louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03833414: Does Surgical-approach Affect Outcome After Fixation of Intra-articular Fractures of Distal Humerus?
Official title: Surgical Approach for Distal Humerus Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Humerus Fracture
Keywords: intra-articular fractures; distal humerus; osteotomy; elbow joint
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all adult patients males and females who met the eligibility criteria.

Brief summary: observational study at tertiary care hospital and level 1 trauma centre aiming to evaluate the difference between two common surgical approaches to distal humerus fracture fixation.

Detailed description: Fractures around the distal humerus fractures make up to 2% of all fractures. Complex intra-articular distal humerus fractures present as challenge to restore of painless, stable and mobile elbow joint. Surgical exposure to all critical structures is of paramount importance to achieve anatomic reduction. Conflict still persists regarding the choice of ideal approach between triceps-sparing approach compared with olecranon osteotomy approach. In this study investigators compare the effect of surgical approach triceps lifting vs olecranon osteotomy on the functional outcome after fixation of distal humerus intra-articular fractures. Investigators conducted a non-funded, non-commercial, retrospective cohort study on participants with closed distal humerus intra-articular fractures between 2010 and 2015 at our tertiary care level-1 trauma and university hospital. Participants \>18 years of age with closed complex intra-articular distal humerus fracture were operated using two different surgical approaches, either triceps lifting approach (Group1) or with olecranon osteotomy (Group 2). Functional evaluation of the participant is carried out with quick DASH scores at the final 1 year follow-up. Investigators concluded that triceps lifting approach can be used equally efficiently for exposure of these complex distal humerus injuries with no comprise in visibility of articular fragments.

Eligibility criteria: Inclusion Criteria:

* All patients \>18 years of age with closed complex intra-articular distal humerus fracture (Intercondylar Fracture Riseborough Radin Classification type lll and lV) were included.

Exclusion Criteria:

* Patients with CVA (Cerebero-Vascular Accident), dementia and associated with neurovascular injuries which may impede with rehabilitation are excluded

Primary outcomes:
measure: Functional outcome using Quick DASH Score
timeFrame: 1 years followup
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06933914: Long-term Safety and Tolerability of MY008211A Tablets in Patients With Paroxysmal Nocturnal Hemoglobinuria
Official title: An Open Label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of MY008211A Tablets in Patients With PNH Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)
Lead sponsor: Wuhan Createrna Science and Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-04-18
Enrollment: 120
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: This is a multicenter, single-arm, open-label study to characterize long-term safety and tolerability of MY008211A tablets and to provide access to MY008211A tablets to patients with PNH who have completed Phase 2 or 3 studies with MY008211A tablets.

Detailed description: The purpose of this open-label, single arm, multicenter study is to evaluate the long-term safety, tolerability and efficacy of MY008211A tablets in patients with PNH and to provide access to patients who have completed (without tapering down) Phase 2 and Phase 3 trials and derived benefit from MY008211A treatment.

Eligibility criteria: Inclusion Criteria:

1. Patients who have previously received and completed MY008211A study treatment, and are judged by the investigator to have treatment benefit and may benefit from continued treatment of MY008211A.
2. Prior vaccinations against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections.

Exclusion Criteria:

1. History of recurrent invasive infections caused by encapsulated organisms, e.g. meningococcus or pneumococcus.
2. Known or suspected hereditary complement deficiency.
3. Any comorbidity or medical condition (including but not limited to any active systemic bacterial, viral or fungal infection or malignancy) that, in the opinion of the investigator, could put the subject at increased risk or potentially confound study data.

Primary outcomes:
measure: Proportion of participants with adverse events, safety laboratory parameters, vital signs, ECG.
timeFrame: About 100 weeks
Secondary outcomes:
measure: Proportion of participants achieving sustained hemoglobin levels ≥ 120 g/L in the absence of red blood cell transfusions
timeFrame: About 100 weeks
measure: Change From Baseline in Hemoglobin
timeFrame: About 100 weeks
measure: The proportion of patients without RBC transfusion.
timeFrame: About 100 weeks
measure: The Clinical BTH Rate
timeFrame: About 100 weeks
measure: The Major Adverse Vascular Events Rate
timeFrame: About 100 weeks
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Chinese Academy of Medical Sciences Hematology Hospital (Institute of Hematology, Chinese Academy of Medical Sciences)
state: Tianjin
Study officials:
References:
Clinical trial NCT00927914: Evaluating the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy
Official title: A 2-year, Randomized, Double-blind, Placebo-controlled, Multi-center, Phase II-III Study to Evaluate the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Mild to Moderate Diabetic Sensorimotor Polyneuropathy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of 40 mg and 80 mg ranirestat on peroneal motor nerve conduction velocity relative to placebo in subjects with mild to moderate diabetic sensorimotor polyneuropathy.


Eligibility criteria: Inclusion Criteria:

* Subjects with Type 1 or Type 2, insulin-dependent or non insulin-dependent diabetes mellitus.
* Subjects with a history of distal symmetric polyneuropathy, secondary to diabetes, diagnosed in accordance with the American Academy of Neurology criteria.
* Female subjects, who are of non-reproductive potential (\>=12 months post-menopausal or surgically sterile) or who are using adequate contraception which includes abstinence or double barrier methods (diaphragm and condom with spermicidal cream, intrauterine device and condom with spermicidal cream). Male subjects with partners of child-bearing potential must also use adequate contraception.
* Subjects must be able to read, understand, and provide written informed consent before enrolling in the study at screening.

Exclusion Criteria:

* History of diabetic foot ulcers or lower extremity amputation.
* Diabetic amyotrophy or non-diabetic cause of lower limb neuropathy/neuropathic symptoms.
* Clinically significant illness which, in the opinion of the investigator, would compromise a subject's suitability to participate in the study for reasons of safety or would confound the efficacy assessments.

Primary outcomes:
measure: Peroneal motor nerve conduction velocity: the mean of duplicate bilateral recordings made within 1-21 days of each other.
timeFrame: 24 months
Secondary outcomes:
measure: Neuropathy total symptom score-6 via a self-administered questionnaire and vibration perception threshold recorded with a neurothesiometer.
timeFrame: 24 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Eisai Limited
name: Roderick Junor
role: STUDY_DIRECTOR
References:
citation: Polydefkis M, Arezzo J, Nash M, Bril V, Shaibani A, Gordon RJ, Bradshaw KL, Junor RW; Ranirestat Study Group. Safety and efficacy of ranirestat in patients with mild-to-moderate diabetic sensorimotor polyneuropathy. J Peripher Nerv Syst. 2015 Dec;20(4):363-71. doi: 10.1111/jns.12138.
Clinical trial NCT01100814: Expression of S100A2 and Trefoil Factor Family Members in Epstein-Barr Virus Related Gastric Cancer
Official title: Expression of S100A2 and Trefoil Factor Family Members in Epstein-Barr Virus Related Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2010-04-09
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 200 gastric tumour and normal tissue samples, as well as up to 50 non-neoplastic gastric tissues samples from individuals without gastric cancer (treated for other reasons, such as gastric ulcers) will be obtained from the tissue archives of the NUH Department of Pathology. These samples were selected because relevant clinical information of these samples are available from gastric database and will allow us to perform association studies.

Brief summary: The investigators hypothesize that aberrant hypermethylation of tumour suppressor genes is an important mechanism for Epstein-Barr Virus (EBV) - related gastric carcinogenesis, the promoter hypermethylation status and the expression of S100A2 and TFF1 might be different between EBV-associated gastric cancer (GC) and non EBV-associated GC.


Eligibility criteria: Inclusion Criteria:

* Nil

Exclusion Criteria:

* Nil

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
Clinical trial NCT05508295: Long COVID-19 and MAB Study
Official title: Setting up a Community Based Patient Cohort to Understand Long COVID: Monoclonal Antibody and Post-Infection COVID Vaccine Administration as the FOCI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: MultiCare Health System Research Institute
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A small representative sample of up to 50 patients (25 hospitalized and alive at the time of the extraction) will be randomly selected and invited to test for the PRO instrument

Brief summary: This study will be observational only. It will provide real-world evidence generated from a representative and large-scale COVID patient base. The adoption, pilot testing and use of NIH PROs among viral tested patients with research purpose on long COVID will be unique and innovative. With the existing and proven scientific rigor, NIH PRO system will be adopted, then modified and tailored to form the long hauler specific, comprehensive instrument, helping generalize future knowledge regarding COVID-infected patients.


Eligibility criteria: Inclusion Criteria:

* Have been tested for COVID at one of the MultiCare facilities,
* AND 18 years old or older at the viral test,
* AND have no problem understanding English or Spanish.

Exclusion Criteria:

* Pediatric patients younger than 18 years old at the time of testing,
* OR patients who are pregnant,
* OR patients who plan to get pregnant in 3 months,
* OR patients who are hospitalized at the time of recruitment,
* OR patients who have cognitive impairment(s) at the recruitment.

Primary outcomes:
measure: Adopt the NIH PROMIS system (The Assessment Center Instrument Library, which includes all Fixed Length Short Form and Computer Adaptive Test/Item Bank instruments from PROMIS) to construct a modified comprehensive PRO instrument.
timeFrame: 18-month study length, with a pilot reliability study.
Secondary outcomes:
measure: Selected comorbidities, all-cause hospitalization and ER visits.
timeFrame: 3 months and 6 months follow-up.
measure: Patients' COVID vaccination and mAb therapy history will be verified based on self report and EHR.
timeFrame: 18-month study length
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: MultiCare Health System
state: Washington
Study officials:
References:
Clinical trial NCT02405195: Renal Perfusion, Filtration and Oxygenation During Cardiopulmonary Bypass (CPB)
Official title: Renal Perfusion, Filtration and Oxygenation During Cardiopulmonary Bypass (CPB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Extracorporeal Circulation
Renal Impairment
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elective complex cardiac surgery

Brief summary: Acute kidney injury is a common complication after cardiac surgery with cardiopulmonary bypass (CPB). This study aims to investigate the effects of CPB on renal perfusion, filtration and oxygenation.

Detailed description: After approval of the regional ethics committee, patients (n=16) undergoing combined cardiac surgery procedures during normothermic CPB will be included after informed consent. Systemic and renal variables will be measured by pulmonary artery and renal vein catheters. Glomerular filtration rate (GFR) will be measured by renal extraction of 51Cr-EDTA and renal blood flow (RBF) by the infusion clearance technique for para-aminohippuric acid (PAH) corrected for by renal extraction of PAH. Repeated measures ANOVA followed by Fisher's PLSD post-hoc test were used for statistical analyses

Eligibility criteria: Inclusion Criteria:

* Preserved left ventricular function (LVEF \> 50%)
* Normal preoperative S-creatinine

Exclusion Criteria:

* Contraindications to radiocontrast
* Cardiac transplantation och dissection

Primary outcomes:
measure: Renal Blood Flow (RBF)
timeFrame: 6 hours
measure: Glomerular Filtration Rate (GFR)
timeFrame: 6 hours
measure: Renal Oxygenation
timeFrame: 6 hours
Secondary outcomes:
measure: Excretion of NAG
timeFrame: 24 hours
measure: Development of Acute Kidney Injury (AKI)
timeFrame: 72 hours
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of thoracic anesthesia, Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska Academy, dept of clinical science
name: Sven-Erik Ricksten, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lannemyr L, Bragadottir G, Redfors B, Ricksten SE. Effects of milrinone on renal perfusion, filtration and oxygenation in patients with acute heart failure and low cardiac output early after cardiac surgery. J Crit Care. 2020 Jun;57:225-230. doi: 10.1016/j.jcrc.2019.12.022. Epub 2020 Jan 6.
Clinical trial NCT01025895: Anterior Cruciate Ligament (ACL) Reconstruction: Single Bundle Versus Double Bundle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anterior Cruciate Ligament Tear
Keywords: arthroscopic surgical procedure
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ACL tear is a common injury among athletes. The recommended treatment includes reconstruction of the ligament. The common reconstruction technique is single bundle reconstruction. However, this technique does not simulate the natural structure of the ligament. The purpose of the study is to compare between the common procedure, Single Bundle reconstruction with the Double Bundle reconstruction technique.


Eligibility criteria: Inclusion Criteria:

* knee instability with a history of ACL tear
* diagnosed ACL tear according to MRI
* age range 16-40.

Exclusion Criteria:

* previous surgery in the knees
* multiple ligament raptures
* partial ACL tear
* severe cartilage degeneration
* genovaruse/genovalgus
* thin hamstrings tendons
* oper epiphysis in the knee joint
* patient with muscle/neurological problem that increases the tendency to fall

Primary outcomes:
measure: WOMAC, VAS, SF-36, Lisholm, Knee society score, isokinetic muscle strength testing, Single HOP test , Tripple Hop Test
timeFrame: pre-op. 1 day post op., 7-14 days post op., 6 weeks post op., 12 weeks post op., 26 weeks post op., 1 year post op., 2 years post op.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06137495: Immunoblot, Chemiluminescence and ImmunoCap Allergen Specific IgE Evaluation of in Allergic Rhinitis Patients
Official title: Immunoblot and Chemiluminescence Assays Versus ImmunoCap: Evaluation of Allergen Specific IgE in Egyptian House Dust Mites Allergic Rhinitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diagnoses Disease
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-11-18
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In the present study the investigators assay house dust mites (HDMs) IgE in sera of allergic rhinitis patients (AR) using immunoblotting, chemiluminescence, and ImmunoCAP assays to compare between the accuracy of both immunoblotting and chemiluminescence assays, and ImmunoCAP as gold standard.

Detailed description: All allergic rhinitits patients who were monosensitized to mixed HDMs, identified by SPT, will be subjected to complete history taking and assessment of the inclusion and exclusion criteria, performance of skin prick test and measurement of total serum IgE, measurement of specific IgE by Chemiluminescence Immunoassa, immunoblot assay and ImmunoCAP™ Phadiatop™. The patients will be followed-up for 6 months.

Eligibility criteria: Inclusion Criteria:

1. Patient consent.
2. Patient with (18-40) years age known to be allergic rhinitis.
3. Patient with IgE mediated allergic rhinitis (positive total IgE).
4. Patient with positive skin prick testing and monosensitized to HDM

Exclusion Criteria:

1. Patient refusal
2. Patients taking oral corticosteroid.
3. Patients taking anti-IgE injections.
4. Patients taking intranasal corticosteroid.
5. Patient with non- IgE mediated allergic rhinitis.
6. Patients with chronic diseases.

Primary outcomes:
measure: Reduction of serum specific IgE
timeFrame: 6 months from diagnosis to end of Follow-up period
measure: Conversion of SPT to negative
timeFrame: 6 months from diagnosis to end of Follow-up period
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Faculty of Medicine
state: Sharkia
Study officials:
affiliation: Faculty of Medicine, Zagazig University
name: Noha M Hammad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01268995: Improving Secretion of Insulin in New Onset Diabetes After Renal Transplantation
Official title: A Randomized, Prospective Trial to Evaluate the Effect of Conversion From Tacrolimus to Cyclosporine A After Early Initiation of Insulin Therapy in Patients With New-onset Diabetes Mellitus After Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: New Onset Diabetes Mellitus After Renal Transplantation
Keywords: NODAT
kidney transplantation
beta cell function
insulin
Tacrolimus
Cyclosporine A
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: New onset diabetes after transplantation (NODAT) is a frequent and feared complication after kidney transplantation and leads to an increase in cardiovascular complications as well as in the rate of graft loss. Very little data exist on how patients in which NODAT has been diagnosed should be treated. It is suspected that Cylosporine A (Sandimmun, TM) is less diabetogenic than Tacrolimus (Prograf, TM). Furthermore, it has been described that early initiation of insulin treatment in Diabetes mellitus type 2 can preserve and improve the function of the insulin secreting cells in the pancreas. Therefore, the investigators test the effects of conversion from Tacrolimus to Cyclosporine A in patients with newly diagnosed NODAT who have just started early treatment with insulin. The hypothesis is that patients who are treated with insulin and who are switched to Cyclosporine A have improved glucose metabolism compared to patients who are treated with insulin and who remain on Tacrolimus therapy.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed NODAT defined by pathologic OGTT (2h, 75mg glucose):

glucose ≥ 200mg/dl

* Defect in insulin secretion as judged by OGTT and HOMA B
* Renal transplantation (deceased or living donor) and treatment with the standard immunosuppression at our center, consisting of tacrolimus, mycophenolate mofetil, prednisone triple therapy without any induction
* stable graft function for more than 3 months post transplant
* informed consent of the patient

Exclusion Criteria:

* patients with prior history of type 1 or type 2 diabetes
* time since transplantation more than 20 years
* allergy against long-acting insulin or cyclosporine A
* body mass index (BMI) \> 35
* pregnancy

Primary outcomes:
measure: 90 days OGTT
timeFrame: 90 days
Secondary outcomes:
measure: Beta cell function
timeFrame: 90 and 180 days
measure: Graft rejection
timeFrame: whole study period
measure: Hypoglycemia
timeFrame: whole study period
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna/General Hospital
Study officials:
References: