louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00977717: Pharmacogenomic Study to Predict Neurotoxicity of Oxaliplatin
Official title: Pharmacogenomic Study to Predict Toxicity and Response in Colorectal Cancer Patients Treated With Oxaliplatin-based Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Curatively Resected Stage III Colon Cancer
Keywords: oxaliplatin
neuropathy
SNPs
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-09-16
Enrollment: 100
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: Curatively resected stage III colon cancer

Brief summary: In order to explore genetic factors that may determine the neurotoxicity of oxaliplatin-based chemotherapy, germinal gene polymorphisms will be analyzed.

Detailed description: To investigate the impact of single nucleotide (SNP) polymorphism on the toxicity profile in colorectal cancer patients treated with FOLFOX chemotherapy, 10 cc of blood will be drawn in EDTA tube for extraction. DNA will be extracted from peripheral blood samples using DNA isolation kit, and SNP polymorphisms will be evaluated.

Eligibility criteria: Inclusion Criteria:

* aged 18 or older
* curatively resected colon adenocarcinoma
* pathologically staged III
* adequate performance status
* adequate major organ functions
* to be treated with adjuvant FOLFOX chemotherapy
* written informed consent

Exclusion Criteria:

* those who disagree the study

Primary outcomes:
measure: neuropathy
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Seoul, Korea
name: Se Hoon Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baek KK, Lee J, Park SH, Park JO, Park YS, Lim HY, Kang WK, Cho YB, Yun SH, Kim HC, Lee WY, Chun HK. Oxaliplatin-induced chronic peripheral neurotoxicity: a prospective analysis in patients with colorectal cancer. Cancer Res Treat. 2010 Dec;42(4):185-90. doi: 10.4143/crt.2010.42.4.185. Epub 2010 Dec 31.
Clinical trial NCT04405817: Outcome of Patients Treated With ECLS
Official title: Outcome of Patients Treated With Extracorporeal Life Support
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Cardiac Arrest
Heart Failure
Acute Respiratory Failure
Acute Respiratory Distress Syndrome
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving ECMO for circulatory and/or respiratory support

Brief summary: Extracorporeal life support (ECLS), also called extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique of providing effective circulatory and (or) respiratory failure, with a growing number of critically ill patients benefit from it. The aim of this study is to investigate the outcome of patients treated With ECMO, and to evaluate the short-term and long-term outcomes of patients with ECLS.


Eligibility criteria: Inclusion Criteria:

* Patients receiving ECMO for circulatory and/or respiratory support

Exclusion Criteria:

* Refusal of consent

Primary outcomes:
measure: Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device
timeFrame: 30 days after ECMO implantation
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 days after ECMO implantation
measure: All-cause mortality
timeFrame: 12 months after ECMO implantation
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The first affiliated hospital of nanjing medical university
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Yong-feng Shao
role: STUDY_DIRECTOR
References:
Clinical trial NCT03127917: Effect of L-Citrulline on Vascular Function
Official title: Impact of Reduced Arterial Stiffness on Peripheral Vascular Function and Mobility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Citrulline
Blood Flow
Aging
Keywords: Gait Speed
Cognitive Function
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2017-04-25
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this project is to determine the importance of peripheral vascular function on gait performance in older adults.

Detailed description: This project employed a placebo controlled, double-blind, crossover trial. Participants were randomized to oral L-citrulline (6 g/day) or placebo (maltodextrin) for 14 days, and switched to the other treatment for another 14 days after washout. Peripheral vascular function was assessed under conditions of rest, leg exercise, and cognitive engagement. Gait performance was assessed using clinical walking tests.

Eligibility criteria: Inclusion Criteria:

* older adults
* women and men
* aged 60-79 yrs
* must be able to swallow capsules
* fully mobile without assistive walking devices

Exclusion Criteria:

* have physician diagnosed cardiovascular, pulmonary, or metabolic disease
* are current smokers
* currently taking medications affecting cardiovascular function
* have high blood pressure (\>159/99 mmHG)
* have high fasting blood glucose (\>110 mg/dL)
* are considered obese (body mass index ≥ 30 kg/m2)
* have orthopaedic limitations that limit walking ability
* have pacemaker or other metal objects in their body

Primary outcomes:
measure: Blood Flow
timeFrame: baseline and 2 weeks for L-citrulline and placebo
Secondary outcomes:
measure: Gait Performance
timeFrame: baseline and 2 weeks for L-citrulline and placebo
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01723917: Phytoserms for Menopause Symptoms and Age-Associated Memory Decline
Official title: Estrogen Receptor-beta phytoSERMs for Management of Menopause and Age-Associated Memory Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Memory Loss
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2012-11-08
Enrollment: 71
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the safety and efficacy of a soy based dietary supplement (phytoSERM) for hot flashes and age associated memory loss.


Eligibility criteria: Inclusion Criteria:

* post-menopausal women
* ages 45 - 60 (inclusive)
* must have a vasomotor symptom (e.g., hot flash) and a memory complaint

Exclusion Criteria:

* history of clinically significant stroke
* current evidence or history in past 2 years of epilepsy, seizure, focal brain lesion, head injury with loss of consciousness or any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
* Known allergy to soy derived products; hypersensitivity to estrogens or progestins

Primary outcomes:
measure: safety and tolerability
timeFrame: 12 weeks
measure: efficacy
timeFrame: 12 weeks
measure: efficacy
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Keck School of Medicine
state: California
Study officials:
affiliation: University of Southern California
name: Lon S Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schneider LS, Hernandez G, Zhao L, Franke AA, Chen YL, Pawluczyk S, Mack WJ, Brinton RD. Safety and feasibility of estrogen receptor-beta targeted phytoSERM formulation for menopausal symptoms: phase 1b/2a randomized clinical trial. Menopause. 2019 Aug;26(8):874-884. doi: 10.1097/GME.0000000000001325.
citation: Hernandez G, Zhao L, Franke AA, Chen YL, Mack WJ, Brinton RD, Schneider LS. Pharmacokinetics and safety profile of single-dose administration of an estrogen receptor beta-selective phytoestrogenic (phytoSERM) formulation in perimenopausal and postmenopausal women. Menopause. 2018 Feb;25(2):191-196. doi: 10.1097/GME.0000000000000984.
Clinical trial NCT01868217: A Retrospective Study to Investigate Prevalence of Capsular Bag Distention Syndrome and Its Influencing Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Capsular Bag Distention Syndrome After Cataract Surgery
Lead sponsor: Evidence Based Cataract Study Group
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 239
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients Who Underwent Cataract Surgery at Eye and ENT Hospital of Fudan University, Xuhui, Shanghai, China

Brief summary: * To Investigate the Prevalence of Capsular Bag Distention Syndrome
* To Analyze Influencing Factors of Capsular Bag Distention Syndrome


Eligibility criteria: Inclusion Criteria:

* patients who underwent uneventful phacoemulsification and posterior-chamber IOL implantation at the Eye and ENT Hospital of Fudan University, Xuhui, Shanghai, China, between November 2011 and December 2012

Exclusion Criteria:

* Patients with traumatic cataracts or zonular weakness were excluded from the study, as were eyes with intraoperative complications, such as a posterior capsule opening, radial tearing of the continuous curvilinear capsulorhexis (CCC), or inappropriate IOL implantation.

Primary outcomes:
measure: Dimension of the eyeball(mm)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06166017: Lingual Keratinized Tissue in Fully Edentulous Patients and Its Impact on Implant Health
Official title: Lingual Keratinized Tissue in Fully Edentulous Patients and Its Impact on Implant Health
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Peri-Implantitis
Peri-implant Mucositis
Recession, Gingival
Lead sponsor: George Eastman Dental Hospital, Italy
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteers presenting with integrated implants supporting a fixed or removable full-arch prosthesis. Minimum loading time of 12 months.

Brief summary: Cross-sectional study involving the measurement of the width of lingual keratinized tissue (in the implant locations) in fully edentulous patients restored with dental implants. The width of KT will be correlated with the primary outcome, diagnosis of peri-implantitis, defined as Probing depth (PPD)\>= 6 mm, inflammation/ bleeding on probing (BOP) and bone loss \>= 3 mm from the implant platform.

Detailed description: The study will be conducted with a cross-sectional design. All clinical parameters (width of buccal and lingual keratinized tissue, probing depth, bleeding on probing, plaque, crestal bone loss, gingival index, suppuration) will be collected in mandibular implants in fully edentulous lower arches. The width of lingual band of keratinized tissue (KT) will be be correlated with diagnosis of peri-implantitis or peri-implant mucositis.

Eligibility criteria: Inclusion Criteria:

* Osseointegrated (non-mobile) and loaded dental implant
* Mandibular implants
* Full-arch implant-supported prostheses
* Removable full-arch prostheses
* Fixed full-arch prostheses

Exclusion Criteria:

* Implants loaded less than 12 months before examination
* Mobile (non integrated) implants
* Partially edentulous patients

Primary outcomes:
measure: Diagnosis of peri-implantitis (composite outcome made of different outcomes): yes or no (dichotomous)
timeFrame: Day 1
Secondary outcomes:
measure: Mucosal recession
timeFrame: Day 1
measure: Bleeding on probing (BOP)
timeFrame: Day 1
measure: Probing pocket depth (PPD)
timeFrame: Day 1
measure: Self-assessed Brushing discomfort
timeFrame: Day 1
measure: Crestal bone loss (mm)
timeFrame: Day 1
measure: Suppuration on probing
timeFrame: Day 1
measure: Diagnosis of mucositis
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06086717: Comparison of Kinesio Taping and Dry Needling in Grade 1, 2 Knee Osteoarthritis
Official title: Comparison of Kinesio Taping and Dry Needling in the Management of Grade 1, 2 Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Dry Needling
Joint Flexibility
Kinesio Tape
Knee Osteoarthritis
Pain
Quality of Life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Concurrent Parallel Randomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: This study's aim was:

- To determine the effects of kinesio taping and dry needling on pain, ROMs, functional mobility, and quality of life in knee OA patients.

Detailed description: This was a randomized clinical trial in which Grade 1, 2 Knee Osteoarthritis patients were randomized into two groups: Group-A and Group-B. Group-A participants received Kinesio taping while Group-B participants received dry needling as an adjunct to the conventional physical therapy treatment. The intervention was carried out for four weeks with frequency of two sessions per week. Outcome measures were assessed at baseline, after two weeks, and after 4 weeks, using Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Range of Motion (ROM), and SF-12 Quality of Life Questionnaire.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed patients of grade 1, 2 knee OA (Kallgren and Lawrence).
* Pain and/or tenderness around knee joint
* Knee OA patients with tightness in Quadriceps, Hamstrings, and Iliotibial band.
* Patients with pain of \>4 on VAS.

Exclusion Criteria:

* Patients who had received Intra-articular Steroid injections in knee joints.
* Patients who had suffered a traumatic injury to knee joint within past 6 months prior to this study.
* Patients with any surgical intervention to the knee joints.
* Patients with peripheral vascular disease.
* Patients with diagnosed tumors, malignancies, infection associated with knee joint.
* Patients with lower limb metallic implants.

Primary outcomes:
measure: Pain Score
timeFrame: Baseline, after 2 weeks, and after 4 weeks.
measure: Knee ROM
timeFrame: Baseline, after 2 weeks, and after 4 weeks.
Secondary outcomes:
measure: WOMAC Score
timeFrame: Baseline, after 2 weeks, and after 4 weeks.
measure: Quality of Life Score
timeFrame: Baseline, after 2 weeks, and after 4 weeks.
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University (RIU)
state: Islamabad Capital Territory
Study officials:
affiliation: Riphah International University, Islamabad.
name: Noman Sadiq, MS-SPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02814617: The Efficacy and Safety of Cordyceps Sinensis Mycelium Culture Extract(Paecilomyces Hepiali, CBG-CS-2) on Promotion of Immunity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Immunity
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators performed randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract (Paecilomyces hepiali, CBG-CS-2) on promotion of immunity. The investigators measured promotion of immunity parameters , including Cytotoxicity, Cytokine (IL-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ, TNF-α).


Eligibility criteria: Inclusion Criteria:

* Males and females 20-75 years old
* Able to give informed consent

Exclusion Criteria:

* WBC concentration below 3000 ㎕, over 8000㎕
* Subjects with BMI \< 18.5 kg/m2 at screening visit
* Allergic or hypersensitive to any of the ingredients in the test products
* Diagnosed of gastrointestinal disease such as Immune-related diseases, severe hepatic, renal failure, and diabetes
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.

Primary outcomes:
measure: Changes in serum natural killer cell activity
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Changes in Cytokine(IL-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ, TNF-α)
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
citation: Jung SJ, Jung ES, Choi EK, Sin HS, Ha KC, Chae SW. Immunomodulatory effects of a mycelium extract of Cordyceps (Paecilomyces hepiali; CBG-CS-2): a randomized and double-blind clinical trial. BMC Complement Altern Med. 2019 Mar 29;19(1):77. doi: 10.1186/s12906-019-2483-y.
Clinical trial NCT00754117: Early Response Assessment in Diffuse Large B-Cell Lymphoma (DLCL) Patients by 18-fluoro-2-deoxyglycose Positron Emission Tomography (FDG-PET)
Official title: Early Response Assessment in Patients With Diffuse Large B-cell Lymphoma Using 18-fluoro-2-deoxyglycose Positron Emission Tomography (FDG-PET)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B-cell Lymphoma
Keywords: diffuse large b cell lymphoma
newly diagnosed
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2008-09-17
Enrollment: 8
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: Newly diagnosed diffuse large b cell lymphoma patients planning to receive 6-8 cycles of R/CHOP chemotherapy.

Brief summary: Newly diagnosed DLCL patients will have baselne FDG-PET as part of initial staging (PET-1). Patients will then undergo 2 cycles of chemotherapy with R/CHOP. 14 to 21 days following cycle 2 of R/CHOP, patients will undergo repeat FDG-PET scan (PET-2). They will then complete therapy as planned. Following completion of therapy, standard response assessment will be performed, including CT scans of the chest, abdomen and pelvis and FDG-PET scan (PET-3).


Eligibility criteria: Inclusion Criteria:

* Patients must have histologically or cytologically confirmed diagnosis of CD20+ diffuse large B cell lymphoma (LBCL) of any stage, including subtypes mediastinal large B cell, centroblastic, immunoblastic, T cell rich B cell and anaplastic B cell lymphoma
* Patients must have received no prior anti-lymphoma therapy.
* Age \>18 years.
* Patients must have a treatment plan to include R/CHOP or R/CHOP followed by radiotherapy.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who have known HIV infection.
* Patients who are, in the opinion of their treating oncologist, unable to undergo R/CHOP chemotherapy.

Primary outcomes:
measure: evaluating the predictive value of a positive PET scan early in the course of standard chemotherapy
timeFrame: after 2 cycles of chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Rebecca Elstrom, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01038817: Impact of Fluoride Vanish Application in Dental Prevention for Elderly
Official title: Evaluation of the Impact of Fluoride Vanish Application in Dental Prevention Among Institutionalised Elderly People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tooth Decay
Keywords: tooth-decay
prevention
fluoride-varnish
institutionalised elderly people
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-12-24
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study questions the interest of fluoride varnish dental application in preventing tooth decay in a population of institutionalised elderly people.

Detailed description: Application of fluoride varnish on one side of the mandibles (left or right, randomly selected) in a population of institutionalised elderly people.

Eligibility criteria: Inclusion Criteria:

* patient hospitalised in nursing home or long-stay hospital department
* patient older than 18 years old
* obtention of informed consent
* 3 or more healthy or treated teeth on each side (left and right) of the mandibles

Exclusion Criteria:

* patient in palliative care or end-of-life care
* patient without social security affiliation
* patient participating in another research dealing with dental care
* contra-indication to fluoride varnish

Primary outcomes:
measure: incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Colombes
country: France
facility: APHP, Louis Mourier Hospital
Study officials:
affiliation: Assistance Public Hôpitaux de Paris
name: Philippe Charru
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Public Hôpitaux de Paris
name: Marysette Folliguet
role: STUDY_CHAIR
References: