louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00364403: A Low Glycemic Load Diet During Pregnancy in Overweight Women
Official title: Glycemic Load and Infant Birth Weight in Pregnant Overweight/Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Pregnancy
Keywords: Glycemic index
Glycemic load
Low fat
Impaired glucose tolerance
Large for gestational age infant
Excessive body weight
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Thrasher Research Fund
name: Beth Israel Deaconess Medical Center
First posted: 2006-08-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will compare the effects of a low glycemic load versus standard diet for pregnancy on outcomes related to risk for obesity, diabetes, and heart disease in both mother and infant.


Eligibility criteria: Inclusion Criteria:

* Pregnant women with prepregnant or first trimester BMI equal to or greater than 25 kg/m2 and less than 45 kg/m2
* Singleton pregnancy
* Willing to consume the diets for duration of pregnancy
* Participant to be at week 28 or less of pregnancy at baseline visit

Exclusion Criteria:

* Smoking during pregnancy
* Major medical illness (e.g., diabetes mellitus, hypertension, thyroid disease)
* Patients taking prescription medication known to affect body weight
* Alcohol consumption during pregnancy
* Patients who declare their intention to deliver infants in the environment outside of Beth Israel Deaconess Medical Center, Boston
* High level of physical activity

Primary outcomes:
measure: Birth weight as assessed by z-scores
timeFrame: At birth
Secondary outcomes:
measure: Maternal energy intake
timeFrame: During pregnancy
measure: Maternal weight gain
timeFrame: During pregnancy
measure: Maternal insulin resistance assessed by HOMA
timeFrame: During pregnancy
measure: Maternal metabolic syndrome components
timeFrame: During pregnancy
measure: Infant body composition (ponderal index, skinfold thickness)
timeFrame: At birth
measure: Cord blood glucose
timeFrame: At birth
measure: cord blood insulin
timeFrame: At birth
measure: cord blood leptin
timeFrame: At birth
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: David S Ludwig, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Erinn Rhodes, MD
role: STUDY_DIRECTOR
References:
citation: Rhodes ET, Pawlak DB, Takoudes TC, Ebbeling CB, Feldman HA, Lovesky MM, Cooke EA, Leidig MM, Ludwig DS. Effects of a low-glycemic load diet in overweight and obese pregnant women: a pilot randomized controlled trial. Am J Clin Nutr. 2010 Dec;92(6):1306-15. doi: 10.3945/ajcn.2010.30130. Epub 2010 Oct 20.
Clinical trial NCT03094403: To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel
Official title: A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Azeliac Acid Gel and Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rosacea
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2017-03-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects in this randomized, double-blind, placebo controlled, parallel-group, multiple-center study will be randomly assigned in a 2:2:1 ratio to treatment with the test product, reference product or placebo control, respectively
Primary purpose: TREATMENT

Brief summary: A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study

Detailed description: A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, comparing AZELAIC ACID TOPICAL GEL 15% TO FINACEA® and both active treatments to a Placebo Control in the treatment of Moderate of Facial Rosacea.

Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female ≥ 18 years-of-age with a clinical diagnosis of moderate facial rosacea;
* Subjects had to have a definite clinical diagnosis of facial rosacea severity Grade 3 as per the IGE

Exclusion Criteria:

* Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;

Primary outcomes:
measure: Change in inflammatory lesion counts
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: http://catawbaresearch.com/contact/
name: Catawba Research
role: STUDY_CHAIR
References:
Clinical trial NCT06492603: Examination of Biomechanical Characteristics of Linea Alba in Diastasis Recti Patients
Official title: Examination of Linea Alba Biomechanical and Viscoelastic Characteristics in Patients Diagnosed with Diastasis Recti Using Ultrasound
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Separated Recti Abdominis
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 40 post-Cesarean women who are diagnosed with or without diastasis rectus abdominis. They will be selected from the teaching Hospitals of South Valley University.

Brief summary: Diastasis recti is an increased distance between the rectus abdominis muscles at the midline caused by weakness in the anterior abdominal wall.

Detailed description: Most healthcare providers agree that in diastasis rectus abdominis there is a weakness, thinning, and widening of the linea alba and weakness of the associated abdominal musculature.

Ultrasonography is regarded as the most accurate method for measuring the IRD and its results are consistent with the data derived from palpation, calipers, and intraoperative measurements.

The MyotonPRO Device is used for the non-invasive measurement of Device is for the non-invasive measurement of biomechanical and viscoelastic properties of superficial soft biological tissues. Skeletal muscles or tendons can be measured at different regions, at full rest or in contraction.

This study aims to assess the biomechanical and viscoelastic properties of the Linea Alba in patients who are diagnosed with diastasis rectus abdominis by ultrasonography.

Eligibility criteria: Inclusion Criteria:

* Postpartum Mothers who delivered by a cesarean section.
* Postpartum Mothers with a BMI below 30 or a Waist-hip ratio below 1.
* Postpartum Mothers above 18 years old and those below 35 years old.

Exclusion Criteria:

* Postpartum Mothers who delivered by a vaginal delivery.
* Postpartum Mothers who had hernias in the abdominal region or laparotomy.
* Postpartum Mothers with a BMI over 30 or a Waist-hip ratio over 1.
* Postpartum Mothers below 18 years old and those above 35 years old.

Primary outcomes:
measure: Linea Alba Stiffness
timeFrame: Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum
measure: Linea Alba Elasticity
timeFrame: Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum
measure: Linea Alba Creep
timeFrame: Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01084603: Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product
Official title: Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Smoking Cessation
Nicotine pharmacokinetics
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.

Detailed description: This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Eligibility criteria: Inclusion Criteria:

* Healthy smokers, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 months preceding the first dose of study medication.

Primary outcomes:
measure: Maximum Plasma Concentration
timeFrame: During 12 hours after start of administration
measure: Bioavailability
timeFrame: 12 hours
Secondary outcomes:
measure: Nicotine Plasma Concentration
timeFrame: During 10 minutes after start of administration
measure: Time of Maximum Concentration
timeFrame: During 12 hours after start of administration
measure: Terminal Elimination Rate Constant
timeFrame: During 12 hours after start of administration
measure: Released Nicotine
timeFrame: After 30 minutes' chewing
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Clinical Pharmacology
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01078103: Corneal Endothelial Changes Associated With Phacoemulsification in Diabetes Mellitus Type II
Official title: Corneal Endothelial Changes Associated With Phacoemulsification in Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Cataract
Keywords: Diabetes Mellitus
cornea endothelium
cell loss
cataract surgery
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 typoe II diabetic and 30 non diabetic undergoing catarct surgery

Brief summary: Some studies indicated that the diabetic corneal endothelium is morphologically abnormal and may be at risk in any intraocular surgical procedure, while others showed no significant differences between diabetic and non-diabetic corneal endothelium.The purpose of this study is to investigate the differences in corneal endothelial cell density and morphology in diabetic patients and normal patients after phacoemulsification with intraocular lens implantation.To investigate if haemoglobin A1c can be used as a predictor of corneal endothelial cell changes after phacoemulsification.

Detailed description: Some studies indicated that the diabetic corneal endothelium is morphologically abnormal and may be at risk in any intraocular surgical procedure, while others showed no significant differences between diabetic and non-diabetic corneal endothelium.The purpose of this study is to investigate the differences in corneal endothelial cell density and morphology in diabetic patients and normal patients after phacoemulsification with intraocular lens implantation.To investigate if haemoglobin A1c can be used as a predictor of corneal endothelial cell changes after phacoemulsification.

Specular microscopy photos will be taken pre-. and 3 month postoperatively. Cellular parameters will be compared between the two groups prior and post surgery. Clinical significant difference is defined as 1 SD (300 cell/mm2)

Eligibility criteria: Inclusion Criteria:

* Cataract, diabetes

Exclusion Criteria:

* Corneal disease
* Uveitis
* Previous intraocular surgery and diabetes type I

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Frederiksberg Hospital
Study officials:
affiliation: Frederiksberg University Hospital
name: Allan V Storr-Paulsen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05747703: Telehealth Treatment for Alcohol Use Disorder
Official title: A Telehealth Intervention to Increase Screening and Treatment for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Alcohol Dependence
Alcoholism
Lead sponsor: Ria Health
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Stanford University
name: University of Washington
First posted: 2023-02-28
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants will be randomly assigned in a 1:1 to the Ria Treatment Platform or a waitlist control condition
Primary purpose: TREATMENT

Brief summary: Participants with alcohol use disorder will be randomly assigned to either the Ria Treatment Platform or a waitlist control. The Ria Treatment Platform is a telehealth approach that incorporates medical assessment, medications for alcohol use disorder, individual and group coaching, educational video modules, and a Bluetooth-enabled breathalyzer. Patients are followed for three months during which data are collected, including measures of alcohol consumption and its consequences.


Eligibility criteria: Inclusion Criteria:

* alcohol use disorder

Exclusion Criteria:

* inability to provide informed consent

Primary outcomes:
measure: percent of subjects without heavy drinking
timeFrame: last four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Ria Health
name: John Mendelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03033303: A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma
Official title: Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin for Consolidation of First Remission of Patients With High-Risk Neuroblastoma: A Phase II Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Neuroblastoma
Keywords: Hu3F8
GM-CSF
Isotretinoin
16-1643
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Y-mAbs Therapeutics
First posted: 2017-01-26
Enrollment: 59
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In this phase II single arm trial, patients with HR-NB in first CR or VGPR undergo consolidation by using hu3F8/GM-CSF.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test see the combined effects of the study drug called Humanized 3F8 (Hu3F8) when used with granulocyte-macrophage colony stimulating factor (GM-CSF). Hu3F8 plus GM-CSF could prevent your neuroblastoma from growing, but it could also cause side effects.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of NB as defined by a) histopathology (confirmed by the MSK Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels.
* Patients must have high-risk NB (MYCN-amplified stage 2/3/4/4S of any age and MYCN-nonamplified stage 4 in patients greater than 18 months of age).
* Patients must be in first CR/VGPR
* Patients must have a negative human anti-hu3F8 antibody (HAHA) titer

Exclusion Criteria:

* Existing major organ dysfunction, i.e., renal., cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity ≥ grade 3, with the exception of hearing loss and hematologic toxicity.
* Active life-threatening infection.
* Inability to comply with protocol requirements

Primary outcomes:
measure: relapse-free survival (RFS)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Brian H. Kushner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03228303: Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia
Official title: Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Chronic Myeloid Leukemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 100
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: Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Detailed description: Study size is 100 patients in 2 arms 50 patients in nilotinib ttt 50 patients in imatinib ttt

Eligibility criteria: Inclusion Criteria:

* chronic phase CML not received treatment
* Pts with no heart disease
* Pts with no abnormal cholesterol level

Exclusion Criteria:

* Any pts treated before with diff. Treatment
* Pts. With past history of heart problems
* Pts. With abnormal cholesterol level

Primary outcomes:
measure: Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Overall survival rate in years
timeFrame: 3 years cutoff
measure: Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Cholesterol level in mg
timeFrame: 3 years cutoff
measure: Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Heart state by assessment by ECG
timeFrame: 3 years cutoff
measure: Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Free survival rate in years
timeFrame: 3 years cutoff
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02281903: Pediatric Resuscitation With Feedback CPR Devices
Official title: Is Chest Compressions Using the TrueCPRTM Feedback Device More Effective Than Manual Compressions During Pediatric Resuscitation? A Manikin Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-04
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the TrueCPR feedback device (with metronome) to standard basic life support (BLS) in terms of the quality of single rescuer pediatric resuscitation. Therefore, our hypothesis was that there would be no difference between both CPR methods in terms of chest compression quality parameters.

Detailed description: Cardiac arrest is a leading cause of death worldwide. High-quality chest compressions are of paramount importance for survival and good neurological outcome. Unfortunately, even health professionals have difficulty performing effective CPR. Chest compression (CC) is often too shallow, compression ratio is inadequate, and hands-off time is too long. CPR feedback devices might be an option for rescuers to in order to increase CC efficiency.

Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* medical profession (paramedics, nurses, physicians) or medical students (nurses, paramedics, physicians)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases

Primary outcomes:
measure: Effective compressions compression with correct depth (40-50mm), correct hand position and complete decompressions
timeFrame: 1 month
Secondary outcomes:
measure: effective compressions ratio effective compressions [%] multiplied by flow time [%]
timeFrame: 1 month
measure: Flow time sum of all periods during which chest compressions were performed.
timeFrame: 1 month
measure: absolute hands-off time sum of all periods without chest compressions or ventilation
timeFrame: 1 month
measure: Compression depth compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer
timeFrame: 1 month
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: Institute of Cardiology
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References: