louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01946997: Evaluation of the Retina of Subjects Without Diabetes Mellitus and Subjects With Diabetes Mellitus Without Diabetic Retinopathy Using Optical Coherence Tomography
Official title: Evaluation of the Retina of Subjects Without Diabetes Mellitus and Subjects With Diabetes Mellitus Without Diabetic Retinopathy Using Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 200
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: Normal, non-diabetic patients

Brief summary: The purpose of this study is to evaluate topographic features of the posterior pole of the eye in normal subjects as well as in subjects with diabetes mellitus but without diabetic retinopathy (DR) using optical coherence tomography (OCT). The investigators proposal is a novel study to determine retinal volume of normal and diabetic subjects without DR. Specifically, the investigators will establish a standardized reference range for retinal thickness and volume that will provide standards for OCT analysis of different clinical trials for retinal diseases.


Eligibility criteria: Inclusion Criteria:

* Healthy retinas
* Willingness to sign informed consent to have OCT images taken.

Exclusion Criteria:

* No macular pathology
* No Diabetes

Primary outcomes:
measure: Normative retinal thickness data for comparison
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Quan D Nguyen, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02828397: Study of the Blood Concentrations of Two Formulations of REGN2222 in Healthy Subjects
Official title: A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Intramuscular (IM) Injection of REGN2222 Produced by 2 Different Cell Lines in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-07-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Primary Objective: Determine blood concentrations of two formulations of REGN2222

Secondary Objective: Assess safety and tolerability of REGN2222


Eligibility criteria: Key Inclusion Criteria:

1. Healthy man or woman aged 18 to 60 years
2. Body weight between 50.0 kg and 95.0 kg, inclusive
3. Willing and able to comply with clinic visits and study-related procedures
4. Provide signed informed consent

Key Exclusion Criteria:

1. Hemoglobin not within normal limits
2. Positive drug and alcohol screen test results at screening visits 1 and 2
3. Participation in any clinical research study that evaluated another investigational drug or therapy within 30 days or at least 5 half-lives, whichever is longer, of the investigational drug, prior to the screening visit
4. Pregnant or breastfeeding women, and women of childbearing potential
5. Sexually active men who are unwilling to practice adequate contraception during the study

Primary outcomes:
measure: Serum REGN2222 concentration-time curve (AUC)
timeFrame: Day 1 to Day 148 (end of study)
measure: Peak REGN2222 concentration (Cmax)
timeFrame: Day 1 to Day 148 (end of study)
Secondary outcomes:
measure: Treatment-emergent adverse events (TEAEs) from baseline to the end of the study
timeFrame: Day 1 to Day 148 (end of study)
measure: Presence or absence of anti-drug antibody (ADA)
timeFrame: Day 1 to Day 148 (end of study)
Other outcomes:
Locations:
city: Daytona Beach
country: United States
state: Florida
city: Evansville
country: United States
state: Indiana
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT06547697: DIALYSATE SODIUM CONCENTRATION AND BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS
Official title: EFFECT OF DIFFERENT DIALYSATE SODIUM CONCENTRATIONS ON BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University Medical Centre Maribor
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 45
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: While hypertension is one of the most common causes of end-stage renal disease, it is also present in the vast majority of hemodialysis patients. It is associated with higher cardiovascular morbidity and mortality in this group of patients. Altering dialysate sodium concentration presents a possibility of sodium balance control and blood pressure management. However, the ideal dialysate sodium concentration remains a topic for discussion.

Randomised and prospective single dialysis centre study is presented. The participants are randomly divided into 3 groups and will go through 3 periods of 2 months. A "low-to-high" dialysate sodium concentration group will start the study with 138 mmol/L in the first period, continue with 140 mmol/L in the second period and finish with 142 mmol/L. In the "high-to-low" group, the participants will go through the opposite design (reduction from 142 mmol/L to 138 mmol/L over 3 periods). One group will continue with 140 mmol/L throughout the study. Systolic and diastolic BP values before and after dialysis sessions, interdialytic weight gain, ultrafiltration, serum sodium concentration and the presence of hypotension between the groups in each period and within each group over all three periods will be evaluated.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Patients with end-stage renal disease hemodialysis for at least 3 months

Exclusion Criteria:

* Non-cooperation
* Active cancer
* Hospitalization during the course of the study

Primary outcomes:
measure: Peridialytic blood pressure
timeFrame: 6 months (3 periods of 2 months)
Secondary outcomes:
measure: Interdialytic weight gain
timeFrame: 6 months (3 periods of 2 months)
measure: Ultrafiltration
timeFrame: 6 months (3 periods of 2 months)
measure: Serum sodium concentration
timeFrame: 6 months (3 periods of 2 months)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03628183: Tolerance of Infants Fed a Hydrolysate Formula
Official title: Tolerance of Infants Fed a Hydrolysate Formula Manufactured With a New Processing Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 51
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.


Eligibility criteria: Inclusion Criteria:

* Subject is judged to be in good health
* Singleton from a full-term birth
* Birth weight was \> or = to 2490 g
* Between 0 and 14 days of age at enrollment
* Parent(s) confirm their intention to feed their infant the assigned study product as the sole source of nutrition for the duration of the study
* Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study
* Subject's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF)

Exclusion Criteria:

* An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
* Subject participates in another study that has not been approved as a concomitant study
* Subject has an allergy or intolerance to any ingredient in the study product
* Subject has been treated with antibiotics within 2 weeks prior to enrollment

Primary outcomes:
measure: Stool Characteristics
timeFrame: Study Day 1 - Study Day 21
Secondary outcomes:
measure: Formula Intake
timeFrame: Study Day 1 - Study Day 21
measure: Weight
timeFrame: Study Day 1 - Study Day 21
measure: Length
timeFrame: Study Day 1 - Study Day 21
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Watching Over Mothers and Babies
state: Arizona
city: Owensboro
country: United States
facility: Springs Medical Research
state: Kentucky
city: Cleveland
country: United States
facility: The Cleveland Pediatric Research Center, LLC
state: Ohio
city: Mentor
country: United States
facility: Institute of Clinical Research, LLC
state: Ohio
city: Memphis
country: United States
facility: Midsouth Center for Clinical Research
state: Tennessee
Study officials:
affiliation: Abbott Nutrition
name: Courtney Allgeier, MS, RD, LD
role: STUDY_CHAIR
References:
Clinical trial NCT00782483: Personalized Interactive Laser Therapy of Port Wine Stain
Official title: Personalized Interactive Laser Therapy of Port Wine Stain - Study 2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Port Wine Stain
Keywords: Diagnosis
Port Wine Stain
PWS
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Arkansas Children's Hospital Research Institute
name: Children's University Medical Group
First posted: 2008-10-31
Enrollment: 6
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lasers are being used to treat Port Wine Stains (PWS), but the laser doesn't always work. Only about 10% of PWS can be completely cleared. The research team believes that the investigators can improve the response of PWS to laser therapy by using a computer program that the principal investigator of this study (Dr. Shafirstein PhD) has developed. The purpose of this study is to test the validity of this computer program. Personalized Interactive Laser Therapy (PILT) could significantly improve clinical outcomes of laser treatment of PWS.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with a PWS
* At least one visible PWS measuring greater than or equal to 15 mm in diameter.
* Information provided regarding alternative treatment methods, includig no treatment.
* Reading, understanding, and signing of an informed consent document.
* Children age 7 years or older has read, understood, and signed an assent document.
* Agreement to participate in the study.
* Agreement to return to at least 1 follow-up evaluation and treatment within 1 year after first treatment.
* Zubrod performance status of 0 or 1 at screening.

Exclusion Criteria:

* Inability or unwillingness of subject to participate in the study.
* Inability or unwillingness of one parent or legal guardian of the subject to sign written informed consent document.
* Subject can not return to at least 1 follow-up visit within 1 year, after the first treatment.

Primary outcomes:
measure: Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.
timeFrame: Three treatments up to one year, whichever is first
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: UAMS, ACH
name: Gal Shafirstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00873483: US Ovulation Inhibition Study in Obese Women
Official title: Multicenter, Open-Label, Uncontrolled Study to Investigate the Impact of Weight and BMI on Inhibition of Ovulation of a Transdermal Patch Formulation Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene in Young Female Volunteers Stratified by BMI Over a Period of 3 Treatment Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Keywords: Pregnancy prevention
female contraception
patch
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-04-01
Enrollment: 173
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Birth Control Patch Study


Eligibility criteria: Inclusion Criteria:

* Female subject requesting contraception
* Age: 18 - 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent
* Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
* History of regular cyclic menstrual periods
* Willingness to use non-hormonal methods of contraception during the entire study.

Exclusion Criteria:

* Pregnancy or lactation (less than 3 menstrual cycles since delivery, abortion, or lactation before start of treatment)
* Hypersensitivity to any ingredient of the study drug
* Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
* Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug (e.g., known skin disease with suspected alteration of dermal absorption or poor adherence of the patch such as psoriasis)
* Any disease or condition that may worsen under hormonal treatment.

Primary outcomes:
measure: Determination of Hoogland Scores
timeFrame: Treatment Cycles 2 & 3
Secondary outcomes:
measure: Laboratory values for E2, progesterone, FSH and LH
timeFrame: Pretreatment & regularly during Treatment Cycles 1, 2, 3
measure: Endometrial thickness
timeFrame: Pretreatment & regularly during Treatment Cycles 1, 2, 3
measure: Follicle size
timeFrame: Pretreatment & regularly during Treatment Cycles 1, 2, 3
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: San Diego
country: United States
state: California
city: Sandy Springs
country: United States
state: Georgia
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01951183: A Study of RO6811135 in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Metformin
Official title: A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP, PHASE 2A STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-DAILY RO6811135 IN TYPE 2 DIABETIC PATIENTS INADEQUATELY CONTROLLED WITH METFORMIN
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-09-26
Enrollment: 0
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: This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety and tolerability of RO6811135 in Type 2 diabetic patients treated with a stable dose of metformin.


Eligibility criteria: Inclusion Criteria:

* Adults between the age of 18 and 65
* Have been diagnosed with diabetes for at least 3 months and treated with a stable dose of metformin for at least 8 weeks
* Hemoglobin A1c between 7.2 and 10.5%
* Fasting plasma glucose less than 250 mg/dL
* C-peptide greater than 1.5 ng/mL
* Body mass index (BMI) between 27 and 44

Exclusion Criteria:

* Pregnant or lactating women
* Type 1 diabetes
* Had undergone weight loss surgery or weight loss procedure involving the gastrointestinal tract, such as gastric bypass, gastric stapling, or gastric banding
* Uncontrolled hypertension or other significant cardiovascular disease as determined by investigator
* Significant kidney or liver disease as determined by the investigator

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: from baseline to Week 12
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose (FPG)
timeFrame: from baseline to Week 12
measure: Pharmacokinetics: Area under the concentration-time curve (AUC)
timeFrame: 12 weeks
measure: Safety: Incidence of adverse events
timeFrame: 19 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00846183: Effect of Local Injury on Implantation
Official title: Effect of Local Injury to Endometrium on the Day of Oocyte Retrieval in First IVF Cycle on Implantation Rate.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Implantation Rate
Keywords: local injury
implantation rate
endometrial receptivity
IVF
Lead sponsor: Yazd Research & Clinical Center for Infertility
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 156
Sex: FEMALE
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Local injury on two sights of endometrium are performed in 60 patients in their first IVF cycle and implantation rate are compared with fresh cycles without local injury.

Detailed description: Low implantation rate is still a major concern in ART cycles. It has been reported that local injury to endometrium may improve endometrial receptivity and implantation rate. A total of 120 patients in first IVF cycles, who are stimulated with long protocol, are randomly divided into two groups. In one group, on the day of oocyte retrieval, local injury to endometrium with a Novak curet to anterior and posterior wall of endometrium are performed and in the other group no interventions are done. After fresh embryo transfers, implantation and clinical pregnancy rates are compared between two groups.

Eligibility criteria: Inclusion Criteria:

* Age \< 35
* First IVF cycle
* Long protocol should be used for stimulation

Exclusion Criteria:

* Day 3 FSH \> 10

Primary outcomes:
measure: implantation rate
timeFrame: 4 weeks
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Yazd
country: Iran, Islamic Republic of
facility: Research and clinical center for infertility
Study officials:
affiliation: Research and clinical center for infertility
name: homa oskouian, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Research and clinical center for infertility
name: Mohamad ali karimzade, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lensen SF, Armstrong S, Gibreel A, Nastri CO, Raine-Fenning N, Martins WP. Endometrial injury in women undergoing in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Jun 10;6(6):CD009517. doi: 10.1002/14651858.CD009517.pub4.
Clinical trial NCT00517283: A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes
Official title: A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
gastric emptying
exenatide
Byetta
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2007-08-16
Enrollment: 17
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: As exenatide slows the rate at which materials leave the stomach, it is likely to alter the rate of intestinal absorption of oral drugs when administered within a certain timeframe relative to exenatide. In addition, the residence time within the stomach of other medication may be prolonged and data from this study will help assess the change in residence time in the presence of therapeutic doses of exenatide. This study will also evaluate the relationship between blood levels of exenatide and parameters measuring rate of stomach emptying.


Eligibility criteria: Inclusion Criteria:

* Subjects with at least 1 year history of type 2 diabetes mellitus.
* Subjects controlled by oral antidiabetic agents or diet and exercise demonstrated by a screening HbA1c ≥7.0% and ≤10.0%.
* Between the body mass index (BMI) of 19 kg/m2 and 40 kg/m2, inclusive.

Exclusion Criteria:

* Within 4 months of the initial dose of study drug, have received a drug that has not received regulatory approval for any indication.
* Persons who have previously completed or withdrawn from this study or any other study investigating exenatide.
* Subjects who are using drugs that significantly affect gastrointestinal motility (including acarbose, metoclopramide, and macrolide antibiotics).
* Subjects who intend to start new concomitant medication during the study, including over-the counter medication, apart from occasional intake of paracetamol or vitamin/mineral supplements. Anti-emetic medication may be permitted at the investigator's discretion, except those that affect gastrointestinal motility.
* Subjects who have used insulin for more than 4 weeks within 3 months prior to screening.
* Blood donation of more than 500 mL in the last 3 months of screening or any blood donation within the last month.

Primary outcomes:
measure: To detect the mean difference in half gastric emptying time for a solid meal between any treatment and placebo
timeFrame: up to 12 hours post meal consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: James Malone, MD
role: STUDY_DIRECTOR
References: