louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01449890: Randomized Trial of Depression Follow-up Care by Email
Official title: Randomized Trial of E-mail Follow-up Care After Cognitive Behavioural Treatment for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorders
Keywords: follow up care
e-mail
effectiveness
depressive disorders
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 92
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: The primary objective of this study is to test in a randomized effectiveness trial if e-mail delivered cognitive behavioural treatment is an effective follow-up care approach in the treatment of depression under clinically representative conditions.

Detailed description: Depression belongs to the most prevalent mental disorders and often goes along with a high burden of disease. Although the efficacy and the effectiveness of psychological treatments for depressive disorders have been demonstrated, there remains the problem of maintaining the benefits achieved during the initial treatment phase. Therefore options of follow-up care have to be considered. Since access to psychotherapeutic treatments is limited and costly, internet-based interventions can offer a feasible opportunity for follow-up care in order to enhance the long-term effectiveness of psychotherapy.

Eligibility criteria: Inclusion Criteria:

* Depressive disorder: F32.0-F32.2; F33.0-F33.2; F34.1 according to ICD-10
* Precursory CBT
* Internet access

Exclusion Criteria:

* No knowledge of the German language
* Risk of suicide
* Acute psychosis or psychotic symptoms
* Established concurrent in vivo CBT after discharge from inpatient CBT

Primary outcomes:
measure: Measure of the severity of depression - Beck Depression Inventory (BDI- II)
timeFrame: Change in the BDI-II from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)
Secondary outcomes:
measure: Measure of health related quality of life - SF-8
timeFrame: Change in the SF-8 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care
measure: GAD-7
timeFrame: Change in the GAD-7 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care)
measure: Depressive relapse/recurrence
timeFrame: Measured at follow up (3 months after termination of the follow-up care)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf, Centre of Psychosocial Medicine, Department of Medical Psychology
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf Centre of Psychosocial Medicine Department of Medical Psychology
name: Birgit Watzke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04805190: Study of Pain Catastrophizing-2 (SPAC-2)
Official title: Neural Mechanisms Underlying Psychosocial Contributions to Ethnic Group Differences in Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: catastrophizing
cognitive-behavior therapy
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2021-03-18
Enrollment: 99
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study experimentally manipulates pain catastrophizing in order to investigate the neural mechanisms by which pain catastrophizing influences the experience of pain in different ethnic groups among adults with knee osteoarthritis. Participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group.


Eligibility criteria: Inclusion Criteria:

* Symptomatic knee OA

Exclusion Criteria:

* Younger than 45 years of age or older than 85 years of age
* Prosthetic knee replacement or other clinically significant surgery to the arthritic knee
* Uncontrolled hypertension (\>150/95)
* Heart disease including heart failure
* Peripheral neuropathy in which pain testing was contraindicated
* Systemic rheumatic disorders including rheumatoid arthritis, systemic lupus erythematosus, gout, and fibromyalgia
* Neurological diseases such as Parkinson's, multiple sclerosis, stroke with loss of sensory or motor function, or uncontrolled seizures
* Significantly greater pain in body sites other than in the knee
* Daily opioid use
* Hospitalization within the preceding year for psychiatric illness
* Currently pregnant or nursing/breastfeeding

Primary outcomes:
measure: Change in Pain Catastrophizing Scale (PCS)
timeFrame: Baseline; Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Ellen Terry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06960590: Determining the Minimal Effective Dose of Static Stretching for Increasing Range of Motion in Adults
Official title: Determining the Minimal Effective Dose of Static Stretching for Increasing Range of Motion in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Static Stretching
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The study is planned to be conducted in 2025. The methods used in the study are non-invasive methods. The study groups will perform 1 to 3 static stretching sessions per week. The number of series per session will be from 1 to 3. The static stretching time of the back band in the series will be from 20 s to 60 s. The total stretching time per week will be from 45 s to 135 s. The break between series will be 45 s, and the duration of the intervention will be from 6 to 8 weeks. During stretching, the subject maintains a maximum bend with straight knee joints for a specified time. Before starting the study, participants will undergo a toe-to-floor test to assess the flexibility of the back band. The test will be repeated after the intervention. The aim of the study is to determine the minimum effective dose of static stretching. Currently, anecdotal evidence suggests that this dose is 90 seconds of static stretching per week.

The study does not involve any likelihood of harm to study participants as a result of participating in the study.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years,
* No lower limb injuries, no spinal injuries and no craniocerebral injuries in the last 6 months,
* No lower limb surgeries, no spinal surgeries and no central nervous system surgeries in the last 6 months,

Exclusion Criteria:

* Age under 18 years
* Injuries to the lower limbs, spine or craniocerebral injuries within the last 6 months,
* Surgical procedures to the lower limbs, spine or surgical procedures to the central nervous system within the last 6 months,

Primary outcomes:
measure: Flexibility
timeFrame: From registration to completion of the study, the duration is up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Józef Piłsudski Academy of Physical Education in Warsaw
Study officials:
References:
citation: Shadmehr A, Hadian MR, Naiemi SS, Jalaie S. Hamstring flexibility in young women following passive stretch and muscle energy technique. J Back Musculoskelet Rehabil. 2009;22(3):143-8. doi: 10.3233/BMR-2009-0227.
citation: Thomas E, Bianco A, Paoli A, Palma A. The Relation Between Stretching Typology and Stretching Duration: The Effects on Range of Motion. Int J Sports Med. 2018 Apr;39(4):243-254. doi: 10.1055/s-0044-101146. Epub 2018 Mar 5.
Clinical trial NCT05979090: Mastery Learning in Communication Skills
Official title: Mastery Learning in Communication Skills to Improve Milestone Performance and Burnout
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Communication Research
Communication, Personal
Burnout, Professional
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to determine whether mastery learning in communication skills can improve skills in a simulated environment and have translational improvements in outcomes. The main questions it aims to answer are: 1. Does mastery learning improve skills in the simulation laboratory? 2. Does mastery learning improve clinical skills as seen by milestone performance? and 3 Does mastery learning improve burnout levels? The study is a multi-institutional randomized controlled trial of anesthesiology residents from five different residency programs. Participants will be randomized to mastery training in communication skills and standard of care, which is vicarious learning. Researchers will compare these two groups to see if mastery learning improves skills and translational outcomes.


Eligibility criteria: Inclusion Criteria:

* Anesthesiology residents rotating at Ann and Robert H. Lurie Children's Hospital of Chicago

Exclusion Criteria:

* Participant refusal
* Study participants who have already undergone the mastery learning in difficult conversations course.

Primary outcomes:
measure: Communication skills
timeFrame: one year
Secondary outcomes:
measure: Milestones Performance
timeFrame: two years
measure: Burnout levels
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Simulation Center
state: Illinois
Study officials:
affiliation: Ann and Robert H. Lurie Children's Hospital of Chicago
name: Heather Ballard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06723990: Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX
Official title: Prospective Observational Monocentric Study to Evaluate the Impact of the HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2-BREAST-DX
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Keywords: HER2 positive breast cancer patients with stage I-III
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HER2 positive breast cancer patients with stage I-III

Brief summary: To prospectively evaluate the impact of HER2DX on the decision-making processes of the treating physicians and especially among the routine multidisciplinary tumour board, in defining type and setting of systemic therapy administration in patients with stage I-III HER2+ BC, and the degree of clinician's confidence in the treatment recommendation.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years of age;
* Histologically confirmed HER2+ breast cancer;
* Stage I-III breast cancer without evidence of distant metastases;
* Being candidate to neoadjuvant/adjuvant therapy and locoregional treatment (surgery +/- radiotherapy);
* Written informed consent, signed by the patient, to study-specific procedures (the consent will consist of 2 levels: level 1 specifically for patients enrolled in the primary endpoint cohort and level 2 for all patients);

Exclusion Criteria:

* HER2- BC;
* Stage IV breast cancer;
* Lack of informed consent because of patient's incapable of discernment or unwilling to participate;

Primary outcomes:
measure: Impact of HER2DX on the decision-making processes of the treating physicians and multidisciplinary tumour board, in patients with stage I-III HER2+ BC
timeFrame: from baseline to the end of treatment at 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
Study officials:
affiliation: Istituto Europeo di Oncologia
name: Carmen Criscitiello
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06305390: Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.
Official title: Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clinical Suspicion of Prostate Cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 167
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men with clinical suspicion of clinically significant prostate cancer (csPCa).

Brief summary: This project aims to evaluate the role of fully hybrid PET/MRI with 18FPSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa).

Our main hypothesis is that adding 18F-PSMA PET to mpMRI prior to biopsy, will reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa.


Eligibility criteria: Inclusion Criteria:

1. Men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy
2. Feasibility to undergo all procedures listed in protocol
3. Ability to provide written informed consent

Exclusion Criteria:

1. Prior diagnosis of prostate cancer
2. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min)
3. Contraindication to prostate biopsy

Primary outcomes:
measure: To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of clinically significant prostate cancer (csPCa)
timeFrame: PET/MRI: day 0 prostate biopsy: day 0-90 days
Secondary outcomes:
measure: To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone To report the reduction in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET
timeFrame: PET/MRI: day 0 prostate biopsy: day 0-90 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: U.O. of Nuclear Medicine, ,Ospedale San Raffaele
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Arturo Chiti, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06855290: Tumor Immunity and Cancer Recurrence Prediction Model
Official title: Tumor Immunity and Cancer Recurrence Prediction Model
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Keywords: cancer
immunity
tumor
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2025-03-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants must be at least 18 years old, not pregnant, and not breastfeeding, diagnosed with cancer (such as liver cancer, lung cancer, gastric cancer, colorectal cancer, etc.), and eligible for surgical resection

Brief summary: The purpose of this observational study is to understand the predictive effect of the laboratory-developed TIMES scoring system on the recurrence status of cancer patients who have undergone surgical tumor resection. The main questions it aims to answer are:

Can the TIMES scoring system accurately predict the recurrence status of cancer patients who have undergone surgical tumor resection? What is the accuracy of the TIMES scoring system? The medical records or biological specimens used in this study were obtained from previous clinical treatments, and the tissues used were collected from post-surgical discarded tissues from the participants, which will not affect their health. Researchers will continuously monitor the disease progression of the participants for up to 10 years or until cancer recurrence occurs.

Detailed description: No grouping, the long-term tracking of participants' disease progression and recurrence status will be compared with the analysis results of the collected discarded tumor tissues from the participants' surgeries

Eligibility criteria: Inclusion Criteria：

1.Adult males and females (non-pregnant, non-lactating)； 2.18 years or older (inclusive); 3.Diagnosis: Diagnosed with cancer (e.g., liver cancer, lung cancer, gastric cancer, colorectal cancer, etc.) and eligible for surgical resection; 4.Informed Consent: Participants must be fully informed about the study prior to participation and voluntarily sign a written informed consent form;

Exclusion Criteria：

1. Specimens from pregnant or lactating patients will not be included in this study, and participant should have no plans for pregnancy or lactation within the next 2 years.
2. Participants must be at least 18 years old.

Primary outcomes:
measure: recurrence
timeFrame: From the date of random grouping to the date of first recorded recurrence or death due to any reason, whichever comes first, the evaluation lasts up to 120 months.
measure: disease-free progression period
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
measure: RECIST1.1
timeFrame: From the start of clinical treatment to the end of clinical treatment, up to a maximum of 120 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00693290: Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy
Official title: Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colonoscopy
Colorectal screening
Colon preparation
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Action Cancer
name: Western Health and Social Care Trust
First posted: 2008-06-09
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Study hypothesis The overall aim of this study is to compare two bowel preparations that are used prior to a colonoscopy procedure.

The principal research questions are:

1. Does the use of a low residue diet increase patient concordance to the bowel preparation instructions?
2. Does the use of a low residue diet decrease the adequacy of assessment of the mucosa?
3. Does the use of a low residue diet increase the willingness of patients to undertake repeated examination as is required for disease follow-up?
4. Does body weight affect perceived tolerability of either group?


Eligibility criteria: Inclusion Criteria:

* Patients attending for Colonoscopy.
* Patients referred for colonoscopy via General Practitioner.

Exclusion Criteria:

* Individuals who would not fully understand trial purpose (assessed by a cognisance scale if required)
* Previous episodes of total or partial small bowel obstruction
* Previous colonic surgery
* Known swallowing disorder
* Pregnancy
* Extremes of age (Less than 16 or greater than 80)
* Small Intestine disorders
* Renal Insufficiency (Serum Creatinine\> 110)
* Congestive Heart failure
* Presence of ascites
* Severe Colitis

Primary outcomes:
measure: Clarity of the mucosa evaluated by the Ottawa Scale.
timeFrame: At endoscopy screening
Secondary outcomes:
measure: Concordance with the bowel preparation.
timeFrame: Prior to the endoscopy
Other outcomes:
Locations:
city: Londonderry
country: United Kingdom
facility: Western Health and Social Care Trust
state: Northern Ireland
Study officials:
affiliation: Western Health and Social Care Trust
name: Daphne Garrett
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05305703: Effectiveness of Soft Tissue Mobilization
Official title: Effectiveness of Soft Tissue Mobilization and Trigger Point Release vs. Stretching on Tension-type Headache in University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension-Type Headache
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: The aim of this study was to determine the effects of soft tissue mobilization and trigger point release verses stretching in tension-type headache among university students. Two randomized groups of participants with tension type headache will be treated with combination therapy of soft tissue mobilization and trigger point release therapy after the application of hot-pack in experimental group while control group received stretching of cervical muscles after hot-pack application .Both, male and female patients meeting the inclusion criteria will be included. Patients having malignancy and cervical tumor will be excluded.

Detailed description: It was a Randomized Control Trial Study. Study setting was Bashir Institute of Health sciences. Inclusion Criteria was Age 18 to 25 year's students, with tension type headache and trigger point in neck muscles. 30 Subjects were randomly and equally allocated to experimental group (n=15) and control group (n=15) through toss and coin method. Outcomes include cervical range of motions were measured by Goniometer and VAS for paini.e., used at baseline and at the final session for duration of 3 weeks.

Eligibility criteria: Inclusion Criteria:

* Age between 18-25 years.
* Both Male and Female gender
* Trigger points in neck muscles

Exclusion Criteria:

* Patients taking pharmacologicaldrugs.
* Presence of co morbidities.
* Malignancy/ Trauma in cervical region
* Skin infections or open wound in cervical region

Primary outcomes:
measure: changes from baseline in Visual Analogue Scale
timeFrame: baseline and 3 weeks
Secondary outcomes:
measure: changes from baseline in Goniometer
timeFrame: baseline and 3 weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Nasir khan
Study officials:
affiliation: Bashir Institute of Health Sciences
name: Nasir khan, DPT
role: PRINCIPAL_INVESTIGATOR
References: