louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00379028: Airway Clearance Study
Official title: A Randomized, Double-blind, Two-way Cross-over Study Evaluating Systemic Bioavailability and Airway Clearance of SymbicortTurbuhaler 320/9mcg vs SeretideDiskus 50/500mcg After Single Inhalations in Patients With COPD and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-09-21
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate how the airways in COPD patients, compared to healthy volunteers, absorb steroid drugs from Symbicort Turbuhaler and Seretide Diskus. The blood concentrations of the steroids will be used as surrogate marker.


Eligibility criteria: Inclusion Criteria:

* COPD patients: ≥40 years of age, Diagnosed COPD with symptoms ≥1 year, Pre-bronchodilatory FEV1 ≤55% of PN, Productive cough with expectoration.
* Healthy volunteers: ≥18 years of age, Healthy, Pre-bronchodilatory FEV1 \>80% of PN, Non-smoker

Exclusion Criteria:

* COPD patients: Current respiratory tract disorder other than COPD, Asthma before 40 years of age, Significant or unstable cardiovascular disorder,
* Healthy volunteers: Use of any regular medication or therapy, Pregnancy or breast-feeding,

Primary outcomes:
measure: Area under the curve (AUC) of the plasma concentrations of the steroid components 0 - 10 hours after study drug inhalation in patients with COPD and healthy volunteers
Secondary outcomes:
measure: Exploratory investigations on the amount of steroids expectorated spontaneously in COPD patients
measure: Correlation between baseline lung function and AUC of steroids after inhalation.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Christer Hultquist, MD
role: STUDY_DIRECTOR
affiliation: Nottingham University
name: Tim Harrisson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dalby C, Polanowski T, Larsson T, Borgstrom L, Edsbacker S, Harrison TW. The bioavailability and airway clearance of the steroid component of budesonide/formoterol and salmeterol/fluticasone after inhaled administration in patients with COPD and healthy subjects: a randomized controlled trial. Respir Res. 2009 Oct 31;10(1):104. doi: 10.1186/1465-9921-10-104.
Clinical trial NCT04393428: Urinary Biomarkers for AKI Diagnosis in Patients With SARS-CoV-2 (COVID-19)
Official title: Urinary Biomarkers (TIMP-2 and IGFBP7) for Early Diagnostic Assessment of Acute Kidney Injury in Patients With SARS-CoV-2 (COVID-19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Renal Replacement Therapy
Acute Kidney Injury
Keywords: Acute Kidney Injury
SARS-CoV-2
Renal Replacement Therapy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients admitted to the Montpellier University Hospital with at least one rine sample drawn

Brief summary: Among patients with SARS-CoV-2 pneumonia, approximately 20% have an acute kidney injury (AKI) and 5% require renal replacement therapy. Occurrence of AKI in patients with COVID-19 is associated with increased morbidity and mortality. Early detection of patients at risk of AKI would allow to prevent onset or worsening of AKI. The aim of this study is to determine if urine biomarkers of renal tubular damage such as TIMP-2 and IGFBP7 could early identify patients with SARS-CoV-2 pneumonia at risk of developing AKI.


Eligibility criteria: Inclusion criteria:

* Age ≥ 18 years
* COVID-19 confirmed by positive SARS-CoV-2 PCR
* at least one urine sample

Exclusion criteria:

* Persons under protection
* Paritcipation rejections

Primary outcomes:
measure: Sensibility and specificity of urinary
timeFrame: Occurence of AKI 7 days after urinary biomarkers measurement
Secondary outcomes:
measure: Sensibility and specificity of urinary
timeFrame: Occurnce of AKI worsening, renal replacement therapy requirement or persistant AKI, 7 days after urinary biomarkers mesurement
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH Montpellier
name: Romaric Larcher, MD, PharmD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03480828: Diaphragm Ultrasound to Predict Weaning Outcomes in Mechanically Ventilated Patients
Official title: Diaphragm Ultrasound to Predict Weaning Outcomes in Mechanically Ventilated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accuracy of DE and DTF in Prediction of Extubation Success
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 36
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: All adult patients who were mechanically ventilated for more than 48 hours and meeting all extubation criteria without a history of neuromuscular disease or severe chronic respiratory failure

Brief summary: This trial enrolled all the adult patients who were mechanically ventilated for more than 48 hours and met all creteria for extubation. Patients who needed reintubation for upper aiway obstruction, neurological or hemodynamic alteration were excluded. The diaphragm ultrasound was performed during spontaneous breathing test or pressure support ventilation trial measuring the dipahragmatic excursion (DE) and the diaphragm thickening fraction (DTF) whithin 24 hours before extubation.

Detailed description: This trial enrolled all the adult patients who were mechanically ventilated for more than 48 hours and met all creteria for extubation. Patients who needed reintubation for upper aiway obstruction, neurological or hemodynamic alteration were excluded. The diaphragm ultrasound was performed during spontaneous breathing test or pressure support ventilation trial measuring the dipahragmatic excursion (DE) and the diaphragm thickening fraction (DTF) whithin 24 hours before extubation. The investigators compared the median values of DE and DTF in the group of successfully extubated patients and the group of patients who needed reintubation.

Our study compared the utility of DTF and DE to predict extubation success.

Eligibility criteria: Inclusion Criteria:

* patients who were mechanically ventilated for more than 48h and meeting all criteria for extubation
* patients without history of neuromuscular disease, or severe chronic respiratory failure

Exclusion Criteria:

* patients who needed reintubation for upper airway obstruction or neurological or hemodynamic instability

Primary outcomes:
measure: extubation success
timeFrame: 48 hours after extubation
Secondary outcomes:
Other outcomes:
Locations:
city: La Marsa
country: Tunisia
facility: Mongi Slim Hospital
state: Tunis
Study officials:
affiliation: Mongi Slim Hospital
name: Mhamed Sami Mebazaa, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04682028: Construction and Evaluation of a Stoma Patient Continuous Care Network
Official title: Construction and Evaluation a Network Platform of Continuous Care for Ostomy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Stomas
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Construct a professional network platformof continuous care for patients with enterostomy and evaluate its availability， Eventually, patients with enterostomy will have access to care outside the hospital.

Detailed description: The project to establish a professional care network for stomas patient will be conducted at first Affiliated Hospital Xi'an Jiaotong University.This network platform that patients can enjoy to make an appointment, video interrogation, the inspection booking, self management, health education, and other health and extension services;nursing staff can undertake colostomy online learning and assessment of the relevant knowledge and skills;professional colostomy care is published to provide remote guidance.the efficacy of the network was evaluated by investigating complications rate,and their self-care ability,quality of life, and medical expenses,and patients'satisfaction.

Eligibility criteria: Inclusion Criteria:

* patients aged≥18 years old;
* patients undergoing enterostomy;
* patients possess a smart phone and know how to use it;
* patients volunteer to participate in the survey.

Exclusion Criteria:

* patients have a history of mental disorders;
* cancer has metastasized to other organs, or there are other serious physical diseases.

Primary outcomes:
measure: stomy Quality of Life,Stoma-QOL
timeFrame: up to 9 months
Secondary outcomes:
measure: Enterostomy Patients Self-management Questionnaire
timeFrame: up to 9 months
measure: Stoma and surrounding complications
timeFrame: up to 9 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: first Affiliated Hospital Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Xiulin Wen
role: STUDY_CHAIR
References:
Clinical trial NCT06790628: Assessment of Facial Symmetry Following Fibula Free Flap Fixated in a Prosthetically Favorable Position Versus the Inferior Border Position for Mandibular Reconstruction
Official title: Assessment of Facial Symmetry Following Fibula Free Flap Fixated in a Prosthetically Favorable Position Versus the Inferior Border Position for Mandibular Reconstruction: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mandible Reconstruction
Keywords: Segmental mandibular defect
mandibular reconstruction
fibula free flap
dental implants
facial symmetry
face scan.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate facial symmetry outcomes after mandibular reconstruction using fibula free flaps, comparing two fixation techniques: the prosthetically favorable position (alveolar level) and the conventional position (inferior border level).

Detailed description: The study aims to evaluate facial symmetry outcomes after mandibular reconstruction using fibula free flaps, comparing two fixation techniques: the prosthetically favorable position (alveolar level) and the conventional position (inferior border level).

Design:

A randomized controlled trial with parallel groups and a 1:1 allocation ratio. The study will assess facial symmetry and patient satisfaction over 12 months post-surgery.

Population:

Patients requiring mandibular reconstruction due to conditions like tumors, trauma, or osteomyelitis, with mandibular defects greater than 9 cm.

Interventions:

Group 1: Fibula free flap fixated at the alveolar level (prosthetically favorable position).

Group 2: Fibula free flap fixated at the inferior border level (conventional position).

Setting:

Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University.

Duration:

Follow-up over 12 months post-surgery, with key data collection points at baseline, 3 days, 1 week, 1 month, 6 months, and 12 months postoperatively.

Eligibility criteria: Inclusion Criteria:

* Patient who requires mandibular resection due to tumor, trauma, osteomyelitis or osteoradionecrosis.
* Patient with Mandibular defect \>9 cm.

Exclusion Criteria:

- Patients with systemic condition counteracting with the surgical procedure.

Primary outcomes:
measure: Facial Symmetry
timeFrame: 6-12 months
Secondary outcomes:
measure: Patient Satisfaction.
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Oral & Maxillofacial department - Faculty of Dentistry - Cairo University.
Study officials:
References:
Clinical trial NCT06567028: OSPM-Enhanced AI Model to Identify Premalignant and Malignant Ocular Surface Tumors
Official title: Prospective Evaluation of an OSPM-Enhanced Deep Learning Model for Identifying Premalignant and Malignant Ocular Surface Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Performance of the Model
Lead sponsor: Ningbo Eye Hospital
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Child, Adult, Older Adult

Brief summary: An OSPM-enhanced deep learning model has been developed for identifying premalignant and malignant tumors using data retrospectively collected from the Ningbo Eye Hospital, Jiangdong Eye Hospital, and the Eye Hospital of Wenzhou Medical University. To further substantiate the model's effectiveness, we intend to evaluate it prospectively at Ningbo Eye Hospital.


Eligibility criteria: Inclusion Criteria:

● Ocular surface tumor images with histopathological findings

Exclusion Criteria:

● Low-quality images

Primary outcomes:
measure: AUROC
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo Eye Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT05562128: Effects of Forest Therapy on Physical and Psychological Parameters in the General Population - a Randomized Controlled Trial
Official title: Effects of Forest Therapy on Physical and Psychological Parameters in the General Population - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: General Population (no Specific Condition or Disease)
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In recent years, nature and forest therapy has increasingly become the focus of medical research. Recent scientific findings indicate overall positive effects of nature and forest therapy on physical and mental health. In Asia and Australia, it has already been implemented as a public health concept of prevention and health promotion. The aim of the project is to replicate the experience gained in Asia over the last three decades on the physical and psychological effects of nature/forest therapy in the context of the German forest and to investigate it further scientifically.


Eligibility criteria: Inclusion Criteria:

- Ability to Consent

Exclusion Criteria:

* Serious acute or chronic illness
* Immobility or limitation of mobility due to orthopedic, neurologic, or other medical causes
* Participation in another study
* Serious mental illness
* Pregnancy and lactation.

Primary outcomes:
measure: Profile of Mood States (POMS)
timeFrame: Change from baseline POMS score at 3 months
Secondary outcomes:
measure: Profile of Mood States (POMS)
timeFrame: Baseline, day 1, day 3, 1 week, 3 months
measure: Perceived Benefits of Nature Questionnaire (PBNQ)
timeFrame: Baseline, 1 week, 3 months
measure: Subjective Vitality Scale state (SVS-G state)
timeFrame: Baseline, day 1, day 3, 1 week, 3 months
measure: Complaint List (B-LR)
timeFrame: Baseline, 1 week, 3 months
measure: Perceive Stress Questionaire (PSQ)
timeFrame: Baseline, day 1, day 3, 1 week, 3 months
measure: Freiburger Fragebogen zur Achtsamkeit (FFA)
timeFrame: Baseline, 1 week, 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 1 week, 3 months
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline, 1 week, 3 months
measure: Allgemeine Selbstwirksamkeit Kurzskala (ASKU)
timeFrame: Baseline, 1 week, 3 months
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline, day 1, day 3, 1 week, 3 months
measure: PROMIS Scale v1.2 - Global Health
timeFrame: Baseline, 1 week, 3 months
Other outcomes:
measure: Heart Rate Variability (HRV)
timeFrame: Baseline, 1 week
measure: Qualitative interviews
timeFrame: 1 week and 8 weeks after inclusion
Locations:
city: Berlin
country: Germany
facility: Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Study officials:
References:
Clinical trial NCT03487328: A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse
Official title: A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterovaginal and Vaginal Vault Prolapse
Keywords: treatment
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective interventional randomized controlled trial is conducted to compare a new technique for Sacrospinous-Sacrotuberous fixation with the traditional sacrospinous ligament fixation technique for treatment of uterovaginal and vaginal vault prolapse.


Eligibility criteria: Inclusion Criteria:

1. Age from 40 to 60 years.
2. POP Q stage III \& IV
3. Uterovaginal prolapse.
4. Vaginal vault prolapse.
5. BMI \>35.

Exclusion Criteria:

1. Age \> 40 years or \< 60 years.
2. POP Q stage I or II.
3. BMI \< 35.
4. Previous repair of uterovaginal or vaginal vault prolapse.
5. Comorbidity with Stress Urinary Incontinence.
6. Presence of persistent risk factor increasing intra-abdominal pressure e.g. chronic chest conditions.
7. Any significant comorbidity or psychiatric disorder that would compromise patient's consent.

Primary outcomes:
measure: Number of participants with recurrence of uterovaginal and vaginal vault prolapse
timeFrame: 1 year
Secondary outcomes:
measure: blood loss
timeFrame: intraoperative
measure: Injury to surrounding structures
timeFrame: intraoperative
measure: operative time
timeFrame: intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
References:
Clinical trial NCT06333028: A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction
Official title: A Non-interventional, Prospective, Multicenter, Single Arm, Post-Marketing Clinical Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2024-03-27
Enrollment: 82
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient population at study site locations

Brief summary: A Study to Evaluate the enVista® Aspire (EA) intraocular lens in Subjects Undergoing Cataract Extraction

Detailed description: A Non-interventional, Prospective, Multicenter, Single Arm, Post-Marketing Clinical Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction

Eligibility criteria: Inclusion Criteria:

1. Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
2. Subjects with a post operative BCDVA of 20/40 or better.
3. Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB) approved ICF and authorization as appropriate for local privacy regulations and willing and able to comply with the follow-up study visit.
4. Subjects implanted bilaterally with enVista Aspire EA IOLs, powers ranging from + 6 to + 34.0 D, prior to enrollment into the study on or after 1 November 2023.
5. All subjects with a visually significant PCO (BCDVA worse than 20/40) who undergo a YAG capsulotomy may be enrolled 30 days post YAG procedure and with a postoperative BCDVA 20/40 or better.

Exclusion Criteria:

1. Subjects with any serious ocular pathology or underlying systemic medical disease (e.g., uncontrolled diabetes) or circumstance that, based on the Investigator's judgment, could confound the results of the study.
2. Subjects for whom a Toric IOL is indicated to achieve emmetropia.
3. Subjects for whom monovision treatment is planned.

Primary outcomes:
measure: Mean binocular BCDVA (logMAR) at Visit 1
timeFrame: Day 60 to Day 270 after second eye implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Dover
country: United States
facility: SITE 104
state: New Jersey
city: Woodland Park
country: United States
facility: Site 105
state: New Jersey
city: Garden City
country: United States
facility: Site 103
state: New York
city: Cranberry Township
country: United States
facility: Site 107
state: Pennsylvania
city: Charleston
country: United States
facility: Site 106
state: South Carolina
city: Sugar Land
country: United States
facility: Site 101
state: Texas
city: Mount Pleasant
country: United States
facility: Site 102
state: Wisconsin
Study officials:
References: