louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06171516: Internet-based Cognitive Behavioral Therapy for Individuals With Gambling Disorder in Indonesia
Official title: Internet-based Cognitive Behavioral Therapy for Individuals With Gambling Disorder in Indonesia: a Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gambling
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Flinders University
First posted: 2023-12-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Gambling disorder (GD) has become a wide concern in Indonesia, as many negative consequences aroused from this psychiatric condition. Prompt treatment with appropriate method of delivery is required to achieve optimal outcome in GD patients. This study aims to determine the effectiveness and feasibility of internet-based cognitive behavioral therapy (iCBT) in treating GD.

This non-randomised pilot and feasibility study will recruit 20 people with GD. All participants will receive the iCBT intervention through self-learning videos and guided weekly group sessions. The effectiveness of the intervention will be assessed at baseline (week 0), post-treatment completion (week 10), and 6 weeks post-treatment (week 16).

Expanded access of the iCBT module will not be available until after the study completion.


Eligibility criteria: Inclusion Criteria:

* be aged 18-59 years old;
* be screened as probable pathological gambler based on South Oaks Gambling Screen (SOGS);
* have access to electronic devices (ie, smartphone, mobile tablet, personal computer) with internet connection;
* be proficient in Indonesian language;
* have agreed to take part in the study by filling out the informed consent form.

Exclusion Criteria:

* have severe mental disorders or intellectual disabilities;
* have extreme agitation that hinder instrument fill out and adequate cognitive behavior therapy participation.

Primary outcomes:
measure: Gambling symptom severity
timeFrame: G-SAS will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
measure: Problem gambling severity
timeFrame: PGSI will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
measure: Gambling urges
timeFrame: GUS will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
measure: Gambling-related cognitive distortions
timeFrame: GRCS will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
Secondary outcomes:
measure: Nonspecific psychological distress
timeFrame: SRQ-20 will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
measure: Subjective quality of life
timeFrame: WHOQOL-BREF will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06856616: Predicting Long-Term Clinical Outcomes in Chinese Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Official title: Machine Learning Models for Predicting Long-Term Clinical Outcomes in Chinese Female Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Neoplasms
Lead sponsor: The Third Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 6000
Sex: FEMALE
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: From 2008 to 2019 (with follow-up ending on December 31, 2024), women with invasive breast cancer who received NAC treatment at various hospitals

Brief summary: At present, the majority of studies on neoadjuvant chemotherapy (NAC) in patients with breast cancer (BC) use pathological complete response (pCR) as a surrogate marker for patient prognosis, with significant improvements in pCR indicating better long-term survival. However, there is still a lack of non-invasive tools for accurately predicting the prognosis and pCR of BC patients undergoing NAC. Recent research has introduced emerging artificial intelligence machine learning (ML) and deep learning (DL) algorithms such as Bayesian methods, K-nearest neighbors (KNN), decision trees, support vector machines (SVM), XGBoost, ResNet, convolutional neural networks, and Transformer models, which have brought new avenues of exploration for cancer researchers.

The integration of AI with imaging, pathology, genomics, and other multi-omics has non-invasively improved preoperative diagnosis of breast cancer and, when combined with clinical factors, can assess postoperative survival. Moreover, current research data is limited, and reliable predictive models require extensive data for training. Therefore, establishing a multi-center database is essential.


Eligibility criteria: Inclusion Criteria:

1. Women with invasive breast cancer who received neoadjuvant chemotherapy (NAC) treatment in various hospitals from 2008 to 2019 (follow-up endpoint December 31, 2024)
2. Women with primary breast cancer (Stage II-III) confirmed by pre-NAC needle biopsy, along with recorded clinical, pathological, and prognostic information
3. With MR images before the first cycle of NAC and before surgery
4. With pathological HE staining images, including biopsy pathology and postoperative major pathology

Exclusion Criteria:

1. Any form of treatment was received before NAC, including endocrine therapy, radiotherapy, and chemotherapy
2. Disease metastasis occurred during NAC
3. Breast cancer patients with secondary malignancies from other cancers
4. Patients did not complete surgery and were lost to follow-up

Primary outcomes:
measure: 5-10 year survival rate
timeFrame: 2008-2019
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: Ming Niu
state: Longjiang Hei
Study officials:
References:
Clinical trial NCT05208216: Neuromuscular Stimulation Versus Intermittent Compression for Venous Thromboembolism Prophylaxis in Critical Care
Official title: Electronic Neuromuscular Stimulation Versus Intermittent pneumAtic Compression Devices for the pRevention of Venous Thromboembolic Disease in Critically Ill Adults: a Randomised Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Sepsis
Acute Illness
Venous Thromboembolism
Keywords: venous thromboembolism
Critical illness
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Firstkind Ltd
name: Manchester Academic Health Science Centre
First posted: 2022-01-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this prospective, randomised, open-label, parallel group, feasibility trial; the investigators will objectively assess whether it is feasible to apply the Geko device to critically ill adults for the prevention of venous thromboembolism (VTE) compared to usual care with intermittent pneumatic compression devices (IPCs).

Detailed description: VTE is a common problem amongst patients in critical care. Current measures include intermittent pneumatic compression devices, used to aid the venous return of blood from the lower limbs. These devices are contraindicated and/or poorly tolerated by some patients. Neuromuscular stimulation of the lower leg muscles might offer a better tolerated and more physiological alternative to IPCs.

In this feasibility trial the investigators will randomly allocate 40 patients to receive either the Geko device (n=20) or IPCs (n=20) as principal means of mechanical VTE prophylaxis.

Eligibility criteria: Inclusion Criteria:

* Male or female aged ≥ 18 years.
* Intact healthy skin at the proposed site of gekoTM device application.
* Within 24 hours of their admission to critical care
* Expected to remain in critical care until the day after tomorrow

Exclusion Criteria:

* Use of any concurrent neuro-modulation drug or device (e.g. neuromuscular blocking agents).
* Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
* Inability to palpate the fibula head in order to apply geko device effectively
* Inability to obtain valid written consent from the participant or their designated legal representative

Primary outcomes:
measure: Successful application of the intervention
timeFrame: Daily measurements up to day 10 after enrolment
Secondary outcomes:
measure: Venous return in the lower limbs
timeFrame: Baseline & day 3-5.
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
Study officials:
References:
Clinical trial NCT00741624: Pain Reduce Following Refractive Surgery
Official title: Mitigating Pain Following Refractive Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: refractive surgery
Lead sponsor: FORSIGHT Vision3
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: applying a material over the exposed stromal bed following refractive surgery to prevent local abrasion and significantly reduce pain

Detailed description: Assessed for pain at 1, 2 and 4 hours and 1, 3 and 5 days. Comparison to non study eye will be performed.

Eligibility criteria: Inclusion Criteria:

1. Patients who underwent bilateral PRK for myopic correction.
2. Age 18-60.
3. Patient complains of significant pain.
4. Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits

Exclusion Criteria:

1. Any other anterior segment abnormality other than that associated with PRK.
2. Any abnormalities associated with the eye lids.
3. Prior laser treatment of the retina.
4. Any ophthalmic surgery performed within three (3) months prior to study excluding PRK.
5. Diagnosis of glaucoma.
6. Active diabetic retinopathy.
7. Clinically significant inflammation or infection within six (6) months prior to study.
8. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
9. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational device.
10. Specifically known intolerance or hypersensitivity to contact lenses.
11. A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
12. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.

Primary outcomes:
measure: Pain relief
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sorasky Medical Center
Study officials:
affiliation: Sorasky Medical Center
name: David Verssano
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02581124: Study to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
Official title: A Phase 1, Open-label Study to Evaluate the Effect of Lapatinib, a BCRP Inhibitor, on the Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease Receiving Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anemia of Chronic Kidney Disease
Keywords: JTZ-951
Lapatinib
Pharmacokinetics
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to evaluate the effect of lapatinib, a breast cancer resistance protein (BCRP) inhibitor, on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety and tolerability of JTZ-951 when administered alone and one hour after the administration of lapatinib.


Eligibility criteria: Inclusion Criteria:

* Subjects with end stage renal disease on hemodialysis
* Post-dialysis body weight \>45.0 kg
* BMI between 18.0 and 40.0 kg/m2 (inclusive)

Exclusion Criteria:

* Subjects with positive test results for HBsAg (hepatitis B surface antigen), HCV antibody or HIV antibody
* Subjects with known history of liver failure or liver surgery
* Subjects with a history or current clinically significant chronic or acute blood loss

Primary outcomes:
measure: Cmax (maximum concentration)
timeFrame: 10 days
measure: tmax (time to reach maximum concentration)
timeFrame: 10 days
measure: AUC (area under the concentration-time curve)
timeFrame: 10 days
measure: t1/2 (elimination half-life)
timeFrame: 10 days
measure: Number of adverse events
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
state: Minnesota
Study officials:
References:
Clinical trial NCT01008124: The Liberatory Maneuver for the Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
Official title: The Liberatory Maneuver for the Treatment of Benign Paroxysmal Positional Vertigo: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vertigo
Vestibular Disease
Keywords: Benign Paroxysmal Positional Vertigo
BPPV
PC
BPPN
Vertigo
Lead sponsor: Midwestern University
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2009-11-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done because the investigators would like to know how effective the Liberatory maneuver is in treating benign paroxysmal positional vertigo (BPPV).

Detailed description: BPPV is a problem with the inner ear that causes brief periods of vertigo triggered by changes in the position of the head such as rolling, looking up, or bending down. BPPV is presently thought to be caused by small pieces of debris or crystals becoming displaced within the inner ear. It can be treated by moving the patient through a series of positions called a maneuver. There are 2 different maneuvers currently used to treat BPPV by the clinician called the liberatory maneuver and the canalith repositioning procedure. We would like to determine how effective the liberatory maneuver is in the treatment of BPPV compared to a placebo maneuver.

Eligibility criteria: Inclusion Criteria:

* BPPV involving the posterior canal on only one side

Exclusion Criteria:

* No other canals involved (anterior canal or lateral canal), no central nervous system disorder, and no other medical condition that would not enable the individual to have the maneuver done.

Primary outcomes:
measure: Negative Dix-Hallpike maneuver
timeFrame: 1-2 weeks
Secondary outcomes:
measure: Self reported willingness to move
timeFrame: 1-2 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Chicago Dizziness and Hearing
state: Illinois
city: Downers Grove
country: United States
facility: Midwestern University
state: Illinois
Study officials:
affiliation: Midwestern University
name: Janet O. Helminski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salvinelli F, Trivelli M, Casale M, Firrisi L, Di Peco V, D'Ascanio L, Greco F, Miele A, Petitti T, Bernabei R. Treatment of benign positional vertigo in the elderly: a randomized trial. Laryngoscope. 2004 May;114(5):827-31. doi: 10.1097/00005537-200405000-00007.
citation: Massoud EA, Ireland DJ. Post-treatment instructions in the nonsurgical management of benign paroxysmal positional vertigo. J Otolaryngol. 1996 Apr;25(2):121-5.
Clinical trial NCT01584024: Resin Infiltration to Arrest Early Tooth Decay
Official title: Radiographic Progression of Early Caries Lesions After Resin Infiltration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Dental caries
Proximal surfaces
Posterior teeth
Carious lesions
Tooth diseases
Preventive therapy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: DMG Dental Material Gesellschaft mbH
First posted: 2012-04-24
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether lesion infiltration is an effective management strategy to arrest early tooth decay.

Detailed description: A 3-year prospective, randomized control clinical trial (RCT) is designed incorporating a split mouth intra-oral design. Young volunteers (18-24 years old) with at least two early lesions in posterior teeth will be enrolled into this clinical trial to evaluate the clinical effectiveness of arresting lesion progression by resin infiltration therapy as adjunct to standard-of-care preventative measures. Lesion status (non-cavitated) is clinically confirmed prior to implementing the assigned therapy.

Eligibility criteria: Inclusion Criteria:

* DMFT ≥ 3 (DMFT = index of decayed-missing-filled permanent teeth)
* Having at least two early caries lesions in approximal posterior tooth surfaces
* Lesions visible on radiograph

Exclusion Criteria:

* Current participation in another clinical study
* Medically compromised subjects
* Hyposalivation
* Pregnancy
* Allergic to methylmethacrylates
* Allergic to latex
* Symptomatic teeth

Primary outcomes:
measure: Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions)
timeFrame: 3 Years
Secondary outcomes:
measure: Number of Lesions With Progression as Measured by Depth Category (N=Lesions)
timeFrame: 3 Years
Other outcomes:
Locations:
city: West Point
country: United States
facility: Saunders USADC
state: New York
Study officials:
affiliation: University of Michigan
name: Mathilde C Peters, DMD, PhD
role: STUDY_CHAIR
References:
citation: Peters MC, Hopkins AR Jr, Zhu L, Yu Q. Efficacy of Proximal Resin Infiltration on Caries Inhibition: Results from a 3-Year Randomized Controlled Clinical Trial. J Dent Res. 2019 Dec;98(13):1497-1502. doi: 10.1177/0022034519876853. Epub 2019 Sep 16.
Clinical trial NCT01322724: Comparing Warm Versus Cool Temperature Water During Colonoscopy
Official title: Comparing Warm Versus Cool Temperature Water During Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Keywords: colonoscopy
colon cancer screening
patient discomfort scores
sedation medication requirements
water insertion method
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
First posted: 2011-03-25
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study will be to determine if the temperature of water used during insertion of colonoscopy makes a difference in patient discomfort and sedation requirements. The hypothesis of this study is patients receiving screening colonoscopy utilizing the water insertion method with room temperature (cool) water will have similar pain scores and medication requirements compared to water insertion method using body temperature (warm) water.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 85 years undergoing elective outpatient screening colonoscopy for colon cancer screening

Exclusion Criteria:

* Patients undergoing colonoscopy for any other indication besides colon cancer screening
* Patients with prior colonic resections
* Patients with chronic narcotic or benzodiazepine use
* Poor bowel preparation (i.e. Boston bowel preparation score \< 8)
* Patients with obstructing colonic lesions detected on colonoscopy

Primary outcomes:
measure: Dose of sedation medication used (fentanyl and midazolam)
timeFrame: Duration of the colonoscopy; Up to 3 hours
Secondary outcomes:
measure: Patient pain/discomfort score
timeFrame: During the day of the procedure; Up to 1 day
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: M. Brian Fennerty, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee BY, Katon R, Herzig D, Fennerty MB. Warm water infusion during sedated colonoscopy does not decrease amount of sedation medication used. Gastrointest Endosc. 2012 Dec;76(6):1182-7. doi: 10.1016/j.gie.2012.08.002. Epub 2012 Sep 26.
Clinical trial NCT04633824: Health Disparities on the Labor Floor
Official title: Health Disparities on the Labor Floor
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pain
Pregnancy Related
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 2500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women admitted to the labor and delivery unit from 1/1/2015 to 12/31/2019, who meet the above defined inclusion and exclusion criteria

Brief summary: The Agency for Healthcare Research and Quality (AHRQ) defines a disparity as a difference or a gap that exist between two groups, which is both statistically significant, larger than 10%, and indicates poor quality for the minority (non-referent) group. Despite advances in public health initiatives and medicine, disparities in healthcare are persistent. For example, in the United States, maternal mortality ratio has doubled since 1987 to 2009 where African American women were 4 times as likely to die from childbirth. Although there was no observed racial disparity in maternal deaths at University of Alabama Birmingham, there is anecdotal experience that may suggest health disparities do exist on the labor floor when examining neuraxial utilization and effectiveness. This retrospective study will seek to examine the successful extension of labor analgesia for cesarean section as it relates to insurance status.


Eligibility criteria: Inclusion Criteria:

* Pregnancy
* Age \>/= age 18 years

Exclusion Criteria:

* Women less than age 18 will be excluded.

Primary outcomes:
measure: Successful extension of labor epidural catheter for cesarean section
timeFrame: from the time of admission to the time of delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Patrick Hussey, MD
role: PRINCIPAL_INVESTIGATOR
References: