louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05749198: Portal Hypertension Using Magnetic Resonance Elastography
Official title: Non-invasive Assessment of Portal Hypertension Using Quantitative Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Portal Hypertension
Magnetic Resonance Imaging
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients requiring prophylactic treatment of esophageal varices

Brief summary: This prospective study was conducted in a tertiary university hospital. The investigators researched the correlation between MRE-assessed stiffness of the liver and spleen and the Hepatic venous pressure gradient (HVPG) values. Furthermore, the investigator evaluated whether MRE-assessed stiffness reflected changes in portal hypertension (PH) after administering non-selective beta-blockers (NSBBs).


Eligibility criteria: Inclusion Criteria:

* diagnosed liver cirrhosis
* requiring prophylactic treatment of esophageal varices

Exclusion Criteria:

* the coexistence of hepatocellular carcinoma
* refractory ascites who regularly underwent large-volume paracentesis
* the use of selective beta-blocker or carvedilol therapy for at least 4 weeks
* undergoing liver transplantation
* contraindication with magnetic resonance imaging

Primary outcomes:
measure: Change of liver stiffness and spleen stiffness by MRE
timeFrame: Change from baseline stiffness of MRE at 6 months
measure: The change of portal pressure (HVPG) prior to and after treatment with NSBB
timeFrame: Change from baseline and at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wŏnju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon
Study officials:
References:
Clinical trial NCT03675698: Radiological Images for Nasotracheal Tube Size Estimation
Official title: Nasal Cavity Evaluation by CT Scan/ Magnetic Resonance Imaging to Access the Size of Nasotracheal Tube for Nasal Intubation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasotracheal Tube Passage Through Nasal Cavity
Keywords: Nasotracheal tube size based on radiological images of nose.
Lead sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: oncosurgical patients with oral malignancies who required nasotracheal intubation for COMMANDO surgeries.

Brief summary: This trial is planned to estimate the size of nasotracheal tube (NTT) by calculating the diameter of both nasal cavity in radiological images of nose (CT scan/MRI) at the level below the inferior turbinate and floor of nose in coronal planes. Smallest diameter will be considered to calculate the outer diameter of NTT, hence the size .

Detailed description: The planned trial will estimate the size of nasotracheal tube (NTT) by calculating the diameter of both nasal cavity in radiological images of nose (CT scan/MRI) at the level below the inferior turbinate and floor of nose at different levels in coronal planes. Smallest diameter will be considered to calculate the outer diameter of NTT, hence the size. The side of nasotracheal intubation will be decided after view the radiological images and the estimated size of NTT will be used. Finally the ease of intubation and complications will be recorded.

Eligibility criteria: Inclusion Criteria:

1. patients requiring nasal intubation for oromaxillofacial surgeries

   Exclusion Criteria:
   * 1. Midface instability
2. Coagulopathy
3. Suspected basilar skull fractures
4. Large nasal polyps
5. Suspected nasal foreign bodies
6. Recent nasal surgery
7. History of frequent episodes of epistaxis
8. Prosthetic heart valves (increased risk of bacteremia during the insertion).
9. Patients with deranged liver and renal functions.

Primary outcomes:
measure: Successful nasal intubation by selecting the correct size of nasotracheal tube estimated by measuring the diameter of nasal cavity in coronal section just below the inferior turbinate in radiological images.
timeFrame: After enrolment of the patient and before intubation
Secondary outcomes:
measure: To find the complications associated with nasal intubations that were performed after assessing the radiological images.
timeFrame: At the time of intubation
Other outcomes:
Locations:
city: Rohini
country: India
facility: Amit
state: Delhi
Study officials:
References:
citation: Evans SW, McCahon RA. Management of the airway in maxillofacial surgery: part 2. Br J Oral Maxillofac Surg. 2018 Jul;56(6):469-474. doi: 10.1016/j.bjoms.2018.05.012. Epub 2018 Jun 12.
Clinical trial NCT00937898: Beef in an Optimal Lean Diet (BOLD) Effects on Cardiovascular Disease (CVD) Risk
Official title: BOLD (Beef in an Optimal Lean Diet) Effects on Established and Emerging Cardiovascular Disease (CVD) Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Hypertriglyceridemia
Keywords: lean beef
cholesterol
lipids
diet intervention
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Cattlemen's Beef Association
First posted: 2009-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The study is designed to assess the effects of a heart-healthy diet that includes lean beef as the primary source of high quality protein on risk factors for cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

1. BMI \> 20 and \< 37
2. LDL-C level between the 50th and 90th percentile (±5% for assay variation) according to NHANES data for sex and age (ex. for men: 128-177 mg/dL and for women: 121-172 mg/dL)
3. TG level \< 150 mg/dL

Exclusion criteria include:

1. self-reported history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication)
2. high alcohol consumption (≥ 14 drinks/week)
3. intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods)
4. treatment with lipid-lowering agents (statins and fibrates) or blood pressure control medications
5. vegetarian diet
6. weight loss or gain ≥ 10% body weight in the previous 6 months,
7. lactation, pregnancy, or desire to become pregnant during the study

Primary outcomes:
measure: Lipids (Total cholesterol, LDL-C, HDL-C, TG)
timeFrame: End of each 5 week diet period (weeks 5, 11, 17, 23)
Secondary outcomes:
measure: Apolipoprotein levels
timeFrame: End of each 5 week diet period (weeks 5, 11, 17, 23)
measure: Vascular function
timeFrame: End of each 5 week diet period (weeks 5, 11, 17, 23)
measure: Oxidative Stress
timeFrame: End of each 5 week diet period (weeks 5, 11, 17, 23)
Other outcomes:
Locations:
Study officials:
affiliation: Penn State University
name: Penny M Kris-Etherton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roussell MA, Hill AM, Gaugler TL, West SG, Heuvel JP, Alaupovic P, Gillies PJ, Kris-Etherton PM. Beef in an Optimal Lean Diet study: effects on lipids, lipoproteins, and apolipoproteins. Am J Clin Nutr. 2012 Jan;95(1):9-16. doi: 10.3945/ajcn.111.016261. Epub 2011 Dec 14.
Clinical trial NCT01697098: Dexamethasone for Preterm Labour
Official title: Dexamethasone Dosing Interval: 12 or 24 Hours Apart? A Randomized,Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prematurity
Keywords: Dexamethasone
preterm labour
respiratory distress
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators sought to determine whether the incidence of neonatal respiratory distress syndrome (RDS) in preterm fetuses is similar with 12- vs 24-hour dosing interval of dexamethasone.

Detailed description: The administration of glucocorticoids to accelerate fetal lung maturity in patients with preterm delivery plays an important role for obstetrics and neonatal care. Many studies have shown that maternal administration of glucocorticoids has a significant beneficial effect in decreasing the incidence of respiratory distress syndrome (RDS) in infants delivered at 28-34 weeks of gestation.

Eligibility criteria: Inclusion Criteria:

* All patient with threatened or established preterm labor between 28 - 34 weeks attended to our emergency unit

Exclusion Criteria:

* emergent obstetric conditions like:

  * Antepartum hemorrhage in severe attack
  * Antepartum eclampsia

Primary outcomes:
measure: respiratory distress syndrome (RDS)
timeFrame: 6 month
Secondary outcomes:
measure: Perinatal mortality
timeFrame: 6 month
Other outcomes:
measure: Neonatal intensive care
timeFrame: 6 month
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT04424498: Treatment of Displaced Radial Neck Combined With Olecranon Fractures
Official title: Absorbable Rods and Kirschner Wires for the Treatment of Displaced Radial Neck Combined With Olecranon Fractures in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child
Keywords: Kirschner wires
Absorbable rods
Radial neck fracture
Olecranon fracture
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 31
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Medical records of patients who attended our hospital between Jan 2012 and Dec 2016 were retrospectively reviewed.

Brief summary: This study aimed to evaluate the outcomes of using absorbable rods and Kirschner Wires technique for severe displaced radial neck fractures combined with olecranon fractures in children.

Detailed description: The most common fracture in children is the elbow fracture, and the three most common elbow fractures are supracondylar, lateral condylar, and medial epicondylar fractures. Elbow fractures are easy to diagnose and the treatment modalities are studied often. However, proximal radius fractures, which include radial neck and head fractures, remain challenging to diagnose and manage. In addition, proximal radius fractures are often combined with other fractures, most commonly, an olecranon fracture. Most radial neck fractures can be treated conservatively if the displacement is less than 3 mm and the angle is less than 30º. However, for severe Judet type III and type IV radial neck fractures, surgery is inevitable.

This study focused on radial neck fractures combined with an olecranon fracture. In this study, absorbable rods were used for fixation of radial head fractures, and with no need for removal of the inner fixation, we performed anatomy reduction via the same incision with direct vision of the olecranon, and we were able to fix the fractures with Kirschner wires (K-wires). In this retrospective study, we aimed to evaluate a treatment method for severe displaced radial neck combined with olecranon fractures in children using a Boyd incision, absorbable rods, and K-wires.

Eligibility criteria: Inclusion Criteria:

* open reduction of severe radial neck fractures combined with an olecranon fractures in the same elbow
* fixation performed using absorbable rods and K-wires

Exclusion Criteria:

* single radial head fractures or single olecranon fractures
* fixation performed with bands
* old fractures,
* Boyd incision was not used,
* guardians did not agree with the surgery

Primary outcomes:
measure: Mayo Elbow Performance Index score
timeFrame: 3th month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Children's hospital of Chongqing Medical Univeristy
name: Yuxi Su, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03699098: The Incidence and Risk Factors of Radiotherapy Induced Hypothyroidism in Head and Neck Cancer With Long Term Follow up
Official title: The Incidence and Risk Factors of Radiotherapy Induced Hypothyroidism in Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: hypothyroidism
radiotherapy
head and neck cancer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a retrospective study with long term follow up to evaluate the incidence, timing and risk factors of radiotherapy induced hypothyroidism in non-thyroid head and neck cancer patients who were treated with RT alone or in combination with surgery and/or chemotherapy.

Detailed description: For any patient, fixation was done by a thermoplastic mask. CT scan was done at 3mm thickness for the head and neck region. CT images were transferred to the planning system. Three-dimensional conformal RT, intensity-modulated radiotherapy (IMRT) or Volumetric modulated arc therapy (VMAT) was created. All patients were irradiated with once-daily fractionation at 1.8-2.0 Gy/d with 6-MV photon beams for five days a week. The gross target volume (GTV) was treated with a dose of 70Gy and the lymphatic site (CTV) and areas of high risk microscopic disease (CTV) including lymph nose levels received a radiation dose ranging from 54-66 Gy according to its risk. PTV is a circumferential margin of 5mm around CTV.

Thyroid function parameters:

The patient's serum T4, T3 and TSH levels, were measured during follow up. Clinical hypothyroidism is defined as the increase in TSH above 5.0mIu/ml with a decrease in free thyroxine levels (free T4) in the serum while elevated TSH with normal free T4 levels was labeled as subclinical hypothyroidism .As per institutional values, the normal values intervals of T4 level (7- 25 PMOL/L), T3( 1.5-7 PMOL/L),TSH (0.2-5 mIu/L).

The median time to onset of hypothyroidism was defined as the time interval between completion of radiotherapy and first abnormal recorded T3/T4/TSH value.

For all treated patients, thyroid gland was delineated and by reviewing the DVH, the V45, V50, V55, V60, V65 and V70 which means the volume of the thyroid gland receiving 45 Gy, 50 Gy, 55Gy, 60 Gy and 70 Gy respectively.

Eligibility criteria: Inclusion Criteria:

* Non-thyroid head and neck cancer patients who were treated with RT alone or in combination with surgery and/or chemotherapy

Exclusion Criteria:

* Patients with thyroid gland disease or abnormal thyroid hormone levels before radiotherapy

Primary outcomes:
measure: The the incidence of hypothyroidism
timeFrame: 8 months
Secondary outcomes:
measure: The risk factors of hypothyroidism
timeFrame: 8 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of clinical oncology and nuclear medicine, Cairo university
Study officials:
References:
Clinical trial NCT00463398: Fertility Surgery, Prospective Analysis
Official title: Quality Control in Surgical Diagnosis and Treatment of Endometriosis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Keywords: Endometriosis
Fertility Surgery
Quality of Life
Pain
Sexual Function
Health economics
Recurrence
Pregnancy
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 600
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients operated at the Leuven University Fertility Centre (LUFc) between september 2006 and August 2008.

Brief summary: From September 2006 a prospective cohort study is conducted among all patients operated at the Leuven University Fertility Centre to evaluate clinical and economical outcome after CO2 laser laparoscopic fertility surgery.

Detailed description: The main outcome measurements are postoperative complications, pain, quality of life, sexual satisfaction, economic life circumstances, cumulative pregnancy rate and cumulative recurrence rate of endometriosis.

Eligibility criteria: Inclusion Criteria:

* All patients
* operated at the Leuven University Fertility Centre of the Department of Obstetrics and Gynaecology of the University Hospitals Leuven, Leuven,Belgium,
* from September 2006 to August 2008.

Exclusion Criteria:

* patients of other than the Dutch language

Primary outcomes:
measure: complication rate, quality of life, pain, sexual activity, economic life circumstances, pregnancy rate, reintervention rate, recurrence rate
timeFrame: 1 month preop, 6 - 12 - 18 and 24 months postop
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
affiliation: University Hospital Gasthuisberg, Catholic University, Leuven, Belgium
name: Christel LC Meuleman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Gasthuisberg, Catholic University, Leuven, Belgium
name: Thomas D'Hooghe, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Van den Broeck U, Meuleman C, Tomassetti C, D'Hoore A, Wolthuis A, Van Cleynenbreugel B, Vergote I, Enzlin P, D'Hooghe T. Effect of laparoscopic surgery for moderate and severe endometriosis on depression, relationship satisfaction and sexual functioning: comparison of patients with and without bowel resection. Hum Reprod. 2013 Sep;28(9):2389-97. doi: 10.1093/humrep/det260. Epub 2013 Jun 24.
citation: Meuleman C, Tomassetti C, Wolthuis A, Van Cleynenbreugel B, Laenen A, Penninckx F, Vergote I, D'Hoore A, D'Hooghe T. Clinical outcome after radical excision of moderate-severe endometriosis with or without bowel resection and reanastomosis: a prospective cohort study. Ann Surg. 2014 Mar;259(3):522-31. doi: 10.1097/SLA.0b013e31828dfc5c.
Clinical trial NCT02886598: Safety and Efficacy of Firmagon® (Degarelix) for Injection
Official title: Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Firmagon® (Degarelix) for Injection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-09-01
Enrollment: 368
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who visit department of Urology in hospitals for treatment of prostate cancer.

Brief summary: The purpose of this study is to assess the safety and efficacy of Firmagon® (degarelix) for injection under the conditions of general clinical practice in Korea.


Eligibility criteria: Inclusion Criteria:

* Patients who are eligible for the treatment of Firmagon® (degarelix) for injection according to the approved product label, and Firmagon® (degarelix) treatment decided before study enrolment. Moreover, patient should have not previously received Firmagon® (degarelix) for injection before the study commencement date at each site. - Indication: treatment of advanced, hormone-dependent prostate cancer.

Exclusion Criteria:

* Patients with previous or concurrent known hypersensitivity to any component of the drug.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References:
Clinical trial NCT01946698: Endometriosis, Food Consumption and Fertility
Official title: A Study on the Differences in Inflammatory Markers Between Women With Endometriosis and Women Without in Relation to Fertility and Food Consumption.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women attending an infertility Clinic, some with endometriosis compared to women without endometriosis

Brief summary: To investigate parameters related to fertility in women with endometriosis in relation to food items.

Detailed description: The study has been reviewed and accepted by the legal registrations in Denmark (The Regional Committee on Biomedical Research Ethics and The Danish Dataprotection Agency). The data will be anonymous and kept as described by the Danish register law.

Eligibility criteria: Inclusion Criteria:

* Fertility patients

Exclusion Criteria:

* mental challenges

Primary outcomes:
measure: The level of Free Fatty Acid in follicular fluid will be different in women with endometriosis compared to controls
timeFrame: The fluid will be collected, frozen and tested december 2014
Secondary outcomes:
measure: methylation pattern of specific genes in the endometrium
timeFrame: Collecting of cells and testing december 2014
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Professor, Consultant at the Fertility Clinic, Arhus University Hospital
name: Ulla B Knudsen, Professor
role: PRINCIPAL_INVESTIGATOR
References: