louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06953934: A Mass Balance Study of Oral [14C] ABBV-932 in Healthy Adult Male Participants
Official title: Mass Balance Study of [14C] ABBV-932 Following Single Oral Dose Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
ABBV-932
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-05-01
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective of this study is to assess the safety and tolerability of ABBV-932 in healthy adult male participants.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 29.9.0 kg/m\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
* Male participant who is not considering fathering a child or donating sperm during the study and for 100 days after the study drug administration
* A condition of general good health, based upon the results of a medical history, physical exam

Exclusion Criteria:

* Has not participated in another \[14C\] absorption, distribution, metabolism, excretion (ADME) study with a radiodose above 0.1 MBq in the period of 12 months prior to screening.
* Use of any medications/products known to alter drug absorption, metabolism, or excretion processes, within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration.
* Prior exposure to ABBV-932 or cariprazine within the past 90 days.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of ABBV-932
timeFrame: Up to approximately 86 days
measure: Time to Cmax (Tmax) of ABBV-932
timeFrame: Up to approximately 86 days
measure: Terminal phase elimination rate constant (λz) of ABBV-932
timeFrame: Up to approximately 86 days
measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-932
timeFrame: Up to approximately 86 days
measure: Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932
timeFrame: Up to approximately 86 days
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932
timeFrame: Up to approximately 86 days
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to approximately 103 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02857634: Confocal Microscopy Dual Band in the Management of Bladder Cancer
Official title: Study of the Contribution of Confocal Microscopy Dual Band in the Management of Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Bladder Neoplasm
Keywords: Urinary Bladder cancer
diagnosis
Cellvizio Dual Band
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients following a tumor resection of the bladder

Brief summary: Bladder cancer is one of the most common cancer worldwide and the second most frequent urological cancer. The photodynamic diagnosis technique (PDD) currently used (Hexvix®) has improved tumor detection but with a high false positive rate. Indeed, the main limitation of the PDD is its lack of specificity, ranging from 35 to 66%. The association of this technique with new technologies such as the Cellvizio Dual Band featuring simultaneous dual wavelength illumination and detection, could improve the identification of tumoral lesions. The objective of this study is to demonstrate the efficacy of Cellvizio dual band technique for the diagnosis of tumors bladders.


Eligibility criteria: Inclusion Criteria:

* Patients having 18 years old or more
* Patients with a bladder carcinoma and with indication of tumor resection under Hexvix procedure.
* Patients giving consent to participate in the study

Exclusion Criteria:

-No consent to participate in the study

Primary outcomes:
measure: Determination of the nucleo-cytoplasmic ratio of cells
timeFrame: at inclusion
Secondary outcomes:
measure: Number of neoplastic lesions identified by Cellvizio compared to number of lesions identified by pathology
timeFrame: through the study completion, an average of 6 months
Other outcomes:
Locations:
city: Lomme
country: France
facility: Groupement des Hôpitaux de l'Institut Catholique de Lille
state: Nord
Study officials:
affiliation: Service d'Urologie, Groupement des hôpitaux de l'Institut Catholique de Lille
name: Jean-Louis Bonnal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05916534: We Care About Brooklyn - A Digital Behavioral Intervention to Optimize Engagement in Maternal Healthcare
Official title: Brooklyn Digital Community Care Intervention to Address Unmet Social Needs and Optimize Engagement in Maternal Health Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Health
Pregnant Women
Keywords: Digital
Lead sponsor: State University of New York - Downstate Medical Center
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to test a behavioral intervention in pregnant women who identify as Black and live in Central Brooklyn. The main question it aims to answer is whether the WeCAB intervention leads to a net improvement in utilization of postpartum care compared to those receiving usual care.

The WeCAB group will have a dedicated WeCAB community health worker who will be trained in digital care navigation.

Researchers will compare the WeCAB group versus the group receiving usual care to see if the patients randomized to WeCAB will have higher rates of early post-partum care compared to patients in the control group.


Eligibility criteria: Inclusion Criteria:

* Eligible participants for the pilot RCT will be patients
* aged 18-49 years (childbearing age)
* residing in a Central Brooklyn zip code
* self-reporting as Black,
* who speak English or Haitian Creole, and
* plan to deliver or present for delivery at University Hospital at Downstate (UHD).
* In NYC, SMM increases incrementally with later entry into prenatal care (1st trimester: 208/10,000 deliveries; 2nd trimester: 252/10,000; 3rd trimester: 297/10,000; None: 575/10,000). 3 Accordingly, in order to capture the full range of SMM risk profiles for our pilot study, any pregnant patient/client visiting our clinics will be eligible for enrollment from 13 weeks gestation through delivery, thus allowing follow-up to 3 months post-partum within the 2-year study timeline.

Exclusion Criteria:

* Patients planning to move outside of New York City in the ensuing 3 months post-partum
* Patients demonstrating an impairment that limits their ability to provide informed consent.

Primary outcomes:
measure: Initiation of postpartum care
timeFrame: 13 weeks until 3 months postpartum
Secondary outcomes:
measure: Maternal death
timeFrame: 13 weeks until 3 weeks postpartum
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: University Hospital at Downstate
state: New York
Study officials:
affiliation: SUNY Downstate
name: Aimee Afable, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05715034: Single-Session Web-Based Training in Self-Compassion
Official title: Pilot Randomized Trial of Compassionate Care: A Single-Session Web-Based Training in Self-Compassion Among Adults With Stress, Anxiety, and/or Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Anxiety
Depression
Keywords: Randomized controlled trial
Self-Compassion
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two-arm, parallel group randomized clinical trial conducted via Mturk comparing a single-session web-based intervention called Compassionate Care versus a control intervention (nature videos with relaxing music) for adults with moderate-to-severe stress, depression and/or anxiety symptoms.

Detailed description: Procedures include completing: (1) pre-intervention baseline assessment; (2) one of two single-session web-based intervention (approximately 30 to 45 minutes each); (3) a brief post-intervention survey; and (4) a 2-week follow-up assessment.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Fluent in English
* At least moderate stress, anxiety and/or depressive symptoms, as indicated by a score of:

  14 or higher on the PSS-10, and/or 10 or higher on the GAD-7, and/or 10 or higher on the PHQ-9

Exclusion Criteria:

* Fail to meet above-listed inclusion criteria
* Do not pass attention/data quality checks in initial screening or study assessments, including:
* Obvious lack of English fluency in open response questions
* Responding with random text in open response questions
* Respond with either copy/pasted responses from text earlier in the intervention to any of free response questions
* Participants with a completion time less than an average of 1.5 seconds per question for the baseline survey assessment OR who fail all three attention check questions in the baseline survey, indicating very careless, random, inattentive and/or hasty responding
* Exit the study prior to condition randomization

Primary outcomes:
measure: Change in Stress symptoms
timeFrame: Baseline to 2-week follow-up
measure: Change in Anxiety symptoms
timeFrame: Baseline to 2-week follow-up
measure: Change in Depressive symptoms
timeFrame: Baseline to 2-week follow-up
measure: Change in Functional Impairment
timeFrame: Baseline to 2-week follow-up
Secondary outcomes:
measure: Change in Self-Compassion
timeFrame: Baseline to 2-week follow-up
measure: Change in Mindfulness
timeFrame: Baseline to 2-week follow-up
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale
state: Connecticut
Study officials:
References:
Clinical trial NCT05451134: Predictors and Outcomes of Dysglycemia in Pheochromocytoma and Paraganglioma
Official title: Predictors and Outcomes of Dysglycemia in Pheochromocytoma and Paraganglioma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pheochromocytoma
Paraganglioma
Keywords: Pheochromocytoma
Paraganglioma
dysglycemia
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Peking Union Medical College Hospital
First posted: 2022-07-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective cohort study will include all consecutive adult patients who underwent surgery for pheochromocytomas and paragangliomas from January 2018 to June 2020.

Brief summary: The investigators will retrospectively analyze the clinical data of consecutive patients with pheochromocytomas and paragangliomas admitted between January 2018 and June 2020. The clinical characteristics of patients with and without dysglycemia will be compared, and whether surgery could improve the patients'dysglycemia will be also investigated.

Detailed description: This retrospective cohort study will include all consecutive adult patients who underwent surgery for PHEOs and catecholamine-secreting PGLs from January 2018 to June 2020. Patients with recurrent PPGLs, those who required steroids after adrenalectomy, and those with inadequate clinical records were excluded. The patients' electronic medical files were reviewed. Patients with dysglycemia included those with diabetes, or impaired fasting glucose, or impaired glucose tolerance. Clinical history data such as age, sex, body mass index (BMI), the presence of preoperative symptoms, biochemical test results, and tumor characteristics, such as tumor diameters and locations were extracted and analyzed.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years old
* patients with surgical pathological diagnosis of pheochromocytomas and paragangliomas(PPGLs)

Exclusion Criteria:

* recurrent PPGLs
* patients who required steroids after adrenalectomy
* patients with inadequate clinical records were excluded.

Primary outcomes:
measure: Change from baseline OGTT（oral glucose tolerance test）results to 6-12 months after surgery
timeFrame: Baseline, 6-12 months after surgery
Secondary outcomes:
measure: random blood glucose results
timeFrame: baseline, 6-12 months after surgery
measure: HbA1c
timeFrame: baseline, 6-12 months after surgery
measure: fasting blood glucose
timeFrame: baseline, 6-12 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xian-Liang Zhou
state: Beijing
Study officials:
affiliation: National Center for Cardiovascular Diseases; Fuwai Hospital, Chinese Academy of Medical Sciences
name: Xian-Liang Zhou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01698034: Volunteering and Cardiovascular Risk in Adolescents
Official title: How Volunteer Programs Affect Health and Well-being in Low-income Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factors
Keywords: volunteering
cardiovascular health
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: William T. Grant Foundation
name: HopeLab Foundation
name: Social Sciences and Humanities Research Council of Canada
First posted: 2012-10-02
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study tested whether getting youth engaged in helping others (volunteering) would benefit youth's physical health. 106 predominantly minority and low socioeconomic status (SES) youth were randomized to either volunteer weekly with elementary school children in after school programs or to a wait-list control group. The investigators hypothesized that cardiovascular risk markers of C-reactive protein (CRP), interleukin-6 (IL-6), total cholesterol, and body mass index (BMI) would be lower at post-intervention (4 months after baseline) in the volunteer group compared to the control group. The investigators also hypothesized that the intervention might work through pathways such as reducing negative mood, improving self esteem, and increasing prosocial behaviors (empathy, altruism).


Eligibility criteria: Inclusion Criteria:

* 10th grade high school student
* English speaking
* No chronic illnesses

Exclusion Criteria:

* Chronic medical illness

Primary outcomes:
measure: Body mass index
timeFrame: Baseline-adjusted post-intervention scores at 4 months
measure: C-reactive protein
timeFrame: Baseline-adjusted post-intervention scores at 4 months
measure: Interleukin-6
timeFrame: Baseline-adjusted post-intervention scores at 4 months
measure: Total Cholesterol
timeFrame: Baseline-adjusted post-intervention scores at 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Technical Secondary School
state: British Columbia
Study officials:
affiliation: Northwestern University
name: Edith Chen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schreier HM, Schonert-Reichl KA, Chen E. Effect of volunteering on risk factors for cardiovascular disease in adolescents: a randomized controlled trial. JAMA Pediatr. 2013 Apr;167(4):327-32. doi: 10.1001/jamapediatrics.2013.1100.
Clinical trial NCT05439434: Turkish Reliability and Validity of FOPQC-SF
Official title: Turkish Reliability and Validity of The Fear of Pain Questionnaire for Children Short Form (FOPQC-SF) in Children/Adolescents With Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear
Pain
Juvenile Idiopathic Arthritis
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 70
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to question the Turkish validity and reliability of the "The Fear of Pain Questionnaire for Children Short Form (FOPQC-SF)" scale. Children/adolescents between the ages of 7-18 and diagnosed with Juvenile Idiopathic Arthritis followed by the Pediatric Rheumatology Clinic will be included in the study. The sample size of this study was determined as at least 50. To assess the validity of the FOPQC-SF scale, participants will be administered the Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module, the Childhood Health Assessment Questionnaire (CHAQ), and the Juvenile Arthritis Disease Activity Score.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with JIA according to the ILAR classification
* 7-18 years old
* Agree to participate in the study

Exclusion Criteria:

* Psychiatric illness that may affect cooperation,
* Those with heart failure and lung pathology at a level that will affect their daily life activities

Primary outcomes:
measure: Fear of Pain Questionnaire for Children Short Form
timeFrame: 10 minutes
Secondary outcomes:
measure: Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module
timeFrame: 15 minutes
measure: Juvenile Arthritis Disease Activity Score
timeFrame: 10 minutes
measure: Childhood Health Assessment Questionnaire
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
state: Pamukkale
Study officials:
References:
Clinical trial NCT01360034: Nifedipine Versus Indomethacin in the Treatment of Preterm Labour
Official title: Nifedipine vs. Indomethacin in the Treatment of Preterm Labour and Short Cervix. A Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Obstetric Labor, Premature
Keywords: Obstetric labor, premature
Short cervix
Nifedipine
Indomethacin
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2011-05-25
Enrollment: 216
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the effectiveness of nifedipine versus indomethacin as tocolytic for the treatment of preterm labour with short cervix (\< 2.5cms).


Eligibility criteria: Inclusion Criteria:

* Pregnant women between 24 and 34 weeks of gestation.
* Cervical length (determined by transvaginal ultrasound) of 2.5 cms or less

Exclusion Criteria:

* All contraindications for tocolysis (fetal distress, abruptio placenta).
* Multiple pregnancy.
* All contraindications for the use of any of the two drugs (indomethacin or nifedipine).

Primary outcomes:
measure: Reduction of preterm birth (before 48 hours, allowing use of corticosteroids).
timeFrame: 36 months
Secondary outcomes:
measure: Reduction of preterm labour (before 35 weeks).
timeFrame: 48 months
measure: Adverse effects
timeFrame: 48 months
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Hospital
Study officials:
affiliation: Saint Thomas Hospital, Panama
name: Jorge Espinosa, Resident
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Thomas Hospital, Panama
name: Osvaldo Reyes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
Clinical trial NCT04508634: Treating Obese PCOS Patients With LSG vs. Met
Official title: Comparison of the Clinical Efficacy of Laparoscopic Sleeve Gastrectomy and Metformin in the Treatment of Obese Patients With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: laparoscopic sleeve gastrectomy
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Sleeve gastrectomy was an effective threapy for severe obesity patients. This study will evaluate the clinical efficacy of sleeve gastrectomy for obese patients with PCOS. Mealwhile, the specific mechanism of sleeve gastrectomy for improving obese patients with PCOS will be explored through multi-group analysis.


Eligibility criteria: Inclusion Criteria:

* female aged 18- 45;
* meet Rotterdam criteria;
* BMI ≥ 28 kg /m2.

Exclusion Criteria:

* Women who are pregnant or have a pregnancy plan within six months;
* Women who are reluctant to undergo metabolic surgery;
* Congenital adrenocortical hyperplasia;
* Hyperprolactinemia;
* Hyperthyroidism or hypothyroidism;
* Abnormal liver function (≥ 3 times of the upper limit of normal range); abnormal · Rrenal function (GFR\<60ml/min/1.73m2);
* Adrenal or ovarian tumors secreting androgens;
* Used contraceptives, metformin, GLP-1RA, pioglitazone and contraceptives in the last 3 month.

Primary outcomes:
measure: HOMA-IR
timeFrame: 3 months
measure: Screening of metabolites in plasma concentration in fasting condition
timeFrame: 3 months
measure: Screening of transcriptome profile in plasma concentration in fasting condition
timeFrame: 3 months
measure: Screening of Microbiome in faeces
timeFrame: 3 months
Secondary outcomes:
measure: menstrual cycles
timeFrame: 3 months
measure: Gonadotropin level
timeFrame: 3 months
measure: testosterone
timeFrame: 3 months
measure: SHBG level
timeFrame: 3 months
measure: FINS
timeFrame: 3 months
measure: TC
timeFrame: 3 months
measure: TG
timeFrame: 3 months
measure: HDL-c
timeFrame: 3 months
measure: LDL-c
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People' Hospital
state: Shanghai
Study officials:
affiliation: Shang hai Tenth People's Hospital
name: Shen Qu, Dr
role: STUDY_CHAIR
References: