louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06587282: PREEMIE: Study for Treatment of PDA in Premature Infants
Official title: Multicenter, Single Arm Prospective, Non-Randomized Study Designed to Evaluate the Safety and Effectiveness of the BLOOM™ Micro-Occluder System for the Treatment of Patent Ductus Arteriosus (PDA) in Pre-mature Infants (PREEMIE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patent Ductus Arteriosus (PDA)
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 55
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in pre-mature infants over a period of 6 months.


Eligibility criteria: Inclusion Criteria:

* Subject is age ≥5 days at time of enrollment.
* Subject has a diagnosis of a hemodynamically significant patent ductus arteriosus (PDA) requiring closure.
* Subject has a PDA is ≤4.0 mm in diameter.
* Subject has a PDA is ≥5 mm in length.
* Subject's weight is between 600-2500 grams at time of enrollment.

Exclusion Criteria:

* Subject has pre-existing coarctation of the aorta.
* Subject has pre-existing left pulmonary artery stenosis.
* Subject has an Intracardiac thrombus that may interfere with the implant procedure
* Subject has other known hemodynamically significant congenital heart disease conditions at time of enrollment requiring intervention, e.g., valvular atresia, Tetralogy of Fallot, atrial septal defect, ventricular septal defect, transposition of the great vessels, etc.
* Subject has an active systemic infection at the time of enrollment.

Primary outcomes:
measure: Safety Endpoint
timeFrame: 30 days
measure: Effectiveness Endpoint
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health
state: California
city: San Diego
country: United States
facility: UC San Diego-Rady Children's Hospital
state: California
city: Hollywood
country: United States
facility: Memorial Healthcare System-Joe DiMaggio Children's Hospital
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Saint Louis
country: United States
facility: Washington University-St. Louis Children's Hospital
state: Missouri
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Milwaukee
country: United States
facility: Herma Heart Institute-Children's Wisconsin
state: Wisconsin
Study officials:
affiliation: Rady Children's Hospital
name: Howaida El-Said, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02540382: Comparison of Covered and Bare Stent in TIPS
Official title: Comparison of Covered and Bare Stent in TIPS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Keywords: TIPS
Hepatocellular Carcinoma
Portasystemic Shunt
Lead sponsor: Beijing Shijitan Hospital, Capital Medical University
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators aim to compare the efficacy of 8 mm Fluency covered stent and bare stent in transjugular intrahepatic portosystemic shunt (TIPS) for the treatment of cirrhotic portal hypertension.

Detailed description: From January 2006 to December 2010, the covered (experimental group) or bare stent (control group) was used in 131 and 127 patients, respectively. The recurrence rates of gastrointestinal bleeding and refractory hydrothorax/ascites, the cumulative restenosis rates in 1, 2, 3, 4, and 5-years, the incidence rate of hepatic encephalopathy, the rate of secondary interventional therapy, the 1, 2, 3, 4 and 5-year survival rates were compared between the experimental group and the control group.

Eligibility criteria: Inclusion Criteria:

1. portal hypertension patients with defined indications for TIPS treatment;
2. scheduled for elective TIPS; and
3. aged between 18-70 years.

Exclusion Criteria:

1. combined with hepatic encephalopathy before the treatment;
2. combined with portal vein thrombosis;
3. combined with malignant liver tumor or malignancies at the other sites; or
4. combined with hemorrhage of gastrointestinal ulcer.

Primary outcomes:
measure: restenosis/occlusion rate
timeFrame: up to 5 years
Secondary outcomes:
measure: recurrence rate of gastrointestinal bleeding
timeFrame: up to 5 years
measure: recurrence rate of refractory hydrothorax/ascites
timeFrame: up to 5 years
measure: survival rate
timeFrame: up to 5 years
measure: rate of secondary interventional therapy
timeFrame: up to 5 years
measure: incidence rate of hepatic encephalopathy
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital
state: Beijing
Study officials:
affiliation: Beijing Shijitan Hospital, Capital Medical University
name: Jianli Xu, MD, PhD
role: STUDY_CHAIR
References:
citation: Li HB, Yue ZD, Zhao HW, Wang L, Fan ZH, He FL, Dong XQ, Liu FQ. Pathological Features of Mitochondrial Ultrastructure Predict Susceptibility to Post-TIPS Hepatic Encephalopathy. Can J Gastroenterol Hepatol. 2018 Jul 16;2018:4671590. doi: 10.1155/2018/4671590. eCollection 2018.
Clinical trial NCT00130182: A Study in Pediatric Patients With Cystic Fibrosis Lung Disease
Official title: A Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Pediatric Patients With Cystic Fibrosis Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Keywords: lung disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-15
Enrollment: 13
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and effectiveness of two dose strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (CF).


Eligibility criteria: Inclusion Criteria:

* Have confirmed diagnosis of CF
* Have an FEV1 greater than or equal to 60%
* Have oxygen saturation greater than or equal to 90% on room air
* Be clinically stable for at least 4 weeks prior to screening
* Be able to reproducibly perform spirometry maneuvers

Exclusion Criteria:

* Have clinically significant comorbidities
* Have changed their physiotherapy technique or schedule within 7 days prior to screening
* Using prior and concurrent medications according to protocol

Primary outcomes:
measure: respiratory function
Secondary outcomes:
measure: adverse events
measure: change in standard safety parameters
measure: pulmonary exacerbation
Other outcomes:
Locations:
city: Denver
country: United States
facility: The Children's Hospital
state: Colorado
city: Minneapolis
country: United States
facility: General Clinic Research Center University of Minnesota
state: Minnesota
city: Minneapolis
country: United States
facility: The Minnesota CF Center
state: Minnesota
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Amy Schaberg, BSN
role: STUDY_DIRECTOR
References:
Clinical trial NCT01047982: Myo-inositol in Obese Pregnant Women
Official title: Myo-inositol May Prevent Gestational Diabetes in Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: gestational diabetes
macrosomia
hypertension in pregnancy
HOMA-IR
obesity
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2010-01-13
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two hundred and twenty obese pregnant women will be included in the trial and, after an informed consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at 24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be registered.


Eligibility criteria: Inclusion Criteria:

* Obese pregnant women: BMI \> 30 Kg/cm2
* first trimester fast glycaemia \< 126 mg/dl
* single pregnancy

Exclusion Criteria:

* Pregnant women with BMI \< 30 Kg/cm2
* first trimester fast glycaemia \> 126 mg/dl
* previous gestational diabetes
* twin pregnancy
* pregestational diabetes
* associated therapies with corticosteroids

Primary outcomes:
measure: number of gestational diabetes cases diagnosed with OGTT
timeFrame: 24-28th weeks gestation
measure: difference in HOMA values
timeFrame: from first trimester to OGTT
Secondary outcomes:
measure: incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc.
timeFrame: at delivery
Other outcomes:
Locations:
city: Messina and Modena
country: Italy
facility: Obstetrics and Gynecology Unit, University of Messina and Obstetrics and Gynecology Unit of Modena University
Study officials:
affiliation: University of Messina, ITALY
name: Rosario D'Anna, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: D'Anna R, Di Benedetto A, Scilipoti A, Santamaria A, Interdonato ML, Petrella E, Neri I, Pintaudi B, Corrado F, Facchinetti F. Myo-inositol Supplementation for Prevention of Gestational Diabetes in Obese Pregnant Women: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):310-315. doi: 10.1097/AOG.0000000000000958.
Clinical trial NCT01990482: Influence of Coffee Intake on Postoperative Bowel Function After Comprehensive Staging Surgery for Gynecological Malignancies: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ilues
Lead sponsor: Erzincan Military Hospital
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 118
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A delay in the return of normal bowel function with the passage of flatus and feces is one of the most important factors affecting early recovery and discharge in patients undergoing open complete staging surgery for gynecological malignancies. A prolonged hospital stay increases the risk of hospital-acquired infections, deep vein thrombosis, pulmonary compromise and total hospital costs.

The aim of this study was to assess the effectiveness of coffee intake on postoperative bowel function in patients undergoing abdominal complete staging surgery for gynecological malignancies.


Eligibility criteria: Inclusion Criteria:

* Female patients preparing for complete surgical staging for malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancerwere assessed for eligibility. Exclusion Criteria: Exclusion criteria for the study
* included thyroid diseases,
* inflammatory bowel disease,
* complaints of chronic constipation (defined as two or fewer bowel movements per week),
* a history of prior abdominal bowel surgery, abdominal radiation, neoadjuvant chemotherapy,
* need for intensive care more that 24 hpostoperatively,
* nasogastric tube drainage beyond the first postoperative morning,
* bowel anastomosis and upper abdominalmultivisceral surgical approaches in relation to the debulking surgery.

Primary outcomes:
measure: time to first flatus
timeFrame: within the first 30 days after surgery
Secondary outcomes:
measure: time to tolerance diet
timeFrame: within the first 30 days after surgery
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Tepecik Education Research Hospital
state: Tepecik
Study officials:
References:
Clinical trial NCT06874582: Evaluation of Individuals with Partial or Finger Amputation After Silicone Prosthesis Use
Official title: EVALUATION of QUALITY of LIFE, PSYCHOSOCIAL ADAPTATION, and FUNCTIONALITY in SILICONE PROSTHESIS USERS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Quality of Life
Psychosocial Adaptation
Silicone Prosthesis
Functionality
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: This study aimed to evaluate the psychosocial adaptation, functional capacity, and quality of life of individuals who underwent partial hand or foot amputations after using silicone hand and foot prostheses.

Materials and Methods: The study included 32 patients. Demographic and clinical characteristics of the participants were recorded. Participants were divided into two groups as silicone hand or foot prosthesis users. The Visual Analog Scale (VAS) was used to assess pain levels before and after prosthesis use, the Trinity Amputation and Prosthesis Experience Scales (TAPES) were applied to evaluate functional capacity, and the Nottingham Health Profile (NHP) was used to assess quality of life.


Eligibility criteria: Inclusion Criteria:

* Hand and foot amputation.
* Aged between 18 and 60 years
* Active employee
* Able to walk, co-operate, move actively with hands
* Who have been using prosthesis for at least 1 year and have good stump-socket compatibility,
* Literate individuals were determined on a voluntary basis.

Exclusion Criteria:

* Multiple amputations
* Severe neurological or traumatic findings
* Individuals with severe deformity or posture disorder that may lead to loss of gait, balance or function.
* With limitation of movement in the upper extremities

Primary outcomes:
measure: Nottingham Health Profile (NHP)
timeFrame: through study completion, an average of 1 year
measure: Trinity Amputation and Prosthesis Experience Scales (TAPES)
timeFrame: through study completion, an average of 1 year
measure: Visual Analog Scale(VAS)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
References:
Clinical trial NCT01436682: Assisted Nerve Blocks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: Nerve Blocks
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient undergoing surgery which necessitates a peripheral nerve block to relieve postoperative pain.

Brief summary: The study investigates assisted nerve blocks using an ultrasound machine.


Eligibility criteria: Inclusion Criteria:

* indication for nerve blocks

Exclusion Criteria:

* patient not able to provide the informed consent
* allergy to local anesthetics

Primary outcomes:
measure: Feasability of assisted nerve blocks
timeFrame: 24h
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT02502682: Chlorhexidine Bathing Effect on Clostridium Difficile Rates
Official title: Effect of Daily Chlorhexidine Bathing on Clostridium Difficile Rates on the General Medical Floor in Patients Receiving Antibiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clostridium Difficile
Keywords: Chlorhexidine bathing
Lead sponsor: Northwestern Medicine
Sponsor class: OTHER
Collaborators: name: Northwestern Medicine
First posted: 2015-07-20
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Clostridium difficile (C. diff.) infections, whether nosocomial or community borne, may present with profound diarrhea, especially in those patients receiving antibiotics. Based on a preliminary review of hospital data, the investigators have found that these symptomatic c. diff infections occur with a relatively high incidence at Delnor Hospital. Notwithstanding their high mortality, one recent study attributes a near quadrupling of hospitalization costs to c. diff infections. Chlorhexidine baths have been shown in multiple randomized trials to help reduce the incidence of highly virulent pathogens and hospital acquired infections. Further, several studies show a favorable effect of reducing the incidence of c. diff infections by using Chlorhexidine baths on ICU patients. Far fewer studies, however, have focused on the effects of these baths on general medical/surgical wards. This investigation seeks to study the effect of the daily use of 2% Chlorhexidine gluconate wipes in patients on the general medical/surgical wards who are exposed to antibiotics for a suspected or confirmed infection.


Eligibility criteria: Inclusion Criteria:

* Prescription of antibiotics for suspected or confirmed infection.
* Admitted to the 2600 General/Medical ward at Delnor Hospital.

Exclusion Criteria:

* Antibiotics only for surgical prophylaxis
* Not mentally capable
* Cannot provide consent in English
* Pregnant
* Documented chlorhexidine allergy
* Patient is a prisoner
* Health system employee

Primary outcomes:
measure: Number of participants with Relative Risk of C-diff infection
timeFrame: up to 12 months
measure: Duration of Hospital stays
timeFrame: expected average of six days
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: United States
facility: Northwestern Medicine - Delnor Hospital
state: Illinois
Study officials:
affiliation: Hospitalist - Northwestern Medicine Regional Medical Group
name: Brian Poustinchian, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03053882: Efficacy of Peppermint and Green Tea in Malodor
Official title: Comparative Study of the Effects of Green Tea and Peppermint Herbal Mouthwash on Halitosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bad Breath
Keywords: mouth wash , green tea , peppermint , bad breath
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background:

Herbal remedies can have the role of prevention and control of bad breath Since in the previous studies, therapeutic and antibacterial effect of green tea and peppermint had been proven .we studied and compared the effects of green tea and peppermint mouthwashes on halitosis.

Materials and Methods:

This single-blind clinical trial study with cross over design total of 88 volunteer dental students who complained bad breath and had organoleptic score (\>= 2) and higher average test scores were enrolled. The students were divided randomly into two groups Green Tea - Peppermint were assigned. Organoleptic test in the baseline, on the 7 day, 14 and 21 measured after rinsing the mouthwashes .As well as the satisfaction of both plants on the last day was considered. Data analysis was performed using tests; Wilcoxon signed rank test, Mann Whithney u, GEE (Generalized Estimating Equation -ordinal logistic regression).


Eligibility criteria: Inclusion Criteria:

organoleptic number equal to or higher 2 no foods (garlic and onion) 48 hours before organoleptic test

Exclusion Criteria:

systemic disease

* use of antibiotics during study use of other mouthwash during study

Primary outcomes:
measure: evaluation of changes in organoleptic score
timeFrame: baseline,7 days,14 days,21 days
Secondary outcomes:
measure: satisfaction of patients
timeFrame: 21 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06084182: Cognitive Function in Multiple Sclerosis
Official title: The Relationship Between Cognitive Function and Functional Capacity, Cognitive Reserve, Reaction Time in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
cognitive function
cognitive reserve
functional capacity
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to investigate the relationship between cognitive function, functional capacity, cognitive reserve and reaction time in patients with multiple sclerosis.

Detailed description: Cognitive impairment in patients with MS is a common problem that significantly affects quality of life. It shows an association between functional capacity and physical fitness levels and cognition in non-MS populations, and especially in the elderly.

Although cognitive dysfunctions are known, few studies have been found on its relationship with secondary problems caused by the disease and its correlation with other symptoms.

Eligibility criteria: Inclusion Criteria:

* Relapsing-remitting MS diagnosis
* Expanded Disability Status Scale score \<5.5
* Being able to use a smart phone
* No relapse during the last 30 days
* Being between the ages of 18-65
* Mini-Mental State Examination score\>24

Exclusion Criteria:

* Severe Visual Impairment
* Severe Psychiatric Disorder,
* Severe Arthritis in Knee or Hip,
* Pregnancy and other neurological or vestibular disorders that may prevent the patient from completing the functional examination

Primary outcomes:
measure: Functional capacity assessment
timeFrame: Baseline
measure: Functional capacity assessment
timeFrame: baseline
measure: Cognitive function
timeFrame: Baseline
measure: Visiospatial perception
timeFrame: Baseline
measure: Cognitive Reserve Index Questionnaire
timeFrame: Baseline
Secondary outcomes:
measure: Hand grip strength
timeFrame: Baseline
measure: Nottingham Health Profile.
timeFrame: Baseline
measure: Beck Depression Inventory
timeFrame: Baseline
measure: Fatigue Severity Scale.
timeFrame: Baseline
measure: Reaction time
timeFrame: Baseline
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Inonu University
name: Engin Ramazanoglu
role: STUDY_CHAIR
affiliation: Inonu University
name: Mehmet Tecellioglu
role: STUDY_CHAIR
References: