louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02190188: The Influence of Wedge Insoles After Partial Meniscectomy
Official title: Effect of Orthotic Devices in the Recovery After Partial Meniscectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Meniscectomy
Keywords: wedge insoles,
knee brace,
orthotic device
goal
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Research on the implications of orthotic devices and the recovery after knee arthroscopy are widely known. But only a handful of specific issues have been studied to date. However, the effect of orthotic devices on the recovery after partial meniscectomy are largely unknown. To our best knowledge, there are no studies that deal with the treatment of partial medial or lateral meniscectomy with wedge insoles, valgus or varus knee braces. The purpose of this study is to find out if using wedge inserts or knee orthoses improve the outcomes after partial meniscectomy.

We therefore verify the following hypothesis: In patients with partial meniscectomy can be by the postoperative use of exculpatory wedge deposits or relieving knee brace achieve a significantly better clinical outcome than without specific treatment.


Eligibility criteria: Inclusion Criteria:

* full leg x-ray to measure the leg axis
* undersigned Informed Consent Form

Exclusion Criteria:

* at the same time conducted or within one year subsequent corrective osteotomies of the leg axis
* medial meniscectomy combination and valgus
* combination of lateral meniscectomy and varus
* psychiatric or neurological comorbidities that produce a poor compliance
* forth degree cartilage lesions or evident osteoarthritis
* concomitant lesion of the collateral ligaments
* insufficient knowledge of the study language

Primary outcomes:
measure: Knee-specific questionnaires which combine an activity and a quality of life score.
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Department of Orthopedic; Medical University of Innsbruck
state: Tyrol
Study officials:
affiliation: Department of Orthopedic, Medical University of Innsbruck
name: Michael Liebensteiner, Priv. Doz. Mag. Dr. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06269588: Efficacy and Safety of Nexpowder™ for Non-variceal, Upper Gastrointestinal Bleeding
Official title: A Prospective, Multi-center, Single-arm, Pilot Clinical Trial to Evaluate Efficacy and Safety of Nexpowder™ for Hemostatic Treatment of Non-variceal, Upper Gastrointestinal Bleeding
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Hemorrhage
Hematemesis; With Ulcer
Endoscopy
Keywords: gastrointestinal bleeding; hemostatic powder
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
Collaborators: name: Next Biomedical Co., Ltd.
name: Tan Tock Seng Hospital
name: National University Hospital, Singapore
First posted: 2024-02-21
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective single arm intervention cohort
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot clinical trial is to confirm the efficacy and safety of Nexpowder™ for hemostasis in pilot cohort of patients with NVUGIB in Singapore

Detailed description: 24 subjects with non variceal bleeding will be enrolled. The efficacy and safety of Nexpowder™ as primary technique of endoscopci hemostasis will be assessed in this pi,ot study.

Eligibility criteria: Inclusion Criteria:

1. Males or females aged over 21 to 75 years
2. Patients with confirmed nonvariceal, upper gastrointestinal bleeding
3. Patients who voluntarily agree to the clinical trial with informed consent
4. Patients who willing and able to comply with the study protocol

Exclusion Criteria:

1. Patients with an uncorrected coagulation disorder (PLT\<50\*109/L, INR\>2)
2. Patients who are known to be pregnant or in lactation
3. Patients who have received another endoscopic treatment for the same part of the body within the days preceding the study
4. Patients for whom endoscopic treatment is prohibited due to comorbidity
5. Patients for whom the 30-day follow-up period is impossible
6. Patients who have participated within the past month in other related clinical trials that could affect the results of the study
7. Other cases in which participation in the study is judged inappropriate by the investigators

Primary outcomes:
measure: endoscopic hemostasis
timeFrame: up to 24 hours
Secondary outcomes:
measure: recurrent bleeding rate on second-look endoscopy
timeFrame: 24 hours
measure: hydrogel persistence rate at the bleeding site
timeFrame: 24 hours
measure: Recurrent bleeding within 30 days after endoscopic therapy
timeFrame: 30 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
References:
Clinical trial NCT03781388: ED90 for Hyperbaric Bupivacaine in Super Obese Parturients
Official title: ED90 for Hyperbaric Bupivacaine in Spinal Anesthesia for Cesarean Delivery in Super Obese Parturients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity, Morbid
Spinal Anesthesia
Cesarean Delivery
Keywords: Bupivacaine ED90
Cesarean Delivery
Obesity
Spinal Anesthesia
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The starting dose of hyperbaric bupivacaine for the first patient in this study will be 9mg; the dose for the subsequent subject will be based on the response of the preceding subject as per the Narayana Rule, a modification of the biased-coin design (BCD) up-down sequential method (UDM).
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the ED90 of hyperbaric intrathecal bupivacaine for the super obese population undergoing cesarean section under a combined spinal epidural technique.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology (ASA) class 2 and 3
* English speaking
* Gestational age \> 36 weeks
* Scheduled for cesarean delivery under combined spinal epidural anesthesia
* 18 years or older
* BMI \> 50 kg/m2

Exclusion Criteria:

* History of past or current intravenous drug or chronic opioid abuse
* Allergy or contraindication to any study medications
* Intrapartum cesarean delivery under epidural anesthesia
* Cesarean delivery under general anesthesia

Primary outcomes:
measure: Percent of successful blocks for induction (success induction)
timeFrame: 10 minutes after intrathecal drug administration
measure: Percent of successful blocks for operation (success operation)
timeFrame: during surgery up to 90 minutes after intrathecal injection
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Ashraf S Habib, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01679288: Screening for Abdominal Aortic Aneurysm and Abdominal Aortic Atherosclerosis by Hand-Held Ultrasonography
Official title: Feasibility of Hand-Held-Ultrasonography in Primary Care in the Screening of Abdominal Aortic Aneurysm and Abdominal Aortic Atheromatosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Abdominal Aortic Aneurysm
Atheromatosis
Keywords: Hand-Held ultrasonography
Abdominal Aortic Aneurysm
Abdominal Aortic Atherosclerosis
Cardiovascular risk
Primary Health Care
Lead sponsor: Consorci d'Atenció Primària de Salut de l'Eixample
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 106
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to determine the prevalence of abdominal aortic aneurysm (AAA) and abdominal aortic atheromatosis (AA-At) using a hand-held ultrasound by a general practitioner in Primary Health Care.

Detailed description: Pilot study that prospectively study a cohort of men over 50 years with cardiovascular risk factors: active smokers, former smokers, or hypertensive patients, attended in primary health care center. General Practitioner complete an ultrasonography training in an Ultrasound Unit under supervision of experienced radiologists using an standard ultrasound equipment and hand-held ultrasound (Trademark: VScan®, Manufacturer: General Electric, USA). All images and video recorded are blindly evaluated by a radiologist in order to establish the concordance in the interpretation of images between general practitioner and radiologist. Kappa index is calculated to study the agreement on the presence or absence of AAA and AA-At. Logistic regression analysis is used to determine the factors that influence the presence of AA-At

Eligibility criteria: Inclusion Criteria:

* Smokers
* Former smokers.
* Hypertensive patients

Primary outcomes:
measure: Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care.
timeFrame: 24 months
Secondary outcomes:
measure: Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care
timeFrame: 24 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: CAPSE
Study officials:
affiliation: Consorci d'Atenció Primària de Salut de l'Eixample
name: Antoni Sisó Almirall, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02606188: Modified HFNC Oxygen in Patients Undergoing Bronchoscopy.
Official title: Modified High-flow Nasal Cannula Oxygen in Patients Undergoing Bronchoscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchoscopy,Oxygen
Keywords: Modified High-flow nasal cannula
Bronchoscopy
Oxygen therapy
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 812
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the Modified High-flow nasal cannula is effective in the oxygen of the patients undergoing bronchoscopy.


Eligibility criteria: Inclusion criteria

1. age more than 18 years old;
2. need for bronchoscopy for diagnosis purpose.

Exclusion criteria

1. peripheral arterial pulse oximetry was \< 90%
2. platelet count \< 60 × 109/L;
3. nasopharyngeal obstruction or blockage.

Primary outcomes:
measure: the proportion of patients SpO2 < 90% during bronchoscopy
timeFrame: 1 hour
Secondary outcomes:
measure: the operation time
timeFrame: 1 hour
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of respiratory and critical care medicine,Beijing Chaoyang Hospital
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Bing Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lucangelo U, Vassallo FG, Marras E, Ferluga M, Beziza E, Comuzzi L, Berlot G, Zin WA. High-flow nasal interface improves oxygenation in patients undergoing bronchoscopy. Crit Care Res Pract. 2012;2012:506382. doi: 10.1155/2012/506382. Epub 2012 May 20.
citation: Diab S, Fraser JF. Maintaining Oxygenation Successfully with High Flow Nasal Cannula during Diagnostic Bronchoscopy on a Postoperative Lung Transplant Patient in the Intensive Care. Case Rep Crit Care. 2014;2014:198262. doi: 10.1155/2014/198262. Epub 2014 Nov 13.
citation: Wang R, Li HC, Li XY, Tang X, Chu HW, Yuan X, Tong ZH, Sun B. Modified high-flow nasal cannula oxygen therapy versus conventional oxygen therapy in patients undergoing bronchoscopy: a randomized clinical trial. BMC Pulm Med. 2021 Nov 14;21(1):367. doi: 10.1186/s12890-021-01744-8.
Clinical trial NCT01402388: Lifestyle Intervention in Patients With New Onset Type 2 Diabetes.
Official title: Effect of Intensive Lifestyle Intervention on Hormonal Factors Regulating Food Intake and Blood Glucose Control in Patients With New Onset Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: The Royal Bournemouth Hospital
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 22
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 study seeks to establish if weight loss achieved through a program of intensive lifestyle management can result in improvements in GLP-1 and glycaemic control, in patients with newly diagnosed type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* New onset type 2 Diabetes
* Body mass index 25 and above
* Able to give informed consent

Exclusion Criteria:

* Hypoglycaemic and antiobesity agents, or any other prescription medication that may interfere with study results

Primary outcomes:
measure: Lifestyle impact on GLP-1, HbA1c and fasting glycaemia.
timeFrame: 8 months following commencement of study.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00357188: Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects
Official title: Open-Label, Multiple Dose Study to Determine the Relative Bioavailability of Atazanavir (ATV) 400 mg Administered With Ritonavir (RTV) and Efavirenz (EFV) Compared to Atazanavir 300 mg Administered With Ritonavir Alone in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Protease Inhibitor
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-07-27
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess the exposure of Atazanavir 400 mg with Ritonavir 100 mg and with Efavirenz 600 mg compared to Atazanavir 300 mg with 100 mg without Efavirenz in Healthy Subjects


Eligibility criteria: Inclusion Criteria:

* BMI 18-30
* Men and women who are not of childbearing potential, ages 18-50 years, inclusive

Exclusion Criteria:

* History of seizures or other central nervous system disorders (including migraine headaches)
* history of diagnosed mental illness or suicidal tendencies
* positive screening for Hep B surface antigen
* Hep C antibody
* HIV-1, -2

Primary outcomes:
measure: To assess the comparability of atazanavir exposure when dosed in the evening as atazanavir 400 mg with ritonavir 100 mg and with efavirenz 600 mg relative to ATV 300 mg and RTV 100 mg alone in healthy subjects
Secondary outcomes:
measure: To assess the PK of EFV when coadministered with ATV 400 mg and RTV 100 mg in the evening
measure: To assess the PK of RTV when dosed as ATV 400 mg with RTV 100 mg and with EFV 600 mg in the evening relative to ATV 300 mg with RTV 100 mg alone
measure: To assess the safety and tolerability of ATV and RTV alone and when coadministered with EFV in the evening in healthy subjects
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05467488: Light-induced Effects on Dental Implant Stability
Official title: Ultraviolet A and Ultraviolet C Light-induced Effects on Dental Implant Stability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Missing Teeth
Keywords: dental implants
Lead sponsor: CMH Lahore Medical College and Institute of Dentistry
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Until now, limited research has observed the stability of photo functionalized sandblasted acid-etched (SLA) titanium implants. The study includes a sample size of sixty otherwise healthy patients with implant replacement, comparing nonirradiated, irradiated UVA and UVC titanium implants. It was an interventional study with a sample size divided into three groups using simple randomization. Patients with nonirradiated dental implants make the control group A with UVA and UVC dental implants forming groups B and C, respectively. Before functional loading, implant stability was measured on days zero and eight weeks. SPSS 26.0 is used for data analysis. The data for implant stability quotient (ISQ) levels and osseointegration speed index (OSI) were presented as mean ± SD for each group. The effect of UVA and UVC on ISQ2 compared with the baseline ISQ was done by applying multiple simple regression analysis models, whereas the distinction between UVA and UVC was made through a t-test. p ≤ 0.05 was kept statistically significant. The implants irradiated with UVA significantly affected ISQ levels compared to other groups.


Eligibility criteria: Inclusion Criteria:

* systemically healthy patients with age \> 20 with at least one tooth or more missing

Exclusion Criteria:

-

Primary outcomes:
measure: ISQ measurement through Ostelltm Mentor device
timeFrame: eight months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Institute of Dentistry; CMH Lahore Medical College
state: Punjab
Study officials:
References:
Clinical trial NCT02291588: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-11-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This first-in-human, multicenter study to evaluate the administration of placebo or AMG 811 single subcutaneous and intravenous dose to subjects with SLE


Eligibility criteria: Inclusion Criteria:

* Diagnosis of SLE ncluding a positive antinuclear antibodies (ANA) test at least 6 months before randomization; any concurrent SLE pharmacologic regimen (including leflunomide, methotrexate, and anti-malarials) was stable for at least 30 days before randomization; prednisone ≤ 20 mg/day (or equivalent) was permitted; 1 increase or decrease of ≤ 5mg/day prednisone equivalent was allowed within 30 days before randomization

Exclusion Criteria:

* Subjects who, in the clinical judgment of the investigator, had severe disease; subject who had at least 1 BILAG 'A' score or 2 BILAG 'B' scores in any of the organ systems at screening; signs or symptoms of a viral or bacterial infection within 30 days of study randomization, or recent history of repeated infections, evidence of liver disease; concurrent receipt of mycophenolate mofetil or azathioprine; prior administration of another biologic that primarily targets the immune system within 1 year

Primary outcomes:
measure: Safety and tolerability as measured by subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, and ECGs
timeFrame: between 84 and 196 days
Secondary outcomes:
measure: Pharmacokinetic profile of AMG 811 including tmax, AUClast and Cmax
timeFrame: between 84 and 196 days
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02641288: Intraperitoneal Ropivacaine Irrigation in Bariatric Surgery
Official title: Intraperitoneal Ropivacaine Irrigation in Patients Undergoing Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed. Patients will be randomized in 2 groups: those patients undergoing intraperitoneal ropivacaine irrigation (Experimental Group - EG) and those undergoing intraperitoneal irrigation with normal saline (Control Group - CG).

Detailed description: A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed. Patients will be randomized in 2 groups: those patients undergoing intraperitoneal ropivacaine irrigation 300mg in 200 ml(Experimental Group - EG) and those undergoing intraperitoneal irrigation with normal saline 200ml (Control Group - CG).

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) \>40 Kg/m2
* BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity.

Exclusion Criteria:

* patients undergoing other bariatric techniques or revisional surgery
* allergy to local anesthetics
* severe underlying cardiovascular diseases
* chronic renal failure
* hepatic dysfunction
* previous foregut surgery
* patients with any contraindication for bariatric surgery.

Primary outcomes:
measure: Pain
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital General Elche
name: Juan Gonzalez, MD
role: STUDY_DIRECTOR
References:
citation: Ruiz-Tovar J, Gonzalez J, Garcia A, Cruz C, Rivas S, Jimenez M, Ferrigni C, Duran M. Intraperitoneal Ropivacaine Irrigation in Patients Undergoing Bariatric Surgery: a Prospective Randomized Clinical Trial. Obes Surg. 2016 Nov;26(11):2616-2621. doi: 10.1007/s11695-016-2142-z.