louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01682798: Study of Yili "Changqing" Pro-ABB Yoghurt in the Improvement of Human Gastrointestinal Tract System
Official title: The Clinical Research on the Efficiency of Yili "Changqing" Pro-ABB Probiotic Yogurt in the Improvement of Human Gastrointestinal Tract System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Dyspepsia
Flatulence
Abdominal Pain
Lead sponsor: Inner Mongolia Yili Industrial Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2012-09-11
Enrollment: 400
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether Yili "Chang Qing" Pro-ABB yoghurt is effective in improving mild constipation and the intestinal micro-ecology environment \& alimentation.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects, 25-45 yrs;
2. Non-specific and/or moderate constipation;
3. Irregular or occasional gastrointestinal disorders (flatulence, gurgling, feeling heavy after eating, abdominal pain);
4. Slow transit or irregular bowels movements (abnormal feces solidity, bowel movements decreased, e.g. every 2-3 days or less than 3 times per week).

Exclusion Criteria:

1. Diagnosed as chronic constipation;
2. Treated gastrointestinal symptoms;
3. Lactose Intolerance;
4. Treatment by analgesic such as aspirin and paracetamol;
5. Had laxatives or other remedies to promote digestion 2 weeks prior to the study start;
6. Consuming dairy products or supplements containing pro/pre-biotic 10 days prior to the study start;
7. Currently suffering from diarrhea.

Primary outcomes:
measure: Change in constipation condition after 3 weeks
timeFrame: Baseline & 3 weeks
Secondary outcomes:
measure: Change in gut resident flora after 3 weeks
timeFrame: Baseline & 3 Weeks
Other outcomes:
Locations:
city: ChaoYang District
country: China
facility: NanMoFang Community Health Service Center
state: Beijing
city: Gucun, Baoshan District,
country: China
facility: JuQuan Community Health Service Center
state: Shanghai
Study officials:
affiliation: Inner Mongolia Hilo Industrial Group Co., Ltd
name: Ying An, Ph.D
role: STUDY_DIRECTOR
affiliation: Changhai Hospital of Shanghai, Nutriology Dept.
name: Donglian Cai
role: PRINCIPAL_INVESTIGATOR
affiliation: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Geriatric Medicine Dept..
name: Xinwang Gao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02261298: ONO-4538 Phase I Study in Patients With Solid Tumor
Official title: ONO-4538 Multicenter, Open-label, Uncontrolled, Phase I Multiple Dose Study in Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Recurrent Solid Tumors
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2014-10-10
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.


Eligibility criteria: Inclusion Criteria:

* The treatment phase has been completed in the ONO-4538-13 study

Exclusion Criteria:

* The development of PD is identified by the principal or sub investigator according to the RECIST guideline (version 1.1) only in case in which the unplanned tumor assessment with diagnostic image is performed in the treatment phase of ONO-4538-13 study.
* It is determined that continuing the treatment is not appropriate because the worsening of clinical symptoms attributed to disease progression occurs.

Primary outcomes:
measure: Safety outcome: The number of subjects with overall adverse events
timeFrame: Approximately 6 months
measure: Safety outcome: The number of deaths
timeFrame: Approximately 6 months
measure: PK outcome: Cmax of ONO-4538
timeFrame: Approximately 10 months
measure: Efficacy outcome: Response rate
timeFrame: Approximately 6 months
measure: Efficacy outcome: Progression free survival
timeFrame: Approximately 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seongnam-si Clinical Site 105
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 101
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 102
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 103
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 104
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Mitsunobu Tanimoto
role: STUDY_DIRECTOR
References:
citation: Lee KW, Lee DH, Kang JH, Park JO, Kim SH, Hong YS, Kim ST, Oh DY, Bang YJ. Phase I Pharmacokinetic Study of Nivolumab in Korean Patients with Advanced Solid Tumors. Oncologist. 2018 Feb;23(2):155-e17. doi: 10.1634/theoncologist.2017-0528. Epub 2017 Nov 20.
Clinical trial NCT01979198: Thoracolumbar Burst Fracture Treated With Pedicle Screws: Radiographic Outcomes
Official title: Thoracolumbar Burst Fracture Treated With Pedicle Screws: Radiographic Analysis of Discs and Vertebral Body Height at Fractured and Adjacent Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burst Fracture
Keywords: burst fracture, kyphotic angle, surgical outcome
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2013-11-08
Enrollment: 48
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffered from burst fracture of the thoracolumbar and lumbar spine

Brief summary: The surgical results of thoracolumbar and lumbar burst fracture have been reported to be comparable between patients with and without fusion in a midterm follow-up. There is, however, no report comparing the results of fusion and non-fusion with a long-term follow-up. Therefore, a long term comparative study is still needed to focus on the issues of functional and radiographic outcomes, especially preservation of the motion segment in the long run, to determine whether fusion should be a routine procedure for surgically treated burst fractures of the thoracolumbar and lumbar spines. Therefore, we report herein a long-term comparative study of fusion and non-fusion based on our previous work, with an average 134 months of follow-up.


Eligibility criteria: Inclusion Criteria:

* neurologically intact spine with a kyphotic angle more than 20o, decreased vertebral body height more than 50% or a canal compromise more than 50%;
* incomplete neurological deficit with a canal compromise less than 50%;
* complete neurological deficit;
* multilevel spinal injury or multiple trauma.

Exclusion Criteria:

* progression of the neurological deficit;
* a canal compromise still more than 50% in those who showed no improvement of the neurological deficit.

Primary outcomes:
measure: Radiologic outcomes
timeFrame: postoperative 6 weeks
measure: Radiologic outcomes
timeFrame: postoperative 12 weeks
measure: Radiologic outcomes
timeFrame: postoperative 6 months
measure: Radiologic outcomes
timeFrame: postoperative 12 months
measure: Radiologic outcomes
timeFrame: postoperative 24 months
measure: Radiologic outcomes
timeFrame: up to postoperative 161 months
Secondary outcomes:
measure: Functional outcomes
timeFrame: postoperative 24 months
measure: Functional outcomes
timeFrame: up to postoperative 161 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital
Study officials:
affiliation: Department of Orthopedics and Traumatology, Taipei Veterans General Hospital
name: Shih-Tien Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00584298: Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Women With Irritable Bowel Syndrome to Evaluate Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Irritable Bowel Syndrome (IBS)
Keywords: Barostat
distention
IBS
irritable
bowel
syndrome
colorectal
sensation
modulation
reproducibility
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-01-02
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is designed to provide information on feasibility and reproducibility of barostat assessments of colorectal sensory functions and compliance and their pharmacological modulation


Eligibility criteria: Inclusion Criteria:

* A positive diagnosis of IBS.
* Subjects must either have been surgically sterilized, hysterectomized at least 6 months prior to screening, be postmenopausal or be using a double-barrier local
* contraception.
* Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent

Exclusion Criteria:

* History of or evidence for structural diseases/conditions that affect the gastrointestinal system.
* Other diseases or conditions that in the opinion of the Investigator significantly affect colorectal sensitivity.
* Evidence of occult blood at stool analysis, or history of rectal bleeding.
* Using or planning to use drugs or agents during the study period that alter GI physiology and visceral perception.

Primary outcomes:
measure: - 5 sensory pressure thresholds [mmHg] from ascending method of limits (AML) barostat protocol. - 16 sensory intensity ratings from the random phasic distention (RPD) barostat protocol.
timeFrame: throughout the study
Secondary outcomes:
measure: - colorectal compliance
timeFrame: throughout the study
Other outcomes:
Locations:
city: Boston
country: United States
facility: Novartis Investigator Site
state: Massachusetts
city: Rochester
country: United States
facility: Novartis Investigator Site
state: Minnesota
city: Hamilton
country: Canada
facility: Novartis Investigator Site
city: Gothenburg
country: Sweden
facility: Novartis Investigator Site
city: London
country: United Kingdom
facility: Novartis Investigator Site
city: Manchester
country: United Kingdom
facility: Novartis Investigator Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis investigator site
name: NOVARTIS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02782598: The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy With MultiPoint Pacing
Official title: The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy With MultiPoint Pacing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Negative
Atrioventricular
Hysteresis
Cardiac Resynchronization
MultiPoint
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-05-25
Enrollment: 17
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: Enrollment will include patients scheduled to be implanted with MultiPoint Pacing-enabled SJM Quadripolar Pacing Systems

Brief summary: The purpose of this study is to evaluate the application of Negative AV Hysteresis (NAVH) to improve electrical synchrony in MultiPoint Pacing (MPP) Cardiac Resynchronization Therapy (CRT) patients.


Eligibility criteria: Inclusion Criteria:

* Scheduled for implantation of an MPP-enabled SJM Quadripolar CRT Pacing System
* QRS duration \> 140 ms
* Left bundle branch block documented
* Ability to provide informed consent for study participation
* Willing to comply with the study evaluation requirements
* At least 18 years of age

Exclusion Criteria:

* Resting ventricular rate \>100 bpm
* Intrinsic PR interval \> 300 ms
* Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented
* A recent myocardial infarction, ablation, drug intoxication, electrolyte imbalance, or any condition within the last 90 days that would be contraindicated for CRT programming changes in the opinion of the investigator
* Women who are pregnant or who plan to become pregnant during the study

Primary outcomes:
measure: Acute change in QRS duration due to CRT with NAVH, relative to intrinsic conduction
timeFrame: 1 day
Secondary outcomes:
measure: Acute changes in LV pressure-volume hemodynamics due to CRT with NAVH, relative to intrinsic conduction
timeFrame: 1 day
measure: Change in QRS duration after one day of CRT with NAVH, relative to intrinsic conduction
timeFrame: 1 day
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: I.R.C.C.S. Policlinico San Donato
state: MI
Study officials:
References:
Clinical trial NCT03128398: Use of Domperidone for Treatment of Upper Gastrointestinal Disorders
Official title: Use of Domperidone for Treatment of Upper Gastrointestinal Disorders
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Gastroparesis
Keywords: Gastroparesis
Lead sponsor: Palo Alto Medical Foundation
Sponsor class: OTHER
First posted: 2017-04-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an Expanded Access to Investigational Drug program available through the FDA. Some specific conditions to qualify for this program includes gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. Patients failing standard therapies for these conditions may be eligible to receive domperidone. This program facilitates availability of investigational drugs, (such as domperidone) to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor or treat the patients's disease or condition. Authorization must be obtained from FDA prior to the importation, interstate shipment and administration of domperidone.


Eligibility criteria: Inclusion Criteria:

1. Male or female
2. Age 18 and older
3. Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
4. Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.
5. Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

   * Increased prolactin levels
   * Breast changes
   * Extrapyramidal side effects
   * Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)

Exclusion Criteria:

History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.

2. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc \> 450 milliseconds for males, QTc \> 470 milliseconds for females).

3. Clinically significant electrolyte disorders. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.

4. Gastrointestinal hemorrhage or obstruction. 5. Presence of a prolactinoma (prolactin-releasing pituitary tumor). 6. Pregnant or breast feedings female. 7. Known allergy to domperidone.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Palo Alto Medical Foundation
name: Katerina Shetler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06860698: The Impact of Chronic E-Cigarette Usage on Microvascular Health
Official title: The Impact of Chronic E-Cigarette Usage on Microvascular Health
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: E-Cig Use
Keywords: Microvascular Health
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic e-cigs users and never users that are between 18 and 29 years of age.

Brief summary: The study is focused on investigating the mechanisms involved in microvascular health in subjects that use e-cigarettes frequently. To explore microvascular health, different techniques and compounds. For one of the tests, iontophoresis, the drug's use will be stored and handled as described by the approved IND and non-IDS plan.

Detailed description: Electronic cigarettes or e-cigarettes have become increasingly popular, due to their promotion as a healthy alternative to traditional tobacco cigarettes. However, there are large discrepancies of knowledge in understanding how these e-cigarettes affect the subjects health and the way their body uses oxygen. The overall goal of this study is to evaluate e-cigarettes usage on subjects health.

Eligibility criteria: e-Cig users arm

Inclusion Criteria:

* Between 18 and 29 years of age
* Used e-cigarettes with nicotine (≥3 times/week for ≥6 months)

Exclusion Criteria:

* 17 years old and younger or 30 years old or older.
* Former combustible tobacco user/ former smoker
* Use of cigarettes for 15 days or more in the past 60 days
* Use of other tobacco products (cigars, hookah, smokeless), marijuana and/or illicit or prescription drugs weekly or more frequently in the past 60 days
* Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, cerebral diseases or sleep disorders
* Disorder or use of medication that affects cardiopulmonary health
* Evidence of pregnancy or current nursing

Non e-Cig using arm

Inclusion

- Between 18 and 29 years of age

Exclusion

* 17 years old and younger or 30 years old and older
* Use of cigarettes or other tobacco products more than 50 times in their lifetime.
* Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, cerebral diseases or sleep disorders
* Disorder or use of medication that affects cardiopulmonary health
* Evidence of pregnancy or current nursing

Primary outcomes:
measure: Endothelial dependent dilation
timeFrame: Participation is one week
measure: Neurogenic response
timeFrame: Participation is one week
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Paula Rodriguez Miguelez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02747498: Comparison of Circumferential Pulmonary Vein Isolation and Complex Pulmonary Vein Isolation Additional Linear Ablation for Recurred Atrial Fibrillation After Previous Catheter Ablation: Prospective Randomized Trial (RILI Trial)
Official title: Comparison of Circumferential Pulmonary Vein Isolation and Complex Pulmonary Vein Isolation Additional Linear Ablation for Recurred Atrial Fibrillation After Previous Catheter Ablation: Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurred Atrial Fibrillation
Keywords: Recurred atrial fibullation
CPVI
posterior wall isolation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
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 compare the clinical outcomes depending on catheter ablation strategy for repeat ablation procedure among the patients with recurred atrial fibrillation after de novo catheter ablation. After randomization, we will conduct circumferential pulmonary vein isolation alone in a group, and additional posterior box isolation in the other group. Non-pulmonary vein foci ablation will be done in all patients. We will compare clinical recurrence rate, complication rate, and procedure time, etc.


Eligibility criteria: Inclusion Criteria:

1. Patients with AF aged between 20 and 80 years old.
2. Patients possible to anticoagulation and anti arrhythmic drug
3. Patients who had undergone de novo ablation procedures based on circumferential pulmonary vein isolation with no additional linear ablations
4. Patients undergoing a second ablation procedure due to clinical recurrence resistant to antiarrhythmic drugs with findings of PV reconnections

Exclusion Criteria:

1. Structural cardiac disease 2. Contraindication to brain perfusion CT 3. Catheter ablation history for AF, Cardiac surgery for AF 4. active internal bleeding 5. Impossible to anticoagulation or antiarrhythmic drug 6. valvular AF ((MA\> GII, Mechanical valve, Mitral valve raplacement) 7. Patients with severe medical disease 8. Expected survival \< 1year 9. Severe alcoholics, drug addiction 10. Pregnancy 11. LA diameter\>60mm

Primary outcomes:
measure: Clinical recurrence of atrial fibrillation after catheter ablation
timeFrame: 3 years
Secondary outcomes:
measure: procedure time
timeFrame: 1 day
measure: procedure related complication rate
timeFrame: 3 years
measure: rate of hospitalization
timeFrame: 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Kim D, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH, Pak HN. Electrical Posterior Box Isolation in Repeat Ablation for Atrial Fibrillation: A Prospective Randomized Clinical Study. JACC Clin Electrophysiol. 2022 May;8(5):582-592. doi: 10.1016/j.jacep.2022.01.003. Epub 2022 Feb 23.