louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05529394: Effect of Storage Condition on CD47 Expression Level in Platelet Concentrate
Official title: Effect of Storage Condition on CD47 Expression Level in Platelet Concentrate
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Platelet Storage Pool Deficiency
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Effect of storage condition on CD47 expression level in platelet concentrate

Brief summary: Effect of storage condition on CD47 expression level in platelet concentrate

Detailed description: CD47 is a cell surface glycoprotein expressed on all cell types .It is an attractive target for therapy because it is involved in regulation of cell survival and cell death by acting as a ligand for signal-regulatory protein alpha expressed on macrophages

Eligibility criteria: Inclusion Criteria:

* donors met AABB criteria

Exclusion Criteria:

* donors not met AABB criteria

Primary outcomes:
measure: Assessment of CD47 expression level on platelets by exposure to different storage temperatures
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00265694: Random Trial for Elderly Patients With NSCLC
Official title: A Randomized Phase III Trial of Vinorelbine Versus Gemcitabine and Carboplatin for Elderly Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2005-12-15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Recently a radomized trial of vinorelbine versus best supportive care in patients at 70 years of age or older demonstrated a definite improvement in overall survival rate and quality of life with chemotherapy.
2. The role of combination therapy containing the platinum compound, which is the standard therapy for the young patients is still vague.
3. Gemcitabine and carboplatin have favorable toxicity profile.


Eligibility criteria: Inclusion Criteria:

* Patients with pathologically confirmed, advanced(clinical stage IIIB or IV) NSCLC
* No previous chemotherapy history
* Age ≥ 65 years
* ECOG performance status ≤ 2
* Adequate marrow function (ANC ≥ 2,000/mm3, platelet ≥ 100,000/mm3), renal and liver function (total bilirubin \< 2.0 mg/dL, AST/ALT levels \< 3 × the upper limit of normal, serum creatinine \< 2.0 mg/dL)
* Patients with informed written consent

Exclusion Criteria:

* Patients with other major illness(active infection, severe heart disease, concomitant malignancy, etc)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggyepaik Hospital
Study officials:
name: Young Jin Yuh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02006394: Novel Dietary Interventions for Treating Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Obesity
Metabolic Syndrome
Keywords: Inflammation
Monocytes
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 41
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Clinical and rodent studies have demonstrated the impact of specific dietary factors in modulating inflammation-related diseases including insulin resistance, type 2 diabetes, and cardiovascular disease. Such dietary factors include polyunsaturated fats, polyphenols, and glycemic index. The investigators know from previous studies in the literature that reducing the glycemic index and increasing the omega-3 fat and polyphenol content of the diet results in improved metabolic indices and reduced inflammation. These improvements can be observed even within the context of persistent obesity. The investigators will implement a reduced-calorie, multi-pronged dietary approach for improving insulin sensitivity and reducing inflammation in obese subjects with the metabolic syndrome. The active diet will include reduced glycemic index foods together with omega-3 fats and polyphenol supplements. The primary hypothesis is that the dietary combination of reduced glycemic index foods, omega-3 fats and polyphenols will work to reduce insulin resistance and inflammation more efficiently than a placebo-controlled, calorie- and macronutrient-matched diet in obese subjects with the metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI): 30.0-40.9 kg/m\^2
* Metabolic Syndrome

Exclusion Criteria:

* Diabetes
* Inflammatory diseases
* Eating disorders
* Pregnancy
* Known kidney, coronary, gastrointestinal or peripheral artery disease
* Smoking
* Recent fish oil (\>500mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA)/day) or polyphenol supplement use
* Recent weight change
* Strenuous exercise
* Fish/food allergies
* Current diabetic, lipid-lowering (fibrates, statins), anti-inflammatory, immune-suppressant, and/or anti-inflammatory hypertension medication use

Primary outcomes:
measure: Change in insulin resistance
timeFrame: Baseline, 6 weeks, and 12 weeks
Secondary outcomes:
measure: Change in inflammation biomarkers
timeFrame: Baseline, 6 weeks, 12 weeks
Other outcomes:
measure: Change in adipokines
timeFrame: Baseline, 6 weeks, 12 weeks
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Dorothy Sears, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02921594: Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
Official title: Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties: A Cross Sectional Pilot Study Evaluating Intraarticular Kinematics and Standing Balance by Dynamic Fluoroscopy and Force Plate Examination
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2016-10-03
Enrollment: 0
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: Primary: The primary objective of this pilot study is to compare the intraarticular kinematics by fluoroscopy of Vanguard XP to that of Vanguard CR.

Secondary: The secondary objective of this pilot study is to compare the standing balance by force plate of patients with the Vanguard XP prosthesis to those who have Vanguard CR prosthesis. Furthermore, we wish to assess isometric quadriceps muscle strength in both groups.


Eligibility criteria: Inclusion Criteria:

* Participant in the XP vs. CR study (inherited traits from study inclusion)
* Overall healthy. Have attended standard physiotherapy after unilateral total knee replacement
* Are able to perform the tasks
* Excellent clinical scores (Oxford Knee Score above 39 at 1 year follow up)

Exclusion Criteria:

* Knee pain above 20 on a 0-100 visual analogue scale
* Any clinical relevant pain from adjacent joints
* Active Knee flexion below 100
* Signs of implant migration, loosening, and implant mal-alignment

Primary outcomes:
measure: Anterior-posterior translation of the femoral component with respect to the tibia component
timeFrame: at least one year post surgery
measure: Axial rotation of the femoral component with respect to the tibia component
timeFrame: at least one year post surgery
Secondary outcomes:
measure: Traveled distance of center of pressure
timeFrame: at least one year post surgery
measure: Velocity of center of pressure
timeFrame: at least one year post surgery
measure: Rambling-trembling distance
timeFrame: at least one year post surgery
measure: Isometric quadriceps muscle strength
timeFrame: at least one year post surgery
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
Study officials:
References:
Clinical trial NCT03479294: Real-World Study on Adjuvant Therapy Combined With Shenlingcao Oral Liquid in Patients for Stage II and IIIA Non-small Cell Lung Cancer After Radical Resection
Official title: Real-World Study on Adjuvant Therapy Combined With Shenlingcao Oral Liquid in Patients for Stage II and IIIA Non-small Cell Lung Cancer After Radical Resection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Carcinoma, Non-Small-Cell Lung
Chemotherapy, Adjuvant
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 9
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: Patients undergoing adjuvant radiotherapy or chemotherapy for Stage II and IIIA Non-small Cell Lung Cancer After Radical Resection

Brief summary: This study will establish a multi-center, prospective registration database. The included population are stage II and IIIA NSCLC patients undergoing R0 resection and will be scheduled for adjuvant chemotherapy. Before the first adjuvant chemotherapy, under the recommendation of a doctor, patients will voluntarily choose to use (exposed group) or not to use (control group) Shenlingcao Oral Liquid, which donated by Jiangzhong Group for 30 bottles. The research centers need to be consecutively enrolled patients according to the allocation of the number of cases according to the ratio of 3: 1 in exposure group and control group.

The exposed and control groups will be followed up to 36 months (non-allelic follow-up). Information from patients will be prospectively collected, including baseline, chemoradiation, use of Shenlingcao Oral Liquid and the other complementary drugs, and various outcome measures (the questionnaire of EORTC QLQ, death, tumor recurrence, tumor metastasis, and chemotherapy-induced side effects of the blood system, etc.). Follow-up points included: Baseline (before giving chemotherapy), 2-3 days after each chemotherapy cycle, and 6,12,18,24,30,36 months after enrollment.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older;
* Pathological diagnosis of patients with stage II, III A primary NSCLC;
* R0 resection has been accepted;
* Received adjuvant chemotherapy or adjuvant chemotherapy for the first time after surgery;
* Informed consent has been signed.

Exclusion Criteria:

* Incorporation of other malignant tumors (such as leukemia, liver cancer, etc.)；
* Patients with unclear pathological types；
* Patients with unclear pathological staging；
* Preserved Shenlingcao Oral Liquid before R0 resection surgery；
* Received immunotherapy or targeted therapy before R0 resection surgery；
* Radiotherapy and chemotherapy before R0 resection surgery.

Primary outcomes:
measure: The quality of life
timeFrame: About 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
Study officials:
affiliation: The Chinese Cochrane Center，West China Hospital, Sichuan University
name: Xin Sun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01784094: Connective Tissue Motion Measure 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Musculoskeletal Pain
Lead sponsor: Stromatec, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2013-02-05
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: This study aims to compare the Connective Tissue Motion Measure (CTMM) in low back pain and no-low back pain subjects, evaluate the reliability of the CTMM, and examine the correlation of CTMM with low back pain symptoms, disability, and functional measures. The investigators hypothesize that CTMM will be reduced, on average, in low back pain subjects, that CTMM will be reliable with an intra-class correlation greater than 0.8, and CTMM will negatively correlate with low back pain symptoms, disability and functional measures.


Eligibility criteria: Inclusion Criteria for all subjects:

* able to stand and walk without assistance
* able to read and understand English
* able to understand and sign a consent form

Inclusion Criteria for low back pain subjects:

* history of recurrent or chronic low back pain

Inclusion criteria for no-low back pain subjects:

* no history of low back pain or other chronic pain that has limited activities of daily living or work
* numerical chronic pain index of less than 0.5

Exclusion Criteria for all subjects:

* previous severe back or lower extremity injury or surgery
* major structural spinal deformity (scoliosis, kyphosis, stenosis)
* ankylosing spondylitis or rheumatoid arthritis
* neurological deficit (weakness or sensory loss, decreased deep tendon reflexes suggesting nerve root compression, but not subjective symptoms of nerve root irritation (sciatica))
* radicular pain
* neurological or major psychiatric disorder
* bleeding disorders
* corticosteroid or anticoagulant medication
* substance abuse
* pregnancy
* active worker's compensation or disability case
* in litigation for a low back pain problem
* acute systemic infection

Primary outcomes:
measure: Connective Tissue Shear Strain Motion
timeFrame: Baseline
measure: Change in Connective Tissue Shear Strain Motion
timeFrame: Baseline to 1 hour
measure: Change in Connective Tissue Shear Strain Motion
timeFrame: Baseline to one day
measure: Change in Connective Tissue Shear Strain Motion
timeFrame: Baseline to one week
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Stromatec, Inc
state: Vermont
Study officials:
References:
Clinical trial NCT00051194: A 6-week Safety & Efficacy Study of Combination Intraocular Pressure-lowering Therapy in Patients With Open-angle Glaucoma or Ocular Hypertension
Official title: A 6-week Safety and Efficacy Study of Combination IOP-lowering Therapy in Patients With Open-angle Glaucoma or Ocular Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma, Open-angle
Ocular Hypertension
Keywords: Glaucoma
POAG
OAG
OHT
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2003-01-07
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: To compare the intraocular pressure(IOP)-lowering efficacy of morning or evening instillations of a combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Adult patients of any race and either sex with open angle glaucoma or ocular hypertension.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Europe
state: Texas
Study officials:
affiliation: Alcon Research
name: Alcon Investigators
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05035394: Swedish Microinvasive Glaucoma Surgery Study (SMIGS)
Official title: A Prospective Randomized Trial Comparing Cataract Surgery as Stand Alone and Cataract Surgery Combined With Kahook Dual Blade Glide Goniotomy or Istent Inject W Trabecular Micro-Bypass Stent in Open-Angle Glaucoma.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Open Angle Glaucoma
Cataract
Kahook Dual Blade Glide
Istent Inject W
MIGS
Goniotomy
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the efficacy of Cataract Surgery as stand-alone compared to Cataract Surgery in combination with Kahook Dual Blade Glide goniotomy (KDB) or iStent Inject W Trabecular Microbypass Stent (Istent) in eyes with Open-angle glaucoma.

Detailed description: Glaucoma patients with significant cataract are being informed about the study and potential risks, all participants giving written informed consent and meeting the criteria will become eligibility for study entry. Participants meeting the eligible requirements will be randomized to Cataract Surgery as stand-alone (40 patients) or Cataract Surgery combined with Kahook Dual Blade Glide (40 patients) or iStent Inject W (40 patients).

Eligibility criteria: Inclusion Criteria:

* Only one eye per participant
* Clinically significant cataract
* Glaucoma or intraocular hypertension treated with one to four medications and no need for filtering glaucoma surgery at the time of study enrollment.
* Open chamber angle with Schaffer grading three to four in at least two quadrants

Exclusion Criteria:

* Previous glaucoma surgery, including cyclodestructive procedures.
* Selective Laser Trabeculoplasty (SLT) within 90 days prior to planned surgery.
* Exudative age-related macular degeneration, proliferative diabetic retinopathy, clinically significant corneal dystrophy, other eye disease that affect intraocular eye pressure or visual field.
* Unable to participate and make written consent due to another medical condition.

Primary outcomes:
measure: Change in the number of intraocular pressure lowering medications compared to baseline
timeFrame: 12 to 24 months
measure: Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline
timeFrame: 12 to 24 months
Secondary outcomes:
measure: Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg
timeFrame: 12 to 24 months
Other outcomes:
measure: Number of participants that need further surgery
timeFrame: 12 to 24 months
measure: Number of participants that need additional medical therapy
timeFrame: 12 to 24 months
Locations:
city: Ostersund
country: Sweden
facility: Eye clinic at the hospital of Ostersund
state: Östersund
Study officials:
affiliation: Hospital of Ostersund, department of Ophtalmology
name: Anna Barkander, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00452894: Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers
Official title: A Pharmacokinetic, Toleration And Safety Study Of Single And Multiple Oral Doses Of Varenicline In Chinese Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to measure how much of varenicline tartrate is in Chinese healthy smokers' blood and urine after taking a single dose and several doses respectively, and also to test the safety (the impact of the study drug on Chinese healthy smokers' body) of varenicline.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female Chinese subjects between the ages of 18 and 45 years, inclusive.
* Body Mass Index (BMI) of approximately 19 to 24 kg/m2; and a total body weight ≥50 kg.
* Individuals who have smoked an average of at least 10 cigarettes per day during the past year, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

* Heart rate\>100 bpm, QRS Interval\>120 msec, QTc Interval \>430 msec, PR Interval\>220 msec, or any other abnormalities observed on the Electrocardiogram.
* Subjects with a sitting blood pressure of 140/90 mmHg or above at screening.
* Subjects with evidence or history of clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurological disease, or any condition possibly affecting drug absorption.

Primary outcomes:
measure: The PK parameters after a single dose and PK parameters after 7 days of multiple dosing respectively.
Secondary outcomes:
measure: To gather safety data from Day 0 to Day 17 of the study.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02313194: Spinal Cord Neuromodulation for Spinal Cord Injury
Official title: Enabling Forelimb Function with Agonist Drug and Epidural Stimulation in SCI
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cervical Spinal Cord Injury
Tetraparesis
Tetraplegia
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 12
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 study is designed to assess the strategy of using spinal cord stimulation to improve the ability to move in spinal cord injured humans.

Detailed description: An epidural stimulation device will be tested to determine if motor function can be improved.

Eligibility criteria: Inclusion Criteria:

1. Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate hand/arm movement
2. No severe cardiopulmonary diseases such as severe bradycardia, severe autonomic dysreflexia, and/or Chronic Obstructive Pulmonary Disease.
3. No painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or infection that might interfere with upper extremity training
4. No clinically significant depression or ongoing drug abuse
5. No current anti-spasticity medication regimen
6. Non-progressive SCI above C5
7. Must not have received botox injections in the prior six months
8. Be unable to grip or move independently
9. Be at least one-year post injury
10. Must be at least 18 years of age
11. Segmental reflexes remain functional below the lesion
12. Female subjects of child-bearing potential must not be pregnant and must be using a medically acceptable method of contraception
13. No current implant(s) of neurostimulators, cardiac pacemakers, defibrillators, shunts, stents, or aneurysm clips, and must have no future exposure to diathermy following implantation
14. No coagulopathy, cardiac risk factors, or other significant medical risk factors for surgery
15. Must not be involved in another clinical trial
16. Must not have disorders or conditions that would require MRI monitoring

Exclusion Criteria:

None as long as inclusion criteria are met.

Primary outcomes:
measure: Assessment of arm/hand function
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Daniel C Lu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: