louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05197998: Promoting ColorBRAVE Conversations in Families
Official title: Promoting ColorBRAVE Conversations in Families: A Public Health Strategy to Advance Racial Equity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Development
Parents
Prosocial and Emotional Well-Being
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Tufts University
name: University of Chicago
name: University of Illinois at Chicago
name: San Diego State University
First posted: 2022-01-20
Enrollment: 1200
Sex: ALL
Minimum age (years): 5
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Wait-list control design
Primary purpose: PREVENTION

Brief summary: The objective of this research is to evaluate a mobile app-based intervention for parents of children in K-2nd grade designed that guides them in how to have productive conversations about race with their children. This study will recruit a national sample of parents and their K-2nd grade children. The impact of the intervention is tested using a wait-list controlled trial design. Outcomes include prosocial behaviors and indicators of emotional well-being.


Eligibility criteria: Residence in the US; caregiver age 18 years or older and child age 5-8 years old; ability to read and understand English

Primary outcomes:
measure: Racial Socialization Frequency Scale
timeFrame: 0-12 months
measure: Racial Socialization Competency Scale
timeFrame: 0-12 months
measure: Cross-race Friendships
timeFrame: 0-12 months
measure: Colorblind Racial Attitudes (CoBRAS) Scale
timeFrame: 0-12 months
measure: Child Prosocial Behavior Questionnaire (CPBQ)
timeFrame: 0-12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Measures
timeFrame: 0-12 months
measure: Prosocial Children Measure
timeFrame: 0-12 months
measure: Child Bystander Response Questionnaire
timeFrame: 0-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
Study officials:
affiliation: Tulane University
name: David H. Chae, ScD, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01373398: Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)
Official title: Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetics of Intravesical Instillation of EO9 in Patients With Non-muscle Invasive Bladder Cancer(NMIBC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bladder Cancer
Keywords: bladder cancer
EO9
Apaziquone
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-15
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of intravesical instillation of EO9 in patients with non-muscle invasive bladder cancer (NMIBC).


Eligibility criteria: Inclusion Criteria:

* Patients who are clinically diagnosed as having stage Ta, T1, histological grade G1, G2 urothelial carcinoma of the bladder
* Patients who are confirmed to be urinary cytology negative (class I, class II) within 4 weeks prior to the present TURBT.
* P.S : 0-2 according to the ECOG.

Exclusion Criteria:

* Patients with a primary and solitary tumor.
* CIS lesions in the bladder or a history thereof.
* Grade 3 disease or a history thereof.
* Patients experiencing recurrence within 3 months following TURBT for prior NMIBC.
* Patients having stage T1 and high-grade disease.
* Invasive cancer of T2 or greater, with definite lymph node or other organ metastasis, or a history thereof.
* Patients who received intravesical chemotherapy/immunotherapy treatment within 6 months prior to the present TURBT.
* Patients who underwent systemic chemotherapy or radiotherapy whose field of exposure included the bladder.
* Patients with suspected bladder perforation at the time of the present TURBT.
* A complication of a malignant tumor of the upper urinary tract or urethra, or a history thereof.
* Malignancy within 5 years other than NMIBC (except thyroid cancer)
* A serious viral or bacterial infection within the last 4 weeks.

Primary outcomes:
measure: Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.)
timeFrame: 14 weeks
Secondary outcomes:
measure: pharmacokinetics assessment of EO9 and it's metabolites in blood and urine
timeFrame: before, 30, 55, 90 mins of EO9 instillation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Site 01
city: Seoul
country: Korea, Republic of
facility: Site 02
Study officials:
References:
Clinical trial NCT06730698: Thumb Muscle Thickness and Strength in CMC Osteoarthritis
Official title: Ultrasonographic Measurement of Thumb Muscle Thickness and Evaluation of Pinch and Grip Strength in First Carpometacarpal Joint Osteoarthritis: A Comparison of Early and Advanced Stages
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Beylikduzu State Hospital
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes patients aged 50-80 years with first carpometacarpal joint osteoarthritis, classified into early and advanced stages based on radiographs, excluding those with confounding medical or cognitive conditions.

Brief summary: A total of 34 patients aged between 50-80 years, diagnosed with first carpometacarpal joint osteoarthritis based on hand radiographs taken within the last 3 months, will be included in the study from the Physical Therapy and Rehabilitation outpatient clinic. Sociodemographic data such as age, gender, height, weight, and BMI will be recorded. Based on their current radiographs, patients will be classified into two groups according to the Eaton-Littler classification: Stage 1-2 (early stage) and Stage 3-4 (advanced stage). Pain levels will be assessed using the Visual Analog Scale (VAS). Hand grip strength will be evaluated with a Jamar hand dynamometer, and pinch grip strength will be assessed with a Jamar pinch meter. The thicknesses of the abductor pollicis brevis, first dorsal interosseous, and opponens pollicis muscles will be measured using ultrasound. All assessments will be performed separately for the dominant and non-dominant hands.


Eligibility criteria: Inclusion Criteria:

* Patients aged 50-80 years.
* Diagnosed with first carpometacarpal joint osteoarthritis.
* Presence of a hand radiograph taken within the last 3 months.
* Volunteered to participate in the study.

Exclusion Criteria:

* Refusal to participate in the study.
* Use of medications that may suppress osteoarthritis flares.
* Presence of rheumatologic diseases causing peripheral joint involvement.
* History of fractures or surgeries involving the first carpometacarpal joint.
* Presence of psychiatric disorders.
* Presence of cognitive impairments that could hinder understanding or performance of study-related tasks.

Primary outcomes:
measure: Thumb Muscle Thickness (Ultrasound)
timeFrame: 0 day
Secondary outcomes:
measure: Grip Strength
timeFrame: 0 day
measure: Pinch Strength
timeFrame: 0 day
measure: Pain Level (VAS)
timeFrame: 0 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
state: Beylikdüzü
Study officials:
affiliation: Beylikdüzü State Hospital
name: Büşra Şirin Ahısha
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05152498: Fu Zheng Jie Du Hua Yu Principle For Treatment Of Severe HBV Related Hepatocellular Carcinoma (FZJDHYPFTOSHBVHCC)
Official title: Forming a Comprehensive Treatment Plan for the Treatment of Hepatitis B Virus Related Hepatocellular Carcinoma With the Core Principles of Fuzheng Jiedu Huayu
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Hepatocellular Carcinoma
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The treatment of HBV related hepatocellular carcinoma has always been a worldwide problem. The aim of this study is to alleviate the progression of hepatitis B related hepatocellular carcinoma by the Chinese medicine "Fu Zheng Jie Du Hua Yu" Principle.


Eligibility criteria: Inclusion Criteria:

* Meet the criteria of hepatocellular carcinoma
* Ages Eligible for Study: ≤75 years old;
* Informed consent from the patient.

Exclusion Criteria:

* Serious problem of heart, lung, or kidney with severe dysfunction;
* Pregnant or child breast feeding women;
* Mental or cognitive disorders;
* Participating in other drug trials;
* Who are allergic to the study drug

Primary outcomes:
measure: Time to Progression
timeFrame: 1 year
Secondary outcomes:
measure: overall survival
timeFrame: 1 year
measure: progression-free survival
timeFrame: 1 year
measure: complete response
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhiyun Yang
state: Beijing
Study officials:
References:
Clinical trial NCT01242098: Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management
Official title: Retrospective, Real-life Observational, Matched Cohort Evaluation of the Effectiveness of BDP/FOR (Fostair® 100/6) and FP/SAL (Seretide® 125) in Patients Switching From Seretide to Fostair in UK Primary Care Asthma Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Combination therapy
Primary care management
Switch
ICS/LABA
Fostair
Seretide
Lead sponsor: Research in Real-Life Ltd
Sponsor class: NETWORK
Collaborators: name: Chiesi Farmaceutici S.p.A.
First posted: 2010-11-16
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving ICS/LABA therapy as FP/SAL (Seretide® 125) who, at an index prescription date (IPD) receive a routine asthma review\* and either:

(i) Switched to BDP/FOR (Fostair®)at same or lower BDP-equivalent ICS dose;

OR,

(ii) Continues on FP/SAL (Seretide® 125) for the duration of the outcome period at the same or lower BDP-equivalent ICS dose prescribed at baseline.

Brief summary: The purpose of this study is to evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide® 125) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched.


Eligibility criteria: Inclusion Criteria:

* Aged:

  * 18-60 years:
  * 61-80 years who are never-smokers
* Evidence of asthma:

  * a diagnostic code for asthma, or
  * ≥2 prescriptions for asthma at different points in time during the prior year
* Baseline FP/SAL therapy:

  * ≥2 prescription for ICS/LABA therapy as FP/SAL (Seretide® 125).

Exclusion Criteria:

* Any chronic respiratory disease other than asthma
* Are receiving maintenance oral steroid therapy during baseline period.

Primary outcomes:
measure: Exacerbation rate
timeFrame: One-year outcome period
Secondary outcomes:
measure: Exacerbation control (a composite proxy measure)
timeFrame: One-year outcome period
measure: Treatment success 1
timeFrame: One-year outcome period
measure: Asthma hospitalisations
timeFrame: One-year outcome period
measure: Compliance with ICS/LABA therapy
timeFrame: One-year outcome period
measure: Use of reliever medication
timeFrame: One-year outcome period
measure: Cost of therapeutic regimen.
timeFrame: One-year outcome period
measure: Asthma-related / respiratory hospitalisations
timeFrame: one year outcome period
measure: Oral Thrush
timeFrame: One-year outcome period
Other outcomes:
Locations:
city: Cawston
country: United Kingdom
facility: Optimum Patient Care
state: Norfolk
Study officials:
References:
Clinical trial NCT03905798: LORA-PITA IV General Investigation
Official title: LORA-PITA (REGISTERED) Intravenous Injection 2 mg General Investigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Status Epilepticus
Keywords: Status Epilepticus;
Lorazepam;
LORA-PITA;
Ativan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-04-05
Enrollment: 206
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.

Brief summary: Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan.

Detailed description: To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA for Status Epilepticus patients in Japan.

Eligibility criteria: Inclusion Criteria: Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.

Primary outcomes:
measure: Number of the Participants With Adverse Drug Reactions
timeFrame: From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.
Secondary outcomes:
measure: Proportion of Participants Whose Initial Seizure Stopped Within 10 Minutes After the Administration of Final Dose and Who Continued Seizure-free for at Least 30 Minutes (Participants in Whom LORA-PITA Was Used as the First-line Treatment)
timeFrame: From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.
measure: Proportion of Participants Whose Initial Seizure Stopped Within 10 Minutes After the Administration of Final Dose and Who Continued Seizure-free for at Least 30 Minutes (Efficacy Analysis Set)
timeFrame: From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer Local Country office
state: Shibuya-ku
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02129998: The Role of Progesterone and PIF for Successful Implantation and On-going Pregnancy in Assisted Reproductive Technology
Official title: The Role of Luteal Progesterone and Preimplantation Factor (PIF) for Successful Implantation and On-going Pregnancy in Assisted Reproductive Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Infertility
IVF/ICSI
Progesterone
Preimplantation Factor (PIF)
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
name: BioIncept LLC
First posted: 2014-05-02
Enrollment: 873
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing IVF/ICSI treatment at 4 Danish Fertility Centres.

Brief summary: The aim of this study is to achieve a more profound understanding of the endocrine alteration in luteal progesterone level after gonadotrophin stimulated IVF/ICSI cycles and to explore the optimal progesterone level needed for securing implantation and development of early pregnancy.

The second part of the project will determine the value of Preimplantation Factor (PIF) measurement in embryo culture medium as a possible tool for improved embryo selection and the use of PIF as an early pregnancy serum marker for healthy implantation and embryo development.

IVF: In vitro fertilisation, ICSI: Intracytoplasmic sperm injection.


Eligibility criteria: Inclusion Criteria:

-All women undergoing IVF/ICSI treatment at the participating clinics in either antagonist protocol or long agonist protocol will be offered participation.

Exclusion Criteria:

-Prior participation in the study

Primary outcomes:
measure: On-going pregnancy rate
timeFrame: 10th week of gestation
Secondary outcomes:
measure: Implantation rate
timeFrame: 7th week of gestation
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: The Fertility Clinic Skive
Study officials:
References:
citation: Thomsen LH, Kesmodel US, Erb K, Bungum L, Pedersen D, Hauge B, Elbaek HO, Povlsen BB, Andersen CY, Humaidan P. The impact of luteal serum progesterone levels on live birth rates-a prospective study of 602 IVF/ICSI cycles. Hum Reprod. 2018 Aug 1;33(8):1506-1516. doi: 10.1093/humrep/dey226.
Clinical trial NCT00096798: Ethyl Eicosapentanoic Acid (Ethyl-EPA) for Treating Major Depression
Official title: A Double-Blind, Placebo-Controlled Study of Ethyl Eicosapentanoic Acid (Ethyl-EPA) in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder
Depression
Keywords: Fatty Acids, Omega-3
Antidepressive Agents
Eicosapentanoic Acid
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-11-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effectiveness of ethyl-eicosapentanoic acid (ethyl-EPA), an omega-3 fatty acid, in treating depression.

Detailed description: Evidence suggests that omega-3 fatty acids may help reduce symptoms of depression. This study will determine whether ethyl-EPA, an omega-3 fatty acid, can be used safely and effectively to treat major depression.

Participants will be randomly assigned to receive either ethyl EPA-containing pills or placebo daily for 8 weeks. Each week, participants will be asked to complete questionnaires which will be used to assess the severity of their depression.

Eligibility criteria: Inclusion Criteria:

* Major depressive disorder

Exclusion Criteria:

* Serious comorbid psychiatric disorder
* Unstable medical illness
* Prior use of any omega-3 fatty acid product

Primary outcomes:
measure: Alleviation of depressive symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: David Mischoulon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
citation: Mischoulon D, Papakostas GI, Dording CM, Farabaugh AH, Sonawalla SB, Agoston AM, Smith J, Beaumont EC, Dahan LE, Alpert JE, Nierenberg AA, Fava M. A double-blind, randomized controlled trial of ethyl-eicosapentaenoate for major depressive disorder. J Clin Psychiatry. 2009 Dec;70(12):1636-44. doi: 10.4088/JCP.08m04603. Epub 2009 Aug 25.
Clinical trial NCT03065998: Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction
Official title: Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction: Medical and Cognitive Effects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Drug Abuse
Lead sponsor: Ministry of Health, Israel
Sponsor class: OTHER_GOV
First posted: 2017-02-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is examining the combination of two FDA approved drugs, Opipramol and baclofen, which may increase rehabilitation from psychoactive substances. Previous studies have indicated a connection of sigma-1 receptor to cocaine abuse and raised the possibility that these receptors as mediators of drug craving . However previous studies showed partial efficacy with no significant relapse in relapse rates. The same is true for the use of GABAb-1 receptor antagonist. Opipramol is a selective agonist for sigma-1 receptor. It is clinically used as an antidepressant and anxiolytic agent. Moreover, previous open and controlled trials indicated that the GABAb-1 antagonist baclofen partial efficacy in suppressing withdrawal symptoms in alcohol addicts and cocaine. Our studies in an animal model for addiction have shown a significant effect of the combine treatment of the indicated medications both in decreasing relapse and increase of -number of respondents.


Eligibility criteria: Inclusion Criteria:

* Age will be 60-18, both sexes, seeking treatment in order to stop the consumption of materials

Exclusion Criteria:

* Did not include trial addicts with co-morbidity, kidney, heart, metabolic, neurological and psychiatric disorders (psychosis, chronic depression).

Primary outcomes:
measure: Decreased craving
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bet Shemesh
country: Israel
facility: Retorno rehabilitation center
Study officials:
affiliation: Bar Ilan University
name: Gal Yadid, PhD
role: PRINCIPAL_INVESTIGATOR
References: