louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01844063: Safety and Efficacy of Diverse Mesenchymal Stem Cells Transplantation for Liver Failure
Official title: Clinical Comparison of Safety and Efficacy of Allogeneic Umbilical-Cord and Bone Marrow-derived Mesenchymal Stem Cells Transplantation for HBV-related Liver Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Liver Failure
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-05-01
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: HBV-related liver failure (HBV-LF), a dramatic clinical syndrome, is characterized with massive necrosis of liver cells. Liver transplantation might be the most effective therapy for HBV-LF. However, there are a lot of problems such as lack of donors, surgical complications, transplant rejection, and high cost, which could limit the application of liver transplantation. It is demonstrated that mesenchymal stem cells could directionally differentiate into hepatocytes and cholangiocytes in injured liver, as well as reduce inflammation of the liver by immune regulation. In this study, we assess the safety and efficacy of human bone marrow and umbilical cord mesenchymal stem cells transplantation for patients with HBV-LF.


Eligibility criteria: Inclusion Criteria:

* Aged 18-65 years
* Liver failure
* Negative pregnancy test (female patients in fertile age)
* Written consent
* HBsAg positive
* TB≥171 μmol/L or ascend ≥17.1 μmol/L/per day,
* INR≥1.5 or 20%\<PTA≤40%
* 17≤MELD score≤30

Exclusion Criteria:

* Hepatocellular carcinoma or other malignancies
* Severe problems in other vital organs(e.g.the heart,renal or lungs)
* Pregnant or lactating women
* Severe bacteria infection
* Anticipated with difficulty of follow-up observation
* Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on
* Other candidates who are judged to be not applicable to this study by doctors

Primary outcomes:
measure: survival rate
timeFrame: 72 weeks
Secondary outcomes:
measure: Liver function
timeFrame: 72 weeks after treatment
measure: Marker of liver cancer
timeFrame: 72 weeks after treatment
measure: The degree of hepatic necrosis
timeFrame: 2 years after treatment
measure: The improvement of symptoms
timeFrame: 72 weeks after treatment
measure: The score for Model for End-Stage Liver Disease
timeFrame: 72 weeks after treatment
measure: The improvement of immune function
timeFrame: 72 weeks after treatment
measure: complications
timeFrame: Between 0 to 8 hours after MSC transfusion
measure: The incidence of hepatocellular carcinoma
timeFrame: 72 weeks after treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Qi Zhang
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Qi Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02358863: Molecularly Tailored Therapy for Patients With Metastatic Cancer of the Esophagus and Stomach
Official title: A Pilot Study of Molecular Profile-Directed Chemotherapy for Metastatic HER2(-) Esophagogastric Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Cancer
Gastric Cancer
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 13
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: The purpose of this study is to determine whether molecular profile-directed therapy (otherwise known as personalized treatment) can improve the effectiveness of standard chemotherapy combinations for patients with esophagogastric adenocarcinoma. A series of tests will be performed on a sample of tumor; based on the results of these tests, a patient will be assigned to a chemotherapy treatment.


Eligibility criteria: Inclusion Criteria:

* Advanced, measurable metastatic esophagogastric adenocarcinoma by RECIST criteria
* Patients who have had surgery or radiotherapy with or without neoadjuvant or adjuvant chemotherapy (the wash-out period will be at least 1 month)
* Patients who are not eligible for resection and are chemotherapy naïve
* Patients with HER2(-) status
* Patients who have tumor deposit(s) that are easily accessible by ultrasound or CT guidance
* Patients must have adequate organ function
* Patients must provide written informed consent

Exclusion Criteria:

* Active concurrent malignancy, other than superficial, non-squamous cell carcinoma of the skin or uterine cervix, within the past three years
* ECOG performance status worse than 2
* Prior oral or intravenous chemotherapy for metastatic disease
* Patients with comorbidities that prevent them from being able to receive the chemotherapy regimen
* cardiac ejection fraction 45% or greater

Primary outcomes:
measure: The Number of Patients With Tumor Size Reduction (Objective Response Rate)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: John Marshall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03172663: Body Mass Index and Audiology Function
Official title: Effect of Increased Body Mass Index on Auditory Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss
Keywords: obesity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Obesity may directly or indirectly lead to hearing loss

Detailed description: Obesity is measured by Body Mass Index.it is calculated by dividing a person's weight in kilograms by the square of height in meters. For children and adolescent. Overweight is defined as Body Mass Index is \<85th percentile \<95th percentile but obesity is defined as body mass index at or above the 95th percentile for children and teens of the same age and sex the increasing in body mass index mass may affect auditory function Directly as adipose tissue secretes hormones and cytokines, proinflammatory cytokines lead to release of obesity-induced inflammation which may directly contribute to end-organ damage Also, Adiponectin, which is thought to have anti-inflammatory and antiatherogenic effects, and associated with favorable lipoprotein profile, independent of BMI and insulin resistance, low plasma concentrations of adiponectin have been associated with obesity in children. In adults, low level of adiponectin has been associated with elevated high-frequency thresholds.

Indirectly, by obesity comorbidities including Hypertension, Type 2 diabetes mellitus, Dyslipidemia , Metabolic Syndrome and Cardiovascular Diseases

Eligibility criteria: Inclusion Criteria:

It will include 50 subjects whose:

* Age ranges from 10 to 40 years old.
* Body Mass Index more than the 85th percentile.
* male and female will be included

Exclusion Criteria:

* External or middle ear disease that causes conductive hearing loss such as otitis media, otomycosis, perforated drum, tumors, dislocation of the ossicles.
* High environmental noise exposure which causes acoustic trauma such as exploration, fire shots and noise in industries.
* ototoxic drug intake such as Aspirin, Aminoglycosides, Erythromycin, Vancomycin Streptomycin, Kanamycin, Neomycin, Gentamycin, Tobramycin, Lasix, Cisplatin, Nitrogen Mustard, and Vincristine, and Quinine.
* Major neurological or psychiatric diseases brain tumor, vestibular Schwannoma, stroke, acoustic neuroma, encephalitis, meningitis, and depression.

Primary outcomes:
measure: body mass index
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity and trends in body mass index among US children and adolescents, 1999-2010. JAMA. 2012 Feb 1;307(5):483-90. doi: 10.1001/jama.2012.40. Epub 2012 Jan 17.
Clinical trial NCT05565963: Effectiveness of VR Exercise Intervention on Functional Fitness and Quality of Life Among Elderly
Official title: Effectiveness of VR Exercise Intervention on Functional Fitness and Quality of Life Among Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Promotion
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 98
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of virtual reality-based exercise on the intervention and follow-up retention of functional fitness and quality of life among older adults.

Detailed description: In a worldwide survey of fitness trends last 2021, Virtual Reality (VR) training recently took the top 10 spots. In fact, only a few studies were conducted on the retention of functional fitness and quality of life among older people. The main goal of this study was to assess the effects of virtual reality exercise on the functional fitness and quality of life of older adults after 12 weeks of intervention and another 12 weeks of follow-up.

Eligibility criteria: Inclusion Criteria:

1. aged ≥ 65,
2. are able to perform daily activities,
3. with no past or current history of medical situations found in the Physical Activity Readiness Questionnaire (PAR-Q).

Exclusion Criteria:

1. being less than 65 years of age,
2. being unfit to participate in the study as revealed by the PAR-Q.

Primary outcomes:
measure: Senior Fitness Test to specify that "a period change" is being assessed.
timeFrame: The time points for assessment were week 1 (pre-test), 13 (post-test), and 24 (follow-up).
measure: Quality of Life Test to specify that "a period change" is being assessed.
timeFrame: Measured at week 1 (pre-test), 13 (post-test), and 24 (follow-up).
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: Measured at week 1(pre-test).
measure: International Physical Activity Questionnaire (IPAQ-LV).
timeFrame: Measured at week 1(pre-test).
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTNU
Study officials:
affiliation: Research Ethics Committee, National Taiwan University, Taiwan
name: Szu-Hsien Lee
role: STUDY_DIRECTOR
References:
Clinical trial NCT03010163: Taxi STEP (Social Networks, Technology, and Exercise Through Pedometers)
Official title: Taxi STEP (Social Networks, Technology, and Exercise Through Pedometers)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Physical Conditioning
Keywords: pedometer
walking
taxi driver
16-1659
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 290
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study is divided into four groups. Group 1 includes Health Fairs implemented at NYC taxi garage bases and airport taxi holding lots and pedometers. Group 2 includes Health Fairs, pedometers and text messaging to facilitate walking and living a healthier lifestyle. Group 3 includes Health Fairs, pedometers and social network support. Group 4 includes Health Fairs, pedometers, text messaging and social network support.


Eligibility criteria: Inclusion Criteria:

* Male
* Over 21 years of age
* Planning on remaining in NYC for at least 7 months
* Licensed taxi driver for at least three months
* Speaks English, Bengali, Hindi, Spanish or French
* Currently owns a cell phone, uses text messaging services and is willing to accept text messages for this study

Exclusion Criteria:

* Part-time driver (fewer than 5 shifts/week, totaling less than 35 hours per week)
* History of any CVD or any other medical conditions (e.g. severe osteoarthritis) that will prevent him from walking

  * Please note: All inclusion/exclusion criteria are based upon self reported information captured during study screening procedures.

Primary outcomes:
measure: Increase average daily step counts
timeFrame: 6 months post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Francesca Gany, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00420563: Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer
Official title: A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Keywords: Cancer, palliative treatment
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2007-01-11
Enrollment: 88
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: The scope of the trial is to assess the free progression rate at 2 months for each group of patients.


Eligibility criteria: Inclusion Criteria:

* Age \> or = 18
* PS-WHO \< or = 1
* Histologically proven cancer
* No other therapeutic proposal
* Treatment can be orally taken
* Radiologic proof of evolutive character of the disease
* Effective contraception

Exclusion Criteria:

* Hypercalcemia ( Ca \> 2.65 mmol/l)
* Breast cancer
* Thrombosis or pulmonary embolism
* Dysphagia, malabsorption
* Polynuclear neutrophil leukocytes \< 1000/mm3
* Treatment with Tegretol
* Active and uncontrolled infection
* Evolutive psychiatric disease
* Pregnant or lactating woman

Primary outcomes:
measure: Progression free survival rate at 2 months
timeFrame: 2 months
Secondary outcomes:
measure: Progression free survival rate and objective response (RECIST) at 2, 4 and 6 months
timeFrame: After 2, 4 and 6 months of treatment
measure: Toxicity according to NCI scale v3.0
timeFrame: During study treatment
measure: Biological markers
timeFrame: the 2 first months of treatment
measure: Overall survival
timeFrame: Until death of the patient or until study analysis
measure: Median time between the beginning of treatment and hospitalization due to progression or toxicity
timeFrame: time of the study
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: Hopital Saint Vincent
city: Lille
country: France
facility: Centre Hospitalier Regional - Dermatology
city: Lille
country: France
facility: Centre Hospitalier Regional - Oncology
Study officials:
affiliation: Centre Oscar Lambret
name: PENEL Nicolas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01307163: Systemic Variables in the Saliva of Children Undergoing Liver Transplantation
Official title: Systemic Variables in the Saliva of Children Undergoing Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplant
Keywords: saliva
liver transplantation
children
In this prospective study 60 subjects will be examined
children and adolescents
after a successful liver transplantation
informed consent forms signed be the examinees parents
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this prospective study 60 subjects will be examined. Children and adolescents from Schnaidder's hospital for children after a successful liver transplantation will be characterized as the study group. As a control group, 32 healthy examinees in the same age group will be selected from the dental pediatric department at Hadassah hospital, Ein karem, Jerusalem

Brief summary: Saliva is used nowadays as a significant diagnostic tool due to the latest technological developments. The research compares two experimental groups; children after liver transplantation and a control group.

Our objective is to identify from all the parameters that are evaluated, the ones that differ between the two groups. If such parameters will be found and differ statistically, it will be possible to create a non invasive medical examination protocol, which will probably be much more complaint, and being so would help locate individuals in risk groups with the tendency to develop an end-organ liver disease.


Eligibility criteria: Inclusion Criteria:

* Children after a successful liver transplantation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization IRB
Study officials:
References:
Clinical trial NCT00947063: To Demonstrate the Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions
Official title: A Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergy
Keywords: Antihistamine
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability study of Promethazine HCl 50 mg tablets under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 12 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cetero Research, San Antonio
name: Irwin Plisco, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01655563: Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation
Official title: A Pharmacogenetic Trial of Tacrolimus Dosing After Pediatric Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Transplantation
Liver Transplantation
Kidney Transplantation
Keywords: Transplant
Pediatrics
Tacrolimus
Prograf
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2012-08-02
Enrollment: 75
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tacrolimus is a standard and widely used maintenance immunosuppressive agent after solid organ transplantation.The purpose of this trial is to determine if dosing of tacrolimus through genetics will help in early attainment and maintenance of the correct dosage level in the early post-transplant period. This pilot dose-finding trial will help to determine a dosing strategy guided by genotypes and age for solid organ transplant recipients that will be further validated through a multi-centre trial as an immediate next step. The study hypothesizes that dosage levels determined through age and genotype will be attained faster and more accurately than the standard dosing procedures in the 14-days after the transplant. Further, this study hypothesizes that a genotype and age dosing strategy will cause a faster recovery (tested through the kidneys' ability to clear creatine from the blood) and result in lower frequencies of adverse effects and rejection of the transplant.


Eligibility criteria: Inclusion Criteria:

* Age \< 18 years old
* Assessed and/or listed for heart, kidney, liver transplantation
* Planned oral or enteral maintenance immunosuppression with tacrolimus post transplant
* Informed consent of legal guardian

Exclusion Criteria:

* Contra-indications to oral or enteral tacrolimus
* Co-morbidities that preclude standard dosing e.g. significant renal or hepatic insufficiency
* Participation in other investigational drug trials within 30 days of study initiation

Primary outcomes:
measure: Time to Achieve Therapeutic Tacrolimus Drug Concentrations
timeFrame: From Baseline to 30 days post-dose
measure: Time to Maintain Stable Therapeutic Trough Concentrations
timeFrame: From Baseline to 30 days post-dose
Secondary outcomes:
measure: Clinical Adverse Events
timeFrame: Over 30 days, +/- 3 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Seema Mital, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Min S, Papaz T, Lafreniere-Roula M, Nalli N, Grasemann H, Schwartz SM, Kamath BM, Ng V, Parekh RS, Manlhiot C, Mital S. A randomized clinical trial of age and genotype-guided tacrolimus dosing after pediatric solid organ transplantation. Pediatr Transplant. 2018 Nov;22(7):e13285. doi: 10.1111/petr.13285. Epub 2018 Sep 3.