 at Ain-Shams University isolation Hospitals and 13 healthy controls. Patients will be subjected to: Thorough history taking, Thorough clinical assessment,COVID-19 PCR+/- radiological data collection, Assessment of MTHFR C677T genotypes were determined by RT- PCR of 2 ml EDTA blood sample, Follow up patient for 28 days as regard development of vascular thrombotic manifestation (D. dimer, LL duplex, or CT chest with Pulmonary angiography if needed).

Eligibility criteria: Inclusion Criteria:

* All adult patients diagnosed as COVID -19 by RT-PCR will be included

Exclusion Criteria:

* Patients younger than 18 years old Patients on Antithrombotic treatment before COVID-19.

Primary outcomes:
measure: development of vascular thrombotic manifestation
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Eman B AbdelFattah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01094314: Impact of Culture Medium on Embryo Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embryo Development
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2010-03-26
Enrollment: 790
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare two culture media.


Eligibility criteria: Inclusion Criteria:

* Embryos of patients younger than 36 years old

Exclusion Criteria:

* Embryos of patients older than 36 years old

Primary outcomes:
measure: embryo quality: number and size of blastomeres, degree of fragmentation
timeFrame: day 1 -day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven, Catholic University Leuven
Study officials:
References:
citation: Paternot G, Debrock S, D'Hooghe TM, Spiessens C. Early embryo development in a sequential versus single medium: a randomized study. Reprod Biol Endocrinol. 2010 Jul 7;8:83. doi: 10.1186/1477-7827-8-83.
Clinical trial NCT03160014: Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment
Official title: Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment (Single-Center, Open-label, Parallel-Group, Single-Dose Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-05-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the pharmacokinetics/Pharmacodynamics of the SHR3824 in Patients With Mild, Moderate and Severe Hepatic Impairment Compared with Healthy Volunteers.


Eligibility criteria: Inclusion Criteria:

* 18 years to 75 years (inclusive)
* Body mass index should be between 18 and 33 kg/m2 (inclusive) (ie, a measure of one's weight in relation to height)
* Liver damage due to viral hepatitis, alcoholic liver disease, autoimmune hepatitis, primary biliary cirrhosis of the liver (except for patients with drug-induced liver injury)

Exclusion Criteria:

* allergic to SGLT2 inhibitor analogues or any other similar structure;
* lactose intolerance history or lactose intolerance;
* Suspected or diagnosed as liver cancer or with other malignant tumors;
* Alcoholic liver, autoimmune liver disease, liver transplantation history

Primary outcomes:
measure: The area under the plasma concentration-time curve (AUC) of SHR3824
timeFrame: 72 hours after dosing
measure: The maximum plasma concentration (Cmax) of SHR3824
timeFrame: 72 hours after dosing
Secondary outcomes:
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: 72 hours after dosing
Other outcomes:
Locations:
city: XiAn
country: China
facility: XiJing Hospital
state: Shanxi
Study officials:
References: