louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04705961: Bile Leakage Test in Emergency Hydatid Liver Cyst Surgery Case Report
Official title: Bile Leakage Test in Emergency Hydatid Liver Cyst Surgery Case Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery--Complications
Keywords: Hydatidosis
complications
intra-biliary rupture
biliary duct
echinococcus
echinococcosis
Lead sponsor: Dr. Ersin Arslan Education and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2021-01-12
Enrollment: 1
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: this study is a case report

Brief summary: In liver cyst hydatid surgery, presence of cysto-biliary communication (CBC) is important for the prevention of postoperative morbidity. If cysto-biliary connections are not obvious, diagnosis is not easy. Intraoperative bile leakage test has been shown to reduce postoperative biliary complications by revealing occult CBCs. However, bile leakage testing in emergency conditions such as hydatid cyst perforation has not been experienced so far.

Detailed description: In liver cyst hydatid surgery, presence of cysto-biliary communication (CBC) is important for the prevention of postoperative morbidity. If cysto-biliary connections are not obvious, diagnosis is not easy. Intraoperative bile leakage test has been shown to reduce postoperative biliary complications by revealing occult CBCs. However, bile leakage testing in emergency conditions such as hydatid cyst perforation has not been experienced so far.

Here, a bile leakage test performed in a 23-year-old male patient undergoing emergency surgery due to the perforation of the hydatid liver cyst was presented. Following the treatment of perforated hydatid liver cyst and biliary peritonitis, a bile leakage test was performed. The common bile duct was cannulated with a 22 Gauge catheter, normal saline and parenteral lipid solution were given to demonstrate the CBCs, and leakage areas were suture ligated. The patient was discharged postoperatively without any problem.

The investigators recommend detection and treatment of the CBCs even in emergency hydatid liver cyst surgery for prevention of postoperative biliary complications.

Eligibility criteria: Inclusion Criteria:

* this study is a case report

Exclusion Criteria:

* this study is a case report

Primary outcomes:
measure: recurrent hydatid cyst
timeFrame: 2 or 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Dr. Ersin Arslan Training and Resource Hospital
Study officials:
References:
Clinical trial NCT00946361: Impaired Insulin-like Growth Factor-1 (IGF-1) Generation Causes Protein Catabolism and Poor Growth in Children With Crohn Disease
Official title: Impaired IGF-1 Generation Causes Protein Catabolism and Poor Growth in Children With Crohn Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Crohns Disease
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2009-07-27
Enrollment: 1
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: GI clinic patients

Brief summary: The investigators will prospectively recruit 26 children with moderate - severe active Crohn disease (PCDAI \>30). Results will be compared to 26 patients in sustained remission (PCDAI \<10 and physician global assessment of remission over the previous 6 months) who are matched for age and gender. Subjects will be studied at baseline and six months. The primary study end-points will be leucine rate of appearance (a measure of protein breakdown) and IGF-1 levels.

This study will test the hypothesis that children with greater disease severity will have worse longitudinal growth and protein catabolism. The investigators will also explore the secondary hypothesis that children with Crohn disease have abnormal IGF-1 generation which is linked to underlying inflammation and disease severity.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Crohn disease by endoscopy and histologic samples
* Chronological and/or bone age 6-15 years old
* Tanner 1 - 2
* Willing to participate in our longitudinal evaluation

Exclusion Criteria:

* Concomitant persistent chronic infectious disease
* Inflammatory bowel disease not diagnosed as Crohn disease
* Immunological disorder (excluding Crohn disease)
* Associated severe concomitant chronic illnesses (CF, liver failure)
* Pregnancy

Primary outcomes:
measure: Height velocity
timeFrame: 6 months
Secondary outcomes:
measure: Protein catabolism
timeFrame: 6 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: The Research Institute at Nationwide Children's Hospital, The Ohio State University
name: Dana S Hardin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02461511: Impact of Therapeutic Education, Being Set up Under the Authorized Program for Diabetics Patients in Hospital
Official title: Impact Des Actions d'éducation thérapeutique Mises en Place Dans le Cadre d'un Programme autorisé auprès de Patients diabétiques hospitalisés
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes Complications
Lead sponsor: Hôpital Léon Bérard
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diabetics hospitalized patients

Brief summary: To Assess the impact of therapeutic education on:

* the occurrence of long term diabetes complications .
* balance of his diabetes

Detailed description: evaluation of the benefits of therapeutic education by:

* glycated hemoglobin assay
* telephone monitoring
* quiz
* monitoring of adverse event related to diabete

Eligibility criteria: Inclusion Criteria: Patients

* diabetic
* hospitalized in Léon Berard
* with telephone line
* written consent given
* belong to a social security system

Exclusion Criteria:

* no diabetics
* patient having alredy completing a therapeutic education program
* minor patient (\<18 years)
* pregnant woman
* without telephone line
* no belong to a social security system
* patient alredy inclued on clinical study.
* patient tutelage or under curatorship

Primary outcomes:
measure: glycated hemoglobin measure
timeFrame: 3 months
Secondary outcomes:
measure: hopitalization
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: medecin
name: Alkassoum Sapha, Medecin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03800511: Prediction of Intra-abdominal Adhesion Before CS
Official title: Prediction of Intra-abdominal Adhesion Before CS: A Diagnostic Test Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intra-Abdominal; Adhesion
Keywords: sliding test , ceaserean section
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 27
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women in their 9th-month singleton planned for elective repeated CS and had a history of previous CS

Brief summary: Recognition of intraabdominal adhesion before doing repeated cesarean section is helpful for the surgeon and patients.

Detailed description: the repeated cesarean section is associated with recorded maternal morbidity including placenta preavia and accreta , liability to injuries to the bladder, intestine or vascular injuries. The anticipation of the problem is important for decreasing its adverse effect . preoperative diagnosis of pelvic adhesion between the uterus and anterior abdominal wall, bladder, intestine or omentum could b of help to give time for a surgeon to prepare senior staff obstetrician or others and theatre requirements to overcome any problem happened.

Eligibility criteria: Inclusion Criteria:

* pregnant in their 9th-month singleton, planned for elective CS and had a history of previous CS

Exclusion Criteria:

* included multiple pregnancies, preterm labour, emergency CS, skin burn at the site of CS

Primary outcomes:
measure: intra-abdominal adhesion
timeFrame: intra-operative period
Secondary outcomes:
measure: skin to uterine incision time
timeFrame: intra-operative period
measure: need to insert intra-peritoneal drain
timeFrame: intraoperative period
Other outcomes:
Locations:
Study officials:
affiliation: Al-Azhar University
name: Taiseer Maarouf, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02362711: Efficacy and Safety, Long-Term Study of NPC-16 to Treat Dysmenorrhea
Official title: Phase3, Placebo Controlled, Randomized, Double-blinded, Long-Term, NSAID-Add-on, Clinical Trial of NPC-16 for Treatment of Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dysmenorrhea
Lead sponsor: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2015-02-13
Enrollment: 248
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this long-term study is to determine whether NPC-16 is effective in the treatment of dysmenorrhea.


Eligibility criteria: Inclusion Criteria:

* dysmenorrhea

Exclusion Criteria:

* severe hepatopathy
* pregnant woman

Primary outcomes:
measure: Patient Response to Treatment for Dysmenorrhea, as Evaluated by Total Dysmenorrhea Score
timeFrame: 52 weeks
Secondary outcomes:
measure: Patient Response to Treatment for Dysmenorrhea, as Evaluated by Visual Analogue Scale (VAS) of Dysmenorrhea
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Tottori University
name: Tasuku Harada, MD, PhD
role: STUDY_CHAIR
affiliation: St. Luke's International Hospital
name: Mikio Momoeda, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01721811: Retinal Function in Relation to Transient or Chronic Challenges to Retinal Metabolism
Official title: Retinal Function in Relation to Transient or Chronic Challenges to Retinal Metabolism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Individuals
Patients With Diabetes.
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2012-11-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of the study is to investigate how the retina adapts to different metabolic challenges, e.g. chronic systemic hypoxia, hyperglycemia, special training conditions or diets as well as transient changes in the content of oxygen and glucose in the blood.


Eligibility criteria: Healthy individuals

Inclusion Criteria:

* Healthy volunteers.
* No known systemic or ocular disease.

Exclusion Criteria:

* Any systemic or ocular disease.

Patients with diabetes

Inclusion criteria:

* Diabetes mellitus
* No intraocular disease other than conditions attributable to diabetes.

Exclusion criteria:

* Intraocular disease other than conditions attributable to diabetes.
* Systemic conditions which might contraindicate hyperoxic stimulation.

Primary outcomes:
measure: Retinal vessel diameters during hyperoxia
timeFrame: Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia
measure: Retinal perfusion velocities during hyperoxia
timeFrame: Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia
measure: Retinal oximetry during hyperoxia
timeFrame: Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia
measure: Retinal vessel diameters during hyperglycemia
timeFrame: Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load
measure: Retinal perfusion during hyperglycemia
timeFrame: Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load
measure: Retinal oximetry during hyperglycemia
timeFrame: Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Ophthalmology, Glostrup University Hospital
Study officials:
affiliation: Glostrup UH
name: Oliver Klefter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Glostrup UH
name: Michael Larsen, Professor, DMSci
role: STUDY_DIRECTOR
References:
Clinical trial NCT03755011: White Noise to Improve Sleep in the Medical Intensive Care Unit (MICU): a Pilot and Feasibility Study
Official title: White Noise to Improve Sleep in the MICU: a Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A feasibility study to evaluate the use of white noise to improve sleeping conditions in an ICU setting.

Detailed description: The ICU is full of alarms and critically ill patients, so it is no surprise that sleep is very much fragmented and poor in this setting, as documented in numerous studies. White noise is a simple intervention that has been shown to improve sleep, including in the ICU setting. The aim is to conduct a pilot trial evaluating the feasibility of providing white noise to patients in the ICU at night to help improve sleep. The plan to measure feasibility metrics including patient acceptance, patient tolerance, and intervention fidelity; also to seek feedback from patients, nurses, and providers. Secondly is to evaluate the benefits of providing white noise at night in the ICU on sleep as measured by actigraphy and Richards-Campbell Sleep Questionnaires and total room sound.

Eligibility criteria: Inclusion Criteria:

* Adults \>18yo admitted to MICU with expected stay of at least two nights after enrollment

Exclusion Criteria:

* Excluding intubated patients (so communication can be better) and patients on high-flow nasal cannula (which is already high background noise).
* Patients who are on therapeutic hypothermia or are on comfort measures only will also be excluded

Primary outcomes:
measure: Intervention fidelity: percent of intervention time during which white noise is actually delivered
timeFrame: 48 hours
Secondary outcomes:
measure: Sound Levels
timeFrame: 48 hours
measure: Sleep Questionnaire: Sleep Questionnaire. Patients will be surveyed after Study Night 1 and Study Night 2 with Richards- Campbell Sleep Questionnaires.
timeFrame: 48 hours
measure: Actigraphic rest-activity :Patients will wear Actiwatch Spectrum devices to measure rest-activity patterns. Sleep will be identified using Actiwatch Software as provided by the manufacture.
timeFrame: 48 hours
measure: Patient tolerance: percent of days that patients agree to continue white noise
timeFrame: 48 hours
measure: Patient acceptance: percent of patients or surrogates who agree to receive white noise at night
timeFrame: 48 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Catherine Gao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01268111: Effect of Vitamin D Replacement on Insulin Sensitivity
Official title: Effect of Vitamin D Supplementation on Insulin Sensitivity and Retinol-binding Protein 4 Levels in Subjects With Vitamin D Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insulin Sensitivity
Keywords: vitamin D deficiency, insulin sensitivity
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2010-12-29
Enrollment: 12
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: Healthy subjects with low Vitamin D levels will be randomly assigned to either Vitamin D replacement or placebo for a period of 8 weeks. Insulin sensitivity will be measured before and after the intervention, and the changes will be compared between the two groups. This will help us understand if Vitamin D replacement improves insulin sensitivity. Serum Retinol Binding Protein 4 levels will also be measured to see if changes in insulin sensitivity are mediated by RBP4.


Eligibility criteria: Inclusion Criteria:

* 1. Age 18-60 years 2. No known medical illnesses requiring pharmacotherapy 3. Not on any mineral or vitamin supplements in the last 3 months

Exclusion Criteria:

* 1. Subjects requiring prompt initiation of pharmacotherapy, such as those with incidentally discovered diabetes mellitus or hypertension.

  2. Previous administration of glucocorticoids, retinoic acid derivatives, or insulin sensitizers in the preceding 3 months.

  3. Bariatric surgery or liposuction 4. Unintentional weight loss \>5% of the body weight in last 3 months 5. Chronic smokers (\> 1 pk/d for 10 years) 6. Alcohol use \> 2 drinks/day

Primary outcomes:
measure: M Value (Insulin Stimulated Glucose Uptake)
timeFrame: Baseline and at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Odessa
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Mayo Clinic
name: Vinaya Simha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simha V, Mahmood M, Ansari M, Spellman CW, Shah P. Effect of vitamin D replacement on insulin sensitivity in subjects with vitamin D deficiency. J Investig Med. 2012 Dec;60(8):1214-8. doi: 10.2310/JIM.0b013e3182747c06.
Clinical trial NCT03102411: Impact of Diet on Functional Gastrointestinal Symptoms
Official title: Impact of Diet on Functional Gastrointestinal Symptoms; a National Population Based Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Disorder, Functional
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 1881
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General popultion in the United States

Brief summary: This cross-sectional survey study is to determine the prevalence of functional gastrointestinal (GI) disorders in the general population and to describe common triggers for food-related GI symptoms.

Detailed description: Functional gastrointestinal disorders, involving symptoms such as gas/bloating, diarrhea, constipation and abdominal pain, are estimated to impact between 35 and 45 million Americans, an overwhelming 15-20% of the population. These symptoms are responsible for upwards of 20 billion dollars in healthcare costs and extensive loss of quality of life for sufferers. Moreover, many patients suffer in silence, with 67% of subjects waiting more than a year before treatment, and 11% waiting over 10 years. Irritable bowel syndrome is the most prevalent functional gastrointestinal disorder, and several recent studies support the idea that dietary modifications may be key to alleviating this condition.

The purpose of this study is to document gastrointestinal symptoms among the US population, as well as to ascertain awareness and utilization of dietary treatments that exist.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Visual impairment
* Inability to read
* Inability to understand English
* Inability to use a computer to respond to questions.

Primary outcomes:
measure: Most Common Triggers for Food-related GI Symptoms (Top 5)
timeFrame: During the past 3 months before the survey
Secondary outcomes:
measure: Self-reported Functional GI Disorders
timeFrame: During the past 3 months before the survey
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Urogynecology Associates
state: Ohio
Study officials:
affiliation: TriHealth - Cincinnati Urogynecology Associates
name: Rachel Pauls, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00155311: The Regulation of Osteoprotegerin by Mechanical Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malocclusion
Keywords: orthodontic tooth movement
OPG
RANKL
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2005-09-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To test whether levels of OPG can be changed during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different period of time in volunteers. In situ hybridization and immunohistochemistry analysis for OPG and RANKL will reveal their roles in this physiological process.

Detailed description: Long treatment time is a major factor causing high fee for orthodontic treatment. Patients would have dental caries or periodontitis resulted from improper oral hygiene care during this long treatment period. Therefore, how to speed up the tooth movement which determines the duration of orthodontic treatment, can help more people to obtain good occlusion and esthetics. Orthodontic force on tooth induces bone resorption on the compression side and bone deposition on the tension side, thus bone remodels and then tooth moves. Bone resorption is a complex process. Osteoblasts play an important role during initiation of bone resorption.

Changes OPG expression of osteoblasts under mechanical stimulation can play a role in bone remodeling. In order to test this hypothesis, the following specific aims will be achieved:

1. To test whether levels of OPG can be changed during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different period of time in volunteers. In situ hybridization and immunohistochemistry analysis for OPG and RANKL will reveal their roles in this physiological process.
2. To optimize the regulation by changing magnitude and frequency of pressure, and characterize the time table for these changes..

Eligibility criteria: Inclusion Criteria:

* patients with two mandibular impaction third molars containing at least one mesially angular impaction with crown exposed to the oral cavity

Exclusion Criteria:

* pregnancy or diseases with abnormal bone metabolism

Primary outcomes:
measure: OPG staining
timeFrame: at most 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Dentistry, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chung-Chen Yao, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: