louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03334864: Observational Cohort Study of Advanced Non-small Cell Lung Cancer (CAPTRA-LUNG)
Official title: Observational Cohort Study of Advanced Non-small Cell Lung Cancer (CAPTRA-LUNG)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Non-small Cell Lung Cancer
Keywords: Advanced non-small cell lung cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 5000 advanced NSCLC patients

Brief summary: Investigators propose to establish and maintain a cohort of patients with advanced non-small cell lung cancer, and to assess the treatment pattern, host genetic, and clinical factors which influence the prognosis and survival, as well as the interaction among these factors on disease diagnosis and treatment, short and long-term outcomes.

Study type: Observational (Patient Registry)

Study design: Observational Model: Cohort

Time Perspective: Prospective and retrospective


Eligibility criteria: Inclusion Criteria:

* Cohort I: diagnosis of advanced non-small cell lung cancer from 2012-2016;
* Cohort II: documented positive driver gene mutations; and diagnosis of advanced non-small cell lung cancer;
* Cohort III: diagnosis of advanced non-small cell lung cancer and in immune-therapy;
* Cohort IV: diagnosis of advanced non-small cell lung cancer, and with wild-type driver gene or unknown driver gene status;
* Cohort V: treated with anti-VEGF drug in first line, diagnosis of advanced non-squamous and non-small cell lung cancer in 6 months before recruit;
* Age\>18 years;
* Provision of written informed consent.

Exclusion Criteria:

* not applicable

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
citation: Xu Y, Zhang L, Fang J, Wang Z, Li J, Li L, Ai B, Nie L, Mu X, Liang L, Zhang S, Zhang Y, Song Y, Song X, Wang Y, Xin T, Jin B, Wang X, Ding C, Wang M. Establishment of a prospective multicenter cohort for advanced non-small cell lung cancer in China (CAPTRA-Lung study). Thorac Cancer. 2018 Dec;9(12):1795-1800. doi: 10.1111/1759-7714.12865. Epub 2018 Sep 27.
Clinical trial NCT06684990: Point-of-Care Testing in Outpatient Diabetes Care
Official title: Evaluation of a Fast Point-of-care Platform for Diabetes Care At Out-patient Clinics
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
HbA1c
cystatin C
point of care
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will conduct POC testing for HbA1c and cystain C in outpatients with diabetes, and present the results to their providers. Follow up data on fasting glucose, HbA1c, serum creatinine, urine albumin to creatinine ratio (UACR), lipids profile, ...etc will be collected every 6 months for 3 years. Patients who decline to POC testing but provide consent to observational follow up will serve as the controls. The investigators will examine the effects of POC testing on changes in glycemic control and renal function in study participants.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Using a point-of-care (POC) platform, the investigators will investigate the effects of POC testing for glycated hemoglobin (HbA1c) and cystatin C at out-patient clinics on long-term diabetes outcomes.

Detailed description: Laboratory testing for HbA1c and cystatin C is time-consuming, and healthcare providers often do not have update results when they evaluate outpatients with diabetes. A POC testing platform may help address this issue, and the investigators aim to examine its effects on diabetes outcomes.

Eligibility criteria: Inclusion Criteria:

-Adults aged 18 to 80 receiving treatment and follow-up for diabetes at outpatient clinics of Taichung Veterans General Hospital, Taichung, Taiwan.

Exclusion Criteria:

1. Past medical history of hemolytic anemia, hemoglobinopathies (sickle cell anemia HbS, fetal hemoglobin HbF), iron deficiency anemia, thalassemia, pernicious anemia, recent blood transfusions, acute bleeding requiring erythropoiesis-stimulating agents.
2. Chronic liver disease, cirrhosis, hyperbilirubinemia, asplenia (splenomegaly, splenectomy).
3. Hypertriglyceridemia (over 500 mg/dl), or alcoholism.
4. Thyroid dysfunction, active malignant tumors under treatment, HIV infection.
5. Long-term use (over three months) of steroids or cyclosporine.
6. Severe proteinuria (e.g., nephrotic syndrome), or a baseline eGFR \<60 ml/min/1.73 m².

Primary outcomes:
measure: Changes from baseline to the end of study in eGFR
timeFrame: Observational follow up period of 3 years
Secondary outcomes:
measure: Changes from baseline to the end of study in UACR
timeFrame: Observational follow up period of 3 years
Other outcomes:
measure: Incident chronic kidney disease
timeFrame: Observational follow up period of 3 years
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References:
Clinical trial NCT03585790: The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers
Official title: The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthenopia
Myopia
Keywords: Eye Fatigue
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2018-07-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Despite its prevalence, the ocular causes of eye fatigue or unknown and may be related to the cornea/contact lens surface, the accommodative system, the convergence system, overall postural/muscle fatigue, or a combination of these or other causes. The current study aims to systematically investigate the incremental benefits in ameliorating eye fatigue.


Eligibility criteria: Inclusion Criteria:

1. Self-reported "eye fatigue" at least once per week attributable to digital device use with baseline.
2. Uses a digital device (phone, tablet, computer, etc) at least 4 hours per day
3. Mobile digital device with active data and text plan, able to receive email and text messages
4. Habitual 2-week or monthly silicone single vision hydrogel soft contact lens use; habitually wearing lenses for 6 or more hours per day for 5 or more days per week for the past 30 days
5. Habitual soft contact lens prescription optimized over-refraction within ±0.25 D
6. 18-35 years of age
7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
8. Vertex corrected refractive cylinder must be -0.75 or less.
9. Visual acuity best correctable to 20/25 or better for each eye
10. The subject must read and sign the Informed Consent form.

Exclusion Criteria:

1. A habitual wearer of any of the test lenses
2. Any active conditions that may prevent soft contact lens wear.
3. Any doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
4. Any doctor diagnosed, self-reported accommodative or binocular vision issues
5. History of issues of eye alignment or binocularity by self-report

Primary outcomes:
measure: Subject Reported Eye Fatigue
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University Clinical Optics Research Lab
state: Indiana
Study officials:
References:
Clinical trial NCT00403390: Generic vs. Name-Brand Levothyroxine
Official title: Generic vs. Name-Brand Levothyroxine: Assessment of Bioequivalence Using TSH as a Marker in Children With Permanent Hypothyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Hypothyroidism
Hypothyroidism
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2006-11-23
Enrollment: 34
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study compares two different brands of thyroxine (thyroid hormone). Currently, pharmacists may be substituting generic formulations of thyroid hormone without your doctor knowing about this. Although a small difference in thyroid function is not significant in most healthy children, adolescents and adults, in infants and toddlers even a small difference in thyroid function can have important harmful consequences on brain development. The purpose of the present study is to learn whether the difference between brands of thyroid hormone that are currently being substituted is sufficient to cause a difference in thyroid function.

Detailed description: This study is an unblinded, randomized controlled cross-over study, which involves taking 2 different forms of levothyroxine sequentially over a 16 week period. Subjects will have a total of 3 visits over this time period. At the first visit, subjects are randomized to receive either generic (Sandoz) levothyroxine or Synthroid (Abbott) brand of levothyroxine. Blood is drawn for baseline thyroid function studies and other markers which are influenced by thyroid hormone at each visit. The second visit is the cross-over visit, and the final visit is a close-out visit, after which each subject will resume taking their previous formulation of levothyroxine.

Eligibility criteria: Inclusion Criteria:

* Age between 3 and 18 years
* Diagnosis of Congenital Hypothyroidism with initial TSH \> 100
* Ability to understand directions and follow all instructions

Exclusion Criteria:

* Not on any drug interfering with absorption of levothyroxine

Primary outcomes:
measure: Thyroid Stimulating Hormone as Primary Endpoint Measured at Initiation of Study, After 8 Weeks of One Drug, and Then 8 Weeks After the Second Drug.
timeFrame: 3 points over 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Rosalind S Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carswell JM, Gordon JH, Popovsky E, Hale A, Brown RS. Generic and brand-name L-thyroxine are not bioequivalent for children with severe congenital hypothyroidism. J Clin Endocrinol Metab. 2013 Feb;98(2):610-7. doi: 10.1210/jc.2012-3125. Epub 2012 Dec 21.
Clinical trial NCT06820190: Analgesic Efficacy of Multiple Mid-Transverse Process to Pleura (MTP) Block and PCA in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion
Official title: Comparison of Analgesic Efficacy of Multiple Mid-Transverse Process to Pleura (MTP) Block and PCA in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Mid-Transverse Process to Pleura
PCA
Idiopathic Scoliosis
Posterior Spinal Fusion
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-02-11
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: This study aims to compare the analgesic efficacy of multiple mid-transverse process to pleura (MTP) block and PCA in idiopathic scoliosis patients undergoing posterior spinal fusion surgery.

Detailed description: The postoperative period for idiopathic scoliosis patients undergoing posterior spinal fusion (PSF) is fraught with challenges, including adequate postoperative pain control and prolonged hospitalization.

Regional anesthesia techniques, mainly epidural analgesia and, more recently, paravertebral blocks, became crucial parts of the multimodal analgesia (MMA) regimen after introducing ultrasound (US) in the regional anesthesia practice. Erector spinae plane (ESP) block and mid-transverse to pleura (MTP) block are the latest developments in postoperative pain therapy.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Idiopathic scoliosis patients undergoing posterior spinal fusion surgery.

Exclusion Criteria:

* Patients with pre-existing infection at block site.
* Known allergy to study drugs.
* Coagulation disorder.
* History of psychiatric illness.
* Pre-existing neurological deficits.
* Patient with morbid obesity (body mass index \>40 kg/m2).
* Presence of any pre-operative pain or history of chronic pain.
* History of regular analgesic.

Primary outcomes:
measure: Degree of pain
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperatively
measure: Time to the first request for the rescue analgesia
timeFrame: 24 hours postoperatively
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
measure: Mean arterial pressure
timeFrame: Every 15 minutes until the end of the surgery (Up to 2 hours)
measure: Heart rate
timeFrame: Every 15 minutes until the end of the surgery (Up to 2 hours)
measure: Degree of patient satisfaction
timeFrame: 24 hours postoperatively
measure: Incidence of complications
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT00520390: A Phase I, Study to Evaluate the Safety and Tolerability of Intravenous EZN-2208 in Patients With Advanced Solid Tumors or Lymphoma (EZN-2208-02)
Official title: A Phase I, Multicenter, Open-Label, Dose-Escalation Study Evaluating the Safety and Tolerability of Intravenous EZN-2208 PEG-SN38) Administered Weekly for 3 Weeks in 4-Week Cycles in Patients With Advanced Solid Tumors or Ymphoma (EZN-2208-02)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma
Advanced Solid Tumors
Lead sponsor: Enzon Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2007-08-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to patients with advanced cancer or lymphoma. The safety of the study drug and its effect on the disease will also be studied.

Enzon will also perform pharmacokinetic (PK) testing of EZN-2208. PK testing measures the amount of a drug in the body at different time points.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma that is refractory to standard therapy
* Measurable or evaluable disease
* Score of 0 to 2 on the ECOG performance scale

Exclusion Criteria:

* Concurrent serious medical illness
* Known, clinically suspected, or history of central nervous system (CNS) tumor involvement
* Active diarrhea
* Known history of coagulation disorder
* Patients requiring cytochrome P450 3A4 (CYP3A4) enzyme inducing medications
* Requirement for ketoconazole or other strong inhibitor of CYP3A4 enzymes
* Prior chemotherapy, immunotherapy, investigational agent, or other therapy used to treat the cancer within 4 weeks (6 weeks for prior treatment with mitomycin C or nitrosoureas) prior to the scheduled administration of EZN-2208.

Primary outcomes:
measure: Determine the MTD of i.v. EZN-2208 administered weekly for 3 weeks in a 4-week cycle and recommended Phase 2 dose of i.v. EZN-2208
Secondary outcomes:
measure: Evaluate the safety and tolerability of EZN-2208, assess the pharmacokinetic PK profile of EZN-2208, SN38, and SN38G.
timeFrame: 1.5 years
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
Study officials:
affiliation: South Texas Accelerated Research Therapeutics
name: Amita Patnaik, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
Clinical trial NCT05426590: Evaluation of Corneal Endothelial Changes After Uneventful Phacoemulsification in Diabetic and Non-diabetic Patients in Relation to the Level of Glcosylated Hemoglobin Level
Official title: Evaluation of Corneal Endothelial Changes After Uneventful Phacoemulsification in Diabetic and Non-diabetic Patients in Relation to the Level of Glcosylated Hemoglobin Level
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Corneal Endothelial Changes After Phacoemulsification
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 68
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluation of corneal endothelial changes after uneventful phacoemulsification in diabetic and non-diabetic patients using specular biomicroscopy in relation to the level of glcosylated hemoglobin level

Detailed description: 86 patients will be divided into two equal groups of diabetic and non-diabetic patients will undergo phacoemulsification of cataract will be evaluated thier endocelium before surgery and 3 weeks after surgery to detect the effect of level of glcosylated hemoglobin on the endothelial changes after uneventful phacoemulsification

Eligibility criteria: Inclusion Criteria:

* Diabetics and non-diabetic patients undergo cataract surgery
* Age between 50-60 years old
* Corrected distance visual acuity\<0.4
* Gender: both genders.

Exclusion Criteria:

* Chronic Ocular diseases (glaucoma,uveitis, amblyopia, strabismus,keratoconus, corneal opacity).
* corneal dystrophy History of previous keratitis or viral corneal infection. Corneal dystrophy Ocular trauma. Previous ocular surgery. Complicated cataract surgery

Primary outcomes:
measure: Defferentiate patients into diabetic and non-diabetic patients according to the endothelial changes after uneventful phacoemulsification
timeFrame: 6 monthes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Mohamed A Hosny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04097990: Characterization of Fatty Acid Composition of Triglycerides in Patients With Hypertriglyceridemia-induced Acute Pancreatitis
Official title: Characterization of Fatty Acid Composition of Triglycerides in Patients With Hypertriglyceridemia-induced Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertriglyceridemia
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-09-20
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 10 healthy participants, 10 participants with hypertriglyceridemia without prior pancreatitis and 10 participants with hypertriglyceridemia and at least one case of severe pancreatitis in the last 5 years.
Primary purpose: DIAGNOSTIC

Brief summary: ) Finding a unique pattern in the triglyceride composition of patients with hypertriglyceridemia that increases the chances of getting pancreatitis and which can serve as a laboratory predictive tool for patients and define them as a at-risk population.

2) Finding the typical fatty acid composition in triglycerides for patients at high risk of pancreatic acute inflammation that can be used to develop unique drugs for pancreatic acute inflammation caused by high levels of triglycerides.

Detailed description: The study will be conducted at the Sheba Medical Center Lipid Institute, number of participants: 10 healthy participants, 10 participants with hypertriglyceridemia without prior pancreatitis and 10 participants with hypertriglyceridemia and at least one case of severe pancreatitis in the last 5 years.

A total of 30 participants Participants who are found suitable during their visit to the Lipid Institute Clinic or during their hospitalization at Sheba Medical Center will receive an explanation of the study, will be asked to sign a consent form. And check the fatty acid levels. Healthy volunteers who meet the inclusion conditions will also be asked to sign a consent form and their blood will be taken and kept frozen for further study

Eligibility criteria: Inclusion Criteria:

* 1) Healthy participants - triglyceride levels\< 150 mg / dl over the past 5 years, with no diabetes or cardiovascular disease in the background.

  2) Participants with triglyceride levels 1000-5000 mg / dl without acute pancreatitis cases in the past.

  3) Participants with triglyceride levels 1000-5000 mg / dL and at least one case of acute pancreatitis in the last 5 years.

Exclusion Criteria:

1. A past pancreatitis event that occurred with measurement of triglyceride levels greater than 5000 mg / dL.
2. Acute pancreatitis events in the past that occurred for a cause other than hypertriglyceridemia -

Primary outcomes:
measure: Finding a unique pattern in the triglyceride composition
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel HaShomer
country: Israel
facility: Lipid center
Study officials:
References: