louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06137014: Fortified Oral Rehydration Therapy for Pediatric Diarrhea
Official title: Reduction of Severity and Duration of Pediatric Gastroenteritis Through Amino Acid Fortified Oral Rehydration Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Acute Gastroenteritis
Keywords: Gastroenteritis
Intestinal Diseases
Pediatric Diseases
Diarrhea, Infantile
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2023-11-18
Enrollment: 72
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare amino acid-fortified oral rehydration therapy (ORT) to the standard of care ORT in pediatric patients with acute gastroenteritis (AGE). The main questions it aims to answer are:

* can amino acid-fortified ORT reduce the duration and severity of AGE compared to standard of care ORT?
* can amino acid-fortified ORT increase the secretion of antimicrobial peptides in the gastrointestinal tract compared to standard of care ORT?

Participants will be assigned to the experimental treatment (amino acid-fortified ORT) or the standard of care ORT and their disease severity, duration, and stool antimicrobial peptide content.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 6 months and 5 years.
* Experiencing mild to moderate acute gastroenteritis for less than two (2) days before admission to Pediatric Emergency Department.
* Diarrhea presumed infectious

Exclusion Criteria:

* Severe gastroenteritis with moderate to severe dehydration
* Requiring inpatient care
* Requiring antibiotics
* Requiring IV rehydration
* History of chronic diarrhea
* Presenting with diarrhea for greater than 2 days prior to admission
* Allergy to any of the ingredients in the study products
* Inborn metabolic disorder of amino acids
* Receives post-pyloric feedings

Primary outcomes:
measure: Daily Stool Frequency
timeFrame: Up to 14 days
measure: Daily Stool Mass
timeFrame: Up to 14 days
measure: Duration of Diarrhea
timeFrame: Up to 14 days
Secondary outcomes:
measure: Consumption of Study Intervention
timeFrame: Up to 14 days
measure: Stool Consistency
timeFrame: Up to 14 days
measure: Body Weight
timeFrame: Up to 14 days
measure: Stool Human Beta-Defensin-2 Content
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Paul Breslin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03246295: Identification of Gestational Diabetes Mellitus Related Urinary Biomarkers Along Pregnancy (From Early Pregnancy to Postpartum) by Using Proteomics and Metabolomics Analysis
Official title: Identification of Gestational Diabetes Mellitus Related Urinary Biomarkers Along Pregnancy (From Early Pregnancy to Postpartum) by Using Proteomics and Metabolomics Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Diabetes Mellitus
Keywords: Proteomics
Metabolomics
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women were recruited in early pregnancy, and followed up to 6 weeks postpartum

Brief summary: Gestational diabetes mellitus (GDM) has many adverse effects on pregnant women and fetuses. At present, no prediction marker for GDM in early pregnancy is accepted. There is still a lack of recognized early predictors. This study was designed to identity valuable biomarkers for GDM.This was a prospective observed cohort study. 140 pregnant women were recruited in early pregnancy, and followed up to 6 weeks postpartum. Glucose challenge test and 75g oral glucose tolerance test were performed after 24 weeks of pregnancy, and GDM was diagnosed according to the latest ADA standard. Urinary samples were collected in the first (\<12 weeks), second (24\~28 weeks) and third (32\~weeks) trimester of pregnancy. Urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry. 15 cases of GDM women and 50 cases of control women were used for longitudinal analysis; 15 cases of GDM women and 15 cases of age matched control women were used for difference analysis.


Eligibility criteria: Inclusion Criteria:

-Pregnant women （\<12 weeks）

Exclusion Criteria:

* with renal dysfunction
* urine routine examination abnormalities for twice
* history of urinary and reproductive system diseases
* with other chronic diseases

Primary outcomes:
measure: Urinary samples were analyzed
timeFrame: in the first (<12 weeks) trimester of pregnancy
Secondary outcomes:
measure: Urinary samples were analyzed
timeFrame: in the second (24-28 weeks) trimester of pregnancy
measure: Urinary samples were analyzed
timeFrame: in the third (>32 weeks) trimester of pregnancy
Other outcomes:
Locations:
Study officials:
References:
citation: Liu X, Wang X, Sun H, Guo Z, Liu X, Yuan T, Fu Y, Tang X, Li J, Sun W, Zhao W. Urinary metabolic variation analysis during pregnancy and application in Gestational Diabetes Mellitus and spontaneous abortion biomarker discovery. Sci Rep. 2019 Feb 22;9(1):2605. doi: 10.1038/s41598-019-39259-2.
Clinical trial NCT03897595: Assess the Mid-term Performance of the Mpact Cup in Subjects Requiring Total Hip Arthroplasty
Official title: A Multi-centre, Prospective Post Marketing Surveillance Study to Assess Mid-term Performance of the Mpact Cup in Subjects Requiring Primary Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Osteoarthritis
Lead sponsor: Medacta USA
Sponsor class: INDUSTRY
First posted: 2019-04-01
Enrollment: 187
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.


Eligibility criteria: Inclusion Criteria:

* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.

  * Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use).
  * Patients must be willing to comply with the pre and post-operative evaluation schedule

Exclusion Criteria:

* Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study.

Primary outcomes:
measure: Change from baseline Harris Hip Scores (HHS)
timeFrame: Pre-operative, 3 or 6 months, 1 year, 2 year and 5 year
measure: Change from baseline of implant survivorship
timeFrame: Post-operative 3 or 6 months, 1 year, 2 year, and 5 year
measure: Change in baseline of Complications
timeFrame: Day of surgery, post-operative 3 or 6 months, 1 year, 2 year, and 5 year.
measure: Change in baseline fixation and wear
timeFrame: Post-operative 3 or 6 months, 1 year, 2 year and 5 year
measure: Change in baseline fixation
timeFrame: Post-operative 3 or 6 months, 1 year, 2 year and 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Parker
country: United States
facility: Denver Vail Orthopedics
state: Colorado
city: Boise
country: United States
facility: Saint Alphonsus Medical Group
state: Idaho
city: Libertyville
country: United States
facility: Illinois Bone and Joint Institute
state: Illinois
city: Oklahoma City
country: United States
facility: McBride Orthopedic Hospital
state: Oklahoma
city: West Jordan
country: United States
facility: Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence
state: Utah
Study officials:
References:
Clinical trial NCT01171495: Impact of Nutrition Intervention on HIV/AIDS Infected Patients
Official title: Phase 3 Study That Assesses the Impact of a Nutrition Intervention on HIV/AIDS Infected Patients: Kingston, Jamaica
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Human Immunodeficiency Virus (HIV)
Acquired Immune Deficiency Syndrome (AIDS)
Keywords: HIV/AIDS
Nutrition Therapy
Dietary Supplement
Antioxidant
Immunity
CD4 count
Anthropometry
Body Mass Index
Lead sponsor: Caribbean Health Research Council
Sponsor class: OTHER
Collaborators: name: The University of The West Indies
First posted: 2010-07-28
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intervention to investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.

Detailed description: To investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.

A total of 120 participants will be stratified by age and gender and randomly assigned to two treatment arms. Sixty (60) participants will be assigned to receive dietary counselling and a multivitamin/mineral supplement, with sixty (60) additionally receiving an oral Medical Nutritional Supplement (MNS).

Participants will be followed for six months post-randomization: at baseline, 3 months and 6 months. The principal outcome measure is Body Mass Index, used as a proxy for 'nutritional status'. Secondary outcome measures include immune status and antioxidant status.

Eligibility criteria: Inclusion Criteria:

* HIV positive individuals in the age range 18 to 50 years.
* Individuals whose CD4 count was between 300-550 cells/uL.
* Individuals who met the study criteria and were interested in being enrolled.
* Individuals not on ARV therapy.
* Women who were not pregnant.

Exclusion Criteria:

* On the clinician's advice, individuals could be excluded from enrollment.
* Individuals who were unable to carry out the study intervention e.g. homeless, impaired mental state etc.
* Individuals who were unlikely to complete follow-up based on pre-enrolment assessment.

Primary outcomes:
measure: Effects of nutritional intervention on anthropometry in HIV infected individuals.
timeFrame: 6 months
Secondary outcomes:
measure: Effects of nutritional intervention on the clinical and immune status in HIV infected individuals.
timeFrame: 6 months
Other outcomes:
Locations:
city: Kingston
country: Jamaica
facility: Comprehensive Health Centre
Study officials:
affiliation: University of the West Indies, Mona ,Jamaica, West Indies
name: Sharon M Dawson, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00823095: Topical Nitric Oxide Trial in Chronic Non-Healing Wounds
Official title: The Observational Effects of the Topical Application of ViaNOx-H (Gaseous Nitric Oxide) on the Bio-Burden in Chronic Non-Healing Colonized Ulcers of the Lower Extremities
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Ulcer of Lower Extremity
Keywords: chronic cutaneous ulcers
Nitric Oxide
topically applied
Biofilm
Colonized chronic non-healing ulcers
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Nitric BioTherapeutics, Inc
First posted: 2009-01-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the effects of topically applied ViaNOx-H for 8 hours daily for 2 weeks on the reduction of the bio-burden in biofilms on chronic non-healing wounds as recorded by measurements of wound size and wound culture.

Detailed description: The primary goal of this study is to determine the effects of topically applied gaseous nitric oxide on the bio-burden of chronic non-healing wounds of the lower extremities. Reports will include:

* Comparisons of the demographics and diagnoses of those patients treated with ViaNOx-H.
* Tabulation as to the organisms found and the bio-burden as measured by counts (0 to +4).
* Tabulation of the number and types of adverse events during ViaNOx-H treatment.
* Comparisons of the response of different organisms to ViaNOx-H treatment.

Eligibility criteria: Inclusion Criteria:

* Have a chronic (\> 8 weeks duration) colonized cutaneous ulcer (defined as a wound containing a local margin of erythema, edema or tenderness; presence of exudates; and/or presence of a malodorous smell)in their lower extremity (below the knee) resulting from either diabetes or venous stasis disease.
* Are 18 years of age or older.

Exclusion Criteria:

* Have had a change in their topical treatment during the last 4 weeks
* Have evidence of Clinical Infection
* Have a transcutaneous oxygen tension \<30mmHg
* Have evidence of the ulcer or infection extending to the underlying muscle or bone.
* Are pregnant.
* Are less than 18 years of age.

Primary outcomes:
measure: The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.
timeFrame: at 28 days post enrollment
Secondary outcomes:
measure: The Secondary Endpoint Measure is a Reduction on Wound Size.
timeFrame: 28 days post enrollment
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University Medical Center
name: Takkin Lo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01168414: A Study of Ganfort Versus Duotrav in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Official title: A Randomized, Comparison of the Effects of Ganfort and Duotrav on Intraocular Pressure in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Open Label/Evaluator-blind/Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Hypertension
Primary Open Angle Glaucoma
Lead sponsor: Ministry of Health, Malaysia
Sponsor class: OTHER_GOV
First posted: 2010-07-23
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single-center, cross-over comparison parallel group randomized trial designed to evaluate the efficacy and safety of Ganfort compared to Duotrav for a treatment period of 8 weeks each.


Eligibility criteria: Inclusion Criteria:

1. Visual acuity 6/60 or better
2. Patients who are controlled (IOP \< 21 mmHg) on non-fixed combination of Latanoprost \& Timolol for at least 3 months before the baseline visit and
3. Patients on mono-therapy either Latanoprost or Timolol who are eligible for dual therapy being not satisfactorily controlled (IOP\>21mmHG)

Exclusion Criteria:

1. Angle closure glaucoma
2. Neovascular Galucoma
3. Secondary open angle glaucoma
4. Ocular infection/inflammation within 3 months
5. Ocular surgery within 3 months
6. History of Refractive surgery
7. Argon laser trabeculoplasty/Selective laser trabeculoplasty
8. Pregnancy/nursing
9. Hypersensitivity to benzalkonium chloride or to any other components of the trial drugs solution.
10. Patients in whom beta-blockers are contraindicated
11. Patients on any drugs known to affect IOP.

Primary outcomes:
measure: Mean intraocular pressure of the 12-hour IOP curve
timeFrame: 8 weeks
Secondary outcomes:
measure: Mean intraocular pressure
timeFrame: 12 hours
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Ophthalmology Department, Hospital Kuala Lumpur
state: Wilayah Persekutuan
Study officials:
References:
Clinical trial NCT02981095: Effect of Bupivacaine Application on Postthyroidectomy Pain
Official title: Bupivacaine Application Reduces Postthyroidectomy Pain: Cerrahpaşa Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Disease
Analgesia
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 91
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: Investigators aimed to evaluate the impact of bupivacaine administration into the surgical field after total thyroidectomy on post-operative pain and analgesic requirement with a double-blind, prospective, clinical, randomized study.

Pain assessment was performed with the visual analog score (VAS). Participants were pre-operatively, divided into two groups randomly to receive either bupivacaine or not. One group received a 10 ml of bupivacaine solution while the other group was treated with the same volume of 0.9% sodium chloride (NaCl) through the drain after completion of total thyroidectomy procedure. All participants were anesthetized and operated with the same anesthesia and surgical team.


Eligibility criteria: Inclusion Criteria:

* Subjects need to be operated for thyroid diseases

Exclusion Criteria:

* History of previous thyroid disease,
* History of previous neck operations,
* Hypersensitivity to the drugs that were used in the study protocol,
* Spinal bone disease,
* Depression,
* Kidney failure,
* Heart failure,
* Liver failure,
* Pulmonary failure,
* Mental retardation,
* Subjects not able to ascertain pain scoring with the visual analog score (VAS),
* Patients with American Society of Anesthesiologists (ASA) scores III or higher,
* Expected airway difficulty according to Mallampati scores,
* Sedative, steroid, and chronic analgesic drug users,
* Alcoholics

Primary outcomes:
measure: Post-operative pain in 8 hours after surgery using VAS
timeFrame: 8th hour
Secondary outcomes:
measure: Post-operative pain in in first post-operative day using VAS
timeFrame: 1 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Cerrahpasa Medical Faculty
Study officials:
affiliation: Istanbul University
name: Yusuf BUKEY, Prof. MD
role: STUDY_CHAIR
References:
Clinical trial NCT00911495: Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease
Official title: Phase 1/Phase 2 Study of the Safety, Pharmacokinetics, and Microvascular Effect of Titrating Doses of Intravenous GMI-1070, a Pan-Selectin Inhibitor, in Adults With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Disease
Lead sponsor: GlycoMimetics Incorporated
Sponsor class: INDUSTRY
First posted: 2009-06-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Phase 1/Phase 2 study will evaluate GMI-1070, a pan-selectin inhibitor, in adults with stable sickle cell disease. The study will assess safety, pharmacokinetics, and microvascular effects of intravenous GMI-1070 in the outpatient setting.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 45 years
* Established diagnosis of SCD-SS or SCD-SB0-thal
* At medical baseline, with no evidence of worsening of disease over the last 3 months
* Available and agree to return for follow-up visits for the full duration of the study
* Able to cooperate with study procedures
* Documented and observed written informed consent

Exclusion Criteria:

* Vaso-occlusive crisis
* Recent major surgery, hospitalization, infection, significant bleeding, cerebrovascular accident or seizure, or transfusion
* Currently receiving, or has received within the previous 4 weeks, any other investigational agent
* Pregnant or lactating female; or female of childbearing age unable or unwilling to comply with birth control or abstinence during the course of the study

Primary outcomes:
measure: Safety as Measured by the Number of Participants With Adverse Events
timeFrame: 28 days
Secondary outcomes:
measure: Total Plasma Clearance
timeFrame: 48 hours
measure: Volume of the Central Compartment
timeFrame: 48 hours
measure: Intercompartmental Clearance
timeFrame: 48 hours
measure: Volume of the Peripheral Compartment
timeFrame: 48 hours
Other outcomes:
measure: Blood Flow and Biomarkers of Adhesion
timeFrame: 48 hours
Locations:
city: Oakland
country: United States
facility: Children's Hospital & Research Center Oakland
state: California
city: Sacramento
country: United States
facility: University of California at Davis, CCRC
state: California
city: Durham
country: United States
facility: Duke Comprehensive Sickle Cell Center
state: North Carolina
Study officials:
affiliation: GlycoMimetics Incorporated
name: Helen Thackray, MD
role: STUDY_DIRECTOR
References:
citation: Wun T, Styles L, DeCastro L, Telen MJ, Kuypers F, Cheung A, Kramer W, Flanner H, Rhee S, Magnani JL, Thackray H. Phase 1 study of the E-selectin inhibitor GMI 1070 in patients with sickle cell anemia. PLoS One. 2014 Jul 2;9(7):e101301. doi: 10.1371/journal.pone.0101301. eCollection 2014.
Clinical trial NCT04736095: 3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas
Official title: 3 Dimensional Ultrasound in Comparison to Hysteroscopy in Diagnosis of Myomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibroid
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2021-02-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women between 20 and 60 years with abnormal uterine bleeding

Brief summary: • three-dimensional saline infusion sonohysterography (3D SIS) was performed in all cases. A sterile Cuscoe speculum was passed, the cervix visualized and cleaned with sterile chlorhexidine solution. A 3.3 mm soft plastic paediatric naso-gastric suction catheter was then passed through the cervix into the uterine cavity without grasping the cervix.

Detailed description: The speculum was removed and a 5 MHz transvaginal 3D ultrasound probe inserted into the vagina (Voluson 730; KretzTechnik, Austria).

Eligibility criteria: Inclusion Criteria:

* • Women between 20 and 60 years with abnormal uterine bleeding in form of heavy menstrual bleeding, irregular and heavy menstrual bleeding) diagnosed on non-enhanced two-dimensional ultrasonography with submucous fibroids.

  * Absence of STD, PID, active vaginal bleeding.

Exclusion Criteria:

* Presence of general cause of abnormal uterine bleeding

  * History of drug use that can cause vaginal bleeding (anticoagulants, OCPs, HRT)
  * History of recent hormonal treatment
  * High risk of undergoing hysteroscopy
  * Vaginal, Vulval causes of bleeding

Primary outcomes:
measure: The accuracy of 3D ultrasound in doiagnosis of submucous myomas in comparison to hysteroscopy
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
city: Giza
country: Egypt
facility: Aljazeera( Al Gazeera) hospital
Study officials:
affiliation: Algezeera hospitaland National Research Centre ,Egypt
name: Mahmoud Alalfy, PhD
role: STUDY_CHAIR
References: