louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00683462: An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
Official title: An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: ADHD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Targacept Inc.
First posted: 2008-05-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A 3-way cross-over trial of two weeks of treatment with three drug conditions. AZD3480 will be given in doses of (A) 5mg/day, (B) 50 mg/day and (C) placebo to 24 non-smoking adults with DSM-IV confirmed ADHD. Three week washout between each treatment period. CYP2D6 genotyping will be completed at screening and slow metabolisers will be excluded from participation in this study. Cognitive, ADHD symptom, safety and pharmacokinetic (PK) assessments will be made during each treatment period. Safety and tolerability assessments will be a major component of the trial and all serious adverse events (SAE) will be immediately (within 24 hours) reported to both Targacept and to AstraZenca.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of DSM-IV ADHD
* Score of equal or more than 2 on at least six of nine items in at least one of the subscales of the Connor´s Adult ADHD Rating Scale (CAARS-INV)
* Score of equal or more than 4 (at least moderate severity) on the Clinical Global Impressions-Severity (CGI-S) test

Exclusion Criteria:

* Current DSM-IV Axis I psychiatric disorder (other than ADHD)
* Current user of cigarettes or other nicotine-containing product.
* Slow metabolizers as indicated by CYP2D6 genotyping.
* Use of drugs affecting cognitive function within 8 weeks prior to enrollment visit or intended use during the study.

Primary outcomes:
measure: The Total Symptoms Scale Score (of ADHD) of the Connors Adult ADHD Rating Scale-Investigator Rating (CAARS-INV).
timeFrame: Visit 1, 2, 3, 4, 5, 8, 9, 10,13, 14 and 15
Secondary outcomes:
measure: Clinical Global Impressions Scales (NIMH 1985)
timeFrame: Visit 1, 2, 3, 4, 5, 8, 9, 10, 13, 14,15
measure: CDR computerized cognitive battery
timeFrame: 2, 3, 5, 8, 10, 13, 15
measure: CNRU computerized cognitive battery
timeFrame: 2, 3, 5, 8, 10, 13, 15
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Research Site
state: Vermont
Study officials:
References:
citation: Potter AS, Dunbar G, Mazzulla E, Hosford D, Newhouse PA. AZD3480, a novel nicotinic receptor agonist, for the treatment of attention-deficit/hyperactivity disorder in adults. Biol Psychiatry. 2014 Feb 1;75(3):207-14. doi: 10.1016/j.biopsych.2013.06.002. Epub 2013 Jul 12.
Clinical trial NCT05736991: Deep Learning Signature for Predicting the Novel Grading System of Clinical Stage I Lung Adenocarcinoma
Official title: Deep Learning Signature Based on PET-CT Images for Predicting the Novel Grading System of Clinical Stage I Lung Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Adenocarcinoma
Radiomics
Grading System
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
Collaborators: name: Ningbo No.2 Hospital
name: Zunyi Medical College
name: The First Affiliated Hospital of Nanchang University
First posted: 2023-02-21
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clinical Stage I Lung Adenocarcinoma

Brief summary: The purpose of this study is to evaluate the performance of a PET/ CT-based deep learning signature for predicting the grade 3 tumors based on the novel grading system in clinical stage stage I lung adenocarcinoma based on a multicenter prospective cohort.


Eligibility criteria: Inclusion Criteria:

(1) Participants scheduled for surgery for radiological finding of pulmonary lesions from the preoperative thin-section CT scans; (2) The maximum diameter of lesion less than 4 cm on CT scans; (3) The maximum short axis diameter of lymph nodes less than 1 cm on CT scan; (4) The SUVmax of hilar and mediastinal lymph nodes less than 2.5; (5) Pathological confirmation of primary lung adenocarcinoma; (5) Age ranging from 20-75 years; (6) Obtained written informed consent.

Exclusion Criteria:

(1) Multiple lung lesions; (2) Poor quality of PET-CT images; (3) Participants with incomplete clinical information; (4) Mucinous adenocarcinomas; (5) Participants who have received neoadjuvant therapy.

Primary outcomes:
measure: Area under the receiver operating characteristic curve
timeFrame: 2022.11-2023.4
Secondary outcomes:
measure: Sensitivity
timeFrame: 2022.11-2023.4
measure: Specificity
timeFrame: 2022.11-2023.4
measure: Positive predictive value
timeFrame: 2022.11-2023.4
measure: Negative predictive value
timeFrame: 2022.11-2023.4
measure: Accuracy
timeFrame: 2022.11-2023.4
Other outcomes:
Locations:
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Yangpu
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Ningbo
country: China
facility: Ningbo HwaMei Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT06318091: Nanofat Versus Platelet Poor Plasma Gel for Infraorbital Rejuvenation
Official title: Nanofat Versus Platelet Poor Plasma Gel for Infraorbital Rejuvenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tear Trough Eyelid Deformity
Keywords: platelet poor plasma gel
nanofat
infraorbital rejuvenation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study was conducted for evaluation of the clinical efficacy, safety, and potential side effects of platelet poor plasma gel versus nonfat injection in infraorbital rejuvenation


Eligibility criteria: Inclusion Criteria:

* all patients with infraorbital dark circles

Exclusion Criteria:

* pregnancy
* breast feeding
* infectious disorders

Primary outcomes:
measure: the degree of changes in the skin texture and homogeneity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Manousra University, Faculty of Medicine
state: Dakahlia
Study officials:
References:
Clinical trial NCT06689891: Video-Based Pelvic Floor Muscle Therapy
Official title: Utilizing Remote, Video-Based Pelvic Floor Muscle Therapy: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Floor Disorder
Pelvic Floor Muscle Exercise
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study population will include patients who have an indication for referral for pelvic floor rehabilitation (PFR).
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study is a feasibility, pilot trial of remote, video-based pelvic floor muscle therapy (PFMT) for patients with pelvic floor disorders, including pelvic organ prolapse, urinary incontinence and anorectal dysfunction. PFMT has been shown to improve these symptoms in multiple studies.

Detailed description: This will be a feasibility and acceptability trial of a novel remote, web-accessible PFMT curriculum, designed by pelvic floor physical therapists.

Patients will be expected to complete a 5-10-minute survey at initial enrollment. They will have one in-person session with a pelvic floor therapist prior to starting the 8-week video-based PFMT course. Afterwards, they will have a final in person session with a pelvic floor therapist along with a final set of surveys that should take an estimated 10-15 minutes.

The primary objective is to the determine the feasibility and accessibility of using a video-based PFMT for patients with pelvic floor dysfunction.

The secondary objective is to determine whether video-based PFMT can improve symptomatology and quality of life.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of pelvic floor dysfunction with referral for PFR
* English-speaking

Exclusion Criteria:

* Unable to access web-based videos
* Unable to speak English

Primary outcomes:
measure: System Usability Scale (SUS) Score
timeFrame: 8 weeks
measure: Percentage of participants video completion
timeFrame: 8 weeks
measure: Change in graded evaluation of exercises by pelvic floor therapist
timeFrame: baseline and 8 weeks
measure: Adverse Events
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Short Form-12 (SF-12)
timeFrame: baseline and week 9
measure: Cleveland Clinic Incontinence Score (CCIS)
timeFrame: baseline and week 9
measure: Patient Assessment of Constipation Symptoms (PAC-SYM)
timeFrame: baseline and week 9
measure: International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
timeFrame: baseline and week 9
measure: Pelvic Organ Prolapse Symptom Score (POP-SS)
timeFrame: baseline and week 9
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
References:
Clinical trial NCT02902991: The Study on the Clinical Utility of Liquid Biopsy in Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: liquid biopsy, breast cancer,circulating tumor biomarker
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients diagnosed with breast cancer for the first time, including postoperative patients within one month and the patients diagnosed with Stage IV breast cancer for the first time.

Brief summary: Through this prospective clinical trial,the investigators will focus on the relationship between circulating tumor biomarkers (i.e. circulating tumor cells, circulating tumor DNA and other biomarkers) and the status of primary tumor to discuss its application for assessing prognosis and individualized therapeutic direction. Moreover, the relationship between the circulating tumor cell subpopulations based on epithelial-mesenchymal transition and molecular pathological classification of breast cancer will be determined, which may enable the determination of the value of its application in therapeutic decision making.


Eligibility criteria: Inclusion Criteria:

* Female patients aged ≥18 years with histologically confirmed breast cancer.
* The patients diagnosed with breast cancer for the first time, including postoperative patients within one month and the patients diagnosed with Stage IV breast cancer for the first time.

Exclusion Criteria:

* The patients who has begun medication for breast cancer.

Primary outcomes:
measure: the enumeration of circulating tumor biomarkers
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03884491: A Study Investigating Formulations of Vortioxetine Applied Under the Tongue in Healthy Subjects
Official title: Interventional, Open-label, Sequential-period Study Investigating the Pharmacokinetic Properties and Safety and Tolerability of Sublingual Formulations of Vortioxetine in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study investigates formulations of vortioxetine applied under the tongue

Detailed description: Apart from the first two doses, the study design is flexible in terms of doses and pharmaceutical formulations and will be decided upon based on an evaluation of the safety and tolerability as well as plasma exposure obtained during the study.

* The study consists of 5 periods. Single-doses of vortioxetine will be administered in all periods.
* All subjects will receive the same pharmaceutical formulations of the same dose strength in the same period and sequence.
* In Period 1, each subject will receive an intravenous (IV) 10 mg dose of vortioxetine infused over 2 hours. The exposure obtained after IV administration will serve as the reference for the sublingually administered dosage forms.
* In Period 2, each subject will receive 5 mg of formulation A (SLA) of vortioxetine in a sublingual (SL) formulation with a holding time of 90 seconds. The holding time is the time where swallowing of saliva should be avoided.
* For the 3 remaining dosing periods, one or more of the following options in pharmaceutical formulation, dose, and dosing condition apply to this study:

  * Increases or decreases in dose (≤25mg) using same formulation
  * Change from formulation SLA to formulation SLB
  * Change in the holding time
  * Change to formulation SLC
  * Change in swallowing technique of the sublingual dosage forms

Eligibility criteria: Inclusion Criteria:

-The subject has a BMI ≥18.5 and ≤30.0 kg/m2 at the Screening Visit and at the Baseline Visit.

Exclusion Criteria:

-The subject is identified or confirmed to be a CYP2D6 poor metabolizer (PM)

Primary outcomes:
measure: absolute bioavailability (F)
timeFrame: From predose to 72 hours post dose
measure: tmax
timeFrame: From predose to 72 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences Ltd
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT02546791: Frequency and Severity of Pleural Effusion Associated With the Use of Dasatinib in Patients With Chronic Myeloid Leukemia. A Descriptive, Mexican Multicenter Study
Official title: Frequency and Severity of Pleural Effusion Associated With the Use of Dasatinib in Patients With Chronic Myeloid Leukemia. A Descriptive, Mexican Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-09-11
Enrollment: 101
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Public centers in the Mexican Republic

Brief summary: This is a retrospective, multicenter, descriptive analysis of patients with a diagnosis of chronic myeloid leukemia, treated with dasatinib for at least 45 days. The study will include 100 patients treated in different public centers in the Mexican Republic.


Eligibility criteria: Inclusion Criteria:

* Men and women ≥15 years of age
* Diagnosis of chronic myeloid leukemia in any phase that used dasatinib at any time between January 2008 and November 2014
* Have received dasatinib as part of their first-line or second-line treatment for at least 45 days

Exclusion Criteria:

* Patients who received dasatinib as part of any clinical trial
* Patients who do not have complete data on the data collection sheet
* Patients who do not have medical records available at the moment of the data verification

Primary outcomes:
measure: Detect the absence and presence of pleural effusion in Mexican patients measured from the medical records and databases of each of the participating medical centers
timeFrame: 1 year and 4 month of data collection
Secondary outcomes:
measure: Establish the factors associated with response of the patients who develop pleural effusion
timeFrame: 1 year and 4 month of data collection
measure: Main characteristics of the patients who develop pleural effusion
timeFrame: 1 year and 4 month of data collection
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06232291: Observation of Safety and Tolerability Within 1 Year of the Use of R-ketamine / Placebo in Drug-resistant Depression
Official title: Observation of Safety and Tolerability Within 1 Year of the Use of R-ketamine / Placebo in Drug-resistant Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Treatment-Resistant Depression
Major Depressive Disorder
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
Collaborators: name: Perception Neuroscience
First posted: 2024-01-30
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients participating in the PCN-101-21 study from March 4, 2022, on site.

Brief summary: An observational-comparative study, without interfering with the treatment, based on an operationalized interview.

Detailed description: Patients with treatment-resistant depression constitute a significant proportion (even 30%) of patients diagnosed with major depressive disorder (MDD. Since 2014, there have been reports of a potential antidepressant effect of the R-ketamine stereoisomer. At the UCK Department of Psychiatry, a phase 2 clinical trial (2a) has been conducted since 2022 with the use of R-ketamine in the form of an intravenous solution, administered by an infusion pump to patients with drug-resistant depression (sponsor Perception Neuroscience, Inc., protocol PCN-101-21, NCT05414422). The available data from studies indicate a potential treatment-transformative effect of the drug, but do not provide comprehensive information on the long-term effects of treatment in terms of effectiveness, tolerability, and safety of R-ketamine use. The study is cognitive and comparative study, without interfering with the diagnostics, treatment, and rehabilitation. It aims to collect effectiveness and safety observations within 12 months of participation in the PCN-101-21 study, at quarterly intervals (3, 6, 9, 12 months, +/- 4 weeks), with particular emphasis on exacerbations of the underlying disease, hospitalization, correction of psychotropic treatment or functional impairment requiring support from social security authorities. The study does not involve additional diagnostic, therapeutic or rehabilitation goals and is a retrospective analysis performed during a single visit.

Eligibility criteria: Inclusion Criteria:

Expressing informed consent to participate in the study and earlier participation in the PCN-101-21 study on site.

Exclusion Criteria:

Informed consent withdrawal.

Primary outcomes:
measure: Safety record post IMP exposure.
timeFrame: Single psychometric assessment is performed along with a structured interview covering a period of 12 months after participation in the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk
Study officials:
References:
Clinical trial NCT04550091: Role Of Multi-detector Computed Tomography In Differentiation Between Different Types Of Ascites
Official title: Role Of Multi-detector Computed Tomography In Differentiation Between Different Types Of Ascites
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ascites
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are diagnosed with ascites by clinical examination or by any other investigations such as ultrasound.

Brief summary: Role Of Multi-detector Computed Tomography In Differentiation Between Different Types Of Ascites

Detailed description: 1. To detect accuracy of MDCT in differentiation between different types of ascites and its underlying cause .
2. To evaluate the diagnostic accuracy of measuring the CT density of the ascitic fluid (in Housefield units) to differentiate between different types of ascites in comparison to aspiration cytology results.

Eligibility criteria: Inclusion Criteria:

* All patients who are diagnosed with ascites by clinical examination or by any other investigations such as ultrasound.

Exclusion Criteria:

* Patient with bleeding tendancy and on anticoagulant drugs.-
* Patients who are pregnant .

Primary outcomes:
measure: differentiate between different types of ascites and its underlying cause
timeFrame: 2022
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02817191: Effects of Holy-Comod and Tears Naturale Forte in Patients After Phaco+IOL
Official title: Effects of Holy-Comod and Tears Naturale Forte on Ocular Surface and Tear Inflammatory Mediators in Patients After Phaco+IOL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Age-related Cataract
Keywords: age-related cataract
Holy-Comod
Tears Naturale Forte
phacoemulsification
inflammatory mediators
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study it to compare the effects of Holy-Comod and Tears Naturale Forte on ocular surface and tear inflammatory mediators in patients after Phaco+IOL.


Eligibility criteria: Inclusion Criteria:

* 60-72 years old
* classification of lens nucleus is LOCS Ⅱ

Exclusion Criteria:

* patients with previous history of ocular surgery, corneal diseases,uveitis ,ocular hypertension or glaucoma ,systemic diseases.

Primary outcomes:
measure: scale of Schirmer I test
timeFrame: up to 2 months after surgery
measure: scale of corneal fluorescein staining
timeFrame: up to 2 months after surgery
measure: scale of noninvasive tear breakup time
timeFrame: up to 2 months after surgery
measure: questionnaire of ocular surface disease index
timeFrame: up to 2 months after surgery
measure: scale of central corneal sensitivity
timeFrame: up to 2 months after surgery
measure: scale of tear meniscus height
timeFrame: up to 2 months after surgery
measure: concentration of Interleukin-1α
timeFrame: up to 2 months after surgery
measure: concentration of tumor necrosis factor-α
timeFrame: up to 2 months after surgery
measure: concentration of nerve growth factor
timeFrame: up to 2 months after surgery
measure: concentration of interferon-γ
timeFrame: up to 2 months after surgery
measure: concentration of transforming growth factor-β1
timeFrame: up to 2 months after surgery
measure: concentration of matrix metalloproteinase-9
timeFrame: up to 2 months after surgery
Secondary outcomes:
measure: Correlation Between Inflammatory Mediators and Ocular Surface Changes
timeFrame: up to 2 months after surgery
Other outcomes:
Locations:
city: Haikou
country: China
facility: Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University
state: Hainan
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xingwu Zhong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: