louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04969679: Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment.
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Mutaflor in Patients With Mild-to-moderate Ulcerative Colitis on 5-ASA Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ulcerative Colitis
Keywords: Mutaflor
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 134
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: E.coli Nissle 1917 (Mutaflor®) is equivalent to mesalazine in preventing disease relapse in ulcerative colitis. However, data on ability of E.coli Nissle 1917 (Mutaflor®) to induce remission compared with placebo is limited. Investigators aim to investigate the efficacy of E.coli Nissle 1917 (Mutaflor®) as an add-on treatment to 5-ASA in mild to moderate ulcerative colitis.

Detailed description: This is a multicentre, double-blind, randomised, placebo-controlled study in patients with mild-to-moderate UC.

Subjects were randomly assigned to receive either E.coli Nissle 1917 (Mutaflor®) or placebo once daily for 8 weeks, and inflammatory bowel disease questionnaire (IBDQ) scores, clinical remission, and response rate were compared.

Eligibility criteria: Inclusion Criteria:

* Ulcerative colitis patients over the age of 19 with mild to moderate symptoms using 5-ASA (Mayo score 3-9)
* Patient who signed the consent form

Exclusion Criteria:

* The extent of ulcerative colitis is limited to proctitis
* History of bowel resection
* History of using other medication than 5-ASA such as immunomodulators, steroid or biologics within 3months
* history of using antibiotics or probiotics within 2 weeks
* Pregnant or lactating woman
* Requiring hospitalization and imminent need for surgery

Primary outcomes:
measure: Compare and evaluate the increase in IBDQ(Inflammatory bowel disease questionnaire) score between the Mutaflor group and the Placebo group
timeFrame: 8weeks
Secondary outcomes:
measure: Evaluate the clinical remission between Mutaflor group and Placebo group
timeFrame: 4weeks, 8weeks
measure: Evaluate the clinical response between Mutaflor group and Placebo group
timeFrame: 4weeks, 8weeks
measure: Improvement in endoscopic scores between Mutaflor group and Placebo group
timeFrame: 8weeks
measure: Evaluate the endoscopic response between Mutaflor group and Placebo group
timeFrame: 8weeks
measure: Evaluate the Microbiome(stool) change between Mutaflor group and Placebo group
timeFrame: 8weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Soo-kyung Park
Study officials:
References:
citation: Park SK, Kang SB, Kim S, Kim TO, Cha JM, Im JP, Choi CH, Kim ES, Seo GS, Eun CS, Han DS, Park DI. Additive effect of probiotics (Mutaflor) on 5-aminosalicylic acid therapy in patients with ulcerative colitis. Korean J Intern Med. 2022 Sep;37(5):949-957. doi: 10.3904/kjim.2021.458. Epub 2022 Mar 31.
Clinical trial NCT05224479: Clinical Validation of Machine Learning Triage of Chest Radiographs
Official title: Clinical Validation of Machine Learning Triage of Chest Radiographs
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chest--Diseases
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Society of Thoracic Radiology
First posted: 2022-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Radiologists will triage chest radiographs using traditional, machine learning, and random methods.
Primary purpose: DIAGNOSTIC

Brief summary: Artificial intelligence and machine learning have the potential to transform the practice of radiology, but real-world application of machine learning algorithms in clinical settings has been limited. An area in which machine learning could be applied to radiology is through the prioritization of unread studies in a radiologist's worklist. This project proposes a framework for integration and clinical validation of a machine learning algorithm that can accurately distinguish between normal and abnormal chest radiographs. Machine learning triage will be compared with traditional methods of study triage in a prospective controlled clinical trial. The investigators hypothesize that machine learning classification and prioritization of studies will result in quicker interpretation of abnormal studies. This has the potential to reduce time to initiation of appropriate clinical management in patients with critical findings. This project aims to provide a thoughtful and reproducible framework for bringing machine learning into clinical practice, potentially benefiting other areas of radiology and medicine more broadly.


Eligibility criteria: Inclusion Criteria:

* Radiologist at Stanford Hospital and Clinics

Exclusion Criteria:

* None

Primary outcomes:
measure: Turnaround time
timeFrame: up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Emily Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02305979: Evaluation of Loratadine for G-CSF Induced Bone Pain in Patients With Hematologic Malignancies
Official title: Evaluation of Loratadine for Granulocyte-Colony Stimulating Factor Induced Bone Pain in Patients With Hematologic Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Lymphoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 61
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: Wake Forest Baptist Health Hematology and Oncology Clinic

Brief summary: The purpose of this project is to assess the efficacy of loratadine in decreasing the incidence and severity of bone pain following G-CSF administration in patients with hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells, and patients who have undergone an autologous hematopoietic cell transplant. This is a different patient population than those being assessed in current clinical trials.

Detailed description: Objectives

The primary objective is to determine the incidence of bone pain following G-CSF administration in patients with hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells, and patients who have undergone an autologous hematopoietic cell transplant. Incidence will be determined via patient-reported incidence following G-CSF administration.

Secondary objectives include determining the efficacy of loratadine for bone pain prevention as indicated by a decrease in incidence and a decrease in severity (questions 4 and 5 of the survey).

Eligibility criteria: Inclusion Criteria:

* Receiving a G-CSF after the institution practice change
* Receiving a G-CSF for one of the following indications:
* Prevention/treatment of neutropenia along with treatment for leukemia or lymphoma
* Mobilization of hematopoietic progenitor cells
* Neutropenia prevention following autologous hematopoietic cell transplant
* Took loratadine per protocol with G-CSF administration
* Completed a survey

Exclusion Criteria:

* Taking daily antihistamines for allergies, asthma, or other indications, not including bone pain
* Taking daily NSAIDs, with the exception of aspirin, for chronic conditions
* Treatment for solid tumor cancers
* Receiving bone modifying agents for bone pain associated with metastatic disease or other chronic conditions

Primary outcomes:
measure: Incidence of bone pain following G-CSF administration
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: LeAnne Kennedy, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04021979: Effectiveness of Enteral Nutrition for Dose Reduction of Low Dose PEG
Official title: Comparison of Two Bowel Cleansing Regimens（Controlled Dietary Restriction With Enteral Nutrition and 1.5L Polyethylene Glycol vs Controlled Dietary Restriction and 2.0L Polyethylene Glycol）：an Endoscopist-blinded, Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bowel Preparation
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This clinical trial is being conducted to assess whether dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS.

Detailed description: Bowel preparation plays a vital role in the quality of colonoscopy.Bowel preparation consists of 2 key steps: dietary restriction and purgative ingestion.Two liters of PEG-ELS are widely used in Asian countries, but in a well-designed clinical trial，additional reduction of PEG-ELS volume seems feasible. Enteral nutrition may simplify the process and avoid unexpected intake of fiber-containing food.

We hypothesized that dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS.

Eligibility criteria: Inclusion Criteria:

1. the age of 18-75year
2. Outpatients undergoing colonoscopy
3. Informed consent

Exclusion Criteria:

1. the age \>75 years or \<18 years
2. history of colectomy or bowel obstruction
3. severe constipation (defined as stool frequerncy of 3 or less/week)
4. current pregnancy or breastfeeding
5. BMI \>30, diabetes
6. known allergies to cleansing agents or ingredients of Enteral nutrition
7. inability to follow the oral bowel preparation regimen.

Primary outcomes:
measure: the quality of bowel preparation
timeFrame: 1day
Secondary outcomes:
measure: patients' satisfaction with the process of bowel preparation
timeFrame: 1day
measure: patients' willingness to have the colonoscopy done again at this facility in the future
timeFrame: 1day
measure: comparison with previous experience
timeFrame: 1day
measure: adverse events
timeFrame: 1day
measure: Convenience of Protocol between enteral nutrition with low volume 1.5L PEG and Self-controlled diet with normal amount of 2L PEG Protocol
timeFrame: 1day
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo first hospital
state: Zhejiang
Study officials:
affiliation: Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China
name: Hongpeng Lu, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03015779: Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease
Official title: Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Limbal Stem Cell Deficiency
Lead sponsor: He Eye Hospital
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 7
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 aim of this trials investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease.

Detailed description: A number of external factors can result in limbal stem cell deficiency(LSCD), causing pain, pathological corneal epithelium regeneration, inflammation reaction and seriously visual loss. For patients with unilaterally damaged eye, transplantation of limbal tissue from the healthy eye can be used in the past years in the risk of inducing limbal stem cell damaged in the healthy eye. While graft of human leukocyte antigen matched allogenic limbal stem cells require immune suppressive medications, it can cause side effects in the body. Over the past 10 years, the clinical trials of application of cultured autologous oral mucosal epithelial cell sheet to treat LSCD have been emerged as a promising strategy in many countries. However, little study has been reported in China. This study investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease in China.

Eligibility criteria: Inclusion Criteria:

* Male or female aged\>=18 years old
* Normal intraocular pressure
* Normal Eyelid
* No cataract and retinal disease
* No ulcers and tumor in the mouth

Exclusion Criteria:

* Severe Systemic infection
* History of acute phase of ocular and oral inflammation
* History of hyper sensibility or allergy to antibiotics or serum
* Women who are or may be pregnant
* Patients with infectious diseases
* Patients with other complications

Primary outcomes:
measure: The area of reepithelialization of corneal epithelium
timeFrame: 3 months
Secondary outcomes:
measure: Improvement of best correct visual acuity
timeFrame: one year
measure: Decrease of corneal neovascularization
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04440579: Utilization of PTNS During Office-Based Cystoscopy
Official title: Utilization of Percutaneous Tibial Nerve Stimulation During Office-Based Cystoscopy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystoscopy
Keywords: Cystoscopy
Urology
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be a double-blind, randomized control trial, with one additional unblinded arm. This study has been designed to identify a means of improving quality of life for patients requiring in-office cystoscopy. Percutaneous tibial nerve stimulation (PTNS) has been shown to improve quality of life and symptom control in multiple urological conditions based on shared neuroanatomical structures between the genitourinary system and the tibial nerve The goal of this project is to demonstrate the efficacy and safety of PTNS in minimizing patient discomfort during cystoscopy to develop a larger randomized control trial in the near future.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Patients undergoing routine office-based cystoscopy by a urology provider

Exclusion Criteria:

* Patients for whom ancillary procedures are performed during cystoscopy, including ureteral stent removal, bladder stone removal, biopsy, or fulguration
* Patients undergoing cystoscopy due to concern for urologic injury
* Patients undergoing cystoscopy due to concern for prosthetic abnormality, including erosion or malposition
* Patients who perform clean intermittent catheterization
* Patients with pre-existing neurological pathology, including but not limited to multiple sclerosis, spinal cord injury, Parkinson's disease, or peripheral neuropathy of any etiology
* Patients having undergone prior non-endoscopic prostatectomy (radical prostatectomy, simple prostatectomy)
* Patients with a history of interstitial cystitis/chronic pelvic pain
* Patients who have taken an analgesic (excluding 81mg aspirin) in the past 12 hours
* Patients with a history of urethral stricture disease

Primary outcomes:
measure: Patient Discomfort
timeFrame: One year
Secondary outcomes:
measure: Safety of PTNS: adverse events
timeFrame: One year
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Health System
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jeffrey Holzbeierlein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03910179: Dynamic Arterial Elastance During General Anesthesia Induction
Official title: Dynamic Arterial Elastance as Predictive Parameter of Hypotension During General Anesthesia Induction.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Lead sponsor: Università Politecnica delle Marche
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergone to general anesthesia for surgery that need mini-invasive cardiac output monitoring.

Brief summary: This study evaluates if dynamic arterial elastance measured before general anesthesia induction can predict the occurrence of hypotension due to general anesthesia induction.

Detailed description: As general anesthetics may be responsible for vasodilation and cardiac depression, arterial hypotension after induction of general anesthesia is a common event and may contribute to an adverse outcome. Dynamic arterial elastance has been proposed as a functional parameter of arterial tone and studies showed that it was able to predict pressure response to fluid administration in fluid-responsive patients and the amount of mean arterial pressure riduction as a conseguence of noradrenaline dose reduction in critically ill patients.

Eligibility criteria: Inclusion Criteria:

* Patients that will be undergone to general anesthesia for surgery
* Patients that need mini-invasive cardiac output monitoring during surgery

Exclusion Criteria:

* Age \<18 yo
* Pregnancy
* Arrhythmia
* Severe valvular diseases
* Uncorrectable alterations of arterial signal

Primary outcomes:
measure: Baseline value of Eadyn as predictor of hypotension occurrence due to general anesthesia induction
timeFrame: From baseline (before general anesthesia induction) up to 30 minutes.
Secondary outcomes:
measure: Correlation between Eadyn and severity of hypotension due to anesthesia induction
timeFrame: From baseline (before general anesthesia induction) up to 30 minutes.
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Azienda ospedaliero Universitaria Ospedali Riuniti Ancona
Study officials:
affiliation: Università Politecnica delle Marche
name: Abele Donati, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01949779: TransForm™ Occlusion Balloon Catheter Registry
Official title: TransForm™ Occlusion Balloon Catheter Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysms
Keywords: Coil embolization
TransForm™ Occlusion Balloon Catheter
Registry
Neurointerventional procedures
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2013-09-25
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care/hospitals

Brief summary: The primary objective of this registry is to collect real world data on the safety and performance of the TransForm™ Occlusion Balloon Catheter when used in current neurointerventional procedures

Detailed description: * This is a prospective, single-arm, non-randomized, multi-center, observational registry.
* The expected duration for study enrollment is approximately 6 months-1 year.
* Study participation for each subject will be completed upon removal of the guide catheter post-procedure.
* Up to 140 subjects will be enrolled at up to 15 study sites. A given site will be allowed to enroll a maximum of 20 subjects.
* Enrollment in the registry occurs after a signed Informed Consent Form has been obtained, and the index procedure starts.

Eligibility criteria: Inclusion Criteria:

1. Subject or legal representative is willing and has provided informed consent.
2. Subject is scheduled to undergo a neurointerventional procedure that may include the use of the occlusion balloon catheter.
3. Subject is over 18 years of age.

Exclusion Criteria:

1. Subject's anatomy precludes safe delivery of the TransForm Occlusion Balloon Catheter.
2. Subject's pregnant

Primary outcomes:
measure: Catheters Visualized That Reached Intended Target
timeFrame: intra-procedure
Secondary outcomes:
measure: Angiographic Assessment on Catheter
timeFrame: intra-procedure
measure: Procedural Technical Success
timeFrame: post-procedure
Other outcomes:
Locations:
city: Palm Springs
country: United States
facility: Desert Regional Medical Center
state: California
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: San Sebastian
country: Spain
facility: Hospital Universitario Donostia
Study officials:
References:
Clinical trial NCT06852079: Safety & Efficacy of Qurs e Fishar in Mild to Moderate Hypertensive Patients in Pakistan
Official title: Safety & Efficacy of Qurs e Fishar in Mild to Moderate Hypertensive Patients in Pakistan
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hypertension
Keywords: HTN
Hypertension
Qurs e Fishar
Lead sponsor: Hamdard University
Sponsor class: OTHER
Collaborators: name: Hamdard University
First posted: 2025-02-28
Enrollment: 119
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The herbal medicine Qurs-e-Fishar to treat mild to moderate High blood pressure or hypertension comprises of Rauwolfia serpentina. A product of Hamdard Laboratories (Waqf) Pakistan.

A Phase III Safety \& Efficacy Open-label, Single-Arm, Interventional, Multicenter, Study in mild to moderate hypertensive, adults (30 to 60 years of age) prescribed with study product for 12 weeks (84 days).

Primary End Points:

1. Reduction in diastolic blood pressure less than 130 / 80 mmHg at the end of the study period (accepted by WHO) or if there was a fall of 20 / 10 mmHg or more in diastolic blood pressure as compared to baseline.
2. Type, frequency and severity of ADRs during the study period.

Secondary End Points:

1. Compliance of the prescribed study medication.


Eligibility criteria: Inclusion Criteria:

* Ability to sign ICD
* Participant(s) are willing and able to fulfill the requirements of the study protocol
* Mild to moderate hypertensive
* Mild hypertension range (140-159/90-99 mm Hg)
* Moderate hypertension range (160-179/100-109 mm Hg)
* Be between the age of 30 to 60 year

Exclusion Criteria:

* Patients with recent history of following will be excluded:

  * Severe hypertension,
  * Congestive cardiac failure,
  * Left ventricular failure,
  * Myocardial ischemia,
  * Renal failure or
  * Cerebrovascular accidents

Primary outcomes:
measure: Blood Pressure
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Taj Medical Complex, Hamdard University Hospital
state: Sindh
Study officials:
References: