louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05349461: Comparison of Post-operative Knee Range of Motion and Functions Between Intraoperative Complete and Incomplete Patellofemoral Articular Contacts in Patients Undergoing Total Knee Arthroplasty
Official title: Comparison of Post-operative Knee Range of Motion and Functions Between Intraoperative Complete and Incomplete Patellofemoral Articular Contacts in Patients Undergoing Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complete Contact
Incomplete Contact
Lead sponsor: Navamindradhiraj University
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare clinical outcome in knee range of motion and functions between intraoperative complete and incomplete patellofemoral articular contacts


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
* Age 50-80 year

Exclusion Criteria:

* Revision surgery
* Bilateral total knee arthroplasty
* History of patellar fracture
* History of patellar chondromalacia
* History of Patellar instability

Primary outcomes:
measure: Knee range of motion (ROM)
timeFrame: Change from baseline Knee range of motion (ROM) at 3 months, 6 months, and 12 months after surgery
measure: Knee flexion
timeFrame: Change from baseline knee flexion at 3 months, 6 months, and 12 months after surgery
measure: Knee extension
timeFrame: Change from baseline knee extension at 3 months, 6 months, and 12 months after surgery
Secondary outcomes:
measure: Knee Society and Knee Society function score
timeFrame: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery
measure: New patellar score
timeFrame: Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery
measure: Oxford knee score
timeFrame: Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery
measure: Prevalence of anterior knee pain ,AKP
timeFrame: Change from baseline Prevalence of anterior knee pain ,AKP 3 months, 6 months, and 12 months after surgery
Other outcomes:
Locations:
city: Dusit
country: Thailand
facility: Navamindradhiraj University
state: Bangkok
Study officials:
affiliation: satitthh@hotmail.com
name: Satit Thiengwittayaporn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03827161: Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients
Official title: GLANCE 2 - Glucosamine and Chondroitin (G&C) Effects Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subject
Overweight
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 2
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This trial studies glucosamine and chondroitin in preventing inflammation in overweight patients. Chronic inflammation contributes to cancer formation, and biomarkers of inflammation have been associated with cancer risk. Glucosamine and chondroitin may prevent inflammation and this trial may help identify the bacteria that help process them in the gut.


Eligibility criteria: Inclusion Criteria:

-Individuals from the Greater Seattle area who are overweight (body mass index \[BMI\] of 25-32.5 kg/m\^2)

Exclusion Criteria:

* Chronic medical illness, history of gastrointestinal, hepatic, or renal disorders, or inflammatory conditions (including autoimmune and inflammatory diseases)
* Pregnancy or lactation
* Currently on a weight-loss diet
* BMI (body mass index) \< 25 or \> 32.5 kg/m\^2
* Alcohol intake of greater than 2 drinks/day (2 drinks being equivalent to 720 ml beer, 240 ml wine or 90 ml spirits)
* Current use of prescription or over-the-counter medications other than oral contraceptives and hormone secreting intrauterine device (IUD)s, multivitamin pills or infrequent use of aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs), or use of aspirin or NSAIDs more than 2 days per week
* Abnormal renal, liver or metabolic test
* Inability to swallow pills
* Known allergy to shellfish
* Not willing to take pills made from shellfish or animal sources
* Intention to relocate out of study area within next 2 months
* Any antibiotic use in the past 6 months

Primary outcomes:
measure: Effects of glucosamine sulfate/chondroitin sulfate tablet (G&C) on gut microbial community modulation
timeFrame: Up to 2 years
measure: Effects of G&C on serum C-reactive protein (CRP)
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Johanna Lampe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05372861: Nanopore Sequencing in Ophthalmology
Official title: Nanopore Sequencing in Ophthalmology - a Paradigm Shift in Pathogen Determination?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endophthalmitis
Keywords: Endophthalmitis
Nanopore sequencing
Next Generation Sequencing
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2022-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eyes of adult patients with endophthalmitis

Brief summary: In this pilot study, the feasibility of the Oxford Nanopore MinION to identify pathogens from vitrectomy samples in eyes with endophthalmitis shall be assessed. The MinION is a low cost commercially available device for DNA/ RNA analysis that, in studies, has been used for pathogen determination in various infectious diseases as well as for the genetic characterization of hematologic tumors.

Detailed description: Vitreous samples and anterior chamber taps from eyes with endophthalmitis are taken during routine vitrectomy. The gathered samples are divided in half to undergo routine culture for microbial growth and nanopore sequencing with the MinION Mk1b, a commercially available device for DNA/RNA sequencing. Base reads from Nanopore sequencing are then compared with available libraries for pathogen identification. The Nanopore sequencing results for pathogens are compared versus the results of the microbiological culture of the same eye as the gold standard. Clinical features and visual function before and after vitrectomy are gathered from patient charts. Treatment is not altered due to results of the Nanopore sequencing.

Eligibility criteria: Inclusion Criteria:

* Eyes of patients with endophthalmitis

Exclusion Criteria:

* No informed consent possible
* Participation in other studies

Primary outcomes:
measure: Pathogen detection
timeFrame: In vitro analysis after vitrectomy for endophthalmitis. Start of analysis: Within the next working day after sample acquisition. Time for Nanopore sequencing: Approximately up to 10 hours. Time for culture: 24 hours up to 14 days.
Secondary outcomes:
measure: Time to pathogen detection
timeFrame: Time measured from start of analysis until arrival of results. Time for Nanopore sequencing: Approximately up to 10 hours. Time for culture: 24 hours up to 14 days.
measure: Visual acuity
timeFrame: Gathered from patient charts two months after vitrectomy.
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitäts Augenklinik Graz
state: Styria
Study officials:
References:
Clinical trial NCT04140461: AmB Dose for Cryptococcal Meningitis
Official title: Antifungal Treatment of Cryptococcal Meningitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cryptococcal Meningitis
HIV Infections
Keywords: HIV infection
Cryptococcal Meningitis
Amphotericin B
Lead sponsor: Shanghai Public Health Clinical Center
Sponsor class: OTHER_GOV
First posted: 2019-10-25
Enrollment: 40
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: Cryptococcal meningitis (CM) is one of the leading opportunistic infections and one of the most common causes of death in AIDS patients.

Amphotericin B (AmB) is the corner stone in CM treatment. The effect of AmB was dose-dependent. Recent retrospective study indicated that longer duration rather than higher dose of AmB is necessary to reduce the mortality of CM. We aimed to explore the efficacy and safety of small dose but longer duration of AmB for the treatment of HIV-associated CM.


Eligibility criteria: Inclusion Criteria:

* Confirmed HIV infection
* Naive to antiretroviral therapy
* Cryptococcal antigen, smear or culture positive in cerebrospinal fluid
* Agree to participate the study

Exclusion Criteria:

* Having receiving antifungal treatment for ≥3 days
* ALT or AST \> 5\* upper limit of detection (ULD), or neutrophil\< 0.5\*10E9 cells/L, or hemoglobin \< 90g/L or platelet \<50\*10E9/L or serum creatinine \> ULD
* Pregnancy or breastfeeding
* Concomitant medications that are contraindicated with any research drug
* Any other contraindications for using amphotericin B or 5FC
* Inability to follow-up as accessed by the investigator

Primary outcomes:
measure: Number of subjects died at weeks 48
timeFrame: 48 weeks after randomization
Secondary outcomes:
measure: Number of subjects with CSF culture positive for Cryptococcus at weeks 2
timeFrame: 2 weeks after randomization
measure: Number of subjects with disability at weeks 48
timeFrame: 48 weeks after randomization
Other outcomes:
measure: Treatment-Emergent Adverse Events
timeFrame: 12 weeks after randomization
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
References:
Clinical trial NCT00006061: Study of Phosphatidylcholine in a Patient With Methionine Adenosyltransferase Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methionine Adenosyltransferase Deficiency
Metabolism, Inborn Errors
Keywords: genetic diseases and dysmorphic syndromes
inborn errors of metabolism
methionine adenosyltransferase deficiency
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: UNC Lineberger Comprehensive Cancer Center
First posted: 2000-07-06
Enrollment: 1
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine whether plasma choline and breast milk choline levels are low at fasting in a patient with methionine adenosyltransferase deficiency, and if the choline levels are low, determine whether choline levels respond to dietary supplementation with phosphatidylcholine.

II. Determine whether this patient has a fatty liver by magnetic resonance spectroscopy.

Detailed description: PROTOCOL OUTLINE:

Blood is drawn for liver function tests and measurement of plasma choline levels and breast milk samples are taken for measurement of breast milk choline levels at fasting and at 1 hour after breakfast on day 1. The patient then undergoes magnetic resonance spectroscopy of the liver to assess liver density and choline compound mass. The patient then receives oral phosphatidylcholine supplement, and plasma and breast milk samples are taken at 3 and 6 hours after the dose. Oral phosphatidylcholine supplements continue for 30 days. The above studies are repeated on day 31.

Eligibility criteria: * Patient with methionine adenosyltransferase deficiency who is nursing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Steven H. Zeisel
role: STUDY_CHAIR
References:
Clinical trial NCT03642561: Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
Official title: Liver Cancer Institiute ,Fudan University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group 1 RFA alone group 2 TACE alone
Primary purpose: TREATMENT

Brief summary: Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE

Detailed description: The investigators conduct this clinical trial to evaluate the treatment outcome of RFA in HCC patients with tumor smaller than 7cm and tumor number less than five ,in comparison with TACE treatment.The primary outcome is overall survival.The secondary outcome is objective response rate.

Eligibility criteria: Inclusion criteria:

* age 18 to 75 years ;
* HCC confirmed by pathological or clinical diagnosis according to the American Association for the Study of Liver Diseases criteria ;
* solitary HCC less than 7cm in diameter or multiple HCC lesions less 5
* the absence of portal/hepatic vein invasion, lymph node involvement and extrahepatic metastases;
* lesions visible on ultrasound with a safe path between the lesion and skin;
* an Eastern Cooperative Oncology Group performance status of 0-1;
* Child-Pugh class A or B cirrhosis.

The exclusion criteria :

* received any other previous treatment for HCC;
* severe coagulation disorders;
* evidence of hepatic decompensation including hepatic encephalopathy, ascites as well as esophageal or gastric variceal bleeding;
* presence of serious medical comorbidities, including serious dysfunction of the heart or kidney ;
* currently had other malignancies in addition to HCC.

Primary outcomes:
measure: overall survival
timeFrame: up to 60 months
Secondary outcomes:
measure: objective response rate
timeFrame: up to 60 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital Fudan University
Study officials:
affiliation: Fudan University
name: Zhenggang Ren, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06649461: Efficacy of Ozone Therapy and Splint in Carpal Tunnel Syndrome
Official title: Splint with Ozone Injection for Mild and Moderate Carpal Tunnel: an Electrodiagnostic Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Carpal Tunnel Syndrome (CTS)
Keywords: splint
ozone therapy
rehabilitation
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 34
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 study will investigate the effectiveness of repeated ozone therapy combined with splint therapy for carpal tunnel syndrome (CTS).CTS patients will be split into two groups: ozone plus splint and splint only. Both groups will use wrist splints for 3 weeks, with the ozone+splint group receiving weekly ozone injections for three weeks.


Eligibility criteria: Inclusion Criteria:

* being 18-65 years, with mil-modarete CTS, symptoms continued for at least 3 months

Exclusion Criteria:

* hand edema or prior injections, thenar atrophy, prior CTS surgery, severe EMG results, recent physical therapy, steroids, or platelet-rich plasma for CTS in the past year, and conditions causing secondary CTS (e.g., thyroid disorders, diabetes, pregnancy, rheumatoid arthritis, Dupuytren's contracture, inflammatory arthritis, connective tissue diseases). Also excluded: neck or arm pain conditions (e.g., cervical disc herniation, wrist fracture, proximal upper extremity entrapment neuropathy, polyneuropathy, peripheral nerve damage, fibromyalgia), history of G6PD deficiency, uncontrolled hyperthyroidism, thrombocytopenia, and contraindications to general ozone therapy (e.g., ACE inhibitors for severe cardiovascular instability).

Primary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire
timeFrame: 10 minutes
measure: visual analog scale
timeFrame: 1 minute
measure: electromyography (EMG)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
References:
Clinical trial NCT01020461: Evaluation of Accuvein in Adult Patients
Official title: Evaluation of Accuvein for Blood Sampling and for Intravenous Catheter Placement in Adult Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Catheterization
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 522
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effectiveness of Accuvein to facilitate venous blood sampling and placement of peripheral intravenous catheters in adults. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, decreases the number of sticks, and decreases the patient's perception of the pain.


Eligibility criteria: Inclusion Criteria:

* adults requiring a venous blood sampling or the placement of a venous peripheral catheter

Exclusion Criteria:

* none

Primary outcomes:
measure: Time to successful blood sampling or to successful placement of IV catheter
timeFrame: one hour
Secondary outcomes:
measure: Number of attempts required
timeFrame: Immediately after attempts
measure: Pain
timeFrame: Immediately after attempts
measure: Increases in the ease and efficiency of venous cannulation perceived by the operator)
timeFrame: Immediately after attempts
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
citation: Aulagnier J, Hoc C, Mathieu E, Dreyfus JF, Fischler M, Le Guen M. Efficacy of AccuVein to facilitate peripheral intravenous placement in adults presenting to an emergency department: a randomized clinical trial. Acad Emerg Med. 2014 Aug;21(8):858-63. doi: 10.1111/acem.12437.
Clinical trial NCT00409461: Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts
Official title: Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Islet Transplantation
Type 1 Diabetes
Lead sponsor: AZ-VUB
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
name: Belgian Government
First posted: 2006-12-11
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL

Brief summary: Proof of concept study in islet transplantation, two treatment arms (ATG SIR-TAC versus ATG SIR) each consisting of ten type 1 diabetic patients


Eligibility criteria: Inclusion Criteria:

* Type 1 insulin-dependent diabetic patients
* C-peptide \< 0.15 nmol/l (\<0.45 µg/l) 6 min. after glucagon IV (1mg) (glycemia \> 180 mg/dl)
* diabetic nephropathy
* hypoglycaemic unawareness

Exclusion Criteria:

* smoker before transplantation
* plasma creatinine \> 2 mg/dl
* albuminuria \>1000 mg/24 hrs
* abnormal liver function
* history of thrombosis or pulmonary embolism
* history of malignancy, tuberculosis or chronic viral hepatitis
* history of any other serious illness which could be relevant for the protocol
* HLA antibodies
* EBV antibody negative
* HIV 1 \& 2 antibody positive

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Academisch Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB
city: Leuven
country: Belgium
facility: Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL
Study officials:
affiliation: AZ-VUB
name: Bart Keymeulen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gillard P, Ling Z, Mathieu C, Crenier L, Lannoo M, Maes B, Roep B, Gorus F, Pipeleers D, Keymeulen B. Comparison of sirolimus alone with sirolimus plus tacrolimus in type 1 diabetic recipients of cultured islet cell grafts. Transplantation. 2008 Jan 27;85(2):256-63. doi: 10.1097/TP.0b013e31815e8926.
Clinical trial NCT01741961: Long Term Outcome After Ahmed Glaucoma Valve
Official title: 4-year Follow-up After Ahmed Glaucoma Valve Implantation for Lowering Intraocular Pressure in Different Types of Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: uncontrolled glaucoma
glaucoma drainage device
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from uncontrolled glaucoma, most often after multiple ocular surgery.

Brief summary: Long term results after Ahmed glaucoma valve implantation for uncontrolled glaucoma are retrospectively examined.

Detailed description: The development of intraocular pressure, visual acuity, number of glaucoma medication, number of complications and necessity of revision operations after Ahmed glaucoma valve implantation for uncontrolled glaucoma is examined yearly for a period of 4 years.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from medically uncontrolled glaucoma
* Informed consent

Exclusion Criteria:

* healthy subjects
* under 18 years

Primary outcomes:
measure: intraocular pressure reduction
timeFrame: 4 years
Secondary outcomes:
measure: development of visual acuity
timeFrame: 4 years
Other outcomes:
measure: reduction of glaucoma medication
timeFrame: 4 years
measure: postoperative complications
timeFrame: 4 years
measure: need for revision operation
timeFrame: 4 years
Locations:
city: Dresden
country: Germany
facility: University Eye Clinic Dresden
state: Saxony
Study officials:
affiliation: University Dresden, Eye Clinic
name: Karin R Pillunat, MD
role: PRINCIPAL_INVESTIGATOR
References: