louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06623383: Correlation of Fecal Calprotectin and Fecal Immunochemical Test in Determination of Endoscopic Activity in Inflammatory Bowel Disease Patients
Official title: Correlation of Fecal Calprotectin and Fecal Immunochemical Test in Determination of Endoscopic Activity in Inflammatory Bowel Disease Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Inflammatory Bowel Disease
Keywords: IBD
inflammatory bowel disease
endoscopy
fecal calprotectin
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IBD patients follow-up at Siriraj Hospital, Bangkok, Thailand

Brief summary: Inflammatory bowel disease (IBD) patients often experience a long disease course with periods of remission and flare-ups. Currently, in addition to assessing disease stages based on symptoms, colonoscopy performed by specialized physicians is considered the standard for accurately monitoring disease activity. This procedure allows direct visualization of intestinal lesions. However, colonoscopy is complex, costly, carries the risk of complications, and is not suitable for frequent monitoring. This study aims to explore whether stool tests such as calprotectin and immunochemical tests, which are now standard for assessing disease activity in IBD, correlate with colonoscopy results. It also aims to assess the efficacy of these stool tests in determining whether the disease is in remission or active.

The objective of the study is to investigate the correlation and efficacy of stool test results, calprotectin and fecal immunochemical test, compared to colonoscopy in patients with IBD.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older.
* Diagnosed with inflammatory bowel disease, either ulcerative colitis or Crohn's disease.
* Scheduled for colonoscopy for various indications, including:

  1. Follow-up after treatment to assess disease remission
  2. Clinical symptoms or laboratory results suggesting disease flare, such as increased abdominal pain, more frequent diarrhea, or elevated inflammatory markers in the blood
  3. Screening for colorectal cancer in patients with long-standing inflammatory bowel disease.

Exclusion Criteria:

* Patients who decline participation in the research project. Incomplete or unsuccessful colonoscopy.
* Failure to provide stool samples.
* Patients hospitalized for reasons unrelated to inflammatory bowel disease.

Primary outcomes:
measure: To study the correlation between fecal calprotectin and fecal immunochemical test for hemoglobin results and endoscopic scores from colonoscopy in patients with inflammatory bowel disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital, Mahidol University
Study officials:
References:
Clinical trial NCT00535483: Closed Loop Insulin Therapy in Type 1 Diabetics Based on Blood Microdialysis, Online Sensors and an eMPC Algorithm
Official title: An Open, Mono-centre Pilot Study to Investigate a Novel Technique to Establish Glycaemic Control for Critically Ill Patients, Tested in Type 1 Diabetic Subjects for a Period of 30 Hours.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: blood microdialysis
glucose monitoring
glucose control
automated blood sampling
online-sensor
algorithm
type 1 diabetes
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The EU funded project CLINICIP (Closed Loop Insulin Infusion for Critically Ill Patients) aims to develop a low-risk monitoring and control device which allows maintaining metabolic control in intensive care units. A system will be developed comprising three subsystems: a body interface for the delivery of biofluids, biosensors for the determination of glucose concentration in these biofluids and an adaptive control algorithm that generates advice and thus represents a decision support system with respect to insulin infusion rate to establish glycaemic control in critically ill patients. Within a closed loop system, intensified insulin treatment will make use of the calculations leading to external regulation of glucose.

It is the aim of this study to evaluate the feasibility to establish glycaemic control in type 1 diabetic subjects over a period of 30 hours by manually combining these three - previously tested - subsystems (ABS System, extracorporeal online glucose sensor and a laptop-based computer algorithm).


Eligibility criteria: Inclusion Criteria:

* Signed informed consent obtained before any trial-related activities
* Age of analysable subjects in the range from 18 to 65 years
* Type 1 diabetes (Treatment with multiple daily injection for more than 12 months)

Exclusion Criteria:

* Severe acute and/or chronic diseases
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
* Taking of any vasoactive substances or anticoagulation medication.
* Diseases of the skin which could interfere with application of the catheters.
* Pregnancy or breastfeeding
* Bleeding disorder
* Known heparin allergy or heparin intolerance

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz - Clinical Research Center
state: Styria
Study officials:
affiliation: Medical University Graz, Graz, Austria
name: Thomas R Pieber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01884883: Evaluation of a Distraction-rotation Knee Unloader Brace in Patients With Medial Knee Osteoarthritis.
Official title: Evaluation of a Distraction-rotation Knee Unloader Brace in Patients With Medial Knee Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to confirm the biomechanical effects and evaluate functional benefits of a new knee brace combining valgus inducing effect on medial compartment and leg external rotation during the stance phase in patients with symptomatic medial knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Patient understanding simple order and able to give written consent.
* Man or woman with age between 40 et 75 years
* Unilateral medial symptomatic knee osteoarthritis, defined using the American College of Rheumatology classification
* Radiologic grade II, III ou IV (Kellgren et Lawrence (KL) classification)
* Medial knee compartment (Medial K\&L g rade higher than lateral K\&L grade
* Knee pain \> 40/100 on visual analog scale and \<30/100 for the other
* No change in medical treatment for at least 3 months.
* Latest radiographic image \< 12 months before inclusion

Exclusion Criteria:

* Patient without healthcare insurance.
* Inflammatory knee arthritis,
* Indication of knee surgery
* Pregnancy, breastfeeding
* Associate neurologic or orthopaedic affection that interferes with gait analysis
* Rapidly destructive arthritis.
* Alzheimer's disease, Parkinson's disease, motor neuronal disorders
* Patient under guardianship or tutelage

Primary outcomes:
measure: Pain score on visual analogic scale
timeFrame: Baseline
measure: Pain score on visual analogic scale
timeFrame: Baseline + 5 weeks
Secondary outcomes:
measure: Evaluation of the functional capacities: KOOS questionnaire.
timeFrame: baseline
measure: Evaluation of the functional capacities: KOOS questionnaire.
timeFrame: baseline + 5 weeks
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
affiliation: CHU Dijon - Department of Rheumatology
name: Jean-Francis Maillefert
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01671683: Additional Chemotherapy After Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer
Official title: A Phase II Study of Additional Four-week Chemotherapy With Capecitabine During the Resting Periods After Six-week Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: rectal cancer
neoadjuvant chemoradiotherapy
Capecitabine
Lead sponsor: Chungnam National University
Sponsor class: OTHER
First posted: 2012-08-23
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of our hospital

Brief summary: The aim of this study is to evaluate the efficacy and safety of additional neoadjuvant chemotherapy with capecitabine during the resting periods in patients with locally advanced rectal cancer.

Detailed description: Neoadjuvant chemoradiotherapy (NCRT) has been used as standard treatment modality in patients with locally advanced rectal cancer (LARC) because of increased local control, enhanced sphincter preservation, and less toxicity.NCRT has enhanced down-staging of tumor and reduced local recurrence. However, survival benefit of NCRT has not been demonstrated and the rate of distant metastasis was still reported as high as 30%.

Patients with pathologic complete remission (pCR) after NCRT have shown excellent survival benefit. We inferred that additional chemotherapy during the resting period could enhance the pCR rate. The aim of the present study is to evaluate the safety and efficacy of an additional 4-week chemotherapy with capecitabine after the conventional 6-week NCRT in patients with LARC.

Eligibility criteria: Inclusion Criteria:

* histologically proven, locally advanced adenocarcinoma of the rectum
* an Eastern Cooperative Oncology Group (ECOG) score of 0-2
* adequate function of major organs
* a signed informed consent.

Exclusion Criteria:

* other co-existing malignancy or malignancy within the last 5 years prior to enrollment
* severe concurrent medical or psychiatric disorders
* prior RT to pelvis
* pregnant or lactating patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
affiliation: Surgical Oncology Research Lab
name: Ji Yeon Kim, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03331783: Assessment of the Effect of Output on New Adhesives
Official title: The Evaluation of the Effect of Output on Newly Developed Adhesives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study investigates the impact real output has on adhesion of new adhesives


Eligibility criteria: Inclusion Criteria:

* Have given written informed consent
* Be at least 18 years of age and have full legal capacity
* Have had a stoma for more than one year
* Have intact skin on the area used in the evaluation
* Has a stoma with a diameter up to (≤) 35 mm
* Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

* Currently receiving or have within the past 2 month received radio- and/or chemotherapy
* Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
* Are pregnant or breastfeeding
* Having dermatological problems in the peri-stomal- or abdominal area (assessed by investigating scientist)
* Actively participating in other interventional clinical investigations or have previously participated in this investigation.

Primary outcomes:
measure: Trans epidermal water loss
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Head of preclinical department
name: Lene Feldskov
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06012383: Alvocade® (Bortezomib) Safety and Effectiveness Study
Official title: A Phase IV, Post Marketing, Prospective, Observational Cohort Study to Investigate Safety and Effectiveness of Alvocade® in Iranian Patients With Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma, Refractory
Keywords: Multiple Myeloma
Bortezomib
Safety
Alvocade
Lead sponsor: NanoAlvand
Sponsor class: INDUSTRY
First posted: 2023-08-25
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A population of 57 Iranian patients diagnosed with multiple myeloma under chemotherapy regimens with Alvocade® (with a dose of 1.3 mg/m2), were enrolled in the study.

Brief summary: This study is a phase IV, post-marketing, observational, cohort study for safety and effectiveness evaluation of Alvocade® use in Iranian patients with multiple myeloma. No control groups were considered in the study design. The primary objective of this study was safety assessment, including the incidence of adverse events (AEs).

Detailed description: This study is a phase IV, post-marketing, observational, cohort study for safety and effectiveness evaluation of Alvocade® use in Iranian patients with multiple myeloma. Data were gathered in two booklets, containing information on sixteen injections, which were filled by the designated physician.

Exposure to Alvocade® in this study was defined as administration of bortezomib (Alvocade®, NanoAlvand) with a dose of 1.3 mg/m2, once every 3 weeks during 2.5 to 5.5 months (16 injections).

The primary objective of this study was safety assessment, including the incidence of adverse events (AEs).

This study was single arm and the sample size of this study was 59 patients.

Eligibility criteria: Inclusion Criteria:

* Patients with multiple myeloma were included in the study.

Exclusion Criteria:

* There were no exclusion criteria for this study.

Primary outcomes:
measure: Safety Assessment
timeFrame: up to 6 months
Secondary outcomes:
measure: Effectiveness Assessment
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Shiraz University of Medical Sciences, Shiraz, Iran
name: Mani Ramzi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04776083: Radiotherapy to the Primary in Metastatic Non-small Cell Lung Cancer Patients
Official title: Role of Radiotherapy to the Primary Lesion in Metastatic Non-small Cell Lung Cancer Patients After First Line Systemic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Carcinoma of Lung, TNM Stage 4
Radiation Therapy
Keywords: bronchogenic cancer
lung cancer
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: study the effect of radiotherapy to the primary lesion after first line systemic therapy in metastatic non-small cell lung cancer patients.

Detailed description: Metastatic non-small cell lung cancer patients after receiving their first line systemic therapy according to their genetic mutation will be randomized to follow up versus radiotherapy to the primary lesion.

Eligibility criteria: Inclusion Criteria:

1. Confirmed histological diagnosis of NSCLC.
2. Stage IV disease.
3. Patients with P.S ≤ 2.
4. finished at least 4 cycles of platinum-based doublet chemotherapy if patient has no diver mutation, or at least 3 months of anti-EGFR, Anti-ALK according to their driver mutation with SD, PR or CR.

Exclusion Criteria:

1. History of prior irradiation to the lung.
2. residual Malignant pleural or pericardial effusion at randomization time.
3. History of prior malignant tumor likely to interfere with the treatment protocol.
4. Severe comorbidities as measured by morbidity index.
5. Disease progression on first line systemic therapy.

Primary outcomes:
measure: progression free survival
timeFrame: six months
measure: patients quality of life
timeFrame: six months
Secondary outcomes:
measure: overall survival
timeFrame: six months
measure: patients toxicity
timeFrame: six months
measure: patients pattern of failure
timeFrame: six months
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Medicine
state: Menoufia
Study officials:
affiliation: Menoufia University
name: Yostena Mekhail, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Menoufia University
name: Eman AR Tawfeek, MD
role: STUDY_CHAIR
affiliation: Menoufia University
name: Enas AB Elkhouly, MD
role: STUDY_CHAIR
affiliation: Menoufia University
name: Reham A Abdel Aziz, MD
role: STUDY_CHAIR
affiliation: Menoufia University
name: Ahmed Sohaib, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06861283: Development and Validation of a Digital Twin-based Clinical Research System (X Town Stage I)
Official title: Development and Validation of a Digital Twin-based Clinical Research System (X Town Stage I)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Disease
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
Collaborators: name: Tsinghua University
name: Shanghai Jiao Tong University School of Medicine
First posted: 2025-03-06
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will mainly include participants at high-risk of or with chronic diseases.

Brief summary: Chronic diseases, characterized by their prolonged duration and slow progression, have emerged as predominant contributors to global morbidity and mortality. The investigators have developed a digital twin-based clinical research system (termed X Town) for chronic diseases, to predict clinical outcomes under various interventions. In this study, the investigators aim to evaluate the reliability of the developed digital twin-based clinical research system in predicting short-term clinical outcomes via virtual and real-world clinical studies.


Eligibility criteria: Inclusion Criteria:

1. Age≥18 years old
2. Receiving care at a community health service centre
3. Able to understand and comply with the study procedures
4. Agrees to participate in the study and signs the informed consent form

Exclusion Criteria:

1. Patients with severe mental illness
2. Patients expected to be unable to complete follow-ups

Primary outcomes:
measure: The agreement between the simulated short-term clinical outcomes in the virtual clinical studies and the real-world short-term clinical outcomes in the real-world clinical studies
timeFrame: Within 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Shanghai Health and Medical Center
state: Jiangsu
Study officials:
References:
Clinical trial NCT05069883: Role of Oral Steroids in Reducing Recurrence of Urethral Stricture After Direct Vision Internal Urethrotomy
Official title: Role of Oral Steroids in Reducing Recurrence of Urethral Stricture After Direct Vision Internal Urethrotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrence
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
Collaborators: name: Armed Forces Institute of Urology, Rawalpindi
First posted: 2021-10-06
Enrollment: 180
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It was a randomized controlled trial conducted at department of Urology, Armed Forces Institute of Urology, Rawalpindi from 1st January, 2018 July 2019 to 31st March 2021 to determine the role of oral steroids after Direct Vision Internal Urethrotomy to reduce the recurrence rate of urethral strictures.


Eligibility criteria: Inclusion Criteria:

* Patients with urethral stricture with restricted urine flow of \< 15 ml/min on uroflowmetry

Exclusion Criteria:

* Patients presenting with post-anastomotic urethroplasty strictures (assessed on history and medical record),
* Patients with post-TURP strictures
* Patients with neurogenic bladder
* Patients with prior history of steroid use
* Patients with extravasation during optical internal urethrotomy

Primary outcomes:
measure: Recurrence of Urethral Stricture
timeFrame: 6 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Armed Force Institute of Urology
state: Punjab
Study officials:
affiliation: barza_afzal@hotmail.com
name: Barza Afzal, MBBS, FCPS
role: STUDY_DIRECTOR
References: