louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06407648: Using Personalized Assessments in the Treatment of Childhood OCD
Official title: Using Personalized Assessments in the Treatment of Childhood OCD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: children
adolescents
exposure with response prevention
cognitive behavioral therapy
ERP
CBT
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel clinical trial
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to learn whether personalized assessment of obsessive-compulsive disorder (OCD) symptoms in childhood OCD using mobile health technology are feasible and acceptable for youth and parents. The investigators will also examine whether personalized cognitive-behavioral therapy (CBT) that is informed by personalized OCD assessments yields better clinical outcomes when compared to standard CBT for youth with OCD


Eligibility criteria: Inclusion Criteria:

1. be 8-17 years of age;
2. meet diagnostic criteria for a primary diagnosis of OCD on a structured clinical interview;
3. have moderate OCD severity as evidenced by a CY-BOCS total score of ≥16;
4. medication free and/or on a stable dose of medication 8 weeks prior to study participation;
5. be English speaking.

Exclusion Criteria:

1. the presence of psychotic disorder, bipolar disorder, or autism spectrum disorders;
2. significant suicidal ideation that warrants medical intervention;
3. concurrent psychotherapy for OCD;
4. inability to complete scales, or attend visits.

Primary outcomes:
measure: Children's Yale-Brown Obsessive-Compulsive Scale Second Edition (CY-BOCS-II) Total Severity Score
timeFrame: Screen, Baseline (Week 0), Week 4, Week 8, and Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Joseph F. McGuire, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04600648: Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children
Official title: Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pediatric Obesity
Keywords: Leptin
Insulin
Sweet Responsiveness
Weight Loss
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Compare the level of insulin, leptin, and sweet taste sensitivity and perception before and after short term weight loss and bariatric surgery
Primary purpose: BASIC_SCIENCE

Brief summary: This study will explore whether a relationship exists between insulin and leptin resistance, sweet taste responsiveness, and adiposity.

Detailed description: Compared to healthy weight peers, some reports have shown that they are less sensitive to, or perceptive of, sucrose solutions and sweet foods, whereas others have observed the opposite pattern of findings or no difference at all. Among those seeking weight loss treatment, one investigation found perception and preferences for sweet taste remained unchanged after weight loss, and another observed a decreased ability to distinguish sweet taste from other taste solutions. Given these discrepancies in the literature, the proposed study will explore whether a relationship exists between insulin and leptin resistance, sweet taste responsiveness, and adiposity.

Eligibility criteria: Inclusion Criteria:

* Patient of Children's Healthy Weigh of Buffalo
* ages of 8-14

If enrolled in the bariatric arm:

• must be scheduled for bariatric surgery prior to enrollment

Exclusion Criteria:

* Patients unable to get labs drawn at a Kaleida facility
* Severe hay fever or seasonal allergies within 2 weeks of enrollment
* smoker or are exposed to second-hand smoke at home,
* has been dieting to lose weight within the past 6 months of enrollment
* currently taking any prescription medications that can influence taste or small functions or are pregnant.
* pregnancy
* Bariatric arm patients will be excluded if they fail to have the surgery.

Primary outcomes:
measure: Higher insulin and leptin levels will be associated with lower sweet taste sensitivity and perception, and higher body fat percentage and z-BMI
timeFrame: to be measured at 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00750048: Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers
Official title: Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: pain,
sensitization,
analgesia
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2008-09-10
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to check if Naloxone induce an inhibiting effect on the analgesic effect of paracetamol in healthy volunteer, using evoked potentials.

Detailed description: Double Blind, cross-over study in healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy men
* between 18 and 40 years old
* written consent given

Exclusion Criteria:

* Naloxone or paracetamol hypersensibility
* Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania
* Concomitant medication

Primary outcomes:
measure: Variation of amplitude of the N2P2 cerebral wave (before and after administration of Naloxone) induced by thermal stimulus applied on the arm.
timeFrame: before and after administration of Naloxone
Secondary outcomes:
measure: Follow up of pain's evaluation using analogical visual scale. Follow up of pain's evaluation using analogical visual scale
timeFrame: following the pain's evaluation
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CPC-CIC
Study officials:
affiliation: CIC-CPC
name: Pickering Gisele, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00896948: Study of Proteins in Head and Neck Cancer Cells
Official title: Novel Protein Regulator of Tumor Suppressor ARF & NF-κB
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: head and neck cancer
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Studying proteins in head and neck cancer cells in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at proteins in head and neck cancer cells.

Detailed description: OBJECTIVES:

* Define the function and mechanism of LZAP in regulating ARF.
* Determine the mechanism and biological consequences of LZAP inhibition of NF-κB.
* Determine if LZAP has tumor suppressor activity by conditional targeting of LZAP in mice.

OUTLINE: Using molecular laboratory techniques, this study examines the biochemical mechanisms by which LZAP activates transcriptional, tumor suppressive activity (both p53-dependent and p53-independent) of ARF and inhibits transcriptional, tumorigenic activity of NF-kB. LZAP regulation of newly identified ARF activities, such as S-phase delay and ARF-mediated B23 degradation are also evaluated. LZAP's tumor suppressive activity is assessed in vivo using a conditional knockout vector to target LZAP in mice and to observe for spontaneous and induced tumor formation. Laboratory analyses used to determine study endpoints include standard recombinant DNA, recombinant protein expression and purification, cell culture and transfection, cell labeling, reporter assays, flow cytometry, yeast-two hybrid, immunoprecipitation, immunoblotting, immunofluorescence, TUNEL assay, ELISA assay, Southern blotting, and protein and gene expression.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Head and neck cancer tumor cell line

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Function and mechanism of LZAP in regulating ARF
measure: Mechanism and biological consequences of LZAP inhibition of NF-κB
measure: Determination of LZAP tumor suppressor activity
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Wendell G. Yarbrough, MD, FACS
role: STUDY_CHAIR
References:
Clinical trial NCT02739048: Changes of Immunologic Function in Patients of Prostate Cancer Induced After Cryoablation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 80
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 patients diagnose with prostate

Brief summary: 1. The overall objective of the study: By evaluating the curative effect of CSAP in localized prostate cancer, locally advanced prostate cancer and metastasis advanced prostate cancer, and the change of state in cellular immunity and humoral immunity before and after CSAP. Validate the clinical therapeutic effect of all kinds of prostate cancer, as well as the change of immune status before and after CSAP.

2. The main content of the study:

1. Included in the samples are patients in hospitals for CSAP. The sample capacity are planned to be 80. The main purpose of the study is to observe the overall survival rate , disease free survival rate, the progress time of the PSA biochemical recurrence as well as the disease progress time.
2. Measure the change of concentration in peripheral blood T lymphocyte subsets (CD3 + T, CD4 + T, CD8 + T, CD4 + / CD8 + T, NK cells) and regulatory T cells before and after cryoablation within 1 month, 3 months and 6 months.
3. Measure the change of concentration in peripheral blood IFN-1, IL-4, IFN-1/IL-4 ratio (Thl/Th2 ratio), and detect the secretion of CD4 + Th tumor-specific IFN-l and the activity of tumor-specific killer CD8 + CTL before and after cryoablation within 2 weeks and 1 month.
4. Before cryoablation, detect the expression and distribution of Follistatin-Like1 (FSTL-1), Besides, verify the connection between the number and activation ratio of tumor local dendritic cells (DC) and the FSTL-1, evaluating the cryoablation effect on the immune response.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with prostate cancer by pathology
* the age of patients should be from 40 to 80 years old
* do not receive other treatments like radical prostatectomy, radiotherapy, etc

Exclusion Criteria:

* can not receive surgery because of bad performance status
* abnormal coagulation function
* receive other treatment before CSAP
* do not want to achieve CSAP because of any reasons

Primary outcomes:
measure: humoral immunity and cellular immunity will be activated after CSAP for patients of prostate cancer
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Jian Kang, director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04139148: Transcranial Direct Current Stimulation (tDCS) Combined With Computerized Cognitive Addiction Therapy(CCAT) and, Electronic Follow-up for Methamphetamine(MA) Dependent Patients
Official title: Study on the Effectiveness of "Treatment Regulation Mode" Based on Neuromodulation and Electronic Follow-up to Reduce Relapse Behavior in Patients With Substance Dependence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Methamphetamine-dependence
Transcranial Direct Current Stimulation
Computerized Cognitive AddictionTherapy
Electronic Health Records
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 100
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: Transcranial direct current stimulation (tDCS) combined with computerized cognitive addiction therapy(CCAT) for methamphetamine(MA) dependent patients in voluntary drug rehabilitation center. Electronic medical systems were applied for drug related knowledge education, self-evaluation and outpatient follow-up reminder after intervention in order to reduce relapse behaviors.


Eligibility criteria: Inclusion Criteria:

* Methamphetamine dependent patients with normal eyesight and hearing.

Exclusion Criteria:

* any diagnosis of DSM-IV axis I diseases.
* any physical diseases which might influence cognitive function such as epilepsy, cerebrovascular disease or brain injury.
* negative behaviors or harm to others.
* cognitive enhance drug use history in last 6 months.
* other drug dependence(except nicotine).

Primary outcomes:
measure: Change from Baseline cue-induced craving at 2 weeks
timeFrame: 2 weeks
measure: Change from Baseline cue-induced craving at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Attention bias towards methamphetamine
timeFrame: 2 weeks，4 weeks
measure: cognitive function
timeFrame: 2 weeks，4 weeks
measure: response inhibition function
timeFrame: 2 weeks，4 weeks
measure: reward-related function
timeFrame: 2 weeks，4 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
affiliation: Shanghai Mental Health Center
name: Na Zhong, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01866748: Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male Subjects
Official title: Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-05-31
Enrollment: 170
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability and pharmacokinetics (the effect of the investigated drug on the body) of single and multiple doses of a long-acting GLP-1 analogue (semaglutide) in an oral formulation in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator
* Body Mass Index (BMI) between 20 and 30 kg/m\^2
* Glycosylated haemoglobin (HbA1c) below 6.0% (only in Part B)

Exclusion Criteria:

* History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (GI), endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
* Use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing. Occasional use of paracetamol or acetylsalicylic acid is permitted

Primary outcomes:
measure: Part A: Number of treatment emergent adverse events (TEAEs)
timeFrame: Day -1 to Day 24
measure: Part B: Number of treatment emergent adverse events (TEAEs)
timeFrame: Recorded from the time of first dosing (Visit 3, Day -1 to day +2) and until completion of the post treatment follow-up visit (Visit 18, Day 90-104)
Secondary outcomes:
measure: Part A: AUC0-24h,semaglutide: the area under the semaglutide plasma concentration curve
timeFrame: From time 0 to 24 hours after a single dose (Day 0)
measure: Part B: AUCτ,semaglutide: area under the semaglutide plasma concentration curve
timeFrame: Over the dosing interval (0-24 hours) after the last 3 daily doses (Days 67-69)
measure: Part B: Change in fasting plasma glucose (FPG) from baseline
timeFrame: Day 0 (pre-dose), day 70
measure: Part B: Change in body weight from baseline
timeFrame: Day -1, day 70
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00919048: Uroflow Measurements in Urogynecology Patients Compared to Healthy Female Volunteers
Official title: Uroflow Measurements in Urogynecology Patients Compared to Healthy Female Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urogynecology
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2009-06-12
Enrollment: 36
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Urogynecology clinic

Brief summary: To compare uroflowmetry measurements of patients undergoing urodynamic testing as part of an incontinence work-up in an urogynecology practice to healthy female volunteers.


Eligibility criteria: Inclusion Criteria:

* All patients who underwent urodynamics at the urogynecology clinic during the past 12 months
* Voids larger than 50 mls.

Exclusion Criteria:

* History of pelvic organ prolapse, incomplete bladder emptying, and voids less than 50cc.

Primary outcomes:
measure: Voiding variables of patients will be compared to those of healthy female volunteers collected from another study.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Gunhilde Buchsbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00701948: New Dosages of Inflammatory Markers for the Early Diagnosis of Nosocomial Bacterial Infections of the Newborn
Official title: Interest of New Dosages of Inflammatory Markers for the Early Diagnosis of Nosocomial Bacterial Infections of the Newborn
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nosocomial Infection
Keywords: Late onset neonatal sepsis
Nosocomial bacterial infection
Inflammatory markers
multiplex dosage
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2008-06-19
Enrollment: 240
Sex: ALL
Minimum age (years): 72
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn hospitalized in neonatal intensive care unit with a clinical suspicion of nosocomial bacterial infection

Brief summary: This study aims to evaluate new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection. We made the hypothesis that these new dosages or new inflammatory markers could be more useful than dosage of inflammatory markers already used in clinical practice (especially the use of a combination of interleukins (6 or 8) and C-reactive protein for the management of newborns with a clinical suspicion of nosocomial bacterial infection and especially could allow to avoid excessive treatment with antibiotics


Eligibility criteria: Inclusion Criteria:

* Newborns \> 72 hours of life hospitalized in neonatal intensive or intermediate care unit presenting a clinical suspicion of NBI

Exclusion Criteria:

* Early post-operative period ( surgery of less than 48 hours)
* Multiple malformations
* Newborn already included in the study for a previous septic events
* Newborn treated with antibiotics in the last 24 hours

Primary outcomes:
measure: Evaluation of new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection.
timeFrame: 48 hours and at 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Service de Pédiatrie 2 - Hôpital d'Enfants CHU de Dijon; 10 - bld Maréchal de Lattre de Tassigny
city: Strasbourg
country: France
facility: Service de Pédiatrie 2 - Hôpital de Hautepierre; 1 - Avenue Molière
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Pierre Kuhn, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02193048: Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-07-17
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Specialist gastroenterological centres

Brief summary: The purpose of this study is to prospectively evaluate a scoring system to predict a mild course of disease in patients newly diagnosed with Crohn's disease.


Eligibility criteria: Inclusion Criteria:

All patients with Crohn's disease who

* have been newly diagnosed (initial diagnosis not more than 6 weeks previously) and
* are as yet untreated (permitted medications are a maximum of 10 days of 5-aminosalicylates (5-ASA) or glucocorticosteroids and antibiotics for non-intestinal indications) and
* have consented to the documentation of their patient data and
* agree to the up to 5-year documentation of the course of disease

Exclusion Criteria:

* Pre-treatment with 5-ASA \> 10 days
* Treatment with steroids \> 10 days
* Treatment with antibiotics, immunosuppressants or biological agents \> 10 days

Primary outcomes:
measure: Evaluation of a Crohn's scoring system
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Altenholz
country: Germany
facility: Investigational site (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References:
citation: Kruis W, Bokemeyer B, Jessen P, Hoesl M, Mross M, Morgenstern J, Reimers B, Muller-Grage N, Leifeld L. Prospective Evaluation of the Prediction Score for a Mild Course of Crohn's Disease (PreMiCC) in Newly Diagnosed Patients With Crohn's Disease: The PROGNOS Study. Inflamm Bowel Dis. 2025 Mar 3;31(3):677-685. doi: 10.1093/ibd/izae086.