louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06927258: Application of Changyanning Granule in Endoscopic Resection of Colorectal Polyps
Official title: Application of Changyanning Granule in Endoscopic Resection of Colorectal Polyps
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Colorectal Polyps
Keywords: colorectal polyps
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of Chanyanning granules in patients undergoing endoscopic resection of colorectal polyps with a basal diameter of 5-30 mm. From one day before the procedure to five days postoperatively, patients will be administered Chanyanning granules. The study will observe intraoperative and postoperative bleeding, perforation, and digestive system-related clinical symptoms such as postoperative abdominal pain, bloating, diarrhea, constipation, hematochezia, and fatigue, as well as related inflammatory markers, to determine the therapeutic effect of Chanyanning granules.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with colorectal polyps through endoscopic examination and who received corresponding endoscopic treatments (EMR, hybrid ESD, ESD).

Exclusion Criteria:

* Concurrent infectious diseases or malignant tumors; Accompanied by severe cardiopulmonary diseases (such as severe heart failure, COPD, etc.)

Primary outcomes:
measure: serum interleukin-6
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: The incidence of complications
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: white blood cells
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: C-reactive protein
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: erythrocyte sedimentation rate
timeFrame: From enrollment to the end of treatment at 2 weeks
Secondary outcomes:
measure: hospital stay
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: hospitalization costs
timeFrame: From enrollment to the end of treatment at 2 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT05698563: Intermetatarsal Bursitis in Patients with Rheumatoid Arthritis
Official title: Clinical Implication of Intermetatarsal Bursitis in Patients with Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intermetatarsal Bursitis
Rheumatoid Arthritis
Keywords: Forefoot pain
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The Danish Rheumatism Association
First posted: 2023-01-26
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective diagnostic study, including a patient and a control group.

There is a treatment option with standard treatment for the patient group, if there is indication based on the diagnostic imaging.
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to investigate the incidence and clinical implications of intermetatarsal bursitis (IMB) in patients with rheumatoid arthritis (RA).

The hypothesis is that IMB is a cause of pain in patients with RA.

Detailed description: Within the recent years more research have focused on IMB in patients with rheumatologic disorders. There is emerging evidence that IMB is an inflammatory alteration in line with synovitis in patients with RA, and presence of IMB have been linked to the early stages of RA, especially due to the focus of the published literature.

The clinical implications of the presence of IMB for the patients are yet to be understood. Limited studies have linked the occurrence of IMB to foot impairment, but no studies have been conducted investigating the direct association between forefoot pain and the presence/absence of IMB.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Forefoot pain and diagnosed with RA (patient group)
* Diagnosed with an axial arthritis (control group)

Exclusion Criteria:

* Age \<18 years
* Open wounds or ongoing infection in the forefoot at the time of examination
* Persons with a history of significant trauma in the forefoot, e.g. any fracture or previous surgeries in the forefoot
* Persons who have previously received intermetatarsal treatment (Morton's neuroma or IMB) in the same foot, e.g. injection within 6 months or operation at any time
* Exclusion from MRI scan only:
* Persons with contraindications to participate in MRI scan
* Persons with severely impaired renal function (GFR \<30 ml/min)

Primary outcomes:
measure: Incidence of intermetatarsal bursitis on MRI
timeFrame: 8 weeks
measure: Incidence of intermetatarsal bursitis on US
timeFrame: 8 weeks
measure: Incidence of other pathology on MRI
timeFrame: 8 weeks
measure: Incidence of other pathology on US
timeFrame: 8 weeks
measure: Change in Visual Analogue Score (VAS) score
timeFrame: At inclusion, 1 and 3 month(s) post treatment
Secondary outcomes:
measure: Incidence of opening toes
timeFrame: 1 day
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup
Study officials:
References:
Clinical trial NCT03544463: Pivotal Study of the iNAP® in Adults With OSA
Official title: A Prospective, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of the iNAP® Sleep Therapy System in Adults With Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Somnics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-01
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Prospective, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of iNAP® Sleep Therapy System in Adults with Obstructive Sleep Apnea (OSA)

Detailed description: Obstructive sleep apnea (OSA) impacts sleep quality of patients, which contributes significantly to hypertension, stroke, myocardial infarction and other health problems. Intraoral devices, such as tongue retaining devices, palatal lifting devices and mandibular repositioning devices designed to increase the patency of the airway and to decrease airway obstruction, are used to treat OSA. To this end, the investigators are conducting a prospective, self-controlled, first-night order cross-over and evaluator-blind pivotal study to evaluate the efficacy and safety of iNAP® Sleep Therapy System (iNAP®), a tongue and soft palate retaining intraoral device, in adults with OSA.

Eligibility criteria: Inclusion Criteria:

* Patients able to read and sign on the informed consent form and able to comply with study requirements.
* Body mass index (BMI) \<33 kg/m2
* AHI between 15\~55
* Pass a device feasibility test

Exclusion Criteria:

* Obstructed nasal passages
* Hypoxemia (SpO2 \<80%)
* Primary insomnia or other suspected sleep disorder other than OSA
* Muscle diseases, e.g. CSA
* Patients with potential complications of sleep apnea that, in the opinion of the Investigator, may affect the study interpretation or the health or safety of the patients

Primary outcomes:
measure: iNAP®-treated response rate over the apnea-hypopnea index (AHI)*
timeFrame: first treatment night
Secondary outcomes:
measure: Clinical Global Impression of Change (CGI-C)
timeFrame: first treatment night
measure: Negative pressure maintenance time (hr)
timeFrame: first treatment night
measure: Change of Oxygen Desaturation Index (ODI)** from the Baseline PSG Study compared to the Tx PSG Study
timeFrame: first treatment night
Other outcomes:
measure: Number of participants with abnormal laboratory values and/or adverse events in this entire study.
timeFrame: through study completion, up to 8 weeks
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Chia-Mo Lin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00948363: The Effect of Kiwi on Blood Pressure, Endothelial Function, Antioxidant Capacity and Gene Expression
Official title: The Effect of Kiwi on Blood Pressure, Endothelial Function, Antioxidant Capacity and Gene Expression in Mildly Hypertensive Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Kiwi fruits
Blood pressure
Endothelial function
Antioxidant capacity
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2009-07-29
Enrollment: 118
Sex: ALL
Minimum age (years): 35
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the intake of kiwi fruits will reduce systolic and diastolic blood pressure compared to intake of apples. The investigators hypothesize that the increased intake lutein or other components in the kiwi fruit will enhance nitric oxide bioavailability and lead to vascular relaxation.

Detailed description: An interesting finding in the Oslo Antioxidant Study was that intake of 3 kiwi fruits reduced blood pressure in a clinical significant manner compared to controls. The mechanism for the blood pressure reducing effect of kiwi or the responsible components are not elucidated. However, plasma lutein levels and antioxidant capacity measured by the ferric reducing antioxidant power was increased in the kiwi group. Moreover, gene expression was also altered by the increased intake of kiwi.

Eligibility criteria: Inclusion Criteria:

* Systolic blood pressure 130-159 mmHg
* Diastolic blood pressure 85-99 mmHg
* Body mass index \<35 kg/m2

Exclusion Criteria:

* Systolic blood pressure \>160 mmHg or \<129 mmHg
* Diastolic blood pressure \>100 mmHg or \<84 mmHg
* Current use or need for blood pressure lowering medication
* Symptomatic cardiovascular disease, diabetes, renal dysfunction, psychiatric disorder, pregnancy or lactation, history of obesity surgery.

Primary outcomes:
measure: Blood pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Endothelial function
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Preventive Cardiology
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Preventive Cardiology, Oslo University Hospital
name: Serena Tonstad, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Svendsen M, Tonstad S, Heggen E, Pedersen TR, Seljeflot I, Bohn SK, Bastani NE, Blomhoff R, Holme IM, Klemsdal TO. The effect of kiwifruit consumption on blood pressure in subjects with moderately elevated blood pressure: a randomized, controlled study. Blood Press. 2015 Feb;24(1):48-54. doi: 10.3109/08037051.2014.976979. Epub 2014 Dec 8.
Clinical trial NCT04394663: High Dose Oral Omeprazole in High Risk UGIB
Official title: High Dose Oral Omeprazole Versus Standard Continuous Intravenous Pantoprazole in Patient With Peptic Ulcer Bleeding and Undergo Successful Therapeutic Endoscopy; Non-inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: GI Bleeding
Keywords: oral proton pump inhibitor
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients with successful endoscopic hemostasis in peptic ulcer bleeding were equally randomized to either high-dose oral PPI or standard IV PPI for 3 days
Primary purpose: TREATMENT

Brief summary: Peptic ulcer bleeding is the most common etiology in upper gastrointestinal bleeding all over the world. After endoscopic treatment, proton pump inhibitor (PPI) is recommended to prevent re-bleeding. Intravenous PPI is recommended as a standard treatment.In the past, there were many trials showing the efficacy of high-dose oral PPI after endoscopic hemostasis but most were industrial sponsor which assessing an expensive PPI. Moreover, the number of patients in those studies were insufficient to confirm a non-inferiority outcome in term of rebleeding by using oral PPI. This study will evaluate a high-dose, local-made PPI (omeprazole) in peptic ulcer treatment after successful endoscopic hemostasis compared to standard IV PPI continuous drip.


Eligibility criteria: Inclusion Criteria:

* Patients with peptic ulcer bleeding and endoscopic finding show ulcer with Forrest classification Ia (spurting haemorrhage), IIa (oozing haemorrhage), Ib (non-bleeding visible vessel)
* Age \> 18 years old

Exclusion Criteria:

* Deny to participate
* Pregnancy or lactation
* Low risk peptic ulcer bleeding including clean base ulcer, flat pigmented spot
* Non-peptic ulcer bleeding eg. erosive gastritis/duodenitis, Mallory Weiss tear, esophageal/gastric/duodenal varices, vascular lesions (eg. Dieulafoy) , malignant ulcer
* Bleeding tendency
* Terminal stage of cancer
* ESRD on hemodialysis
* Decompensated liver cirrhosis

Primary outcomes:
measure: Percentage of 24-hour gastric pH above 6
timeFrame: 3 days
Secondary outcomes:
measure: Rate of 3-day peptic ulcer rebleeding
timeFrame: 3 days
measure: Rate of 30-day peptic ulcer rebleeding
timeFrame: 30 days
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: Rapat Pittayanon
state: Bangkok
Study officials:
affiliation: King Chulalongkorn Memorial Hospital
name: Rapat Pittayanon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01179763: Thickness of Retinal Layers in Amblyopia
Official title: Analysis of Spectral Domain Optical Coherence Tomography Measurements in Amblyopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amblyopia
Keywords: Amblyopia
Retinal layer thickness
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 22
Sex: ALL
Minimum age (years): 4
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients in tertiary hospital

Brief summary: The purpose of this study is to examine retinal layer thickness in amblyopia.

Detailed description: Amblyopia is a visual disorder characterized by a reduction of vision that cannot be immediately improved by refractive correction or accounted for by clinically determined anatomic defects of the eye or visual pathway. Evidence for direct retinal changes in eyes with amblyopia has been controversial. It has been hypothesized that amblyopia may affect the postnatal maturation of the retina including the postnatal reduction of retinal ganglion cells. However, although some studies have found incrased retinal nerve fiber layer thickness in amblyopic eyes, others have found no significant differences. This sutdy will examine the retinal layer thickness in amblyopia and compare the retinal layer thickness between amblyopic eyes and nonamblyopic fellow eyes.

Eligibility criteria: Inclusion Criteria:

* Amblyopia

Exclusion Criteria:

* Other retinal disease
* Anisometropia
* Neurologic abnormalities

Primary outcomes:
measure: Retinal layer thickness
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Sei Yeul Oh, M.D.
role: STUDY_CHAIR
References:
citation: Altintas O, Yuksel N, Ozkan B, Caglar Y. Thickness of the retinal nerve fiber layer, macular thickness, and macular volume in patients with strabismic amblyopia. J Pediatr Ophthalmol Strabismus. 2005 Jul-Aug;42(4):216-21. doi: 10.3928/01913913-20050701-03.
Clinical trial NCT03498963: Pathogens Responsible for Respiratory Infections Associated With Drowning in Seawater
Official title: Early Detection by Molecular Biology Technique of Pathogens Responsible for Respiratory Infections Associated With Drownings in Seawater: Pilot Study at the CHU de Nice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drowning
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-04-17
Enrollment: 9
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: Little data is currently available on the type of pathogen responsible for respiratory infections following drowning. Many environmental germs present in seawater are described as difficult to culture on standard media but are potentially pathogenic. Even using specific culture media nearly 90% of the bacteria present in the water remain non-cultivable. The use of 16S and 18S rDNA amplification followed by high throughput sequencing on respiratory samples could allow us to objectify these bacteria potentially involved in the physiopathological process secondary to drowning and thus improve their overall management.

Carrying out a bronchoalveolar lavage (BAL) within 24 hours after admission to intensive care with analysis on standard and specific culture media of environmental germs, carrying out antibiograms, DNA extraction, amplification by universal 16 and 18S rDNA primers followed by high flow sequencing and phylogenetic analysis of pathogens found. Comparison of these results with the same analyses performed on seawater samples taken near the drowning site and during a new AML at 72h for patients still intubated and showing signs of pneumonia in order to determine if the pathogens detected at the entrance persist and are present in the environment.

AML at the patient's entrance, on day 3 and environmental sampling in the drowning environment within 24 hours. Standard and specific bacteriological analyses with molecular biology techniques (amplification 16 and 18S rDNA) carried out at Pr RUIMY's laboratory (Nice University Hospital) sequencing on INRA's Toulouse genomics platform. Phylogenetic data capture and analysis at IRCAN (Bioinformatics, Croce Olivier). Patient follow-up until resuscitation discharge.


Eligibility criteria: Inclusion Criteria:

* adult patient
* hospitalized in intensive care for severe drowning in sea water (Spilzman stage 5 or 6) (4)
* intubated within 24 hours of admission or before admission to intensive care
* affiliated to social security

Exclusion Criteria:

* patients under guardianship, trusteeship or detention

Primary outcomes:
measure: presence of potentially pathogenic seawater germs not detected by standard cultures and found in the drowning environment.
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fréjus
country: France
facility: Frejus hospital
city: Nice
country: France
facility: university hospital of Nice
Study officials:
References:
Clinical trial NCT01457963: Prevalence of Pulmonary Embolism in ICU
Official title: Pulmonary Embolism in Mechanically Ventilated Patients Requiring Computed Tomography: Prevalence, Risk Factors and Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Deep Venous Thrombosis
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2011-10-24
Enrollment: 176
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: Patients in ICU, mecanically ventilated with a CT scab with iodine injection

Brief summary: The primary objective of this study was to estimate the prevalence of PE among consecutive ICU patients receiving MV who required thoracic computed tomography (CT) with contrast agent injection, regardless of whether PE was suspected clinically. The secondary objectives were to assess the association between PE and DVT, to identify risk factors for VTE, and to determine the outcome of VTE.

Detailed description: Background: Pulmonary embolism (PE) produces nonspecific or minimal symptoms in mechanically ventilated (MV) patients, leading to underdiagnosis. We estimated the prevalence of PE and associations with deep vein thrombosis (DVT) among MV patients.

Methods: Consecutive MV patients who required thoracic computed tomography (CT) in a single ICU. Compression ultrasound of the four limbs was performed within 48 hours of inclusion. Curative anticoagulation therapy was given immediately after PE diagnosis.

Eligibility criteria: Inclusion Criteria:

* all patients requiring invasive MV and thoracic contrast-enhanced CT for any reason

Exclusion Criteria:

* a diagnosis of PE before ICU admission,
* allergy to contrast agents,
* and age younger than 18 years.

Primary outcomes:
measure: Find a pulmonary embolism on the CT scan
timeFrame: CT scan at the day of inclusion
Secondary outcomes:
measure: To find thrombus on compression ultrasound (CUS) of the four limbs
timeFrame: CUS within 48 hours after the CT scan
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University hospital of grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Jean Francois TIMSIT, PU/PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Minet C, Lugosi M, Savoye PY, Menez C, Ruckly S, Bonadona A, Schwebel C, Hamidfar-Roy R, Dumanoir P, Ara-Somohano C, Ferretti GR, Timsit JF. Pulmonary embolism in mechanically ventilated patients requiring computed tomography: Prevalence, risk factors, and outcome. Crit Care Med. 2012 Dec;40(12):3202-8. doi: 10.1097/CCM.0b013e318265e461.