louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01086891: Efficacy of Two Liquid Oxygen Devices in Deambulation
Official title: Efficacy of Two Liquid Oxygen Devices in Deambulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: To Determine the Efficacy of Two Liquid Oxygen Device
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2010-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Some oxygen conserving devices have been developed to diminish oxygen expense. These devices offer optimisation of oxygen therapy for deambulation by improving time autonomy of patients.


Eligibility criteria: Inclusion Criteria:

* Patients with arterial oxygen desaturation to effort.
* COPD with TLC \> 90%
* EPID with TLC \< 90% and FEV1/FVC \> 70%

Exclusion Criteria:

* Patients with long-term oxygen therapy (LTOT) in deambulation.
* Not clinically stable during last month.
* Smokers

Primary outcomes:
measure: To determine the efficacy of correcting desaturation during effort and the acceptance of two different oxygen conserving devices during deambulation,one system with reservoir an another one with oxygen demand valve.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundacio Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: H.Vall d'Hebron
name: Sergi Marti, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marti S, Pajares V, Morante F, Ramon MA, Lara J, Ferrer J, Guell MR. Are oxygen-conserving devices effective for correcting exercise hypoxemia? Respir Care. 2013 Oct;58(10):1606-13. doi: 10.4187/respcare.02260. Epub 2013 Mar 19.
Clinical trial NCT01324791: Laparoscopic Antireflux Surgery Versus Endoscopic Full-thickness Gastroplication for Gastroesophageal Reflux Disease (GERD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: General Public Hospital Zell am See
Sponsor class: OTHER
First posted: 2011-03-29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Endoscopic full thickness gastroplication (Plicator-Procedure) has the potential to be a safe and effective alternative to laparoscopic antireflux surgery (LARS)to improve symptoms of GERD. This prospective randomized study compares objective and subjective outcome parameters of Plicator with that of LARS.


Eligibility criteria: Inclusion Criteria:

* long history of GERD symptoms
* persistent or recurrent symptoms despite optimal medical treatment
* persistent or recurrent complications of GERD
* reduced quality of life owing to increasing esophageal exposure to gastric juice
* pathological values in the preoperative evaluated functional parameters.

Exclusion Criteria:

* any distinct hiatal hernia detectable by gastroscopy or barium radiography
* dysphagia
* esophageal strictures
* poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zell am See
country: Austria
facility: GPH Zell am See
state: Salzburg
Study officials:
References:
Clinical trial NCT06211491: Autonomic Dysreflexia in Spinal Cord Injuries: UDS Filling Speed Impact
Official title: Autonomic Dysreflexia Clinical Characteristics According to the Filling Speed in Urodynamics in Individuals With Spinal Cord Injuries
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spinal Cord Injuries
Autonomic Dysreflexia
UDS Filling Speed
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 20
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: Chronic spinal cord injuries

Brief summary: In patients with spinal cord injury, the investigators want to understand and understand the differences in AD prevalence and characteristics according to bladder injection rate, and to determine which factors have a greater influence between bladder expansion or injection rate.

Detailed description: It has been reported that there is a difference in the degree of AD between the bladder and urinary tract motility tests, suggesting a potential difference according to the injection rate. According to Liu et al., the authors noted that stimulation of the urethra, prostate, and internal sphincter appears to induce AD more strongly than the injection rate. In addition, the two main factors contributing to AD among urinary kinetics tests are the patient's age and bladder maximum urination pressure. Considering these factors is important in preventing AD during urinary kinetics tests. Despite these previous studies, the prevalence and severity of AD according to the injection rate of urinary kinetics tests in SCI have not been quantitatively evaluated.

Eligibility criteria: Inclusion Criteria:

1. Patients with chronic spinal cord injury 6 months after receiving the award
2. Patients with confirmed AD due to bladder fullness in previous urodynamic test
3. Patients confirmed to have neurological damage level C1-T6, AIS A or B

Exclusion Criteria:

1. Patients who cannot perform the test because their systolic blood pressure remains at 150 mmHg during the urodynamic test
2. Patients who cannot undergo testing due to hemodynamic instability
3. Patients who cannot undergo testing due to overt urinary tract infection

Primary outcomes:
measure: Bladder volume (ml)
timeFrame: Immediately after the test
Secondary outcomes:
measure: Bladder compliance (mL/cmH2O)
timeFrame: Immediately after the test
measure: Symptoms (Y/N)
timeFrame: Immediately after the test
measure: Blood pressure (mmHg)
timeFrame: Immediately after the test
measure: Heart rate (bpm)
timeFrame: Immediately after the test
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongnam
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sungchul Huh, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04652791: A Study to Assess Efficacy and Safety of Wangbi Capsule in Patients With Rheumatoid Arthritis
Official title: A Study to Assess Efficacy and Safety of Wangbi Capsule in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 1200
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: RA

Brief summary: The aim of this multi-center, prospective, non-interventional cohort study is to evaluate the efficacy and safety of Wangbi capsule for rheumatoid arthritis patients in the real-world setting.


Eligibility criteria: Inclusion Criteria:

* Subject has a diagnosis of RA as defined by the ACR/EULAR 2010 classification criteria
* Patients older than 18
* Syndrome of insufficiency of liver and kidney or syndrome of cold and dampness defined by traditional Chinese medicine

Exclusion Criteria:

* Patients who are pregnant or breast feeding at enrolment
* History of malignancy prior to screening
* Patients with severe or poorly controlled chronic diseases such as hypertension, diabetes and coronary heart disease
* Patients taking biological agents, \> 10mg prednisone (or equivalent amount of other glucocorticoids) ，more than 2 kinds of DMARDs or similar TCM drug like Wangbi Capsule

Primary outcomes:
measure: Percentage of Participants Achieving Disease Activity Score 28（DAS 28）≤3.2
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology Response 20/50/70
timeFrame: Week 12, Week 24,Week 52
measure: Change from baseline in Disease Activity Score Based on 28-Joint Count (DAS28)
timeFrame: Baseline, Week 12, Week 24, Week 52
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Baseline, Week 12, Week 24,Week 52
measure: Change From Baseline in erythrocyte sedimentation rate(ESR)
timeFrame: Baseline, Week 12, Week 24,Week 52
measure: Change From Baseline in C-reactive protein(CRP)
timeFrame: Baseline, Week 12, Week 24,Week 52
measure: Percentage of Participants Achieving Disease Activity Score 28≤3.2
timeFrame: Week 12, Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06697691: Clinical Prediction Model for In-Hospital Rebleeding in Acute Non-Variceal Upper Gastrointestinal Bleeding
Official title: Construction of a Clinical Prediction Model for In-Hospital Rebleeding in Patients With Acute Non-Venous Upper Gastrointestinal Bleeding
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Non-variceal Upper Gastrointestinal Bleeding
Keywords: rebleeding
acute non-variceal upper gastrointestinal bleeding
Lead sponsor: Wuhan Central Hospital
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consisted of patients hospitalized for AUGIB at the Central Hospital of Wuhan from December 2021 to December 2023

Brief summary: ANVUGIB is a serious condition that can cause symptoms like vomiting blood or passing black stools. Although treatments have improved, about 10% to 30% of patients experience rebleeding shortly after their initial treatment, which increases the risk of death.

Currently, doctors use tools like the Glasgow-Blatchford Score, Rockall Score, and AIM65 Score to predict how patients with ANVUGIB might recover. However, these tools are not very effective at identifying patients who are at risk for rebleeding. This study aims to create a new, more accurate prediction model to help doctors identify high-risk patients earlier. The investigators believe that a new predictive model, which combines patient symptoms, lab test results, and imaging findings, will improve the ability to identify patients at high risk of rebleeding compared to existing tools.The goal is to provide doctors with a more reliable tool to guide their decisions, such as when to give preventive treatments or increase monitoring. This could lead to better outcomes and reduce the risk of complications or death.

This study uses patient data collected during routine care to develop and test the new model, ensuring the findings are directly applicable to real-world clinical settings.


Eligibility criteria: Inclusion Criteria:

* age exceeding 18 years,
* Clinical diagnosis of Acute Non-Variceal Upper Gastrointestinal Bleeding ,
* patients who underwent endoscopy within 24 hours of admission with confirmation of non-variceal bleeding

Exclusion Criteria:

* Upper Gastrointestinal Bleeding during hospitalization;
* transfer from other hospitals;
* variceal bleeding;
* lower gastrointestinal bleeding.;
* bleeding attributed to systemic diseases like disseminated intravascular coagulation (DIC) and hematological disorders;
* patients with incomplete clinical data or laboratory test results;
* patients who either requested early discharge or declined gastroscopy.

Primary outcomes:
measure: relbeeding
timeFrame: up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: the Central Hospital of Wuhan
state: Hubei
Study officials:
References:
Clinical trial NCT04514991: Bone Regenerative Techniques in Endodontic Microsurgery
Official title: Healing After Endodontic Microsurgery Using Resorbable Collagen Based Bone Augmentation Material: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apical Periodontitis
Keywords: Persistent periapical pathology
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized controlled clinical trial was to evaluate two dimensionally and 3-dimensionally the effect of resorbable collagen-based bone filling material on periapical healing following endodontic microsurgery (EMS) on endodontic lesions presenting four-wall defect.


Eligibility criteria: Inclusion Criteria:

* Healthy adult.
* Intact coronal restoration with no sign of leakage.
* Class B (small lesion) and C (large lesion) periapical lesions. (Kim and Kratchman 2006)

Exclusion Criteria:

* Patients with medical conditions and contraindications to surgery.
* Minors.
* Pregnancy.
* Teeth with signs of coronal leakage.
* Teeth with vertical root fractures.

Primary outcomes:
measure: 2D Radiographic Healing at 12 Months Follow up (Overall Cases)
timeFrame: 12 months
measure: 3D Radiographic Healing at 12 Months Follow up (Overall Cases)
timeFrame: 12 months
measure: 2D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
timeFrame: 12 months
measure: 3D Radiographic Healing at 12 Months Follow up (Asymptomatic Cases Only)
timeFrame: 12 months
Secondary outcomes:
measure: C Score (Overall Cases)
timeFrame: 12 months
measure: C Score (Asymptomatic Cases Only)
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: UPenn
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Bekir Karabucak, DMD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05517291: DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease
Official title: Paclitaxel Coated Balloon Angioplasty Versus Primary Selective Stenting in the Treatment of TASC C/D Chronic Femoropopliteal Artery Occlusive Disease: A Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Safety Issues
Efficacy, Self
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the mid- and long-term outcomes between paclitaxel-coated balloon and primary selective stenting in the treatment of TASC C/D femoropopliteal artery occlusive disease.


Eligibility criteria: Inclusion Criteria:

* Subject age 18-85yrs.
* Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
* Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
* Rutherford category 2-5.
* Subject has a de novo TASC C/D femoropopliteal artery lesions which does not exceed to the segment P1 of popliteal artery.
* The total length of target lesion ≤30cm.
* Reference vessel diameter \>4 mm and \<6.5 mm by visual assessment.
* Patent inflow artery with stenosis \<30% and at least 1 infrapopliteal artery to the ankle (\<50% diameter stenosis).
* A guidewire has successfully traversed the target treatment segment.

Exclusion Criteria:

* Acute thrombus in the target vessels.
* Vessel stenosis or occlusion due to Buerger's disease or autoimmune arteritis.
* Subject received prior stents implantation with in-stent restenosis or occlusion.
* Reintervention of the target lesion \<90 days before the study procedure.
* Acquired thrombophilia or uncontrolled hypercoagulation states.
* Life expectancy \<12 months.
* Severe renal（SCr≥2.5 mg/dl）or hemodialysis dependence.
* Pregnancy, suspected pregnancy, or breastfeeding during study period.
* Contraindication to contrast media or any study-required medication (antiplatelet, anticoagulant, or thrombolytic agents, etc.).
* Hypersensitivity to nitinol and/or paclitaxel.

Primary outcomes:
measure: 1-year primary patency rate
timeFrame: 1 year
Secondary outcomes:
measure: clinical-driven target lesion revascularization
timeFrame: 1, 2 and 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT02011191: Biotin Deficiency and Restless Legs Syndrome
Official title: Biotin Deficiency and Restless Legs Syndrome: Evidence for a Causal Relationship From Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Restless Legs Syndrome
Keywords: Biotin
Restless
Kidney
Dialysis
Renal
Lead sponsor: Saint Patrick Hospital
Sponsor class: OTHER
Collaborators: name: Saint Patrick Hospital
name: University of Arkansas
First posted: 2013-12-13
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Restless Leg Syndrome (RLS) is a common neuropathic disorder in patients with end stage renal disease (ESRD). Study Design: Because micronutrient depletion has been associated with RLS in ESRD and because the vitamin biotin is dialyzable, the investigators examined the relationship between biotin status and RLS in ESRD. Objectives: To assess the prevalence of biotin deficiency in those with and without RLS (Study 1) and to determine the effect of biotin supplementation on RLS symptoms (Study 2) in patients receiving chronic dialysis due to ESRD.

Detailed description: Setting and Participants: ESRD patients receiving chronic dialysis as outpatients at Saint Patrick Hospital in Missoula, Montana.

Eligibility criteria: Inclusion Criteria:

* ESRD requiring hemodialysis or peritoneal dialysis therapy for a duration of at least 3 months.

Exclusion Criteria:

* History of consumption of more than 300 micrograms daily of biotin
* Oral contraceptive therapy containing high amounts of estrogen because studies in rats provide evidence that high doses of steroid hormones reduce biotin status {Wang, 1997 #1634}
* Women of childbearing age because of concern that biotin deficiency may be teratogenic {Mock, 2009 #2568}.

Primary outcomes:
measure: Biotin Status of Dialysis Patients
timeFrame: Measurement at baseline and after 8 weeks of treatment
measure: Change in Restless Legs Syndrome (RLS) symptoms after Biotin treatment
timeFrame: Baseline RLS score measurement and measurement after 8 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Saint Patrick Hospital
name: John Lakatua, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00421694: Positive Surgical Margins Rate and EGFR Family Members Expression in Prostate Cancer Treated With Bicalutamide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2007-01-12
Enrollment: 119
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Following radical prostatectomy (RP), about 20% to 40% of the patients with prostate cancer (PCa) exhibit pathological parameters which are associated with a high risk of disease recurrence. The rationale for NHT is based on the theory that androgen ablation induces PCa apoptosis which induces a regression of the primary tumor bulk before RP. However the use of NHT prior RP is highly controversial. In spite of these unenthusiastic results, the relative short time of treatment and the use of different drugs from those utilized in other trials might still to make this regimen attractive in terms of drug related side effects and effectiveness. In this regard, Bicalutamide presents unique characteristics since it work differently respect to other anti-hormonal agents by interfering on both genotropic and non-genotropic mechanisms of androgen receptor


Eligibility criteria: Inclusion Criteria:

* Patients with cT2-T3a prostate cancer

Exclusion Criteria:

* Men\>75 years
* Men\<18 years
* Prior hormonal therapy
* Prior radiation or chemotherapy
* Prior investigational agents
* Life expectancy \> 10 years
* Prior malignancy within the last five years
* Any other serious medical or psychiatric condition

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: University of L'Aquila
state: Abruzzo
Study officials:
affiliation: University of L'Aquila
name: Giovanni Luca Gravina, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02683694: Characteristics and Limitations of Intraoperative OCT Supported Membrane Peeling in Macular Diseases
Official title: Characteristics and Limitations of Intraoperative OCT Supported Membrane Peeling in Macular Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Diseases
Keywords: Epiretinal membrane
lamellar holes of the macula
macular holes
vitreomacular traction syndrome
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 81
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: During the last decade optical coherence tomography (OCT) extended the possibilities for in vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased scanning speed and image-resolution provides more detailed information of microstructures in the macula.

Epiretinal membrane (ERM), lamellar macular hole, macular hole and vitreomacular traction syndrome are disorders involving the posterior pole of the eyeball with consecutive vision loss. In patients with loss of vision and metamorphopsia disturbing their lifestyle, vitrectomy and membrane peeling is usually performed to remove traction and the ERM.

Different study groups showed that intraoperative use of SD-OCT is possible and improves the quality of peeling surgery.

Detailed description: The aim of the study is to assess the benefits and limits of intraoperative OCT (i-OCT), for example whether I-OCT assisted membrane peeling is possible without use of dyes for enabling better localistion of the ERM during surgery and to compare that scheme with different "gold standard" dyes for peeling such as membrane blue dual and triamcinolone. Rationale for that study is to work out which setting enables best visualisation of ERM and ILM (ILM) in i-OCT. A limitation of that method seems to be visualisation of the inner limiting membrane, so that dying of the ILM will probably be still necessary in all cases where ILM-peeling is sheduled.

Eligibility criteria: Inclusion Criteria:

* Epiretinal Membrane, lamellar hole of the macula, macular hole and vitreomacular traction syndrome

Exclusion Criteria:

* Other diseases of the eye, such as AMD, retinopathia pigmentosa

Primary outcomes:
measure: peeling without staining
timeFrame: intraoperative (10-15 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: VIROS
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery
name: Oliver Findl, Prof
role: PRINCIPAL_INVESTIGATOR
References: