louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01691664: Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer
Official title: Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Keywords: Esophageal Cancer
DC-CIK
immunotherapy
cellular therapy
radiation therapy
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2012-09-25
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: Cytokine-induced killer (CIK) cells show cytolytic activity against tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining Radiation therapy with adoptive cellular therapy after surgery may be more effective than uses radiation therapy alone in treating esophageal cancer.


Eligibility criteria: Inclusion Criteria:

* cytologically or histologically confirmed esophageal carcinoma
* Tumor extension beyond muscularis propria and/or nodal involvement without evidence of M1 disease
* Prior en bloc resection, with curative intent, of all known tumor
* No metastatic disease
* Age: \> 18
* Karnofsky performance status ≥ 70
* At least 3 weeks since prior surgery
* Normal functions of heart, lung, liver, kidney and bone marrow
* Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
* All patients must be evaluated by a radiation oncologist prior to enrollment to ensure patient is appropriate for radiotherapy
* Informed consent signed

Exclusion Criteria:

* Patients with metastatic disease.
* Patients who are pregnant or nursing.
* Patients with poor bone marrow, liver and kidney functions, which would make radiation therapy intolerable
* Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis

Primary outcomes:
measure: Disease free survival
timeFrame: 4 years
Secondary outcomes:
measure: quality of life
timeFrame: Initial assessment → months 1,3,6 and 12
Other outcomes:
measure: Immunological assessment
timeFrame: Initial assessment, months 1,3,6and 12
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital
state: Beijing
Study officials:
affiliation: Capital Medical University Cancer Center
name: Jun Ren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04328064: The Role of Rosuvastatin on Vascular Involvement in Behçet's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behcet's Disease
Keywords: Behcet's Disease
Rosuvastatin
Vascular Markers
Improvement in vascular involvement in Behcet's Disease
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 56
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Behçet's Disease(BD) is a systemic inflammatory vasculitis, which affects all types and sizes of vessels. Statins display numerous effects often independent of the well-established lipid-lowering effects that may be of benefit in retarding or preventing vascular injury and ischaemic vascular events. The aim of the present study was to determine the efficacy of rosuvastatin in improving vascular dysfunction and vascular inflammation and to assess the effect of rosuvastatin on vascular involvement in BD patients. Fifty-six BD patients (51 males and 5 females) mean age 33.4 years, mean disease duration 5.8 years), all fulfilling the classification criteria of the International Study Group for Behçet's disease were recruited.Patients were randomised into 2 groups.

The first group (n=27: 20 active and 7 inactive) were assigned to receive 40 mg of rosuvastatin and the second group(n=29: 21 active and 8 inactive) received placebo for 12 months. Inflammatory and endothelial dysregulation markers were measured at baseline and after 12 months. All patients were examined for vascular involvement. Venous or arterial system involvement was defined as present when confirmed by Doppler ultrasonography, magnetic resonance angiography, conventional angiography or CT.


Eligibility criteria: Inclusion Criteria:

* all patients fulfilling the classification criteria of the International Study Group for Behçet's disease

Exclusion Criteria:

* smoking,
* diabetes mellitus,
* hypercholesterolaemia,
* hypertension,
* cardiac insufficiency,
* coexisting hepatic and renal diseases
* inflammatory diseases.

Primary outcomes:
measure: Changes in endothelial and vascular inflammatory markers
timeFrame: 12 months
Secondary outcomes:
measure: Occurrence of new-onset vascular involvement
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02054364: Feasibility of Combining Family and Cognitive Therapy to Prevent Chronic Anorexia
Official title: Feasibility of Combining Family and Cognitive Therapy to Prevent Chronic Anorexia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Eating Disorder
Anorexia Nervosa
Eating Disorder Not Otherwise Specified
Maudsley
Family-Based Therapy
FBT
Family Therapy
Cognitive Remediation Therapy
CRT
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2014-02-04
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the feasibility of combining Cognitive Remediation Therapy (CRT) with Family Based Treatment (FBT) for future use in a randomized clinical trial to reduce the risk of adolescents developing persistent Anorexia Nervosa. Participants will be randomly assigned to one of two groups: one group will receive FBT and CRT, and the other group will receive FBT and art therapy.


Eligibility criteria: Inclusion Criteria:

* Meets DSM-IV criteria for anorexia nervosa Lives with at least one English-speaking parent who is willing to participate Medically Stable Endorses obsessions/compulsions Adequate transportation to clinic Proficient at speaking, reading, and writing English

Exclusion Criteria:

* Previous FBT or CRT for AN Medical Instability Medical condition that may affect eating or weight

Primary outcomes:
measure: Full remission from AN (%MBW>95)
timeFrame: End of Treatment (6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: James Lock, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01457664: A Study of RO4995819 in Healthy Elderly Volunteers
Official title: A Randomized, Double-Blind, Multiple Dose, Placebo-Controlled, Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of RO4995819 Following Oral Administration in Healthy Elderly Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, tolerability and pharmacokinetics of RO4995819 in healthy elderly volunteers. Volunteers will be randomized to receive once daily doses of RO4995819 or matching placebo. The anticipated time on study treatment is 14 days.


Eligibility criteria: Inclusion Criteria:

* Adult healthy volunteer, 65-85 years of age
* Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive and a total body weight \>50 kg (110 lbs)
* Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria:

* Any history or suspicion of drug or alcohol abuse
* Clinically significant or unstable cardiovascular or bronchopulmonary diseases, or any type of cancer
* History of liver disease
* Significant past or present neurological disorder
* History of psychiatric disorders
* Participation in an investigational drug or device study within 12 weeks prior to screening
* Donation of blood over 500 mL within three months prior to screening

Primary outcomes:
measure: Safety (incidence of adverse events)
timeFrame: 8 weeks
Secondary outcomes:
measure: Pharmacokinetics: area under the concentration time curve (AUC)
timeFrame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 22, 20, 36, 62
Other outcomes:
Locations:
city: Miramar
country: United States
state: Florida
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01728064: Safety and Efficacy of EPI-743 in Patients With Friedreich's Ataxia
Official title: Safety and Efficacy Study of EPI-743 on Visual Function in Patients With Friedreich's Ataxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Friedreich's Ataxia
Keywords: Friedreich's
Ataxia
FRDA
FA
EPI-743
Edison
Lead sponsor: PTC Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-11-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of EPI-743 on visual function and neurologic function in patients with Friedreich's ataxia.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of genetically confirmed Friedreich's ataxia
2. Visual acuity at baseline more than 15 letters on EDTRS at four meters
3. FARS score of 20 to 90
4. Agreement to use contraception if within reproductive years (see specifics in section D1, page 21)
5. Hormone replacement therapy, if used, must remain stable for the duration of the study
6. Willingness and ability to comply with study procedures
7. Willingness and ability to arrive at study site day prior to evaluations
8. Abstention from use of dietary supplements and non-prescribed medications at least 30 days prior to initiation of treatment and for the duration of the study. This would specifically include idebenone, Coenzyme Q10 and vitamin E
9. Abstention from use of other investigative or non-approved drugs within 30 days of enrollment and for the duration of the study

Exclusion Criteria:

1. Allergy to EPI-743 or sesame oil or nuts
2. Clinically significant bleeding condition or abnormal PT/PTT INR (INR \> two; PTT \> two-times normal)
3. Liver insufficiency with LFTs greater than three-times upper normal limit at screening
4. Renal insufficiency with creatinine \> 1.5 at screening
5. Fat malabsorption syndromes
6. Any other respiratory chain diseases of the mitochondria or inborn errors of metabolism
7. Any other ophthalmologic conditions
8. History of alcohol or drug abuse
9. Clinically significant cardiomyopathy with ejection fraction \< 40 percent at screening
10. Clinically significant arrhythmia within past two years requiring treatment
11. Anticoagulant therapy within 30 days of enrollment.

Primary outcomes:
measure: Visual Function
Secondary outcomes:
measure: Color vision
measure: Neurologic function
measure: Neuromuscular function
measure: Neuromuscular function
measure: Quality of life
measure: Disease biomarkers
measure: Cardiac function
measure: Safety
measure: Disease improvement
measure: Visual Function
timeFrame: Baseline, Months 3, 6, 9 and 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Philadelphia
country: United States
facility: Childrens Hospital of Philadelphia
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05719064: Adaptive Cell Phone Support to Promote Medication Adherence
Official title: Adaptive Cell Phone Support to Promote Medication Adherence Among Adolescents and Young Adults with Chronic Health Conditions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medication Adherence
Keywords: Adolescents
Mobile health
chronic illness
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this pilot clinical trial is to refine and test a mobile health intervention for promoting medication adherence in a population of adolescents and young adults with chronic health conditions. The main question\[s\] it aims to answer are:

* How should the intervention be designed to best fit patients' needs and preferences?
* Is an adaptive intervention (personalizing the intensity of support based on patients' needs) efficacious for promoting medication adherence Researchers will compare the adaptive intervention to automated text message reminders see if the adaptive intervention shows stronger positive effects on medication adherence.

Detailed description: An initial cohort of adolescents with chronic health conditions will be asked to try the intervention and give feedback to refine the structure and content. Then, a larger cohort will progress through a sequential multiple assignment randomized trial to 1) be randomized to either automated text reminders (active control condition) or computer-delivered Cell Phone Support and then 2) those in the computer-delivered Cell Phone Support condition who do not show a sufficient response will be re-assigned to continued computer-delivered Cell Phone Support only or to Adaptive Cell Phone Support ( computer-delivered Cell Phone Support + responsive human coaching).

Eligibility criteria: Inclusion Criteria:

* Children's Hospital Los Angeles patient
* between 15-20 years old
* taking at least one oral medication per day for a chronic health condition
* English speaking
* demonstrating sufficient cognitive capacity to engage in the assent/consent process and study procedures
* has a cell phone

There is no exclusion criteria.

Primary outcomes:
measure: Mean scores on the Mobile Health App Usability Questionnaire
timeFrame: 12 weeks
measure: Total scores on the theoretical framework of acceptability questionnaire
timeFrame: 12 weeks
measure: Total scores on the Visual Analogue Scale
timeFrame: 12 weeks
measure: Total scores on Rollnick's Readiness Ruler
timeFrame: 12 weeks
measure: Total Transition Readiness scores on the Successful Transition to Adulthood with Therapeutic = Rx Questionnaire
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Caitlin Sayegh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05262764: Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF)
Official title: Post Marketing Surveillance on Long Term Drug Use of JARDIANCE® Tablets in Patients With Chronic Heart Failure in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2022-03-02
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japanese patients with chronic heart failure (CHF).

Brief summary: Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic heart failure (CHF) under real-world use.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic heart failure (CHF) failure who are prescribed with JARDIANCE® Tablets in Japan
* Patients who have never been treated with Empagliflozin (including treatment for type 2 diabetes mellitus (T2DM)) before enrolment

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of Adverse Drug Reactions (ADRs)
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Incidence of all-cause death
timeFrame: Up to 52 weeks
measure: Incidence of cardiovascular (CV) death
timeFrame: Up to 52 weeks
measure: Incidence of hospitalizations for heart failure
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Nippon Boehringer Ingelheim Co., Ltd.
Study officials:
References:
Clinical trial NCT03974464: Copeptin and the S-100b Protein in Stroke
Official title: Value of Copeptin and the S-100b Protein Assay in Ruling Out the Diagnosis of Stroke-induced Dizziness Pattern in Emergency Departments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertigo, Peripheral
Vertigo, Brain Stem
Vertigo; Central
Vertigo; Cerebral
Keywords: vertigo
stroke
copeptin
S-100b protein
biomarkers
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred and fifty-one patients were included, of whom 16 were secondarily excluded (lost to follow-up n=1, missing biomarkers n=9, missing MRI n=6)(Figure 1). A majority of the remaining 135 patients were women (n=79, 59%) with an average age of 62 years . Specialized advice on the origin of dizziness was sought from ENT and/or neurologist in 102 (76%) of cases. Patients received brain diffusion-weighted MRI alone in 74 cases, contrast brain CT alone in 11 cases and a combination of MRI and CT in 50 cases. In 122 patients (90%), vertigo was not related to stroke.

Brief summary: This study evaluated the value of using copetin and protein S 100 b to eliminate the diagnosis of stroke in patients presenting with vertigo in emergency departments. All patients benefited from the S 100b protein assay, copeptin and brain MRI.

Detailed description: Vertigo is a frequent reason for visiting emergency departments. Differentiating stroke from other causes is challenging for physicians. The role of biomarkers has been poorly assessed. Evaluators evaluated whether copeptin and S100b protein assessment, alone or in combination, could rule out stroke in patients visiting emergency departments for vertigo.

Evaluators included patients visiting the adult emergency departments of a French university hospital for a new episode of vertigo evolving for less than 72 hours. All patients underwent standardized physical examination (HINT \[Head Impulse test, Nystagmus, test of skew deviation\] maneuvers), copeptin and S-100b protein measurement and injected brain imaging. Stroke diagnosis involved diffusion-weighted magnetic resonance imaging or, if not available, neurological examination and contrast brain CT scan compatible with the diagnosis.

Eligibility criteria: Inclusion Criteria:

* We included patients 18 years of age or older, visiting the ED for a new episode of dizziness evolving less than 72 hours and having given written consent to participate in the study

Exclusion Criteria:

* Patients without brain imaging (diffusion-weighted magnetic resonance imaging (MRI) or contrast CT scan compatible with the diagnosis) were excluded.

Primary outcomes:
measure: Show that the negativity of S-100b protein and copeptin eliminates stroke in the face of vertigo
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01257464: Sitagliptin in Cystic Fibrosis-Related Diabetes
Official title: The Effects of the DPPIV Inhibitor Sitagliptin in Cystic Fibrosis-related Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cystic Fibrosis
Keywords: CFRD
sitagliptin
cystic fibrosis-related diabetes
incretins
hyperglycemia
GIP
GLP-1
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2010-12-09
Enrollment: 3
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the dipeptidyl peptidase IV (DPPIV) inhibitor sitagliptin is effective in the treatment of cystic fibrosis-related diabetes (CFRD). We hypothesize that sitagliptin will improve meal-stimulated insulin secretion.

Detailed description: To date, no clinical trials have been conducted using the DPPIV inhibitor sitagliptin in cystic fibrosis-related diabetes. Cystic fibrosis-related diabetes is characterized initially by post-prandial hyperglycemia, with normal fasting sugars. As the disease progresses, fasting hyperglycemia develops. As sitagliptin augments post-prandial insulin release, while avoiding fasting hypoglycemia, it may be an alternative therapy for cystic fibrosis-related diabetes in individuals who do not yet require basal insulin therapy.

Eligibility criteria: Inclusion Criteria:

* 19 years of age or older
* Cystic fibrosis-related diabetes with or without fasting hyperglycemia either untreated or using only pre-prandial repaglinide or pre-prandial bolus insulin therapy

Exclusion Criteria:

* Age under 19 years
* Use of basal insulin therapy
* Creatinine Clearance \< 50 mL/min
* Active cystic fibrosis exacerbation
* Pregnancy
* Women of child-bearing age not using effective contraception
* Current or prior use of DPPIV inhibitor

Primary outcomes:
measure: Insulin release
timeFrame: 180 minutes (during clamp)
Secondary outcomes:
measure: Incretin Response
timeFrame: 180 minutes (during clamp)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia Gerontology & Diabetes Reserach Centre (ViTALITY)
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Graydon Meneilly, MD
role: PRINCIPAL_INVESTIGATOR
References: