louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00599508: Nutritional Supplementation in Cognitive Aging
Official title: Nutritional Supplementation in Cognitive Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Aging
Keywords: memory
aging
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Welch Foods Incorporated
name: U.S. Highbush Blueberry Council
First posted: 2008-01-23
Enrollment: 120
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the effect of supplemented berry fruit juice and whole fruit berry powder on memory performance and brain function in older adults

Detailed description: Randomized trials involving daily supplementation with berry fruits in older adults with early memory changes. The berry products include Concord grape juice, blueberry juice, and whole fruit blueberry powder. Supplementation periods are 12 and 16 weeks, depending on berry product. The Aims of the studies are to assess effects on cognitive performance and in a subset of participants, in brain activity.

Eligibility criteria: Inclusion Criteria:

* Mild Cognitive Impairment

Exclusion Criteria:

* Diabetes
* Weight of under 100 or over 210 pounds
* Chronic use of pain medication

Primary outcomes:
measure: memory performance
timeFrame: at the end of the intervention
Secondary outcomes:
measure: cortisol
timeFrame: at the end of the intervention
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Robert Krikorian, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01568008: Observational Study of Lumigan® 0.01% for Treatment of Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-04-02
Enrollment: 933
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 with POAG or OHT

Brief summary: This is an observational study in patients with POAG or OHT that will collect data on the use of Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) in a routine clinical setting. Patients will be seen at baseline and at a follow-up visit approximately 8-12 weeks after baseline, as per normal clinical practice.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of POAG or OHT
* Prescribed Lumigan® 0.01%

Exclusion Criteria:

* None

Primary outcomes:
measure: Intraocular Pressure (IOP) at Baseline
timeFrame: Baseline
measure: Intraocular Pressure (IOP) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Patient Assessment of Treatment Tolerability Using a 4-Point Scale
timeFrame: 12 weeks
measure: Physician Assessment of Treatment Tolerability Using a 4-Point Scale
timeFrame: 12 weeks
measure: Physician Reported Reasons for Treatment Discontinuation
timeFrame: 12 weeks
measure: Number of Patients Continuing Treatment After 12 Weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Gent
country: Belgium
state: Oost-Vlaanderen
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06786208: Real-world Study of Sunvozertinib Treatment in Advanced EGFR-Mutant NSCLC After EGFR-TKI Treatment Failure
Official title: Real-world Study of Sunvozertinib Treatment in Locally Advanced or Metastatic EGFR-Mutant NSCLC After EGFR-TKI Treatment Failure
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer
Sunvozertinib
EGFR
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-22
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Locally advanced or metastatic NSCLC with EGFR-sensitive mutations who have been previously treated with EGFR-TKIs and PD for last therapy can be involved in this study. Investigators will assess patients whether to be suitable for sunvozertinib treatment.

Brief summary: Observe the efficacy and safety of sunvozertinib in the real world in the treatment of EGFRm aNSCLC patients with previous EGFR-TKI treatment

Detailed description: Locally advanced or metastatic NSCLC with EGFR-sensitive mutations who have been previously treated with EGFR-TKIs and PD for last therapy can be involved in this study. Investigators will assess patients whether to be suitable for sunvozertinib treatment. And this study will evaluate the safety and efficacy.

Eligibility criteria: Inclusion Criteria:

1. To provide a signed and dated, written informed consent.
2. Age ≥ 18 years old
3. Histologically or cytologically confirmed non-squamous NSCLC with documented EGFR mutations from a local laboratory
4. EGFR-sensitive mutations including exon 19 deletion and exon 21 L858R mutated，at least one line chemotherapy and progress again
5. Predicted life expectancy ≥ 12 weeks
6. Adequate organ system function:
7. Patient must have measurable disease according to RECIST 1.1. -

Exclusion Criteria:

1. Spinal cord compression or meningeal metastasis
2. Not Recover from AEs caused by previous treatment yet
3. A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing.
4. Any severe or poorly controlled systemic disease per investigator's judgment .active infections, including but not limited to hepatitis B (HBV), hepatitis C HCV, and human immunodeficiency HIV

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Time from first dose to last dose, up to 24 month
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Time from first dose to first documented disease progression assessed by investigator or death due to any cause up to 24 month
measure: Overall survival (OS)
timeFrame: Time Frame: Time from first dose to the death of the subject due to any cause assessed up to 36 months.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Qiming Wang
state: Henan
Study officials:
References:
Clinical trial NCT03246308: Investigation of Vitamin Levels During Phototherapy
Official title: Investigation of Vitamin Levels During Phototherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phototherapy Complication
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing UVB therapy.

Brief summary: Research project in which blood samples of patients undergoing UVB phototherapy for the treatment of different cutaneous diseases will be investigated for changes of folate levels and further vitamins over the course of treatment.

Detailed description: UVB phototherapy is used to treat a plethora of different dermatoses with a favorable side effect profile compared to systemic alternatives. One rarely mentioned issue related to phototherapy is the question of whether it holds potential to decrease folate serum levels, which is of particular interest to women of childbearing age, as birth defects, such as neural tube defects (NTD), cardiac defects, and facial clefting have all been noted to be increased in women with folate deficiency. Several studies, involving different patient groups and modes of phototherapy, have investigated the changes of folate levels throughout therapy showing mixed results. While two small open studies from Egypt showed a significant reduction of folate levels after 24 and 18 / 36 exposures (1-2), several other studies failed to show a significant change (3-6). In addition, there are also conflicting data on the influence of UVB phototherapy on vitamin D, vitamin B12 and homocysteine levels. Therefore, the presented prospective trial aims at investigating the changes of these vitamins during a routine course of phototherapy. The study will focus on the following specific aims: Measure the levels of folate as well as the levels of further vitamin parameters (including homocysteine, 25-OH-vitamin D3, 1,25-OH-vitamin D3, holotranscobalamin and methylmalonic acid) before and during phototherapy (at baseline, after 12, 24 and 36 exposures and/or at the end of treatment)

Eligibility criteria: Inclusion Criteria:

* Patients undergoing UVB phototherapy (narrowband UVB or broadband UVB)
* Male and female participants minimum 18 years old
* Written informed consent by the participant after information about the research project

Exclusion Criteria:

* Regular sunbed use
* Underlying disease with abnormal folate metabolism (e.g. thalassemia)
* Age below 18 years
* Patients who will not be able to attend regularly for treatment

Primary outcomes:
measure: Folate level
timeFrame: 3 years
measure: vitamin D level
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT03577808: Organoids in Predicting Chemoradiation Sensitivity on Rectal Cancer
Official title: Validation of Organoids Potential Use as a Companion Diagnostic in Predicting Neoadjuvant Chemoradiation Sensitivity in Locally Advanced Rectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Organoids
Rectal Cancer
Chemoradiation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced rectal cancer will receive neoadjuvant chemoradiation. The radiation procedure and concurrent chemotherapy drugs will base on clinical practice.

Brief summary: Patients with locally advanced rectal cancer will receive biopsy before the standard treatment of neoadjuvant chemoradiation. The investigators are going to establish organoids model from the pre-treatment biopsies and expose organoids to irradiation and the same chemotherapy drugs. The sensitivity of irradiation and chemotherapy drugs will be tested in the organoids model. Here, the investigators will launch the observational clinical trial to validate whether the organoids could predict the clinical outcome in locally advanced rectal cancer patients underwent neoadjuvant chemoradiation.


Eligibility criteria: Inclusion Criteria:

* pathological confirmed adenocarcinoma
* clinical stage T3-4 and/or N+
* the distance from anal verge less than 12 cm
* without distance metastases
* KPS \>=70
* without previous anti-cancer therapy
* sign the inform consent

Exclusion Criteria:

* pregnancy or breast-feeding women
* serious medical illness
* baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN

Primary outcomes:
measure: Response of the rectal cancer organoids to irradiation and the same chemotherapy drugs as the corresponding patient.
timeFrame: 2018.08-2020.11
Secondary outcomes:
measure: Response of the rectal cancer patients to neoadjuvant chemoradiation.
timeFrame: 2018.08-2020.11
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University
Study officials:
affiliation: Fudan University
name: Zhen Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Radiation Medicine, Fudan University
name: Guoqiang Hua, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04970108: Efficacy and Safety of Egito Association in the Treatment of Type II Diabetes Mellitus and Hypertension
Official title: National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Egito Association in the Treatment of Type II Diabetes Mellitus and Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hypertension Associated
Type II Diabetes Mellitus
Keywords: Hypertension
Type II Diabetes Mellitus
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2021-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 evaluate the efficacy and safety of Egito association in the treatment of type 2 diabetes mellitus and hypertension


Eligibility criteria: Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants of both sexes, with age greater than or equal to 18 years and less than or equal to 85 years;
* Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and previous therapies at a stable dose in the last 3 months;
* Participants presenting the diagnosis of hypertension, and who did not reach the therapeutic goals with previous therapies.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* History of alcohol abuse or illicit drug use;
* Participation in a clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Known hypersensitivity to any of the formula compounds;
* Type 1 diabetes mellitus;
* Known or suspected secondary hypertension.

Primary outcomes:
measure: Glycated hemoglobin
timeFrame: 120 days
measure: Systolic blood pressure (SBP)
timeFrame: 120 days
Secondary outcomes:
measure: Adverse events
timeFrame: 150 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06803108: Pyramidal Versus Continuous Training Effects on Fatty Liver
Official title: Pyramidal Versus Continuous Training Effects on Fatty Liver
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 38
Sex: FEMALE
Minimum age (years): 37
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: exercise is very important maneuver in the control of elevated liver enzymes in complaint of fatty liver .. the exercise forma are many.. from these exercises, pyramidal training or continues aerobic one.

Detailed description: the total participating subjects of the two groups of this study will be fatty liver subjects (19 subjects in every group). aerobic training on electronic treadmill will be adopted for 60 minutes in one group. In the other group, a pyramidal training will be adopted for nearly 60 minutes (nearly two rounds of 21 minutes of running on electronic treadmill will be separated with 10 minutes of rest between the two rounds. Also, warming (4 minutes before start of pyrimidal trianing) and cooling (4 minutes after pyramidal training) will be done through gentle stretching exercises/activities. the both forms of exercises will be done three times per week. the total study time will be 12 weeks. to be mentioned , the two groups followed low clorie diet

Eligibility criteria: Inclusion Criteria:

* fatty liver patients
* obese patients
* all patients will class one obesity

Exclusion Criteria:

* cardiovascular complaint
* metabolic complaints
* othopedic pains in lower limbs

Primary outcomes:
measure: alanine transamianse
timeFrame: it will be measured after 12 weeks
Secondary outcomes:
measure: aspartate transaminase
timeFrame: it will be measured after 12 weeks
measure: alkaline phosphatase
timeFrame: it will be measured after 12 weeks
measure: Gamma-glutamyl transferase
timeFrame: it will be measured after 12 weeks
measure: triglycerides
timeFrame: it will be measured after 12 weeks
measure: high density lipoprotein
timeFrame: it will be measured after 12 weeks
measure: body mass index
timeFrame: It will be measured after 12 weeks
measure: waist circumference
timeFrame: It will be measured after 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Unoversity
Study officials:
affiliation: Cairo University
name: Ali MA Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04268108: L-TIL in Patients With Malignancy Resistance to Anti-PD-1 Therapy
Official title: Clinical Study of Liquid Tumor Infiltrating Lymphocytes in Patients With Advanced Malignancies Resistance to Anti-PD-1 Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Solid Tumor
Keywords: liquid tumor-infiltrating lymphocytes
anti-PD-1
resistance
solid tumor
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients in our hospital

Brief summary: Safety and effectiveness of liquid tumor infiltrating lymphocytes in patients with advanced malignant tumors who have failed to anti-PD-1 therapy


Eligibility criteria: Inclusion Criteria:

* Expected lifespan is over 3 months
* malignant tumors diagnosed by pathological examination
* Imaging examination is at advanced stage with at least one measurable lesion
* Ineffective or resistant to previous anti-PD-1 therapy
* ECOG score 0-2
* Adequate organ function
* No other serious diseases that conflict with this protocol
* Women of childbearing age must check for a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the test and within 3 months
* witten informed consent from the patients

Exclusion Criteria:

* Severe infectious disease within 4 weeks before enrollment
* Active hepatitis B or C virus or HIV infection
* Severe autoimmune disease or immunodeficiency disease
* Severe allergies
* Severe mental disorder
* Systematically used a large amount of glucocorticoids within 4 weeks before enrollment
* With severe heart, liver, kidney insufficiency, diabetes and other diseases
* Participation in other clinical studies in the past 3 months or having been treated with other gene products

Primary outcomes:
measure: the rate of reverse events
timeFrame: three months
Secondary outcomes:
measure: clinical benefit rate
timeFrame: three months
measure: time to progression
timeFrame: six months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
state: Henan
Study officials:
References:
Clinical trial NCT01900808: Improvement of Transient Elastography Applicability and Diagnostic Accuracy to Identify Significant Fibrosis by Experienced Operators Using the M and XL Probe.
Official title: Improvement of Transient Elastography Applicability and Diagnostic Accuracy to Identify Significant Fibrosis by Experienced Operators Using the M and XL Probe.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Liver Diseases (CLD)
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2013-07-16
Enrollment: 868
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with liver stiffness

Brief summary: Transient elastography (TE)is the reference method to identify liver stiffness (LSM) but fails to obtain a measurement in 3% of cases and results are considered unreliable in 16%. The aim of this study is to evaluate the applicability and diagnostic accuracy of TE performed by trained operators (\<500 explorations), after a second evaluation by experienced explorers (\>500 explorations) and after a third exploration using XL probe. Inadequate LSM will be re-evaluated by experienced operators with the M (standard size) probe. A third register will be performed with XL (obese size) probe in those patients with inadequate M probe determination. Diagnostic accuracy will be estimated in patients with liver biopsy to identify significant fibrosis with a TE cut-off value of 7.6 kPa (kilo pascal).


Eligibility criteria: Inclusion Criteria:

* Patients with chronic liver disease evaluated with TE by trained operators (experience \<500 explorations).
* Signed inform consent.
* Aged between 18-90.

Exclusion Criteria:

* Patients with ascites.
* Pregnancy.

Primary outcomes:
measure: Applicability of transient elastography (TE)
timeFrame: Will be calculated after evaluation of all included patients with M probe by trained operators (at baseline and after 48 weeks), M probe by experienced operators after 72 weeks and XL probe after 72 weeks.
Secondary outcomes:
measure: Diagnostic accuracy of TE
timeFrame: Will be calculated after evaluation of all included patients with M probe by trained operators after 48 weeks, M probe by experienced operators after 72 weeks and XL probe after 72 weeks.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar, Servei de Digestiu
Study officials:
References:
citation: Carrion JA, Puigvehi M, Coll S, Garcia-Retortillo M, Canete N, Fernandez R, Marquez C, Gimenez MD, Garcia M, Bory F, Sola R. Applicability and accuracy improvement of transient elastography using the M and XL probes by experienced operators. J Viral Hepat. 2015 Mar;22(3):297-306. doi: 10.1111/jvh.12296. Epub 2014 Aug 27.