louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00219427: Retina Projection System Trials for Low Vision People
Official title: Multicenter Clinical Trials of Retina Projection System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vision, Low
Keywords: Low vision
Lead sponsor: Osaka City University
Sponsor class: OTHER
Collaborators: name: Nihon University
name: Kurume University
name: Miyata Eye Hospital
name: Fukuoka Kinen Hospital
name: Kimura Eye and Internal Medicine Hospital
First posted: 2005-09-22
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: 1. Purpose

   a. Examination on Efficacy of Retina Projection System
2. Patients

   a. Low vision patients
3. Methods

   1. Vision aids

      * Retina Projection System
      * Face-mounted video display as control
   2. Comparison of Reading Speeds with both vision aids

Detailed description: 1. Purpose

   a. Examination on efficacy of a new vision aid of Retina Projection System
2. Patients

   1. Low vision patients
   2. Vision between 0.06 and 0.3
   3. no exclusion on kinds of ocular diseases
3. Methods

   1. Vision aids

      * Retina Projection System
      * Face-mounted video display as control
   2. Computer-aided measurement of reading speeds of individual characters
   3. Comparison of reading Speeds with the two vision aids

Eligibility criteria: Inclusion Criteria:

* low vision patients
* vision between 0.06 and 0.3

Exclusion Criteria:

* light perception
* hand motion
* vision less than 0.06

Primary outcomes:
measure: Reading speeds with two different vision aids
timeFrame: Visits for measuring reading speeds
Secondary outcomes:
Other outcomes:
Locations:
city: Kurume
country: Japan
facility: Kurume University
state: Fukuoka
city: Kure
country: Japan
facility: Kimura Eye and Medical Hospital
state: Hiroshima
city: Miyakonojo
country: Japan
facility: Miyata Eye Hospital
state: Miyazaki
city: Fukuoka
country: Japan
facility: Fukuoka Kinen Hospital
city: Osaka
country: Japan
facility: Osaka City University
city: Tokyo
country: Japan
facility: Nihon University Surugadai Hospital
Study officials:
affiliation: Dept. of Ophthalmology and Visual Sciences, Osaka City University, Graduate School of Medicine
name: Kunihiko Shiraki, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01960127: Effects of Aerobic Training on Exercise Capacity in Patients With Advanced Cirrhosis 2
Official title: Effects of Aerobic Training on Exercise Capacity in Patients With Advanced Cirrhosis 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2013-10-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an impact on morbidity and mortality. Regular aerobic exercise training is a proven effective therapy to improve exercise capacity in healthy and clinical populations. The effect of this training has not yet been evaluated in the decompensated cirrhosis patient population. The safety of this intervention also requires further study. Using a randomized controlled design, the investigators aim to determine the safety and efficacy of eight weeks of aerobic exercise training on aerobic capacity, functional performance, and muscle mass in decompensated cirrhosis patients.


Eligibility criteria: Inclusion Criteria:

* Age \>18 and ≤ 70 years
* Cirrhosis
* Child Pugh class B or C
* If required, primary or secondary variceal prophylaxis in place

Exclusion Criteria:

* Post-liver transplantation
* Hepatocelluar carcinoma beyond transplant criteria
* Active non-hepatocelluar carcinoma malignancy
* Significant cardiac disease
* Hemoglobin (\<80 g/L)
* Oxygen saturation at rest \<95%
* Known myopathy
* Chronic renal failure on dialysis
* Physical impairment making it impossible to ride an exercise bike or treadmill
* Orthopedic abnormality preventing exercise training
* HIV infection
* Patient unwilling to consent to study

Primary outcomes:
measure: Change in peak exercise pulmonary oxygen uptake (peak V02)
timeFrame: Baseline (day1) and Study End (8 weeks)
Secondary outcomes:
measure: Change in muscle mass as measured by thigh ultrasound
timeFrame: Baseline (day 1) and Study End (8 weeks)
measure: Change in quality of life-Chronic Liver Disease Questionnaire
timeFrame: Baseline (day1) and Study End (8 weeks)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta, Mazankowski Heart Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Mark Haykowsky, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00561327: PPARgamma Activation by Losartan in Hypertensive Patients: The Importance of Losartan-Metabolites
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Keywords: hypertension
angiotensin receptor blockers
peroxisome proliferator activated receptor gamma
Lead sponsor: German Heart Institute
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: Merck Sharp & Dohme LLC
First posted: 2007-11-20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this study is to determine whether losartan metabolites are effective in inducing PPARγ target genes in monocytes in losartan-treated patients.

Detailed description: The losartan metabolite EXP3179 potently induces the activity of the peroxisome proliferator-activated receptor γ (PPAR-γ) as a partial agonist in vitro. PPAR-γ is a nuclear hormone receptor and functions as a regulator of lipid- and glucose metabolism. PPAR-γ ligands improve insulin sensitivity and glucose tolerance, and reduce cardiovascular morbidity and mortality in diabetic patients.

Angiotensin II receptor 1-blocking and PPAR-γ-activating properties of losartan metabolites in patients would markedly improve the pharmacological profile of losartan by combining anti-hypertensive and highly beneficial metabolic actions. We developed the following hypothesis:

1. Hypertensive patients chronically treated with losartan exhibit sufficient plasma levels of EXP3179 to activate PPARγ.
2. PPARγ target genes are induced in monocytes from losartan-treated patients.

Eligibility criteria: Inclusion Criteria:

* Age: 19-80
* Sex: male or female
* Prior diagnosis of treated hypertension
* Treatment with losartan 100mg/daily during at least the past 2 months (n=20/ case);
* or: no prior angiotensin receptor 1-blocker treatment during the last 2 months (n=10/ control).

Exclusion Criteria:

* Non-steroidal anti-inflammatory drugs (exception: Acetyl salicylic acid) for the past 21 days (due to structural homologies to glitazones, and activating effects on PPARγ)
* Therapy with glitazones for the past 21 days.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: German Heart Institute
Study officials:
affiliation: German Heart Institute
name: Eckart Fleck, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Pharmacology Charite University Medicine Berlin Germany
name: Ulrich Kintscher, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02625727: Effects of Hyaluronic Acid vs. Hyaluronic Acid on Knee Osteoarthritis
Official title: Comparison of Therapeutic Effects of Hyaluronic Acid vs. Hyaluronic Acid Combined Corticosteroid on Knee Osteoarthritis: A Double Blind, Randomized-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Physical Activity
Keywords: knee osteoarthritis
hyaluronic acid
corticosteroid
intra-articular injection
therapeutic effect
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Shin Kong Wu Ho-Su Memorial Hospital
First posted: 2015-12-09
Enrollment: 76
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis.

Detailed description: A total of 76 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid injection group and hyaluronic acid combined corticosteroid injection group.

Physical activity will be evaluated. The hyaluronic acid group will receive three times of hyaluronic acid injection per week in three weeks; the hyaluronic acid combined corticosteroid group will receive hyaluronic acid combined corticosteroid injection in the first week, followed by hyaluronic acid injection at the second and third week.

Re-evaluation will be arranged at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of knee with Kellgren/Lawrence grade II or III

Exclusion Criteria:

* Who have implant in knee
* History of neurological deficit, such as stroke

Primary outcomes:
measure: physical activity
timeFrame: changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection
Secondary outcomes:
measure: functional performance (Western Ontario and McMaster Universities Osteoarthritis index)
timeFrame: changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection
measure: functional performance (Knee injury and Osteoarthritis Outcome Score)
timeFrame: changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: associate professor
name: Ru-Lan Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03550027: Indwelling Pleural Catheter for Trapped Lung
Official title: Indwelling Pleural Catheter for Trapped Lung: a Pilot Study for Power Calculation of a Randomized Controlled Trial Comparing Pleurocath® Versus PleurX®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleura; Effusion
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 20
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: Malignant pleural effusion (MPE) is a complication of almost any site of primary cancer as well as primary tumors of the pleura. Half of MPE patients have non-expendable trapped lungs not suitable for talc pleurodesis. Indwelling pleural catheters (IPCs), however, can be used in this cohort of patients, bringing about an improvement in dyspnea and quality of life (QOL).

The aim of this study is to obtain pilot data - comparing patients receiving two different types of indwelling pleural catethers normally used in clinical practice (10 patients receiving Pleurocath® and 10 patients receiving PleurX®) - for power calculation of a Randomized Controlled Trial comparing two different drainages for MPE trapped lung.


Eligibility criteria: Inclusion Criteria:

* Adult patients, with a clinical confident diagnosis of symptomatic malignant pleural effusion, enrolled for VATS exploration but not amenable of VATS talc poudrage because of trapped lung (patients with only partial expansion however receiving talc poudrage, but needing permanent pleural cathetes, are also eligible)

Exclusion Criteria:

* - Age younger than 18 years
* Expected survival of less than 3 months
* Chylothorax
* Total white blood cell count less than 1000/microL
* Pregnancy or lactating mothers
* Irreversible bleeding diathesis
* Irreversible visual impairment
* Contraindications to general anesthesia
* Poor general clinical conditions ( ECOG PS \>=2)
* Patients unable to provide informed consent

Primary outcomes:
measure: Visual Analog Scale (VAS) range 0 (no pain) - 100 (maximum pain)
timeFrame: Post operative day 4th
measure: Visual Analog Scale (VAS) range 0 (no dyspnea) - 100 (maximim dyspnea)
timeFrame: Post operative day 4th
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Francesco Petrella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06111027: Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia
Official title: Usability of Laryngeal Vibro-tactile Stimulation as a Non-invasive Treatment for the Voice Disorder Spasmodic Dysphonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Spasmodic Dysphonia
Laryngeal Dystonia
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Usability study
Primary purpose: TREATMENT

Brief summary: The general aim of the study is to provide evidence for usability and feasibility of applying vibro-tactile stimulation (VTS) at home as a non-invasive form of neuromodulation to improve speech in people with spasmodic dysphonia (SD). This work addresses a clinical need to develop alternative or auxiliary treatments for a rare voice disorder with very limited treatment options. Successful completion of the proposed work will be an important step in advancing laryngeal VTS as a therapeutic intervention for improving voice symptoms in SD.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of spasmodic dysphonia (laryngeal dystonia) for a minimum of 6 months with documented symptom relief after Botox injection.
* Diagnosis is made by a voice disorder specialist.

Exclusion Criteria:

* Regular intake of benzodiazepines
* Cognitive impairment: score \< 27 on Mini-mental state examination
* Identifies with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia, Essential Tremor, Huntington's Disease, Multiple System Atrophy, Muscle Tension Dysphonia, Parkinsonism, Progressive Supranuclear Palsy, Spasticity, Intracranial Neoplasm (brain tumor), Spinal Neoplasm, Cerebrovascular Accident (Stroke), Mild Traumatic Brain Injury, Intracranial Hemorrhage, Multiple Sclerosis

Primary outcomes:
measure: Perceived voice effort
timeFrame: 8 weeks
Secondary outcomes:
measure: The number of voice breaks
timeFrame: 8 weeks
measure: The duration of voice break
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Juergen Konczak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01533727: CIK Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)
Official title: A Phase 2,Open-label Study of Autologous Cytokine-Induced Killer Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Cytokine-Induced Killer Cell
NSCLC
adjuvant therapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non - small cell lung cancer ( NSCLC ) accounts for more than 80% of lung cancer. The main treatment for early stage patients is surgical resection, but about 30% -70% patients will relapse. Postoperative chemotherapy is the major systemic treatment for surgical resection NSCLC patients. However, data show only 5-10% improvement in overall survival with systemic adjuvant chemotherapy. It is necessary to further improve the survival time of patients with lung cancer. Biological treatment is becoming a new treatment modality for Cancer following with surgery, radiotherapy and chemotherapy, and has been confirmed as an effective adjuvant treatment in comprehensive cancer treatment. Cytokine induced killer cells ( CIK) characterized as fast amplification, strong anti-cancer activity and broad anti-tumor spectrum is most widely used and thought to be the first choice for the new generation of anti-tumor adoptive immunotherapy. This Phase II study is investigating the efficacy of Autologous Cytokine-Induced Killer Cell Transfusion plus Chemotherapy as adjuvant therapy for stage IB-IIIA NSCLC.


Eligibility criteria: Inclusion Criteria:

1. Stage IB-IIIA post-surgery NSCLC patients with histologically confirmed.
2. with an Eastern CooperativeOncology Group performance status of 0 or 1,
3. at least 18 years of age
4. adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula
5. patients had fully recovered from its acute effects.

Exclusion Criteria:

1. HIV positive
2. autoimmune disease
3. immune deficiency disorder
4. organ transplantation
5. received high dose glucocorticoid or other immune depressant within 4 weeks
6. active clinically serious infections (\> grade 2 NCI-CTC version 3.0)
7. life threatening medical condition

Primary outcomes:
measure: the relapse rate
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06667427: Pilot Study of Management of Facial Paralysis in the Oncologic Patient: Nerve Transfer Techniques to Improve Facial Function and Quality of Life
Official title: Pilot Study of Management of Facial Paralysis in the Oncologic Patient: Nerve Transfer Techniques to Improve Facial Function and Quality of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Head and Neck Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this research study is to measure changes in patients' quality of life after surgeries that affect the facial nerve, including nerve transfer as treatment for facial paralysis.

Detailed description: Primary Objective:

To evaluate the impact of facial nerve transfer techniques (FNTT) on QoL in head and neck cancer patients with facial paralysis. This study intends to measure the impact of FNTT on QoL utilizing a series of validated questionnaires which include: (i) Facial Clinimetric Evaluation Scale and Facial Disability Index; (ii) Sunnybrook Facial Grading System; and (iii) Facial Nerve Grading Scale 2.0. These instruments will be administered at baseline, after surgery, and at 6, 12, and 18 months post-operatively.

Secondary Objective:

To compare patient-reported outcomes and facial function scales for patients who undergo facial nerve transfer technique with a historical cohort of patients who did not undergo any dynamic nerve reconstruction procedures. The same assessment tools described in primary objective above will be utilized.

Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in the intervention group of this study, an individual must meet all of the following criteria:

* Provision of signed and dated informed consent form
* Aged 18 or greater
* Patient scheduled to undergo facial nerve transfer
* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study

In order to be eligible to participate in the non-intervention historical control group of this study, an individual must meet all of the following criteria:

* Provision of signed and dated informed consent form
* Aged 18 or greater
* Previous facial surgery severing a facial nerve without graft or other form of dynamic facial nerve reconstruction within the last 5 years

Exclusion Criteria:

Patients known to be pregnant

Primary outcomes:
measure: Safety and Adverse Events (AEs)
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas M. D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Z-Hye Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: