louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03436576: Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye
Official title: Comparison of Autologous Serum 20% and Autologous Serum 50% for the Treatment of Severe Dry Eye
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dry Eye
Keratoconjunctivitis Sicca
Sjogren's Syndrome
Corneal Diseases
Conjunctival Diseases
Keratitis
Lacrimal Apparatus Diseases
Keywords: Autologous serum
Concentration
Autologous serum 20%
Autologous serum 50%
Severe dry eye
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Hospital Dr Sotero del Rio
First posted: 2018-02-19
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: The purpose of this study is to compare the effects of autologous serum 20% and autologous serum 50% for the treatment of Severe Dry Eye Syndrome

Detailed description: To determine the difference between autologous serum 20% vs 50%, in terms of improvement of symptoms, improvement of ocular surface parameters and acceptable tolerability in patients with severe dry eye syndrome.

Eligibility criteria: Inclusion Criteria:

* Man/woman ≥ 18 years old, able to freely give consent to participate in the study
* At least 1 of the following tests altered:

  * Ocular Surface Disease Index (OSDI) Test symptoms \> 32
  * BUT ≤5 seconds
  * Oxford staining ≥ 3
  * Schirmer Test without anesthesia ≤ 5 mm

Exclusion Criteria:

* Sensitivity or known intolerance to any of the products used in the study
* Contraindication of venipuncture
* Story of ocular infections within the 6 previous months to study inclusion
* Any active ocular pathology other than Dry Eye Syndrome
* Use of contact lenses in the 3 previous months to study inclusion
* No pregnant or breastfeeding women is allowed to participate in the study. Childbearing potential women must use contraceptive means during the whole study.
* Participation in another clinical trial in the last 30 days before study inclusion

Primary outcomes:
measure: Change in Ocular Surface Disease Index (OSDI) Score
timeFrame: 1 month
Secondary outcomes:
measure: Change in Tear Break Up Time (TBUT)
timeFrame: 1 week, 1 month, 2 months
measure: Change in Oxford Staining score
timeFrame: 1 week, 1 month, 2 months
measure: Change in Schirmer I
timeFrame: 1 week, 1 month, 2 months
measure: Change in Ocular Surface Disease Index (OSDI) Score
timeFrame: 1 week, 2 months
Other outcomes:
Locations:
city: Puente Alto
country: Chile
facility: Hospital Dr. Sótero del Río
state: Región Metropolitana
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Paulina Liberman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02232776: Efficacy and Safety of Losartan in Children With Ig A Nephropathy
Official title: A Prospective Study Evaluating the Efficacy and Safety of Losartan in Children With Immunoglobulin A Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glomerulonephritis, IGA
Keywords: Losartan
Ig A nephropathy
children
proteinuria
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Food and Drug Safety, Korea
First posted: 2014-09-05
Enrollment: 37
Sex: ALL
Minimum age (years): 24
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that using Losartan would help decrease proteinuria in controlling proteinuria in children with immunoglobulin A nephropathy.

Detailed description: Twenty nine patient with IgA nephropathy with proteinuria (urine protein to creatinine ratio \> 0.3 mg/mg) were included in the study. All patients had received losartan treatment for 24 weeks. Changes in blood pressure, proteinuria, renal function, and biochemical parameters were prospectively evaluated before and at 4 weeks and 24 weeks.

Eligibility criteria: Inclusion Criteria:

* Age: 2years or older and younger than 18 years
* Biopsy-proven Ig A Nephropathy
* Estimated GFR ≥ 90mL/min/m\^2
* Mean urinary protein-creatinine ratio \> 0.3 g/g from three first-morning spot urine collections

Exclusion Criteria:

* hypertension
* under dialysis or organ transplanted
* bilateral renal artery stenosis
* primary hyperaldosteronism
* pregnant

Primary outcomes:
measure: the change in urinary protein-creatinine ratio from baseline to the end of study
timeFrame: 24weeks
Secondary outcomes:
measure: the change in urinary albumin-creatinine ratio from baseline to the end of study
timeFrame: 24 weeks
measure: the proportion of patients wifh more than 50% decrease of urinary protein-creatinine ratio
timeFrame: 24 weeks
measure: the proportion of patients wifh urinary protein-creatinine ratio < 0.2 at the end of study
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
affiliation: Seoul National University Children's Hospital Departments of Pediatrics
name: Hee Gyung Kang, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT01099176: Effects of Hypolipemic Treatment on Adipokines
Official title: The Effects of 90-day Monotherapies With Atorvastatin, Fenofibrate and Combined Therapy With Atorvastatin and Fenofibrate on Lipid Profile, Fasting Plasma Glucose, Proinflammatory Cytokines and Adipokines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Impaired Fasting Glycemia
Keywords: hyperlipidemia
impaired fasting glycemia
adipokines
atorvastatin
fenofibrate
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
Collaborators: name: Ministry of Scientific Research and Information Technology, Poland
First posted: 2010-04-06
Enrollment: 78
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study is planned to show whether monotherapies or combined hypolipemic therapy influence the fasting plasma glucose, serum adipokines (leptin, adiponectin, resistin) and proinflammatory cytokines (interleukin-6, TNF alpha) during 30 and 90 day course.


Eligibility criteria: Inclusion Criteria:

* Age (35-64yr)
* Primary hyperlipidemia (Total cholesterol \>200mg/dl, Triglycerides \>150mg/dl)
* Impaired fasting glycemia (glycemia 100-125mg/dl)
* For women:
* Menopause (\>12 months)
* Post hysterectomy
* Mechanical contraception
* Obtained informed consent

Exclusion Criteria:

* Secondary hyperlipidemia
* Morbid obesity (BMI\>40kg/m2)
* Alcohol or drug abuse
* Acute or chronic inflammation
* Congestive Heart Failure (NYHA III or IV)
* Unstable Ischaemic Heart Disease
* Moderate or severe hypertension
* Cancer in less than 5 years
* Chronic kidney disease (stage III-V)
* Liver failure
* Diabetes
* Oral contraception
* Not compliant patient
* Laboratory results:
* alanine transferase (\>3xULN)
* creatine kinase (\>5xULN)
* haemoglobin (\<10/dl)
* PLT (\<100G/l)
* WBC (\<3,5G/l or \>10G/l)

Primary outcomes:
measure: Adipokines
timeFrame: Day 90
Secondary outcomes:
measure: Proinflammatory cytokines
timeFrame: Day 30
measure: Adipokines
timeFrame: Day 30
measure: Proinflammatory cytokines
timeFrame: Day 90
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Department of Pharmacology
state: Śląskie
Study officials:
References:
Clinical trial NCT04628676: Comparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity
Official title: Comparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity During Arthroscopic Rotator Cuff Repair: A Randomized Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: shoulder arthroscopy
irrigation
epinephrine
image quality
tranexamic acid
cuff tear repair
visual clarity
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary aim of this report is to determine whether there is a difference between Epinephrine and Tranexamic acid in providing visual clarity during arthroscopic rotator cuff tear repair.


Eligibility criteria: Inclusion Criteria:

* • Age \> 18 years

  * American Society of Anesthesiologist Physical Status Classification System : 1-2
  * Undergoing a full arthroscopic double-row repair due to full-thickness cuff tear
  * Being willing to participate the study

Exclusion Criteria:

* • Age \< 18 years

  * American Society of Anesthesiologist Physical Status Classification System ≥3
  * Concomitant cardiac diseases
  * Concomitant bleeding disorder or coagulopathy
  * Diabetes mellitus
  * Being pregnant
  * Use of contraceptive pills
  * A history of previous shoulder surgery
  * Uncontrolled hypertension during the operation (\>180/110 mm Hg)
  * Unrepairable rotator cuff tears
  * Being unwilling to participate the study

Primary outcomes:
measure: Visual analog scale
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: total operating time
timeFrame: through study completion, an average of 2 year
measure: average mean arterial pressure
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haseki Training and Research Hospital
Study officials:
References:
Clinical trial NCT05034276: Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder
Official title: Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: BehaVR LLC
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-09-05
Enrollment: 34
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
Primary purpose: TREATMENT

Brief summary: This is a Phase 1 trial that aims to establish the safety of MORE-VR, as well as to collect feasibility, usability, and engagement data, for patients receiving medications for opioid use disorder (mOUD).


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* DSM-5 opioid use disorder diagnosis
* treated with medications for opioid use disorder (MOUD)

Exclusion Criteria:

* Mindfulness intervention experience (MBSR, MBRP)
* Active psychosis or high risk of suicidality
* Cognitive impairment (per self-report or report by clinician)
* Unwilling or unable to remain in MOUD treatment for duration of study

Primary outcomes:
measure: Number of Participants With Adverse Events and/or Serious Adverse Events
timeFrame: Baseline through week 8
Secondary outcomes:
measure: Engagement
timeFrame: Baseline through week 8
measure: Numeric Rating Scale of State Craving
timeFrame: Baseline through week 8
measure: Numeric Rating Scale of State Positive Affect
timeFrame: Baseline through week 8
Other outcomes:
measure: Desire for Drugs
timeFrame: Baseline, week 8
measure: Trait Positive and Negative Affect
timeFrame: Baseline, week 8
measure: Coping Self-efficacy
timeFrame: Baseline, week 8
measure: Cue-elicited Heart Rate
timeFrame: Baseline through week 8
Locations:
city: Salt Lake City
country: United States
facility: Center on Mindfulness and Integrative Health Intervention Development
state: Utah
Study officials:
References:
Clinical trial NCT02612376: Rocky Mountain Alzheimer's Disease Center Longitudinal Biomarker and Clinical Phenotyping Study
Official title: Rocky Mountain Alzheimer's Disease Center at the University of Colorado School of Medicine (RMADC at UCSOM) Longitudinal Biomarker and Clinical Phenotyping Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alzheimer Disease
Down Syndrome
Mild Cognitive Impairment
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-11-23
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants with Mild Cognitive Impairment (MCI), AD, healthy controls

Brief summary: This study plans to establish a large bank of blood, cerebral spinal fluid (CSF), imaging, and clinical data. These data and samples will be used for future research into the causes of Alzheimer's disease (AD), Down Syndrome (DS) and other diseases that cause thinking and memory problems. This future research will also study how treatments for these diseases work. This research may help develop new treatments for some diseases of the nervous system and help understand these diseases better.


Eligibility criteria: Inclusion Criteria:

1. Persons with age-related MCI or AD according to clinical diagnosis, consistent with NIA-AA diagnostic criteria
2. Community-dwelling controls, Age \> 60 years
3. Ability to complete baseline assessments
4. Has an informant (study partner) available to complete functional interviews/survey measures annually

Exclusion Criteria:

* Presence of concomitant medical, neurological, or psychiatric illness or condition that in the opinion of the investigators would confound interpretation of study results. These include: Korsakoff encephalopathy; active substance abuse; hepatitis C; opportunistic brain infection; brain tumor; active neoplastic disease (skin tumors other than melanoma are not exclusionary; participants with stable prostate cancer may be included at the discretion of the project director); multiple sclerosis; history of clinically significant stroke; current evidence or history in the past 2 years of focal brain lesion, head injury with loss of consciousness, or DSM-V criteria for any major psychiatric disorder, including psychosis, major depression, bipolar disorder, alcohol or substance abuse; blindness, deafness or any other disability which may prevent the participant from participating or cooperating in the protocol.
* Presence of contraindication for MRI scan

Primary outcomes:
measure: Longitudinal collection of biospecimens and data from participants with MCI, AD, DS, healthy controls, and parents of DS individuals.
timeFrame: Annually for 15 years or death
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado, Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Brianne M Bettcher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01186276: Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes
Official title: Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2010-08-23
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will assess whether dietary fiber supplements can reduce the production of chemicals which are produced by colon bacteria and normally excreted from the body by the kidney, but build up in the body in patients on hemodialysis.

Detailed description: The study procedures will consist of:

* taking a dietary supplement containing either fiber or starch (starch serves as a control for fiber) for six weeks. The fiber dose initially employed will be 30 g/day of high amylose corn and the control starch dose employed will be 30 g/day of waxy corn starch. Supplements which come in dry powder form will be mixed in liquid or food for consumption.
* filling out a food record and a quality of life questionnaire
* keeping a diary of any gi symptoms
* collecting samples of blood, spent dialysate, urine(if the patient still makes urine) and stool.

Eligibility criteria: Inclusion Criteria:

* stable dialysis patients able to provide consent.

Exclusion Criteria:-- known g.i. disease

* use of antibiotics for the last two month or expected antibiotic use
* recent hospitalization or other event resulting in instability of food intake

Primary outcomes:
measure: Plasma level of p-cresol sulfate
timeFrame: 8 weeks
Secondary outcomes:
measure: Caloric intake
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Redwood City
country: United States
facility: Satellite Dialysis
state: California
city: San Jose
country: United States
facility: SCVMC
state: California
Study officials:
affiliation: Stanford University
name: Timothy W Meyer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06863376: Evaluating the Safety and Efficacy of Carbocisteine in the Treatment of Nonalcoholic Fatty Liver Disease Patients
Official title: Evaluating the Safety and Efficacy of Carbocisteine in the Treatment of Nonalcoholic Fatty Liver Disease Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 46
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: Nonalcoholic fatty liver disease (NAFLD) is a global public health concern, and the leading cause of chronic liver disease, especially in developed countries. NAFLD is characterized by lipid accumulation in the liver not attributed to other causes. Lifestyle interventions, including dietary modification and exercise, remain the cornerstone of NAFLD treatment. Pharmacological treatments aimed primarily at improving liver disease should generally be limited to those with biopsy-proven NASH and fibrosis.


Eligibility criteria: Inclusion Criteria:

* Either male or female adult patients (\>18 years) with fatty liver diagnosis by using upper abdominal ultrasound echography

Exclusion Criteria:

* Pregnant and/or lactating women
* Excessive alcohol use (defined as an average alcohol intake \> 30 g per day in men and \> 20 g per day in women)
* Other etiology of chronic liver diseases such as viral hepatitis, drug-induced hepatitis, autoimmune hepatitis.
* patients suffering from chronic kidney disease, and hyper/hypoparathyroidism
* Hypersensitivity to carbocistiene.

Primary outcomes:
measure: The change in the degree of steatosis in the Ultra Sound
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta Unuversity
Study officials:
References:
Clinical trial NCT03098576: Personalized Cancer Care at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
Official title: Personalized Cancer Care at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: advanced
metastatic solid tumors
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 52
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 advanced and metastatic solid tumors who have failed standard systemic therapy.

Brief summary: The purpose of this study is to examine the usefulness of matching patients to targeted therapy by analyzing a tumor sample taken at diagnosis and testing it against 50 cancer-associated genes. Targeted therapy is a highly personalized, newer approach to cancer treatment that aims to more precisely identify and attack cancer cells, in an effort to do less damage to normal cells.

Detailed description: Targeted therapy in this study can be either off label-use of a U.S. Food and Drug Administration (FDA) approved drug or a clinical trial that includes investigational drugs. Matched targeted therapy outcomes will be compared to the outcomes of patients who were not matched to a treatment.

In order to find a matched treatment, a patient's sample will undergo a test known as a "gene chip algorithm." This is will be done by having a sample of a patient's tumor analyzed at a Cedars-Sinai Medical Center (CSMC) laboratory that specializes in molecular profiling. Molecular profiling is a process used to study a tumor's genetic characteristics. DNA will be taken from the tumor sample and will be screened for "actionable genes." These genes are called actionable because mutations (structural changes) in these genes have FDA-approved matched therapies or are eligible for current clinical studies.

Eligibility criteria: Inclusion Criteria:

* Advanced and metastatic solid tumors who have failed standard treatments known to improve survival
* Female and male adults age 18 and older.
* ECOG PS 0-2
* Acceptable hematological, renal, or liver function
* Patients planning to undergo a systemic treatment
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Significant comorbidities that could interfere with the study (compliance and visits)

Primary outcomes:
measure: Response rate
timeFrame: 3 years
Secondary outcomes:
measure: Progression free survival
timeFrame: 6 months
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinal Medical Center
name: Monica Mita, MD
role: PRINCIPAL_INVESTIGATOR
References: