louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06107387: Binge Eating Self-help for Teens ONLINE Pilot and Feasibility Study
Official title: Binge Eating Self-help for Teens (BEST): A Pilot and Feasibility Test of an Online Behavioral Intervention for Adolescents With Binge Eating and Elevated Weight
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Binge Eating
Binge-Eating Disorder
Overweight or Obesity
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a pilot clinical trial of a new guided self-help CBT for binge eating. Participants will complete an intake assessment; following determination of eligibility, participants will then complete four months of treatment (weekly guided self-help sessions). At the end of treatment, participants will complete an interview with a research clinician to assess outcomes.


Eligibility criteria: Inclusion Criteria: To be included, adolescents must:

1. Be in the age range ≥12 years old and ≤17 years old;
2. Have a BMI that places them above the 85th percentile based on their age and sex;
3. Report 2 episodes of binge/LOC eating (feeling a loss of control while eating) per month for the past 3 months;
4. Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions);
5. Read, comprehend, and write English at a sufficient level to complete study-related materials;
6. Provide a signed and dated written assent prior to study participation;
7. Provide a signed and dated written consent from one parent prior to study participant; and
8. Be available for participation in the study for 4 months.

Exclusion Criteria: Prospective participants will be excluded if the adolescent:

1. Has a medical or psychiatric condition that would require hospitalization or intensive care (e.g., neurological disorder, psychotic disorders, suicidality);
2. Has a medical or psychiatric condition that would prohibit them from engaging in behavioral treatment or moderate physical activity (e.g., cardiovascular problems);
3. Has uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension);
4. Is pregnant or breastfeeding;
5. Is taking medication(s) or participating in treatment(s) that could influence weight or appetite;
6. Began taking hormonal contraceptives less than 3 months prior;
7. Has a developmental or cognitive disorder (e.g., autism spectrum disorder);
8. Has a concurrent feeding/eating disorder (e.g., bulimia nervosa); or
9. Is participating in another clinical research study.

Primary outcomes:
measure: Attendance
timeFrame: 4 months
measure: Retention
timeFrame: 4 months
Secondary outcomes:
measure: Treatment Credibility
timeFrame: 1 week
measure: Treatment Satisfaction
timeFrame: 4 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale
state: Connecticut
Study officials:
affiliation: Yale University
name: Janet A Lydecker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05526287: Effects of Dual-Task Training in People With Multiple Sclerosis
Official title: Effects of Dual-Task Training on Balance, Gait, Dual-Task Performance, Cognitive Function, Fatigue in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Balance
Gait
Dual-Task
Cognitive Function
Functional Mobility
Activities of Daily Living
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 26
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 purpose of this study is to investigate the effects of dual task training on balance, gait, dual-task performance, cognitive function, fatigue and functional mobility in people with Multiple Sclerosis(MS).

Detailed description: Eligible participants will be randomized to dual-task group or control group. Dual-task group will receive 8 weeks of dual-task training twice a week and home exercise program. Control group will receive only home exercise program for 8 weeks. Each participant will be assessed before and after the 8 weeks of treatment.

Eligibility criteria: Inclusion Criteria:

* Having a definitive diagnosis of MS according to the revised McDonald criteria
* Having Expanded Disability Status Scale score between 0-5.5
* No relapse in the last 30 days
* Having a Mini Mental Test score of 24 and above
* Being fluent in Turkish language
* No condition that prevents exercising

Exclusion Criteria:

* Being pregnant
* Presence of a neuro-musculoskeletal disease other than Multiple Sclerosis
* Having received physiotherapy for balance and gait disorders in the last 3 months

Primary outcomes:
measure: Berg Balance Scale(BBS)
timeFrame: eight weeks
measure: Timed Up And Go Test (TUG)
timeFrame: eight weeks
measure: Tetrax((Sunlight Medical Ltd, Israel),Computerized Static Posturography Device
timeFrame: eight weeks
Secondary outcomes:
measure: MS Walking Scale-12(MSWS-12)
timeFrame: eight weeks
measure: Fatigue Severity Index(FSI)
timeFrame: eight weeks
measure: Brief International Cognitive Assesment for MS(BICAMS)
timeFrame: eight weeks
measure: 10 Meter Walking Test(10MWT)
timeFrame: eight weeks
measure: Dual-Task Performance
timeFrame: eight weeks
measure: Dual-Task Questionnaire(DTQ)
timeFrame: eight weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Health Sciences
state: Karsıyaka
Study officials:
affiliation: Ege University
name: Nur YUCEYAR, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05324787: Treatment of Vein Stenosis or Occlusion With the Oblique Stent
Official title: Single Arm, Multi-center Clinical Trial for the Safety and Effectiveness of Venous Stent System in the Treatment of Vein Stenosis or Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iliac Vein Stenosis
Iliac Vein Occlusion
Lead sponsor: Hangzhou Endonom Medtech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-12
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and effectiveness of Grency venous stent system in the treatment of iliac vein stenosis or occlusion.

Detailed description: The purpose of this study was to evaluate the safety and effectiveness of a new dedicated venous stent system (Grency) in the treatment of iliac vein stenosis or occlusion. The Grency stent system has a hybrid oblique self-expanding design, which allows precise positioning at the iliocaval confluence.

Eligibility criteria: Inclusion Criteria:

1. subjects aged 18-80 years;
2. CEAP clinical grade C \>=3;
3. iliac vein stenosis \>=50% or occlusion;
4. patients voluntarily sign informed consent and complete follow-up.

Exclusion Criteria:

1. subjects in pregnancy or lactation;
2. renal insufficiency;
3. subjects are allergic to contrast agents and anesthetics;
4. subjects are allergic to nitinol;
5. the life expectancy of cancer patients is less than 1 year;
6. the length of the stent is expected to exceed the length of the inguinal ligament; 7. both sides of iliac vein stents were required;

8. long term bedridden or wheelchair patients; 9. the target vessel of the subject has been implanted into the iliac vein stent; 10. subjects have anticoagulant contraindications or are unable to receive long-term new oral anticoagulant therapy; 11. the investigator judged that the subjects had poor compliance and could not complete the clinical trial; 12. subjects are participating in clinical trials of other drugs or medical devices and have not yet completed the primary end point of the study.

Primary outcomes:
measure: Patency rate of venous stent
timeFrame: 12 months post-intervention
Secondary outcomes:
measure: The rate of procedural technical success
timeFrame: During procedure
measure: Change in the clinical symptoms
timeFrame: Baseline, 3 months,6 months, and12 months post-intervention
measure: The rate of device related major adverse events(MAE)
timeFrame: 3,6,12 months post-intervention
measure: The rate of adverse events (AE)
timeFrame: 3,6,12 months post-intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
Study officials:
References:
Clinical trial NCT00473187: Effects of GH on Body Proportions and Final Height in X-Linked Hypophosphatemic Rickets
Official title: Effects of Growth Hormone Treatment on Body Proportions and Final Height Among Small Children With X-Linked Hypophosphatemic Rickets
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hypophosphatemic Rickets
Growth Disorders
Somatropin Therapy
Keywords: X-linked dominant hypophosphatemic rickets
growth disorders
anthropometry
human growth hormone
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2007-05-14
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: X-linked hypophosphatemic rickets (XLH) is characterized by rickets, disproportionate short stature, impaired renal phosphate reabsorption and vitamin D metabolism. Despite oral phosphate and vitamin D treatment, most children with XLH demonstrate reduced adult height. The main objective of the study is to determine the beneficial effects of recombinant human growth hormone (rhGH) therapy on body proportions after 36 month in these patients. Secondary objective is to monitor side effects of the therapy.


Eligibility criteria: Inclusion Criteria:

* Tanner stages of puberty B1, G1
* body height \< 2,5 SDS
* growth velocity \< 75%
* confirmed diagnosis of XLHR
* conservative treatment for at least 1 year (phosphate, vitamin D)
* informed consent, written agreement

Exclusion Criteria:

* growth hormone deficiency
* hypothyreosis
* severe rickets
* severe physical deformities
* severe hyperparathyreoidism
* chronic renal failure
* complex syndrome involving failure to thrive
* chronic disease with failure to thrive
* impairment of glucose tolerance
* Tanner stages of puberty greater than B1, G1
* medical history of malignancy
* therapy with growth hormone, glucocorticoides, anabolica
* attending another clinical trial

Primary outcomes:
measure: change of body proportion and final height
timeFrame: within 5 years
Secondary outcomes:
measure: side effects of therapy with rhGH
timeFrame: within 5 years
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: University Childrens Hospital, Rostock
state: MV
Study officials:
affiliation: University Childrens Hospital - Charite, Berlin
name: Dirk Schnabel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Childrens Hospital, Rostock
name: Hagen Staude
role: PRINCIPAL_INVESTIGATOR
affiliation: University Childrens Hospital, Rostock
name: Dieter Haffner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01479387: Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan
Official title: Special Drug Use Investigation of Zevalin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Hodgkin's Lymphoma (NHL)
Keywords: Zevalin
CD20+
Non-Hodgkin's lymphoma
Mantle cell lymphoma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-11-24
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of this study is 40 patients who received In-111 Zevalin to access biodistribution of Zevalin.

Brief summary: This study is a regulatory post-marketing surveillance of Zevalin (ibritumomab tiuxetan) in Japan. In-111 Zevalin is, at first, injected to patient for gamma scan imaging to assess biodistribution of the Zevalin. When the imaging shows no altered distribution, Y-90 Zevalin is injected to the patient for the actual treatment. The objective of this study is to assess appropriateness and necessity of revision of the standardized criteria for image interpretation of In-111 Zevalin by comparing assessment by the investigator and the members of the committee for image interpretation of In-111 Zevalin. A total 40 patients will be recruited.


Eligibility criteria: Inclusion Criteria:

* Patients who received In-111 Zevalin to verify that expected biodistribution is present.

Exclusion Criteria:

* Patients who are contraindicated based on the product label.

Primary outcomes:
measure: Assessment of abnormal distribution of In-111 Zevalin by the investigator [Two scales; Yes or No]
timeFrame: At 48-72 hours after In-111 Zevalin injection
measure: Assessment of abnormal distribution of In-111 Zevalin by the central committee [Two scales; Yes or No]
timeFrame: At 48-72 hours after In-111 Zevalin injection
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03034187: Radiation-induced Toxicity in Prostate Cancer/ Standard-Follow-Up Program Prostate
Official title: Radiation Induced Toxicity in Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: Acute toxicity
Late toxicity
Quality of Life since 2011(set-up SFP-prostate)
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 10000
Sex: MALE
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: All with curative intent treated prostate cancer patients who will be treated with RT will be enrolled in the SFP.

It also includes the post-surgical adjuvant treatment and patients with positive lymph nodes to research the development and toxicity after RT

Brief summary: The goal is to gain insight in the development and course of the toxicity after a curative treatment of prostate cancer

Detailed description: All with curative intent treated prostate cancer patients will be enrolled in the SFP (Standard Follow-up Programme). It also includes the post -operative adjuvant treatments and the patients with positive lymph nodes.

Patients will complete weekly questionnaires to score the patient -rated toxicity. Biweekly patients are seen by the treating radiation oncologist and / or AIOS in which the physician -rated toxicity is scored. In the follow-up will always patient -rated toxicity and physician -rated toxicity can be determined.

Use of an SFP should yield a profit for the practitioner , such as the automatic generation of letters. This should apply to all SFPs .

Quality of life and toxicity in patients will be completed on the touch-screen computers at FU visits.

Eligibility criteria: Inclusion Criteria:

* All curative treated patients with prostatecancer( with positive lymph nodes)
* All patients who will be treated with RT( including post-operative, adjuvant treatments)
* Are willing to fill in toxicity and QOL-questionnarys (QLQ-PR25 en de QLQ-C30)

Exclusion Criteria:

Patients who are not willing to fill in toxicity and QOL-questionnarys Patients who will not get RT Non-curative or palliative treated patients (with bone mestasis) Non-prostate cancer-patients

Primary outcomes:
measure: 1. Change in Acute toxicity
timeFrame: Toxicity:First visit/Wekely during RT, Acute Toxicity: 2-wekely and at the end of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT
Secondary outcomes:
measure: 2. Change in patient -rated Quality-of-Life
timeFrame: First visit/End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT
Other outcomes:
measure: 3. Change in physiological parameters
timeFrame: First visit/2 months after RT/1, 2, 3, 4, 5 years after RT
measure: 4. Change in Acute/ Late toxicity(physician rated)
timeFrame: First Visit/ 2 wekely/ End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
Clinical trial NCT01506687: Increasing Colorectal Cancer Screening Uptake With a Patient Navigator
Official title: Increasing Colorectal Cancer Screening Uptake With a Patient Navigator - Phase III Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: Colorectal cancer screening
50 years or older
Lead sponsor: Cancer Care Ontario
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-01-10
Enrollment: 750
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients who receive tailored navigation (consisting of a letter and patient navigation services) and get screened will be significantly greater than the control group who receives treatment as usual.

A majority of patients will opt for Fecal Occult Blood Testing (FOBT)as one of their preferred tests, after undergoing the "Patient Navigator" intervention and that proportion will be significantly greater than the group who opt for FOBT in the control group.

Detailed description: Primary Outcome Measure:

Number of patients who receive a letter and patient navigation services and get screened compared to the control group.

Secondary Outcome Measures:

Proportion (%) of patients preferring FOBT vs.colonoscopy; Predictors of CRC screening and screening preference.

Subjects: Ambulatory patients (men-women aged 50 years and above) recruited from primary care practices at the Group Health Centre, Sault Ste Marie, Ontario. All patients will be screened for eligibility and those who are eligible and agree to participate in the study will be randomized to either of the two study arms: intervention group or control group.

Eligibility criteria: Inclusion Criteria:

* Average risk men and women aged 50 - 74
* Unscreened - Defined as no prior CRC screening
* Under-screened - Defined as no FOBT screening within the last two years
* No colonoscopy or barium enema screening within the last five years
* Willing to provide consent to participate in the study.

Exclusion Criteria:

* FOBT within the last two years
* colonoscopy within five years
* barium enema within five years
* flexible sigmoidoscopy within five years
* Bowel cancer.

Primary outcomes:
measure: Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks
timeFrame: 48 weeks after baseline assessment
Secondary outcomes:
measure: Screening preferences; predictors of CRC screening and screening preference.
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Sault Ste. Marie
country: Canada
facility: Group Health Centre
state: Ontario
Study officials:
affiliation: Cancer Care Ontario
name: Paul Ritvo, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06568887: Effectiveness of 5% Dextrose Water Versus Corticosteroid Injection for Pain Management of SJD
Official title: Effectiveness of 5% Dextrose Water (D/W) Versus Corticosteroid Injection for Pain Management of Sacroiliac Joint Dysfuntion
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sacroiliac Joint Dysfunction
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The sacroiliac joint (SIJ) is identified as a potential origin of low back pain and referred pain to the lower limb, with a prevalence rate ranging from 7% to 30%. Typically, SIJ pain manifests in the buttock and occasionally extends to the posterior aspect of the ipsilateral thigh, resembling pain originating from lumbar spine sources, such as the zygapophysial joints or intervertebral discs.

Detailed description: For Sacroiliac Joint Dysfunction (SIJD) by examining the comparative effectiveness of two distinct interventions: the innovative 5% Dextrous Water (D/W) solution and the conventional corticosteroid injection. With corticosteroids associated with well-documented side effects and concerns about long-term use, the exploration of 5% D/W is particularly timely and holds promise as a potentially safer alternative.

Eligibility criteria: Inclusion Criteria:

* persons with SIJ pain for at least 3 months

Exclusion Criteria:

* Pregnancy or breastfeeding
* history of allergy or people contra indicated to our dose
* already received Corticosteroid injection in last 3 months

Primary outcomes:
measure: VAS
timeFrame: 12 Months
measure: ODI
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
state: Punjab
Study officials:
References: