louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06351696: The Effects of Bromelain Supplement in Patients With Ulcerative Colitis
Official title: The Effects of Low FODMAP Diets Accompanied With and Without Bromelain Supplement on Quality of Life, Disease Activity Index and Inflammation in Patients With Ulcerative Colitis With and Without Primary Sclerosis Cholangitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Primary Sclerosing Cholangitis
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, patients with active mild to moderate UC with or without PSC will be randomized to receive either bromlein or placebo along with low FODMAP diet for 8 weeks.

IBDQ, SCCAIQ, CRP, TAC, TNF-a will be measured before and after the intervention.


Eligibility criteria: Inclusion Criteria:

* active mild to moderate UC
* no other chronic disorders

Exclusion Criteria:

* changed the type and dosage of their medication in the last month
* those who have relapses that required hospitalization and change the type and dosage of medications during the intervention
* patients who do not want to continue the study protocol

Primary outcomes:
measure: SCCAIQ
timeFrame: At the 1st day and 8th week
Secondary outcomes:
measure: IBDQ
timeFrame: At the 1st day and 8th week
measure: Serum TAC
timeFrame: At the 1st day and 8th week
measure: Serum hsCRP
timeFrame: At the 1st day and 8th week
measure: Serum TNF-a
timeFrame: At the 1st day and 8th week
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Azita Hekmatdoost
state: Middle East
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Azita Hekmatdoost, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06822296: Effect of Core Stability Training on Segmental Trunk Control and Quality of Life in Children with Cerebral Palsy
Official title: Effect of Core Stability Training on Segmental Trunk Control and Quality of Life in Children with Spastic Diplegia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Diplegia
Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spastic diplegia is a common shape of cerebral palsy that significantly affects trunk control and quality of life in children. Core stability training (CST) has been utilized as a potential intervention to improve the trunk function. This study investigated the effects of CST on segmental trunk control and quality of life in children with spastic diplegia.

Forty children with spastic diplegia (age: 3 - 6 years) were randomly assigned to either a control group (n=20) receiving a selected physical therapy program or an experimental group (n=20) receiving the same program plus a 30-minute CST program three times weekly for 12 weeks. Segmental trunk control was assessed using the Segmental Assessment of Trunk Control (SATCO) scale, and quality of life was measured using the Pediatric Quality of Life Inventory (PedsQL). Both outcome measures were evaluated pre- and post-intervention.


Eligibility criteria: Inclusion Criteria:

* 3-6 years
* 1 to 1+ spasticity according to modified Ashworth scale
* level II and III according to GMFCs
* able to follow instructions and understand commands

Exclusion Criteria:

* significant visual or auditory problems
* fixed deformities
* Botox injection
* orthopedic surgery

Primary outcomes:
measure: Segmental Assessment of Trunk Control scale
timeFrame: Baseline and after 12 weeks of training
measure: Quality of Life Inventory Scale
timeFrame: Baseline and after 12 weeks of training
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
state: Cairo
Study officials:
References:
citation: Huang C, Chen Y, Chen G, Xie Y, Mo J, Li K, Huang R, Pan G, Cai Y, Zhou L. Efficacy and safety of core stability training on gait of children with cerebral palsy: A protocol for a systematic review and meta-analysis. Medicine (Baltimore). 2020 Jan;99(2):e18609. doi: 10.1097/MD.0000000000018609.
Clinical trial NCT06837896: Efficacy and Safety Study of QLG1080 in Patients With Hormone-sensitive Advanced Prostate Cancer
Official title: A Multicenter Study Evaluating the Efficacy and Safety of QLG1080 in Patients With Hormone-sensitive Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-20
Enrollment: 110
Sex: MALE
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 was to evaluate the efficacy and safety of QLG1080 in patients with hormone-sensitive advanced prostate cancer.


Eligibility criteria: Inclusion Criteria:

* 1. Histological or cytological diagnosis of prostate cancer;；
* Advanced prostate cancer patients eligible for endocrine therapy, able to receive continuous androgen deprivation therapy for at least 6 months.
* Serum testosterone ≥150 ng/dL (5.2nmol/L) at screening visit;
* The Eastern Cooperative Oncology Group (ECOG) score is 0 to 1.

Exclusion Criteria:

* Diagnosed or suspected of hormone-resistant prostate cancer;
* For prostate cancer patients who have had or are undergoing endocrine therapy
* Patients who have previously undergone pituitectomy or adrenalectomy or have pituitary disease or adrenal dysfunction;
* Those who have had any prostate surgery within 4 weeks prior to initial dosing or prostate surgery or other major surgical treatment during the planned trial period (except urinary tract obstruction relief);
* The imaging results of screening visits clearly showed the presence of brain metastases;

Primary outcomes:
measure: Sustained castration rate of serum testosterone
timeFrame: From study day 29 to the end of the study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06479616: A Long-term Follow-up Study in Participants Who Received CS-101
Official title: A Long-term Follow-up Study Evaluating the Safety and Efficacy of Subjects With β-thalassemia Treated With Base-edited Autologous Hematopoietic Stem Cell (CS-101) Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Beta-Thalassemia
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 5
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a study to evaluate the long-term safety and efficacy of CS-101 in participants who received CS-101 in study CS -101-03 (NCT06065189)

Detailed description: This is a study to evaluate the long-term safety and efficacy of CS-101 in participants who received CS-101 in study CS -101-03 (NCT06065189) .

Subjects in the CS-101-03 study will be entered into long-term follow-up of this study up to 2 years post-infusion at the completion of the last (6-month) follow-up visit after treatment with CS-101 Injection.

Eligibility criteria: Inclusion Criteria:

* Participants (or his or her legally appointed and authorized representative or guardian) must sign and date informed consent form (ICF) and, where applicable, an assent form
* Participants must have received CS-101 infusion in last IIT study

Exclusion Criteria:

* There are no exclusion criteria

Primary outcomes:
measure: Frequency and severity of SAEs and CS-101 related AES as assessed by CTCAE v5.0
timeFrame: Signing of informed consent up to 2 years post CS-101 infusion
measure: Occurrence of all-cause death
timeFrame: Signing of informed consent up to 2 years post CS-101 infusion
measure: New malignancies and hematologic disorders
timeFrame: Signing of informed consent up to 2 years post CS-101 infusion
measure: Occurrence of achieving transfusion independence for at least 12 consecutive months
timeFrame: From 3 months after last RBC transfusion up to 2 years post CS-101 infusion
Secondary outcomes:
measure: Change in fetal hemoglobin(HbF) concentration over time
timeFrame: up to 2 years post-CS-101 infusion
measure: Change in total hemoglobin(Hb) concentration over time
timeFrame: up to 2 years post-CS-101 infusion
measure: Chimerism level in Peripheral blood and bone marrow Proportion of alleles with intended genetic modification in peripheral blood leukocytes and bone marrow over time
timeFrame: up to 2 years post-CS-101 infusion
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xiaowen Zhai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03189316: Anti-inflammatory Cells in Peritoneal Cavity
Official title: Can the Peritoneal Cavity be a Source of Regulatory B Cells to Treat Auto-immune Disease?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ovarian Cysts
Chronic Renal Insufficiency
Keywords: Peritoneal fluid
B cells
Regulatory B cells
Human
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
First posted: 2017-06-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Some subsets of lymphocytes are able to inhibit immune response and thus, could be used to control auto-immune diseases and transplant reject. In mice, the main source of those anti-inflammatory lymphocytes is the peritoneal cavity. No data are available in human. This study aims at exploring the presence of those anti-inflammatory lymphocytes in human peritoneal cavity and at determine how to expand those cells.

Detailed description: B cells will be collected during procedures planned for patients' standard care. Peritoneal fluid and peripheral blood of patients will be collected during coelioscopy for exploration of ovarian cysts or dialysis for treatment of chronic renal insufficiency.

Regulatory B cells (Breg cells) will be measured in peritoneal fluid and in peripheral blood after in vitro stimulation and assessment of intracellular interleukin-10 by flow cytometry. Proportion of Breg cells among B cells will be compared between peritoneal fluid and peripheral blood in both groups.

Different protocols to induce differentiation of B cells into Breg cells will be tested and compared.

Eligibility criteria: Inclusion criteria:

* woman over 18 year old undergoing exploration of ovarian cysts by coelioscopy
* patient with chronic renal insufficiency undergoing peritoneal dialysis
* informed consent obtained

Exclusion criteria:

* pregnancy or breast-feeding
* non affiliation to health care insurance
* treatment with corticosteroids over 15 mg/day
* treatment with rituximab

Primary outcomes:
measure: relative percentage of regulatory B cells among B cells in peritoneal cavity compared to peripheral blood
timeFrame: up to 48 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU montpellier - department of rheumatology
Study officials:
References:
Clinical trial NCT01616316: Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients
Official title: Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Thyroid Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-06-11
Enrollment: 86
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subfascial approach method in thyroidectomy maybe result in better quality of life than conventional approach method in thyroid disease patients


Eligibility criteria: Inclusion Criteria:

* micropapillary thyroid cancer

Exclusion Criteria:

* lateral neck lymph node metastasis
* severe thyroiditis
* goiter
* reoperation
* extrathyroidal extension

Primary outcomes:
measure: Dose subfascial approach make better result of swallowing function?
timeFrame: Until 1 year follow up
measure: Dose subfascial approach make better result of voice symptom?
timeFrame: Until 1 year follow up
Secondary outcomes:
measure: The efficacy of subfascial approach in thyroid cancer
timeFrame: Until 1 year follow up
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
References:
Clinical trial NCT02931916: Evaluation of Reliability and Validity of a Smart-phone Postural Control Assessment Application
Official title: Evaluation of Reliability and Validity of a Smart-phone Application Designed for Chronic Ankle Instability Subjects' Postural Control Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Other Instability, Ankle and Foot
Keywords: smart-phone
assessment
chronic ankle instability
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2016-10-13
Enrollment: 138
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: chronic ankle instability group

Brief summary: The purpose of this study is to evaluate the reliability and validity of smart-phone based system in postural control ability assessment on subjects with chronic ankle instability.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of ankle functional instability

Exclusion Criteria:

* any other condition would affect postural control performance

Primary outcomes:
measure: physiological parameter: acceleration data from built-in sensor with unit: m/s^2
timeFrame: 40 seconds
measure: physiological parameter: orientation data from built-in sensor with unit: degree
timeFrame: 40 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Yang Ming university
Study officials:
References:
Clinical trial NCT02001116: Improving the Quality of Paediatric Hospital Care in the Kyrgyz Republic
Official title: Improving the Quality of Paediatric Hospital Care in the Kyrgyz Republic: Evaluation of the Impact of the Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Quality of Hospital Care for Children
Keywords: Quality of care
Hospital
Children
WHO guideline
Lead sponsor: WHO Collaborating Centre for Maternal and Child Health, Trieste
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: Scientific Center of Children RAMS
name: Post Graduate Institute of Medical Education and Research, Chandigarh
First posted: 2013-12-04
Enrollment: 4626
Sex: ALL
Minimum age (years): 2
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A cooperation agreement between the Ministry of Health (MOH) of Kyrgyz Republic and WHO-EURO was established, for the implementation of a WHO Project to improve the quality of pediatric care in the referral hospitals. The pilot regions selected for this intervention are the three northern regions of Thalas, Chiu and Issik-Kul Region in Kyrgyz Republic. The MOH project will be implemented at a first stage in a group of 10 pilot hospitals, randomly selected among the existing hospitals in the above cited regions. Pilot Hospitals will be compared to "control hospitals", which are the hospitals in the region not receiving the intervention, using a pre-defined set of indicators of quality of care. The results of the present evaluation on the pilot hospitals will provide data that will inform the MOH on how better to scale up this project at a national scale.


Eligibility criteria: Inclusion Criteria:

* The study will evaluate Quality of Care delivered to children at hospital level. This will be assessed by a direct review of patients' charts, in comparison with pre-defined standard. At the hospital level children's charts will be randomly chosen among children 2 months to 59 months, hospitalized with common diseases, such as acute respiratory diseases, diarrhoea, and fever.

Exclusion Criteria:

* Children not included in the above criteria.

Primary outcomes:
measure: Quality of Care
timeFrame: 12 months
measure: Primary outcome
timeFrame: 12 months
Secondary outcomes:
measure: Outcomes of QoC
timeFrame: 12 months
Other outcomes:
Locations:
city: Thalas, Chiu, Issik-Kul
country: Kyrgyzstan
facility: Thalas, Chiu and Issik-Kul Regions
Study officials:
References:
Clinical trial NCT06493916: Measurement of Endotracheal Tube Cuff
Official title: Evaluation of Endotracheal Tube Cuff Pressure Measurements
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Endotracheal Tube Cuff Pressure Levels in Practice
Keywords: Endotracheal tube cuff pressure
Endotracheal tube cuff pressure manometer
Endotracheal tube cuff pressure measuring
Manometer
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All intubated patients

Brief summary: The purpose of this study is to evaluate whether the endotracheal intubation practitioners accordance to the literature knowledge of cuff pressure limits.


Eligibility criteria: Inclusion Criteria:

Intubated Patients

Exclusion Criteria:

No intubation Hemodynamically unstability

Primary outcomes:
measure: Endotracheal tube cuff pressure measurements
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Yozgat Bozok Üniversitesi Araştırma ve Uygulama Hastanesi
state: Merkez/Yozgat
Study officials:
affiliation: Anesthesiology and Reanimation
name: Cevdet YARDIMCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05880316: Prevalence of MAFLD Among Nurses and the Role of Intermittent Fasting
Official title: Prevalence of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Among Nurses in a Single Tertiary Care Centre and the Role of Intermittent Fasting in Improving Hepatic Steatosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatty Liver Disease
Keywords: fatty liver
MAFLD
intermittent fasting
transient elastography
fibroscan
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: This study consists of 2 parts:

Part 1: a cross-sectional study, looking at the prevalence of metabolic dysfunction-associated fatty liver disease (MAFLD) among nurses in Hospital Canselor Tuanku Muhriz (HCTM).

Part 2: a randomized controlled trial of intermittent fasting with MAFLD subjects.

Detailed description: The investigators aim to screen at least 350 participants for fibroscan-detected fatty liver. Baseline anthropometric data will be taken. Questionnaires on dietary habits - Foof Frequency Questionnaire (FFQ) and exercise habits - International Physical Activity Questionnaire (IPAQ) will be done.

Approximately 100 participants who have fatty liver from Part 1 study, will be enrolled and randomized into Part 2. The intervention group will undergo intermittent fasting (3 fasting day:4 non-fasting days) while the control group will continue the usual standard care, for 8 weeks.

Measurements pre- and post-intervention include Fibroscan measurement, blood LiverFASt, anthropometric data, and exercise habit (IPAQ).

Eligibility criteria: Inclusion Criteria:

* nurses at HCTM, 18 years and above

Exclusion Criteria:

* pregnancy
* previous bariatric surgery
* liver cirrhosis
* liver cancer
* steatogenic drugs

Primary outcomes:
measure: Mean change of controlled attenuated parameter (CAP) (dB/m)
timeFrame: 8 weeks
Secondary outcomes:
measure: Mean change of hepatic fibrosis score (kPa)
timeFrame: 8 weeks
measure: Mean change of steatotest, actitest, and fibrotest scores
timeFrame: 8 weeks
measure: mean change of Body Mass Index
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Hospital Canselor Tuanku Muhriz
state: Kuala Lumpur
Study officials:
affiliation: Gastroenterology Unit, Department of Medicine, Faculty of Medicine, UKM
name: Khairul Najmi M Nawawi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06636916: Time at VO2max During High-Intensity Interval Training
Official title: Time at VO2max During High-Intensity Interval Training Manipulating Work and Rest
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: High Intensity Interval Exercise (HIIE)
Keywords: sports
hiit
athletic performance
vo2max
Lead sponsor: University of Maia
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The project titled "Time at VO2max During High-Intensity Interval Training Manipulating Work and Rest" aims to investigate how different high-intensity interval training (HIIT) protocols influence the time athletes spend at or above 90% of their VO2max. By adjusting the work-to-rest ratios in the HIIT formats, the study seeks to determine which configurations maximize the time spent in this high-intensity zone, contributing to more effective endurance training strategies. The findings could help optimize training protocols for athletes targeting improvements in aerobic capacity and performance.


Eligibility criteria: Inclusion Criteria:

* Middle and long distance track and field athletes

Exclusion Criteria:

* Injured athletes

Primary outcomes:
measure: time above 90% vo2max
timeFrame: Duration of the HIIT (up to 20 minute)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: