louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06861010: Evaluating the Safety and Efficacy of Ondansetron in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Official title: Evaluating the Safety and Efficacy of Ondansetron in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pancreatic Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 44
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: Endoscopic retrograde cholangiopancreatography (ERCP (, a key tool that is used in diagnosis and treatment of pancreato-biliary diseases. Post-ERCP pancreatitis (PEP) is the most common and serious complication that can occur following this procedure and can lead to significant morbidity and mortality. A variety of patient-related and procedure-related factors have been associated with higher rates of PEP.


Eligibility criteria: Inclusion Criteria:

1. Age more than 18 years old.
2. Gender: Males and Females
3. Patients with suitable indications for ERCP due to suspected pancreato-biliary disorders.
4. Blood amylase and lipase levels before ERCP are within the normal limits.

Exclusion Criteria:

1. Age of less than18 years.
2. Uncontrolled diabetes mellitus (DM)
3. Severe bleeding tendency
4. Impaired renal function (serum creatinine \> 2 mg/dL), (creatinine clearance \<30 ml/min)
5. Patients with severe heart disease.
6. Subjects who underwent prior biliary or pancreatic sphincterotomy or dilatation or stenting of either duct.
7. Currently pregnant or nursing
8. Admission due to established pancreatitis before ECRP
9. Unwillingness to undergo ERCP.
10. Previously documented allergy to ondansetron.

Primary outcomes:
measure: The primary outcome that will be measured is the development of pancreatitis after the procedure according to consensus criteria
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta Unuversity
Study officials:
References:
Clinical trial NCT04340310: Home Respiratory Polygraphy in Childhood Sleep Apnea-Hypopnea Syndrome (CHILDSLEEP).
Official title: Usefulness of Home Respiratory Polygraphy in the Diagnosis and Therapeutic Decision of Childhood Sleep Apnea-Hypopnea Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea
Home Respiratory Polygraphy Sleep Study
Childhood Sleep Apnea
Polysomnography
Therapeutic Decision
Keywords: Childhood sleep apnea
Sleep apnea syndrome
Obstructive apnea syndrome
Obstructive apnea sleep
Lead sponsor: Hospital Universitario San Juan de Alicante
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 125
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children submited to Pneumology Service with sleep apnea suspicion

Brief summary: The aims of the study is to assess the diagnostic utility of home respiratory polygraphy (HRP) complemented with polysomnography (PSG) in childhood Obstructive Sleep Apnea-Hypopnea Syndrome (OSAS), as well as its usefulness in the therapeutic decisions.

Methods: Children referred with suspected OSAS will be evaluated during one year performing home respiratory polygraphy in all cases. PSG will be chosen in patients with concomitant pathology or according to medical criteria, or complemented with HRP in doubtful cases. Clinical and anthropometric data, severity, technical quality and treatment will be obtained. Patients will be divided in two groups (HRP vs PSG) and compared, and the accuracy from HRP to establish a therapeutic decision it wil calculated. The investigator's hypothesis is that PSG should be recommended only for complex or doubtful cases.


Eligibility criteria: Inclusion Criteria:

* Sleep apnea suspicion

Exclusion Criteria:

* Other sleep conditions
* Non valid home respiratory polygraphy and non valid polysomnography in the same patient
* Non informated consent

Primary outcomes:
measure: To assess the diagnostic utility of home respiratory polygraphy (HRP) complemented with polysomnography (PSG) in childhood Obstructive Sleep Apnea-Hypopnea Syndrome (OSAS), as well as its usefulness in the therapeutic decisions.
timeFrame: two years
Secondary outcomes:
measure: To assess the prevalence of childhood sleep apnea in Pneumology hospital consultations
timeFrame: two years
Other outcomes:
Locations:
city: San Juan de Alicante
country: Spain
facility: Eusebio Chiner Vives
state: Alicante
Study officials:
affiliation: Hospital Universitario San Juan de Alicante
name: Eusebi Chiner Vives
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00832910: Assessment of Body Image in Patients With Rheumatoid Arthritis
Official title: Body Image in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Image
Rheumatoid Arthritis
Keywords: Body image
Rheumatoid Arthritis
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2009-01-30
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Rheumatoid arthritis in study group
* Community sample in control group

Brief summary: Investigate body image of patients with rheumatoid arthritis, correlating with self-esteem, function and quality of life.

Detailed description: Methods: Forty-three RA patients and thirty-nine control patients between 18 and 70 years were evaluated. The RA group was made up of individuals with a diagnosis of RA and the control group was made up of individuals from the community, paired for gender, age and body mass index. The patients were assessed with regard to body image (Body dysmorphic disorder examination (BDDE)), self-esteem (Rosenberg self-esteem scale), function (Health assessment questionnaire (HAQ)) and quality of life (Short form-36 (SF-36)).

Eligibility criteria: Inclusion Criteria:

* The RA group included patients between 18 and 70 years of age, of either gender, with an established diagnosis of RA based ACR criteria and belonging to functional classes I, II and III. The control group was made up of individuals from the community paired for gender, age and body mass index with RA group.

Exclusion Criteria:

* Individuals with fibromyalgia, neurological disease, psychiatric disorders or other severe co-morbidity were excluded from the study.

Primary outcomes:
measure: Body Dysmorphic Disorder Examination
timeFrame: baseline
Secondary outcomes:
measure: Short Form - 36
timeFrame: baseline
measure: Health assessment questionnaire
timeFrame: baseline
measure: Rosenberg self-esteem scale
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Jamil Natour, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02827110: Tracheal Intubation in Patient With Semi-rigid Collar Immobilization of the Cervical Spine: A Comparison of Fiberoptic Bronchoscope Assisted With Pentax-airway Scope and Fiberoptic Bronchoscope Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A semi-rigid cervical collar is recommended for immobilization of the cervical spine in patients with cervical spine injury. It has been suggested that a reduction in mouth opening is the major contributing factor to the deterioration in the glottic view obtained. Fiberoptic intubation is among the most versatile techniques for managing both the anticipated and the unanticipated difficult airway. Recently, combination of fiberoptic bronchoscope with videolaryngoscope has been suggested to permit visual control of the passage of the tube over the fibrescope into the laryngeal inlet. The aim of this study is to compare the intubation time and ease of intubation between fiberoptic bronchoscope alone and bronchoscope with pentax airwayscope.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist physical status class I, II

Exclusion Criteria:

* uncontrolled or limited cardiovascular disease
* abnormality of airway
* necessity for rapid sequence induction
* BMI \> 30

Primary outcomes:
measure: time to intubation
timeFrame: Time from device passing the mouth until confirmation of tracheal intubation by bronchoscope will be measured, about 2 minutes
Secondary outcomes:
measure: ease of intubation
timeFrame: Numeric rating scale will be assessed by practioner of fiberoptic bronchoscope for intubation immediately after intubation.
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
state: Gyeong-gi
Study officials:
References:
citation: Kim DH, Yoo JY, Ha SY, Chae YJ. Comparison of the paediatric blade of the Pentax-AWS and Ovassapian airway in fibreoptic tracheal intubation in patients with limited mouth opening and cervical spine immobilization by a semi-rigid neck collar: a randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):993-999. doi: 10.1093/bja/aex272.
Clinical trial NCT00946010: Investigation of Hepatitis B and Hepatitis C in Taiwan
Official title: Investigation of Hepatitis B and Hepatitis C in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Hepatitis C
Keywords: Hepatitis B
Hepatitis C
genotype
DNA level
RNA level
Taiwan
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-07-24
Enrollment: 6228
Sex: ALL
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People Born before 1985/01/01 who live in Taiwan are HBV or HCV pateints.

Brief summary: The purpose of this study is to investigate the differences of genotypes of hepatitis B and hepatitis C in Taiwan.

Detailed description: The purpose of this study is investigating the differences of genotypes and DNA level or RNA level of hepatitis B and hepatitis C in Taiwan.

Eligibility criteria: Inclusion Criteria:

* Born before 1985/01/01
* HBV or HCV carriers

Exclusion Criteria:

* N/A

Primary outcomes:
measure: genotype and DNA level or RNA level of HBV and HCV virus
timeFrame: once during Mar. 2008- Jan. 2011
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jin-Chuan Sheu, M.D. P.H.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01627210: Evaluation of Glycemic Control Using Adjunctive Continuous Glucose Monitoring With the Dexcom G4 System
Official title: Evaluation of Glycemic Control Using Adjunctive Continuous Glucose Monitoring With the Dexcom G4 System - GLYCOAIM Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Lead sponsor: DexCom, Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-25
Enrollment: 60
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: Adults diagnosed with diabetes mellitus

Brief summary: This is a prospective, non-randomized, observational study conducted in the United States.Up to sixty (60) subjects will be enrolled. The purpose of the study is to evaluate long-term utility and usability of Dexcom G4 Continuous Glucose Monitoring (CGM) System. Subjects will be followed monthly over a period of one year.


Eligibility criteria: Inclusion Criteria:

* Require intensive insulin therapy, defined as use of Continuous Subcutaneous Insulin Infusion (CSII) i.e. insulin pumps or multiple daily injections (MDI.
* Willing to refrain from use of any acetaminophen - containing (ACT) medication during the study, up to 24-hours before the initial sensor insertion.

Exclusion Criteria:

* Have extensive skin changes/ diseases that preclude wearing the device.
* Dialysis.

Primary outcomes:
measure: Evaluate the Dexcom G4 system utility and usability during home use.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Chino
country: United States
facility: Catalina Research Institute
state: California
city: La Mesa
country: United States
facility: Diabetes and Endocrine Associate
state: California
city: West Hills
country: United States
facility: Infosphere
state: California
city: Henderson
country: United States
facility: Desert Endocrinology Clinical Research Center
state: Nevada
Study officials:
References:
Clinical trial NCT02715310: Haemodynamic Monitoring in Head and Neck Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Complications
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Full grown, able to consent patients admitted for major head and neck surgery with planned microvascular transplants for reconstruction due to tumors in the head and neck region.

Brief summary: In order to estimate the effect of fluid management in regard to postoperative complications this observatory study will document every kind of fluid intervention peri- and intraoperatively.

Detailed description: The extend of mass transfusions is known to correlate with postoperative complications. However, also crystalloid and colloidal infusions are under suspicion to cause postoperative complications. This study will capture any kind of fluid intervention perioperatively as well as intraoperatively. Intraoperative fluid management will be documented and matched with the operation steps respectively. The extend of fluid therapy will be correlated with general postoperative complications and especially with the survival of microvascular transplants.

For this purpose, there will be four questionaires. After informed consent, the first questionaire will cover the patient's history, risk factors and previous operations. The second questionaire will cover intraoperative fluid management, documented with the actual operation step. Furthermore, it will also intraoperative complications, cardiovascular-active medication. For closer monitoring, data from Picco will also be included. The third questionaire will be complete in the ICU covering similar content as the second questionaire. The last questionaire will cover the patient's progress on the general ward. Fluid management and tube feeding, as well as general postoperative complication and flap specific complications will be noted.

This study aims for 50-80 patients.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* admitted for head and neck surgery with microvascular transplantation due to head and neck tumors

Exclusion Criteria:

* Pregnancy
* underage
* missing informed consent
* revisions and relapse operations
* non tumor-associated operations
* surgery without microvascular transplants

Primary outcomes:
measure: Postoperative Complications
timeFrame: 1 week
Secondary outcomes:
measure: Transplant Survival via Clinical Examination
timeFrame: One week
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Oral and Maxillofacial Surgery, Technische Universität München
state: Bavaria
Study officials:
affiliation: Technical University Muncih
name: Denys Loeffelbein, PhD, MD, DDS
role: STUDY_CHAIR
References:
Clinical trial NCT04965610: Preoxygenation With High Flow Nasal Cannula Prolongs Normoxia Time During Induction of Anaesthesia of Bariatric Patients and is Superior to Conventional Preoxygenation With Face Mask.
Official title: Preoxygenation With High Flow Nasal Cannula Prolongs Normoxia Time During Induction of Anaesthesia of Bariatric Patients and is Superior to Conventional Preoxygenation With Face Mask.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Compare Preoxygenation Methods in Bariatric Patients
Lead sponsor: Staedtisches Klinikum Karlsruhe
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of patients. One receiving preoxygenation via High Flow Nasal Cannula and one group receiving preoxygenation via face mask
Primary purpose: PREVENTION

Brief summary: To compare preoxygenation for induction of general anaesthesia with High Flow Nasal Cannula vs preoxygenation with face mask in patients undergoing bariatric surgery. The hypothesis is that preoxygenation with High Flow Nasal Cannula prolongs normoxia time during induction of anaeshesia and is superior to conventional preoxygenation with face mask. Primary endpoint will be the time during which spO2 \> 92 %. Secondary endpoint will be paCO2.


Eligibility criteria: Inclusion Criteria:

* age over 18
* elective bariatric surgery
* written consent

Exclusion Criteria:

* preexisting lung diseases, congenital heart diseases
* known difficult airway
* SpO2 \< 92% under ambient air conditions
* known diaphragmal hernia
* clinically relevant reflux

Primary outcomes:
measure: Normoxia time SpO2 > 92%
timeFrame: 10 Minutes after induction
Secondary outcomes:
measure: paCO2
timeFrame: 10 Minutes after induction
Other outcomes:
Locations:
Study officials:
affiliation: Senior Resident Anaesthesia
name: Joachim Jugl
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of Department of Anaesthesia and Intensive Care
name: Franz Kehl, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01675310: Medical Nutrition Therapy Plus Transgestational Metformin For Preventing Gestational Diabetes In High Risk Mexican Women
Official title: EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS IN HIGH RISK MEXICAN WOMEN.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregestational Obesity (BMI > 27kg/m2)
History of Polycystic Ovary Syndrome
Keywords: obesity, polycystic ovary syndrome, gestational diabetes
Lead sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Sponsor class: OTHER_GOV
Collaborators: name: National Council of Science and Technology, Mexico
First posted: 2012-08-29
Enrollment: 90
Sex: FEMALE
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: Gestational diabetes mellitus is one of the most frequent complications of pregnancy, that affect between 1 to 14% of population around the world.

There is a few studies to prevent gestational diabetes mellitus in high risk women as Mexican population.

Metformin has been used during pregnancy in women with gestational diabetes and women with polycystic ovary syndrome, with acceptable security for mother and fetus.

Metformin decrease the insulin resistance and weight gain, we believe that metformin may be decrease the risk of gestational diabetes mellitus in high risk women.


Eligibility criteria: Inclusion Criteria:

* Mexican women with pregnancy \< 16 weeks of gestation, normal oral glucose tolerance 75g-2h test and 3 or more criteria:

  1. Body mass index \> 27 kg/m2
  2. Maternal age \>25
  3. History of infertility with polycystic ovary syndrome
  4. History of macrosomic newborn (Weight \>4000g)
  5. History of diabetes mellitus in first or second degree.
  6. History of gestational diabetes in previous pregnancy

Exclusion Criteria:

* Any form of pregestational diabetes
* Fasting glucose \> 126 mg/dL at first prenatal visit.
* seric creatinine \> 1.5 mg/dL
* Hyperthyroidism
* Heart disease
* Hepatic disease
* Renal diseases
* Epilepsy
* Lupus
* Chronic hypertension.

Primary outcomes:
measure: Gestational diabetes mellitus
timeFrame: 27-28 weeks of gestation
Secondary outcomes:
measure: insulin resistance
timeFrame: At birth
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: National Institute of Perinatology
Study officials:
affiliation: National Institute of Perinatology, Mexico City
name: Enrique Reyes-Muñoz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perichart-Perera O, Mier-Cabrera J, Flores-Robles CM, Martinez-Cruz N, Arce-Sanchez L, Alvarado-Maldonado IN, Montoya-Estrada A, Romo-Yanez J, Rodriguez-Cano AM, Estrada-Gutierrez G, Espino Y Sosa S, Guzman-Huerta M, Ayala-Yanez R, Reyes-Munoz E. Intensive Medical Nutrition Therapy Alone or with Added Metformin to Prevent Gestational Diabetes Mellitus among High-Risk Mexican Women: A Randomized Clinical Trial. Nutrients. 2021 Dec 24;14(1):62. doi: 10.3390/nu14010062.