louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00496899: Clinical Evaluation of New Computerized Labor Monitoring System
Official title: Clinical Evaluation of New Computerized Labor Monitoring System.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obstetrics
Labor
Keywords: Labor
Obstetric
cervical dilatation
Lead sponsor: Barnev Ltd
Sponsor class: OTHER
First posted: 2007-07-06
Enrollment: 3
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Laboring women reffered to maternity center in active labor (3 -7 cm)dilatation and contraction

Brief summary: The study is an open label feasibility study. The purpose of the study is to evaluate the ease of use of the Cervical ITR in terms of duration of attachment and number of detachments.

Detailed description: Every year, millions of babies are born worldwide. Yet, despite great advances in medical technology, the method used to obtain the most critical parameter in labor management - cervix dilatation, remains a vaginal (manual) examination. This vaginal examination, intended to estimate the dilatation of the cervix and the progress of the baby's head, is inaccurate, non-continuous and involves the risk of infection to both fetus and mother. It is also uncomfortable to the mother. The consequences of infections or delayed treatment may range from simple complications to irreversible damage. Early detection of abnormal patterns of labor progress could prevent complications and shorten the labor process and hospitalization, thereby saving both aggravation and cost.

To truly manage the labor process, a labor management system is required. Such a system is expected to provide the obstetrical staff with the flow of accurate, continuous, real-time information, such as cervix dilatation.

Eligibility criteria: Inclusion Criteria:

* Laboring women referred to the Maternity Center in active labor (3cm dilatation and contractions).
* Gestational age 37-42 weeks. (GA)
* Single fetus
* Subjects who understood, agreed and signed the informed consent form

Exclusion Criteria:

* Women with abnormal placentation (placenta previa)
* Women with coagulation abnormalities.
* Abnormal fetal presentation (breech presentation)
* Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes.
* Preterm premature rupture of membranes.
* Need for immediate delivery (cord prolapsed or suspected placental abruption

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel - Aviv
country: Israel
facility: Tel Aviv soraski medical center
Study officials:
affiliation: Sackler school of medicine, Tel Aviv University
name: Ariel Many, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05694299: Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes
Official title: Nasal Bridle Versus Nasal Patch for Fixation of Nasoenteral Feeding Tubes: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Feeding Tube Complication
Feeding Disorders
Lead sponsor: Gelre Hospitals
Sponsor class: OTHER
Collaborators: name: Medisch Spectrum Twente
First posted: 2023-01-23
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim of this study is to compare fixation of nasoenteral feeding tubes using either a nasal patch or a nasal bridle in clinical patients with regard to the occurrence of tube dislocation, complications, and discomfort. 78 (2 \* 39) eligible patients will be included in this randomized controlled trial. The study is executed in two general teaching hospitals in the Netherlands (Gelre Hospitals Apeldoorn and Medical Spectrum Twente).


Eligibility criteria: Inclusion Criteria:

* adult patient (18 years or older)
* received a nasoenteral feeding tube while being hospitalized
* providing written informed consent

Exclusion Criteria:

* contraindication for a nasal bridle (e.g., cleft lip or damaged nasal mucosa)
* clinical need to place a nasal bridle
* anticipated feeding nasoenteral feeding tube placement for \< 3 days
* failure of nasoenteral feeding tube placement

Primary outcomes:
measure: Premature dislocation of feeding tube
timeFrame: Within 14 days after initial placement of the feeding tube
Secondary outcomes:
measure: Complications related to fixation of the feeding tube
timeFrame: During the 14-day period after initial placement of the feeding tube
measure: Pain experienced from the nasal fixation
timeFrame: During the 14-day period after initial placement of the feeding tube
measure: Discomfort experienced from the nasal fixation
timeFrame: During the 14-day period after initial placement of the feeding tube
Other outcomes:
Locations:
city: Apeldoorn
country: Netherlands
facility: Gelre Hospitals
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
Study officials:
affiliation: Gelre Hospitals
name: Mariël Klos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04320199: Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease
Official title: Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcoholic Liver Disease
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Fermented Protaetia brevitarsis seulensis powder on Alcohol-induced Liver Disease in adults for 8 weeks.

Detailed description: Previous studies have indicated that Fermented Protaetia brevitarsis seulensis powder may have the ability to improve liver function in adults with alcohol-induced liver disease. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Fermented Protaetia brevitarsis seulensis powder on liver function in adults with alcohol-induced liver disease; the safety of the compound are also evaluate. The Investigators examine gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, and other metabolic parameters at baseline, as well as after 4 and 8 weeks of intervention. Sixty adults were administered either 4,000 mg of Fermented Protaetia brevitarsis seulensis powder or a placebo each day for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Gamma-glutamyl transferase ranging from upper limit of reference to four times of upper limit

Exclusion Criteria:

* Abnormal liver or renal function (i.e., serum aminotransferase activity \> 3 times of upper limit of reference range and serum creatinine concentrations \> 1.2 mg/dL)
* Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL)
* History of viral hepatitis or cancer
* Uncontrolled hypertension
* History of serious cardiac disease such as angina or myocardial infarction
* History of gastrectomy
* History of medication for psychiatric disease
* Administration of oriental medicine including herbs within the past 4 weeks

Primary outcomes:
measure: Concentration of Gamma-Glutamyl Transpeptidase
timeFrame: 8 weeks
Secondary outcomes:
measure: Concentration of Aspartate aminotransferase
timeFrame: 8 weeks
measure: Concentration of Alanine aminotransferase
timeFrame: 8 weeks
measure: Fatigue Severity Scale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Ami-dong
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05336799: Prevalence and Environmental Factors for Myopia Among Chinese School-aged Children and Adolescent in Tianjin
Official title: Prevalence and Environmental Factors for Myopia Among Chinese School-aged Children and Adolescent in Tianjin
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myopia
Refractive Errors
Keywords: Myopia
Socioeconomics
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 500000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All school-aged children and adolescents completed the vision screening in the included school.

Brief summary: The high prevalence of myopia has become a global public health problem. The study amied to investigate the prevalence and progression of myopia associated with social environmental factors in Tianjin, a Chinese megacity in north China.

Detailed description: The high prevalence of myopia has become a global public health problem, especially in East and South Asian countries. It's still not clear for the prevalence and progression of myopia associated with social environmental factors. Thus, the investigators will conducted a long-term observational study to the effect of the socioeconomics, medical resources and school-related environmental parameters and others on the prevalence and progression of myopia among Chinese school-aged children and adolescent.

Eligibility criteria: Inclusion Criteria:

* aged 6 to 18 years
* no ocular diseases and systemic diseases
* consent to undergo an eye examination

Exclusion Criteria:

* schoolchildren unwilling to participate

Primary outcomes:
measure: Prevalence of myopia
timeFrame: up to 3years
Secondary outcomes:
measure: Changes in prevalence of myopia
timeFrame: up to 3years
measure: Changes of Spherical equivalent
timeFrame: changes from baseline at 36months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Eye Hospital
name: yan wang
role: STUDY_CHAIR
References:
citation: Morgan IG, French AN, Ashby RS, Guo X, Ding X, He M, Rose KA. The epidemics of myopia: Aetiology and prevention. Prog Retin Eye Res. 2018 Jan;62:134-149. doi: 10.1016/j.preteyeres.2017.09.004. Epub 2017 Sep 23.
citation: Guo Y, Liu LJ, Xu L, Lv YY, Tang P, Feng Y, Meng M, Jonas JB. Outdoor activity and myopia among primary students in rural and urban regions of Beijing. Ophthalmology. 2013 Feb;120(2):277-83. doi: 10.1016/j.ophtha.2012.07.086. Epub 2012 Oct 23.
citation: Tenovuo J, Mielityinen H, Paunio K. The effect of dental plaque grown in the presence of xylitol or sucrose on bone resorption in vitro. Pharmacol Ther Dent. 1981;6(1-2):35-43.
Clinical trial NCT01539499: Complications of Endocrine Surgery: Data From the United HealthSystem Consortium
Official title: Complications of Endocrine Surgery: Data From the United Health System Consortium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Disease
Parathyroid Disease
Endocrine Gland
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2012-02-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted through a United HealthSystem Consortium query of endocrine surgery done as a primary procedure for specific diagnosis.

Brief summary: The goal of this study is to help better determine the complication rates for endocrine surgery across the nation for both benign and malignant disease. It is our hypothesis that the complication rates are low overall and that malignant disease results in a higher complication rate than benign disease. This study will do a database review from all University HealthSystem Consortium (UHC).


Eligibility criteria: Inclusion Criteria:

* All patients between the ages of 18 and 90 years who have a diagnosis of benign multinodular goiter and/or malignant thyroid disease and have undergone a total thyroidectomy as a primary procedure.
* Parathyroid patients will also be studied.

Exclusion Criteria:

* Non endocrine surgery patients

Primary outcomes:
measure: Complication Rates for Endocrine Surgery
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Brendan Stack, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01222299: Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-10-18
Enrollment: 89
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: The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.


Eligibility criteria: Inclusion Criteria:

* Subjects 18 to 65 years of age with a positive skin prick test with ragweed allergen

Exclusion Criteria:

* No active respiratory tract infection

Primary outcomes:
measure: Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS
timeFrame: Baseline, 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: ISTA Pharmaceuticals, Inc.
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Tim McNamara, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00151099: Safety of Preoperative Oral Administration of a High Caloric Drink With Protein
Official title: Safety of Preoperative Oral Administration of a High Caloric Drink With Protein in Patients With Dysgnathia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Keywords: preoperative nutrition
postoperative nausea and vomiting
Dysgnathia
anesthesia
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2005-09-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to determine whether the oral administration of a high caloric drink with protein decreases the postoperative nausea and vomiting in patients with dysgnathia.


Eligibility criteria: Inclusion Criteria:

* Patients with surgery for dysgnathia

Exclusion Criteria:

* Diabetes mellitus

Primary outcomes:
measure: gastric residual at induction of anesthesia
Secondary outcomes:
measure: postoperative wellness
measure: thermoregulation
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Department of Anesthesiology and Intensive Care, University Hospital Münster
Study officials:
affiliation: Department of Anesthesiology and Intensive Care, University Hospital Muenster
name: Christiane Goeters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00398099: To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections (0826-052)
Official title: Clinical Evaluation for the Efficacy, Safety, Tolerability & Medical Resource Utilization of Invanz (Ertapenem Sodium) Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection
Pneumonia
Urinary Tract Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To collect clinical response data with the use of ertapenem in approved indications.


Eligibility criteria: Inclusion Criteria:

* Male or female patients, 20 years of age or older
* Patients did not receive any systemic antibiotic before enrollment, or patients with failed clinical response (no improvement on symptoms or laboratory data) through previous antibiotic treatment
* Patients who required therapy prior to identification of cause of infection

Exclusion Criteria:

* Patient has a concomitant infection that may interfere with the evaluation of the response to ertapenem
* Patient has an apache ii \> 30.
* Patient has an infection caused by pathogens resistant to ertapenem
* Patients with known allergy to ertapenem or other drugs in the same carbapenem class, beta - lactams, lidocaine or local anesthetics of the amide type
* The patient requires antibiotics other than ertapenem (such as: glycopeptides, macrolides or antifungal agents)

Primary outcomes:
measure: Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment
Secondary outcomes:
measure: Safety and Tolerability
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01993199: Deep Biopsy Via Endoscopic Submucosal Dissection in Upper GI Subepithelial Tumors
Official title: Prospective Study: Deep Biopsy Via Endoscopic Submucosal Dissection in Upper GI Subepithelial Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Neoplasm
Pathology
Lead sponsor: Hanyang University Seoul Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Upper gastrointestinal subepithelial tumors are frequently encountered during esophagogastroduodenoscopy. Treatment plans for subepithelial tumors are determined by algorithms based on endoscopic ultrasonography images. However, endoscopic ultrasonography alone may not be able to diagnose and evaluate upper gastrointestinal SETs with sufficient accuracy. Adequate tissue samples are required to increase the diagnostic accuracy of subepithelial tumors.

Deep biopsy is method that normal mucosa was dissected using enodsocpi submucosal dissection technique and multiple endoscopic biopsies were performed.

The investigators will perform deep biopsy in subepithelial tumor.


Eligibility criteria: Inclusion Criteria:

* patients with upper GI SETs

Exclusion Criteria:

* none

Primary outcomes:
measure: the number of pathologic diagnosis of deep biopsy
timeFrame: within the 7 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Tae HJ, Lee HL, Lee KN, Jun DW, Lee OY, Han DS, Yoon BC, Choi HS, Hahm JS. Deep biopsy via endoscopic submucosal dissection in upper gastrointestinal subepithelial tumors: a prospective study. Endoscopy. 2014 Oct;46(10):845-50. doi: 10.1055/s-0034-1377627. Epub 2014 Aug 11.
Clinical trial NCT00225199: Efficacy and Safety of SH T00660AA in Treatment of Endometriosis
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Daily Oral Administration of SH T00660AA for the Treatment of Endometriosis Over 12 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometriosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-23
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to placebo in the treatment of endometriosis

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Female patients with endometriosis-associated pelvic pain

Exclusion Criteria:

* Pregnant or lactating women
* history or suspicion of hormone dependent tumor
* therapy resistant endometriosis
* need for primary surgical treatment
* any other conditions which forbid the participation.

Primary outcomes:
measure: Efficacy
timeFrame: Assessment of pain relief at end of treatment
Secondary outcomes:
measure: Adverse event collection
timeFrame: Assessment at end of study
measure: Treatment satisfaction by patient
timeFrame: Assessment at end of study
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: