louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07026357: Impact of 3D-planimetry on Optimized Therapeutic Assessment in Complex Benign Esophageal Stenosis
Official title: Impact of 3D-planimetry on Optimized Therapeutic Assessment in Complex Benign Esophageal Stenosis; a Prospective Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Esophageal Stricture
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
name: University Hospital Augsburg
name: University Hospital Munich
First posted: 2025-06-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Esophageal stenosis has a high impact on patients quality of live and food intake affecting personal nutrition status and general health.

For benign strictures of the esophagus, endoscopic dilatation therapy is recommended by actual guidelines.

Since the extent of dilatation is currently directed by endoscopic view and fluoroscopic imaging, patients are exposed to radiation and the determination of the appropriate extent of dilatation is difficult.

Therefore, the aim of this study is to compare the effect of 3D-planimetric measurement with current fluoroscopic monitoring on the success of endoscopic esophageal dilatation therapy in patients with benign esophageal stenosis.


Eligibility criteria: Inclusion Criteria:

* symptomatic benign esophageal stenosis
* medical indication for endoscopic therapy
* written consent after detailed information

Exclusion Criteria:

* non-benign esophageal stenosis
* missing written consent
* trans-oral endoscopic access is not possible
* medical contraindication for endoscopic dilatation therapy
* age \<18 years

Primary outcomes:
measure: Endoscopic therapy success
timeFrame: 3 months after intervention at endoscopic control examination
Secondary outcomes:
measure: Length measurement of esophageal stenosis
timeFrame: during endoscopic intervention
measure: Postinterventional esophageal diameter
timeFrame: directly after endoscopic intervention
measure: Hospitalization time after endoscopic dilatation therapy
timeFrame: within 3 months after study intervention
measure: Number of endoscopic interventions
timeFrame: within 3 months after study intervention
measure: Number of hospitalizations due to complications
timeFrame: within 3 months after initial study intervention
measure: Quality of life assessed by German Sydney Swallow Questionnaire
timeFrame: Baseline study intervention and 2 weeks after study intervention
measure: Complication rate
timeFrame: during the procedure
measure: Duration of endoscopic examination
timeFrame: during the procedure
measure: Sedation dose
timeFrame: during the procedure
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University Hospital Ulm, Clinic for Internal Medicine I
state: Baden-Wuerttenberg
Study officials:
affiliation: University Hospital Ulm
name: Benjamin Walter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01259557: Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm
Official title: Multi-center, Phase Ⅳ, Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Meditoxin® in Subjects With Essential Blepharospasm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Blepharospasm
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2010-12-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of Essential blepharospasm.


Eligibility criteria: Inclusion Criteria:

* Men and women aged above 18
* Subjects who was diagnosed with Essential Blepharospasm
* Subjects who voluntarily Signed written informed consent
* Subjects who can adhere to protocol and study requirements

Exclusion Criteria:

* Subjects with known history of allergy considered due to Botulinum toxin type A
* Subjects who have received botulinum toxin A type within 3 months
* Any disease that might affect neuromuscular function (e.g.. Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis ect.)
* Subjects who are participating in other clinical trials
* Pregnant or lactating female Subjects
* Subjects who are not eligible for the study at the discretion of the Investigator.

Primary outcomes:
measure: the change rate of Jankovic Rating Scale score
timeFrame: 4weeks
Secondary outcomes:
measure: the change rate of Jankovic Rating Scale scale
timeFrame: 0 week, 16weeks(or retreatment point)
measure: the change rate of Blepharospasm Disability Index
timeFrame: 0week, 4weeks, 8weeks, 16weeks(or retreatment point)
measure: Global assessment about the improvement
timeFrame: 4weeks
measure: the duration of efficacy
timeFrame: retreatment point or 16 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sevrance Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang Univesity Yongsan Hospital
Study officials:
affiliation: Chung-Ang university Yongsan Hospital
name: Jaechan Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01059357: Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System
Official title: A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasms
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2010-01-29
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.

Detailed description: Patients are going to be evaluated in their usual regular clinical follow ups starting with preoperative first visit, 3 weeks, 3 months and 6 months postoperatively with a Quality of Life survey (Head and Neck Cancer Inventory, HNCI-QOLQ).

Eligibility criteria: Inclusion Criteria:

* Patient must present with indications for diagnostic or therapeutic approaches for benign and malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
* Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation

Exclusion Criteria:

* Unexplained fever and/or untreated, active infection
* Patient pregnancy
* Previous head and neck surgery precluding transoral/robotic procedures
* The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches

Primary outcomes:
measure: The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.
timeFrame: At time of surgery, lasting up to 3 hours. Assessed for up to 6 months
Secondary outcomes:
measure: Operative Time
timeFrame: At time of surgery, up to 3 hours
measure: Number of Participants With Blood Loss and Complications
timeFrame: 6 months
measure: Average Time to Set up and Perform Procedures
timeFrame: At time of surgery, up to 3 hours
measure: Number of Correctly Predicted Success of TORS Preoperatively
timeFrame: preoperative
measure: QOL
timeFrame: 6 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Joshua D. Waltonen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04118257: Short-term Sugary Beverage Consumption on Glucose Control and Cardiovascular Disease Risk Factors
Official title: Effects of Short-term Sugary Beverage Consumption on Type-2 Diabetes and Cardiovascular Disease Risk Factors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Glucose control
Cardiovascular disease risk factors
Sugary beverages
Pulmonary function
Lead sponsor: Kansas State University
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Our goal is to determine how the addition of sugar-sweetened beverages to the diet affects glucose control, cardiovascular disease risk factors, and pulmonary function in healthy, young adults.

Detailed description: In a 3-arm randomized controlled trial, 36 participants consumed one of three beverages for three weeks: water (W), caffeine-free soda (S), or 100% fruit juice (FJ). Participants consumed two servings/day (\~710mL) of their randomized beverage for three weeks, along with their habitual diets. At baseline and following the 3-week intervention, participants completed glucose control, cardiovascular disease risk factor, and pulmonary function assessments.

Eligibility criteria: Inclusion Criteria:

* Free from diagnosis of diabetes and pulmonary illness
* Have no intake of glucose or lipid lowering medication.

Exclusion Criteria:

* Smoke
* Currently pregnant
* Have bronchitis
* Have more than 2 risk factors for cardiovascular disease, as defined by the American College of Sports Medicine (ACSM).

Primary outcomes:
measure: Change in glucose iAUC
timeFrame: Week 0 and Week 3
Secondary outcomes:
measure: Change in plasma lipids
timeFrame: Week 0 and Week 3
measure: Change in homeostatic model assessment for insulin resistance
timeFrame: Week 0 and Week 3
measure: Change in blood pressure
timeFrame: Week 0 and Week 3
measure: Change in BMI
timeFrame: Week 0 and Week 3
measure: Change in pulmonary function
timeFrame: Week 0 and Week 3
measure: Change in insulin iAUC
timeFrame: Week 0 and Week 3
measure: Change in serum fructosamine
timeFrame: Week 0 and Week 3
Other outcomes:
Locations:
city: Manhattan
country: United States
facility: Lafene Health Center
state: Kansas
Study officials:
affiliation: Kansas State University
name: Sara Rosenkranz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03390257: Study to Evaluate the Safety and Initial Effectiveness of the Sinusway™ for Endoscopy of Sinuses in Conjunction With BSD
Official title: Safety and Effectiveness Evaluation of the Sinusway™ Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses in Conjunction With Sinus Balloon Dilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinusitis
Keywords: Endoscopy, BSD
Lead sponsor: 3NT Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-04
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 3NT flexible endoscope is a single-use disposable handheld endoscope that provides a means to visualize the nasal cavity and paranasal sinus space and deliver irrigation to treat the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures

Detailed description: The rationale behind this feasibility study is to show that access and visualization of the nasal anatomy and paranasal sinuses (Maxillary, Frontal and Sphenoid sinuses) in conjunction with Balloon Sinus Dilation in patients suffering from symptoms attributable to sinusitis is feasible in the office and operating room settings; This is an essential step in the development of a combined dilation and visualization system that will allow visualization, dilation and lavage of the sinuses via their natural ostia during an office visit, and minimize radiation exposure, antibiotic use, multiple office visits, and cost.

Eligibility criteria: Inclusion Criteria:

1. Male or female patient indicated for balloon sinus dilation procedure by the ENT specialist
2. Patient age: adult (\>18 years old)
3. Patients in general good health in the opinion of the investigator as determined by medical history and physical examination
4. A patient who is able to understand the requirements of the study, is willing to comply with its instructions and schedules, and agrees to sign the informed consent

Exclusion Criteria:

1. Known history of any significant medical disorder, which in the investigator's judgment contraindicates the patient's participation
2. Patients with known current or previous bleeding disorder receiving anticoagulants (e.g., chronic Coumadin treatment)

Primary outcomes:
measure: Number of Adverse Device Effects
timeFrame: 4 hours
Secondary outcomes:
measure: Percent of Sinuses Accessed and Visualized Successfully
timeFrame: 1 hour
measure: User Satisfaction (1-bad, 5-good)
timeFrame: 1 hour
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: SF Otolaryngology
state: California
city: Salt Lake City
country: United States
facility: Ogden Clinic
state: Utah
Study officials:
affiliation: SF Otolaryngology
name: Jacob Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06534957: Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy
Official title: Online Mindfulness-based Stress Reduction Intervention for Patients with Breast Cancer Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Stress
Keywords: mindfulness-based stress reduction
chemotherapy-related stress
breast cancer
Lead sponsor: Medicos e Investigadores en la Lucha contra el Cancer de Mama
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this prospective, waitlist-controlled, 1:1 randomized study is to evaluate if an online mindfulness-based stress reduction (MBSR) intervention reduces treatment-related stress levels among patients with breast cancer receiving chemotherapy.

The main questions it aims to answer are:

* Does an online MBSR intervention reduce stress levels (measured through the Perceived Stress Scale) among participants?
* Does an online MBSR intervention reduce anxiety, depression, insomnia, fatigue, nausea, diarrhea, constipation, pain, and peripheral neuropathy (measured through the PRO-CTCAE of the National Cancer Institute) among participants?

Researchers will compare the online MBSR intervention to no intervention to see if online MBSR reduces treatment-related stress.

Participants will:

* Participate in an online MBSR intervention or no intervention for 6 weeks
* Answer the study surveys at baseline, 7 weeks, and 11 weeks of follow-up


Eligibility criteria: Inclusion Criteria:

* Female sex
* Age ≥18 years
* Diagnosis of non-metastatic breast cancer
* Plan to start neoadjuvant or adjuvant chemotherapy in \<4 weeks
* Internet access at home or in their mobile phone
* Availability to participate in the online MBSR intervention for 6 weeks
* Availability to answer the study surveys
* Provision of signed informed consent

Exclusion Criteria:

* Disease recurrence
* Current meditation or mindfulness practice
* Inability to read or write

Primary outcomes:
measure: Stress
timeFrame: 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Pedro Garza Garcia
country: Mexico
facility: Hospital Zambrano Hellion
state: Nuevo Leon
Study officials:
References:
Clinical trial NCT04197557: Bone Age of Chinese Child (BACC)
Official title: The National Survey on Bone Age of Child in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Development
Keywords: bone age
bone mineral density
X-ray
Chinese child
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
Collaborators: name: National Institute for Nutrition and Health Chinese Center for Disease Control and Prevention
name: Beijing pediatric research institute
First posted: 2019-12-13
Enrollment: 20166
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: As part of the "National Nutrition and Health Systematic Survey for 0-18 years old Children and Utilization of Survey Findings" (ChiCTR1900022825). This population is the subset of the ChiCTR1900022825 study, age 3-18 years old, sample proportion to the general study population. General healthy children age over 3 years old up to 18 years old from the kindergarden, primary school, middle school and high school.

Brief summary: The bone age of the hand and wrist will be assessed with X-rays in more than 20,000 healthy children age 3-18 years old recruited in 28 sites from 14 province.The bone mineral density (BMD) will be measured as well.

Detailed description: As part of the "National Nutrition and Health Systematic Survey for 0-18 years old Children and Utilization of Survey Findings "(ChiCTR1900022825), more than 20,000 children age 3-18 years old was recruited from 28 sites of 14 provinces within the framework of the ChiCTR190002282 study protocol. The population of this study was proportional to the ChiCTR190002282 study. The X-ray of no-dominant hand and wrist was taken with a mobile X-ray unit with shielding. A step wedge was imaged along the side of the hand at the same time for bone mineral density measurement. The bone age of the hand and wrist was assessed by trained MSK radiologists according to Chinese standard. The bone mineral density of the wrist was measured with radioabsorptiometry (RA). The demographic parameters were collected by the study of ChiCTR190002282 protocol.

Eligibility criteria: Inclusion Criteria:

* participants of ChiCTR1900022825 study
* healthy children age 3 to 18 years old.
* willing to participate this study
* Consent by parents

Exclusion Criteria:

* no consent by parents
* under 3 years old

Primary outcomes:
measure: the bone age of the wrist and hand
timeFrame: 3 years
Secondary outcomes:
measure: bone mineral density (BMD)
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan hospital
state: Beijing
Study officials:
affiliation: Beijing Jishuitan Hospital
name: xiaoguang cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05229757: The Effect of Family Education on Functional Level, Activity Level and Families in Children With Cerebral Palsy
Official title: The Effect of Family Education on Functional Level, Activity Level and Families in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Children With Cerebral Palsy
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 28
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The activity status of children with cerebral palsy between the ages of 3 and 18 who participated in the physiotherapy program in special education institutions throughout the province of Gaziantep was evaluated. The effect of the family education to be given on the activity status of the children and the psychosocial status of the families was investigated.

The individuals included in the study were divided into two groups as patient and control. In the beginning, the scales used to determine the activity status and the scales to determine the depression status of their families were applied in order to determine the status of both groups. Children with cerebral palsy in the patient group received treatment in a special education and rehabilitation center two days a week for 8 weeks. Individuals in the control group were followed up with a home program. After 8 weeks of treatment, the same tests were repeated and it was examined whether the family education provided made a difference in children with cerebral palsy and their parents.


Eligibility criteria: Inclusion Criteria:

* Be in the age range of 3-18 years.
* Getting a diagnosis of cerebral palsy.
* Agree to participate in the study.

Exclusion Criteria:

* If the child interrupts supportive education for any reason,
* Failure of the family to ensure continuity in participation

Primary outcomes:
measure: Abilhand Kids (For patients)
timeFrame: Change from Baseline Abilhand Kids at 8 weeks.
measure: GMFM 66 (For patients)
timeFrame: Change from Baseline GMFM 66 at 8 weeks.
measure: PEDI (For patients)
timeFrame: Change from Baseline PEDI at 8 weeks.
measure: Beck Depression Scale (For family)
timeFrame: Change from Baseline Beck Depression Scale at 8 weeks.
measure: IPFAM (For family)
timeFrame: Change from Baseline IPFAM at 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
state: Şahinbey
Study officials:
References: