louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03434145: Changes of Ocular Structures After Hemodialysis in Patients With Chronic Kidney Diseases
Official title: Changes of Ocular Structures After Hemodialysis in Patients With Chronic Kidney Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Hemolysis
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with end-stage renal disease who undergoing hemodialysis

Brief summary: To evaluate the effect of hemodialysis on various ophthalmologic parameters in patients with end-stage kidney disease (ESRD).

Detailed description: Subjects: patients with ESRD undergoing hemodialysis at the Dialysis Center of Hanyang Guri Hospital

Ocular parameters: visual acuity, intraocular pressure, axial length, OCT Other systemic parameters: body weight, ultrafiltration volume, and systolic/diastolic blood pressure

All measurements were performed near the dialysis center. Measurements were performed on Monday (for patients who underwent dialysis sessions on Monday, Wednesday, and Friday) or Tuesday (for patients who underwent dialysis sessions on Tuesday, Thursday, and Saturday.

All parameters were measured before and after the hemodialysis.

Eligibility criteria: Inclusion Criteria:

* 1) patients who are regularly dialyzed in our dialysis room to participate in the study
* 2) patients who agree with our study protocol
* 3) patients who have unstable general condition

Exclusion Criteria:

* 1) previous intraocular surgery, (2) baseline IOP greater than 22 mmHg, (3) presence of glaucomatous optic disc changes including excavation, thinning, or notching of the neuroretinal rim, (4) axial length greater than 26 mm, and (5) combined macular and retinal diseases such as central serous chorioretinopathy and age-related macular degeneration, except diabetic retinopathy.

Primary outcomes:
measure: changes of retinal and choroidal thickness after hemodialysis
timeFrame: immediately (within 10 minutes) before and after hemodialysis
Secondary outcomes:
measure: changes of foveal vascular density using optical coherence tomography-angiography (OCTA) after hemodialysis
timeFrame: immediately (within 10 minutes) before and after hemodialysis
measure: the effect of hemodialysis (HD) on anterior chamber angle by anterior segment optical coherence
timeFrame: immediately (within 10 minutes) before and after hemodialysis
Other outcomes:
Locations:
Study officials:
affiliation: Hanyang University
name: Heeyoon Cho, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06928545: MagDI U.S. Registry
Official title: Post-Market Assessment of the Incidence and Severity of Internal Hernia and Bowel Obstruction at One Year Following Use of the MagDI System to Create Side-to-Side Duodeno-Ileal Magnetic Compression Anastomoses (MagDI US Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anastomosis, Surgical
Internal Hernia
Bowel Obstruction
Keywords: GT Metabolic
MagDI System
Magnetic Anastomosis
Lead sponsor: GT Metabolic Solutions, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-15
Enrollment: 80
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients in the U.S. who undergo a side-to-side duodeno-ileal anastomosis with the MagDI System.

Brief summary: Assess the incidence and severity of internal hernia and bowel obstruction at one year in a U.S. population following use of the MagDI System to create side-to-side duodeno-ileal anastomoses.

Detailed description: Small bowel obstruction (SBO) following various abdominal and pelvic surgeries (0.4% - 13.9% at 5 years post-surgery) across obese and non-obese patients has been well studied in the scientific literature and found to be primarily due to intraperitoneal adhesions, with surgical technique (open surgery versus laparoscopic) cited as a key risk factor as reported in a retrospective population-based registry in Sweden (n=108,141). SBO incidence was reported as 3.2% for those undergoing bariatric surgery (n=1,896).

Given the MagDI System premarket clinical study (GTM-001) was conducted outside the U.S., FDA requires one post-market surveillance study to assess and characterize the incidence and severity of internal hernia and bowel obstruction in the U.S. intended use population treated with MagDI System. This study will be conducted through an observational patient registry and compare registry data to the premarket MagDI System clinical study data (GTM-001) and scientific literature. This post-market Registry Study was also a condition of the MagDI System FDA 510(k) clearances K242086 and K243359.

Eligibility criteria: Inclusion Criteria:

1. \>21 years of age, at the time of informed consent.
2. Body Mass Index (BMI) between 30-50 kg/m2.
3. Indicated for a side-to-side duodeno-ileal anastomosis and is treated with the MagDI System at a U.S. registry center.
4. Participant has been informed of the nature of the registry.

Exclusion Criteria:

1. Participant does not provide informed consent to be enrolled and followed in the registry.

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: From date of study index procedure through 360 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Cary
country: United States
facility: Bariatric Specialists of the Carolinas
state: North Carolina
Study officials:
References:
Clinical trial NCT04258345: Artificially Sweetened Beverage Feeding Study
Official title: Artificially Sweetened Beverage Feeding Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aims of the study are to conduct a pre- and post- two week feeding study of artificial sweetened beverage consumption in middle-aged women. The study will also compare metabolic profiles before and after artificially sweetened beverage consumption.

Detailed description: The aims of the study are to:

1. To conduct a pre- and post- two week feeding study of Artificially Sweetened Beverage (ASB) in women.
2. To assess the general levels of ASB consumption.
3. To compare metabolic profiles before and after beverage consumption

Eligibility criteria: Inclusion Criteria:

• Healthy women

Exclusion Criteria:

• Having a history of diabetes or cardiovascular disease and any other health or chronic condition that precludes participation in the study.

Primary outcomes:
measure: Change in artificial sweetener levels pre- and post- feeding
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00490945: Safety and Efficacy of VEC-162 on Circadian Rhythm in Healthy Adult Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of VEC-162 on Circadian Rhythm in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Circadian Rhythm Sleep Disorders
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-06-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of VEC-162 compared to matching placebo on circadian phase shift and sleep parameters.


Eligibility criteria: Inclusion Criteria:

* No medical, psychiatric, or sleep disorders
* Ability to provide written informed consent

Exclusion Criteria:

* Lifetime history of night shift work
* Evidence of any sleep disorder
* Psychiatric or neurological disorders

Primary outcomes:
measure: Circadian Phase Shift
timeFrame: Night 3 and Night 4
measure: Mean Sleep Efficiency
timeFrame: Night 4 and Night 2
Secondary outcomes:
measure: Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS)
timeFrame: Night 2 and Night 4
measure: VEC-162 AUC
timeFrame: Night 4
measure: VEC-162 Cmax
timeFrame: Night 4
measure: VEC-162 Tmax
timeFrame: Night 4
Other outcomes:
Locations:
city: Boston
country: United States
facility: Vanda Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Vanda Investigational Site
state: Michigan
Study officials:
affiliation: Vanda Pharmaceuticals Inc
name: Marlene Dressman, PhD
role: STUDY_DIRECTOR
References:
citation: Rajaratnam SM, Polymeropoulos MH, Fisher DM, Roth T, Scott C, Birznieks G, Klerman EB. Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials. Lancet. 2009 Feb 7;373(9662):482-91. doi: 10.1016/S0140-6736(08)61812-7. Epub 2008 Dec 4.
Clinical trial NCT05445245: The Longitudinal Study of Low Anterior Resection Syndrome in Patients with Newly Diagnosed Rectal Cancer.
Official title: The Longitudinal Study of Low Anterior Resection Syndrome, Psychological Distress, and Fecal Incontinence-related Quality of Life in Patients with Newly Diagnosed Rectal Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: low anterior resection syndrome
psychological distress
quality of life
rectal cancer
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Rectal cancer patients during therapy.

Brief summary: The aims are to identify the trajectory of LAR Syndrome and explore the adaptation process and coping strategies of LAR Syndrome in patients newly diagnosed with rectal cancer. The participants will recruit from a CRC surgical outpatient department of a medical center in northern Taiwan.


Eligibility criteria: Inclusion Criteria:

1. Patients with stage I to III rectal cancer.
2. Patients already know their condition.

4. Aged 20 years and older. 5. Consciously communicate in Mandarin or Taiwanese. 6. Agreed with the interview and had signed the permit.

Exclusion Criteria:

1. Patients with Stage IV rectal cancer.
2. Recurred rectal cancer.

Primary outcomes:
measure: Self-report Questionnaire
timeFrame: Change from baseline symptom at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chung Gung University
state: Kwei-Shan Dist.
Study officials:
References:
Clinical trial NCT05753345: Aquatic Therapy for Children With Neuromotor Deficits
Official title: Aquatic Therapy for Children With Neuromotor Deficits
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Hypoxia, Brain
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Franklin County Board of Developmental Disabilities
First posted: 2023-03-03
Enrollment: 36
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the feasibility, fidelity and acceptability of an aquatic therapy assessment and intervention for children ages 3-9 with neuromotor deficits such as cerebral palsy. The intervention takes place in a warm water therapy pool, twice a week for ten weeks and targets swim safety skills, upper extremity function and self care participation and performance.

Detailed description: The purpose of this study is to explore the feasibility, fidelity and acceptability of an aquatic therapy assessment and intervention. The intervention will target swim safety skills, upper extremity function and self care participation and performance in children with neuromotor conditions such as cerebral palsy. The study includes an intake evaluation session, twenty sessions of aquatic therapy (twice a week for 10 weeks) and a post evaluation session. This takes place in Columbus, Ohio.

Each session will be a combination of land-based self care training and water-based upper extremity exercise and swim skill training. The intervention structure will include the following:

1. Self Care Session: Doffing clothing, preparing for swimming
2. Motor learning aquatic activities guided by individualized goals
3. Self Care session: Towel dry, rinse off, dressing

Individualized activities will be planned according to the individualized goals written for each child participant.

Eligibility criteria: Inclusion Criteria:

* 3-9 years for the children, 18+ for the parents/guardians.
* child with neuro-motor diagnosis (CP, hypoxia, etc.)
* child impairments in upper extremity function
* child deficits in performance of self care activities

Exclusion Criteria:

* compromised airway
* uncontrolled seizures

Primary outcomes:
measure: Change in Water Orientation Test Alyn (WOTA)
timeFrame: Baseline, immediately after the intervention
measure: Change in Pediatric Evaluation of Disability Index, Computer Adaptive Text (PEDI-CAT)
timeFrame: baseline, immediately after the intervention
measure: Change in Quality of Upper Extremity Skills Test (QUEST)
timeFrame: baseline, immediately after intervention
Secondary outcomes:
measure: Change in Participation and Environment Measure (PEM-CY)
timeFrame: baseline, immediately after the intervention
measure: Change in Canadian Occupational Performance Measure (COPM)
timeFrame: baseline, immediately after the intervention
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Erika Kemp
state: Ohio
Study officials:
References:
Clinical trial NCT04021745: Bringing Awareness Into Eating
Official title: Mindful Eating - Bringing Awareness Into Eating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Eating
Reward-based Eating
Craving-related Eating
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test an app-based mindful eating intervention to decrease the reward value of unhealthy food.

Detailed description: Eating healthily is highly beneficial. However, changing eating habits is notoriously difficult. Individuals often believe that they simply need to "restrain" their eating impulses in order to eat more healthily. However, such an approach has not only been shown to be quite ineffective over long time spans, it is also associated with aversive feelings: It simply does not feel good to struggle with one's own impulses.

Investigators are testing a new approach to overcoming unhealthy eating habits, which utilizes mindful eating to change the reward value of unhealthy food. The hypothesis is that if people pay attention to how unhealthy food (e.g. "junk" food) makes them feel in their bodies, their liking it and desire to eat it will decrease naturally. Participants might become aware, for example, that eating a whole bag of chips leads to nausea, while eating a salad makes them feel fresh and energetic.

Investigators will assess whether and how the anticipated and actual satisfaction associated with unhealthy food will decrease the more often participants use this intervention.

Eligibility criteria: Inclusion Criteria:

1. Craves \& overeats a food at least 4 times/week (can be a specific food or food category - i.e. salty or sweet)
2. Desire to change eating habits
3. Owns a smartphone
4. Fluency in English

Exclusion Criteria:

1. Current eating disorder
2. Current strict diet (e.g. paleo, keto, vegan, calorie restriction)
3. Pregnancy
4. Current insulin use
5. Previous use of the EatRightNow application

Primary outcomes:
measure: Change in Reward Based Eating Drive (RED) Scale
timeFrame: 2 months
Secondary outcomes:
measure: Change in Salzburg Stress Eating Scale (SSES)
timeFrame: 2 months
measure: Change in Food Craving Questionnaire - Trait, Reduced (FCQ-T-r)
timeFrame: 2 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Judson Brewer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04844645: Using Mini Program for Self-management VS Conventional Pharmaceutical Care for Cancer Pain
Official title: Comparison of Cancer Pain Patients With or Without Mini Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Pain
Keywords: mini program, self management, cancer pain
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2021-04-14
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experiment involved two groups: a mini program trial group and a control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: With the existing medical system and insufficient medical resources in China, we developed a mini program. a pain management mini app can be useful and appreciated by patients and health care professionals, making it a good choice for the management of cancer pain in our country . our study want to develop and test the mini program for pain management among Chinese cancer patients in or discharged from hospital treatment.

Detailed description: Healthcare interventions delivered via personal mobile device have been shown to be acceptable to users, who have identified benefits such as convenience, access to personalized information, greater awareness of own health. Integrating mini program into the cancer pain care may be an effective strategy to improve cancer pain patients self-management.

To design, construct, and test the mini program in patients managing cancer pain, evaluate the total remission rate of pain and the improvement in medicine compliance to improve pain management for cancer pain patients, and assess patient acceptance of the mini program.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older;
* Be able to read Chinese and use a mobile phone;
* Histologically or cytologically confirmed solid tumor;
* Diagnosed chronic cancer pain
* Could understand the study process and evaluation, agreed to participate in the trial, and signed the informed consent form.

Exclusion Criteria:

* Illiterate person;
* Incompetence;
* Inability to complete the pain assessment;
* Participation in any other therapies or other study protocols that may have an impact on pain intensity, which were the main outcomes of this study;

Primary outcomes:
measure: Change in pain score
timeFrame: Change from baseline at four weeks after discharge
Secondary outcomes:
measure: Change in medication adherence
timeFrame: Change from baseline at four weeks after discharge
measure: Incidence of adverse events
timeFrame: Up to four weeks after discharge
measure: Change in quality of life
timeFrame: Change from baseline at four weeks after discharge
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05146245: Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT
Official title: Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Autism Spectrum Disorder
Keywords: Risperidone
Therapeutic Drug Monitoring
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Stichting de Merel
name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2021-12-06
Enrollment: 140
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to test whether therapeutic drug monitoring of risperidone in children with autism spectrum disorder and comorbid behavioral problems is able to reduce metabolic side effect burden, while retaining clinical effectiveness.


Eligibility criteria: Inclusion Criteria:

* Age 6 to 18 years
* Documented clinical diagnosis of autism spectrum disorder according to DSM IV or DSM V and comorbid behavioural problems
* To start treatment with risperidone

Exclusion Criteria:

* Diabetes type I or II
* Congenital or acquired syndrome associated with changes in appetite, body weight or lipid profile (e.g. Prader Willi)
* Treatment with antipsychotic medication within the last 6 months
* Known Long QT syndrome (LQTS)
* Pregnancy

Primary outcomes:
measure: BMI z-score
timeFrame: 6 months
Secondary outcomes:
measure: Effectivity (ABC)
timeFrame: 6 months
measure: Effectivity (CGI)
timeFrame: 6 months
measure: Quality of Life (PedsQL)
timeFrame: 6 months
measure: Metabolic side effects (glucose)
timeFrame: 6 months
measure: Metabolic side effects (cholesterol)
timeFrame: 6 months
measure: Metabolic side effects (triglycerides)
timeFrame: 6 months
measure: Endocrine side effects (prolactin)
timeFrame: 6 months
measure: Extrapyramidal symptoms (EPS)
timeFrame: 6 months
measure: Endocrine side effects (ghrelin)
timeFrame: 6 months
measure: Endocrine side effects (leptin)
timeFrame: 6 months
measure: Side effects (blood pressure)
timeFrame: 6 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
References: