louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01363934: To Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Erythropoietin
Official title: A Dose-Block Randomized, Double-blind Placebo Controlled, Open-label Active Controlled, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GC1113 After Single Intravenous/Subcutaneous Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Erythropoietin
EPO-hFC
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
Collaborators: name: Symyoo
First posted: 2011-06-02
Enrollment: 100
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Dose-Block Randomized, Double-blind Placebo controlled, Open-label Active controlled, Dose-escalation Study to investigate the safety, tolerability, and Pharmacokinetics/Pharmacodynamics of GC1113 after Single Intravenous/Subcutaneous Administration in Healthy Male Subjects.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Adult male subjects between 20 to 55 years of age
* 60kg ≤ weight ≤ 90kg, 19 ≤ BMI ≤ 27
* 12 g/dL ≤ Hemoglobin ≤ 16 g/dL within the 28 days prior to investigational product (IP)injection
* WBC ≥ 3.0Ⅹ10\^9/L, platelet ≥ 140Ⅹ10\^9/L within the 28 days prior to IP injection

Exclusion Criteria:

* Allergic to IP ingredients
* History of uncontrolled liver, kidney, respiratory, endocrine, neurology, immunology, hematology, mental symptom, circulatory and malignancy disease
* Prior exposure to EPO, darbepoetin, other EPO, immunoglobulin, IV iron supplementation
* History of hypersensitivity reaction to EPO, darbepoetin, excipient of IP or hyperergia to iron supplementation
* Epilepsy within the 6 months prior to IP injection
* Positivity for HIV antibody, HBsAg, HCV antibody test
* Spleen length \> 16㎝

Primary outcomes:
measure: Safety/ Tolerability Evaluation
timeFrame: Up to 29 days after investigational product administration
Secondary outcomes:
measure: AUClast of GC1113, Cmax of GC1113
timeFrame: Up to 29 days after investigational product administration
measure: Immunogenicity of GC1113
timeFrame: Up to 29 days after investigational product administration
measure: To compare safety and Pharmacokinetics/Pharmacodynamics with active control
timeFrame: Up to 29 days after investigational product administration
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, MD., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02036034: Effectiveness of Modified Ophthalmic Draping Method in Preventing Carbon Dioxide Accumulation in Patient Undergoing Eye Surgery Under Local Anesthesia
Official title: Effectiveness of Modified Ophthalmic Draping Method in Preventing Carbon Dioxide Accumulation in Patient Undergoing Eye Surgery Under Local Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: To Prevent Hypercarbia Under the Opthalmology Drape During Surgery.
To Prevent Hypothermia During Opthalmology Surgery.
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that this modified ophthalmic draping will reduce the accumulation and rebreathing of carbon dioxide during eye surgery.

Detailed description: Majority of eye surgery has been widely done under local anesthesia provided by the ophthalmologist with or without sedation.The surgical drapes used often covers the patients face and beyond in order to maintain sterility of the surgical field. This can lead to accumulation of carbon dioxide under ophthalmic drapes due to the exhaled carbon dioxide escapes incompletely through the drapes;hence results in an increase of carbon dioxide in the ambient air surrounding the patient's head.This causes an increase in arterial carbon dioxide partial pressure and thus hyperventilation and patient discomfort with restlessness and unable to stay still during the surgery.

In recent years,several types of ophthalmic drapes have been produced.This study is look for possible difference in accumulation of carbon dioxide under the standard ophthalmic drapes compared to the modified draping.

Eligibility criteria: Inclusion Criteria:

- ASA physical status I,II OR III,adult aged 40 to 80 years old,scheduled to undergo elective eye surgery under local anaesthetic at UMMC will be enrolled in this study.

Exclusion Criteria:

* Pre-existing pulmonary disease,psychological disorders,neurological disorder and patient required sedation.

Primary outcomes:
measure: transcutaneous CO2 level in mmHg under surgical drape with forced air warmer
timeFrame: 10 minutes, 15 minutes, 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Center
state: Wilayah Persekutuan
Study officials:
affiliation: Universiti Malaya
name: Siaw Boon Tan
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Malaya
name: sukhcharanjit S Singh
role: STUDY_CHAIR
References:
Clinical trial NCT03937934: Study Title: Food Rx
Official title: Study Title: Food Rx
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
High Blood Pressure
Obesity
Hypertension
Heart Diseases
Stroke
TIA
Osteoarthritis
Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Researchers are trying to determine if subjects with lack of access to healthy food and a long term health problem, are helped by a weekly box of healthy groceries and nutrition education.

Detailed description: Participants that have a chronic preventable disease and food insecurity will be offered enrollment in the study. Once all participants are enrolled, they will be given weekly boxes of food which includes materials for a nutritious recipe and extra fruit and vegetables for a total of 6 weeks. The SNAP-Ed Educator and SHIP Public health coordinator will be present at food pick up to answer questions about the boxes, food preparation, etc. They will be given the option of participating in grocery store and farmer's market tours, as well as sign up for text messaging of nutrition information and recipes. At the end of 6 weeks, they will be asked to participate in a focus group. At baseline, 3 months and 6 months, they will be asked to complete a survey on lifestyle behaviors and food choices.

Eligibility criteria: Inclusion Criteria:

* Adult patients that have been identified as having food insecurity based on a two question screening tool, AND
* Also has one of more of the following chronic diseases:
* Hypertension,
* Heart disease,
* Stroke/TIA,
* DM 2,
* Cancer/history of cancer,
* obesity
* osteoarthritis

Exclusion Criteria:

* Pregnant women
* Children

Primary outcomes:
measure: Change in the number of self-reported fruits per day
timeFrame: Baseline, 3 months, 6 months
measure: Change in the number of self-reported vegetables per day
timeFrame: Baseline, 3 months, 6 months
measure: Change in number of days a week and minutes per day participants participate in physical activity and sedentary activity
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Change in A1c
timeFrame: 6 months and 12 months
measure: Change in BMI kg/m2 (weight in kg, height in meters)
timeFrame: 6 months and 12 months
measure: Change in Systolic and/or Diastolic Hypertension mmHg
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Mankato
country: United States
facility: Mayo Clinic Health System
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Erin Westfall, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01639534: Biomarkers of Ischemia: Xanthine, Hypoxanthine and Inosine Levels During Carotid Stenting Procedures
Official title: Biomarkers of Ischemia: Xanthine, Hypoxanthine and Inosine Levels During Carotid Stenting Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Identify the Presence of a Marker of Ischemia/Hypoperfusion of the Brain Via Peripheral Blood
Ischemia/Hypoperfusion of Brain
Keywords: Biomarkers of ischemia
Carotid Stenting procedure
Levels Xanthine Hypoxanthine and Inosine
peripheral blood
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for Carotid Stenting Procedure at Virginia Commonwealth University

Brief summary: The purpose of the study is to determine if a new blood test can help the doctor determine if there is brain injury or ischemia. Ischemia occurs when not enough oxygen gets to the brain. In this study the investigators are analyzing your blood for a new test that might help doctors decide if symptoms are from a neurologic problem.

Detailed description: We will compare a new blood test with routine tests that the doctor will order as part of your normal care. This study will measure new biomarkers (biomarker is a specific distinguishing feature used to measure or indicate the effects or progress of a disease or condition) of neurologic stress called xanthine, hypoxanthine, and inosine. Blood will be drawn as a part of the study to measure these biomarker levels in your blood. This blood will be analyzed i the laboratory at Virginia Commonwealth University and possibly at a future date at another institution. No names will be associated with the blood sample

Eligibility criteria: Inclusion Criteria:

* Men and Women over age of 18 non
* Women who are not pregnant
* Subject who are not prisoners
* Subjects presenting to the operation room for a Carotid artery stenting procedure
* Hemoglobin greater than or equal to 11mg/dl
* Subjects who speak english
* Subjects 18 years of age or older

Exclusion Criteria:

* Hemoglobin less than 11mg/dl
* Women who are pregnant
* Children under age of 18
* Prisoners
* Non English

Primary outcomes:
measure: Biomarkers of Ischemia: Levels of Xanthine, Hypoxanthine and Inosine during Carotid Stenting Procedures
timeFrame: analysis will occur after all samples collected
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Lynne Gehr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04646434: Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy
Official title: Investigating the Correlation Between the Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial investigates brain and pelvic floor muscle activity in patients undergoing robot-assisted radical prostatectomy. This trial may help identify the brain waves that are associated with muscles involved in giving patients control over the bladder.

Detailed description: PRIMARY OBJECTIVES:

* Identify pelvic floor muscle (PFM) activity on electromyogram (EMG) and electroencephalography (EEG).
* Identify any synchrony in EMG and EEG for PFM activity.
* Identify any relationship between EEG activity and UDS findings.

SECONDARY OBJECTIVES:

I. Identify changes in EEG and EMG activity with Kegel exercise. II. Examine relationship between EEG activity and continence.

EXPLORATORY OBJECTIVE:

I. Examine feasibility of replacing EMG with EEG monitoring for muscle activity.

OUTLINE:

Patients perform standard of care Kegel exercises while undergoing brain and muscle activity monitoring by EEG and EMG and UDS, respectively, before surgery, 6 weeks after surgery, 3,months after surgery and 6 months after surgery.. Patients complete questionnaires over 5-10 minutes about urinary function.

Eligibility criteria: Inclusion Criteria:

* Adults who had or are undergoing robot-assisted radical prostatectomy (RARP)
* Must be continent preoperatively
* Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Unwilling or unable to follow protocol requirements
* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for study participation

Primary outcomes:
measure: EEG measures obtained during urination.
timeFrame: Up to 6 months after surgery
measure: Pelvic floor muscle (PFM) EEG measures
timeFrame: Up to 6 months
measure: Identification of Areas of synchrony in EEG Patterns and associated Urodynamics (UDS) findings
timeFrame: UP to 6 months
Secondary outcomes:
measure: EEG and EMG biofeedback
timeFrame: Up to 6 months
measure: Improvement of continence
timeFrame: Throughout life of study up to 6 months after surgery
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Khurshid A Guru
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00606034: U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod
Official title: A Prospective Trial of U500 Regular Insulin by Continuous Subcutaneous Insulin Infusion in Patients With Type 2 Diabetes and Severe Insulin Resistance Who Have Failed Previous Insulin Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Insulin Resistance
Keywords: Type 2 diabetes
Insulin Resistance
Continuous Subcutaneous Insulin Infusion
U-500 Insulin
Omnipod
Lead sponsor: Mountain Diabetes and Endocrine Center
Sponsor class: OTHER
First posted: 2008-02-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with Type 2 diabetes and severe insulin resistance with very large insulin requirements who have failed all previous insulin regimens using non-concentrated forms of insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular insulin)infused via insulin pump.

Detailed description: Patients with Type 2 diabetes who have severe insulin resistance and very large insulin requirements (over 1.4 units of insulin /kg/day) often fail insulin regimens with persistent poor blood glucose control when standard U-100 insulin formulations are used. This is due in part to poor absorption of the large insulin volumes required using these less concentrated standard insulin preparations. The hypothesis that using a concentrated form of insulin called U-500 Regular insulin and delivering it by infusion via insulin pump will lower the volume of insulin required and therefore improve insulin absorption, which will lead to improved blood glucose control, will be tested.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes on stable insulin regimen with or without oral agents for at least 3 months
* HbA1c \> 7%
* No significant cardiovascular, renal or other serious medical diseases

Exclusion Criteria:

* HbA1c \< 7%
* Chronic renal, hepatic, cardiovascular, or other serious medical illness
* Females of childbearing age not using adequate contraception
* Use of GLP mimetic

Primary outcomes:
measure: Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of Time Spent in Hypoglycemia
timeFrame: baseline versus 12 months
measure: Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)
timeFrame: Baseline versus 1 year
Other outcomes:
Locations:
city: Asheville
country: United States
facility: Mountain Diabetes and Endocrine Center
state: North Carolina
Study officials:
affiliation: Mountain Diabetes and Endocrine Center
name: Wendy S Lane, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lane WS. Use of U-500 regular insulin by continuous subcutaneous insulin infusion in patients with type 2 diabetes and severe insulin resistance. Endocr Pract. 2006 May-Jun;12(3):251-6. doi: 10.4158/EP.12.3.251.
Clinical trial NCT06762834: Investigating the Role of Ginger Tea ORAC Value in Hypertension Management
Official title: Investigating the Role of Ginger Tea ORAC Value in Hypertension Management
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the antihypertensive effects of ginger tea. By examining its impact on blood pressure levels, this research aims to determine whether ginger tea can be an effective, natural adjunct to conventional hypertension treatments.

Detailed description: This investigation will provide insights into its potential role in reducing the burden of hypertension and improving cardiovascular health

Eligibility criteria: Inclusion Criteria:

* Adults aged 30-65 years
* Diagnosed with stage 1 or stage 2 hypertension
* Not currently taking antihypertensive medication
* Willing to provide informed consent and adhere to study protocols.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Participants on antioxidant supplements or other herbal teas.

Primary outcomes:
measure: Systolic Blood Pressure (SBP)
timeFrame: 12 Months
measure: Total ORAC Value
timeFrame: 12 Months
measure: Diastolic Blood Pressure (DBP)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Azra Naheed Medical College, Superior University
state: Punjab
city: Lahore
country: Pakistan
facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
state: Punjab
Study officials:
References:
Clinical trial NCT01694134: Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.
Official title: Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Lumbago
Modic I Discopathy
Keywords: Discopathy
Modic I
Corticoids
Local Anaesthetic
Intradiscal injection
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The treatment of chronic low back pain is a major objective of public healthcare, because it causes an important number of sick leaves. A correlation between clinical observations and an inflammatory discopathy has been underlined, but there is currently any reference treatment. In this study, the main objective is to assess the efficacy of an intradiscal injection of corticoids versus local anaesthetic on the treatment of pain of patients with low back pain associated to a Modic I discopathy.

Detailed description: This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years
* Signed Informed consent
* Low back pain for more than 6 months associated with Modic I discopathy (diagnosed by MRI)

Exclusion Criteria:

* Past history of lumbar surgery
* Patient under anticoagulant or antisludge treatment, or with coagulation troubles
* Patient with unbalanced diabetes mellitus (blood glucose \> 1.30 g/l)
* Patient with unstabilized high blood pressure (\> 160/95 mmHg)
* Patient with evolving infection
* Patient with iodine allergy or one of the Hydrocortancyl® or Lidocaine components
* Porphyria, hypersensitivity to local anaesthetic
* Patient with sphincter troubles showing a cauda equine syndrome
* Untreated psychotic state
* Pregnant women or of childbearing age without effective contraception means
* Impossible 6 months follow-up
* Participation to another trial
* Vulnerable persons protected by the law
* Persons under guardianship
* Persons unable to express their consent

Primary outcomes:
measure: Pain assessment: VAS
timeFrame: 1 month
Secondary outcomes:
measure: Pain assessment: VAS
timeFrame: 1 week, 2 weeks, 3 weeks, 3 months, 6 months
measure: Quality of life assessment: SF-36
timeFrame: 1 month, 3 months, 6 months
measure: Consumption of analgesics and NSAIDs assessment
timeFrame: 1 month, 3 months,6 months
measure: Specific low back pain parameters assessment
timeFrame: 1 month, 3 months,6 months
measure: Specific low back pain parameters assessment
timeFrame: 1 month, 3 months,6 months
measure: Employment status
timeFrame: 1 month, 3 months,6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hospital University of Montpellier
Study officials:
References: