louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04823780: The Effects of Early Enteral Nutrition on Endoscopic Therapy of Esophagogastric Varices in Liver Cirrhosis
Official title: Investigation of the Effects of Early Enteral Nutrition on Endoscopic Therapy of Esophagogastric Varices in Liver Cirrhosis:An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Esophageal and Gastric Varices
Keywords: Early enteral nutrition
Esophageal and Gastric Varices
Rebleeding
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cirrhosis of gastroesophageal varices undergoing endoscopic

Brief summary: The purpose of this study was to evaluate the safety of early enteral nutrition on endoscopic therapy of esophagogastric varices in Liver Cirrhosis ,and to assess the impact of different eating times on patients, so as to determine the best time for patients to obtain nutrition after surgery.

Detailed description: For patients with gastroesophageal varices in Liver Cirrhosis,, there is no clear guideline and consensus on when to start eating after endoscopic treatment. In 2015, a randomized controlled study in Taiwan of China confirmed that compared with liquid diet given 48 h after endoscopic treatment, liquid diet given 4 h and started enteral nutrition would not increase the risk of rebleeding, and could improve the nutritional status of patients. However, some patients after endoscopic treatment would suffer from post-sternal pain, abdominal pain, nausea, vomiting and other discomforts, affecting appetite and delay the diet time. Based on the above research background, we observed and evaluated the safety and effectiveness of early enteral nutrition in patients with cirrhotic esophageal and gastric varices after endoscopic treatment, and analyzed the influencing factors of enteral nutrition in patients with cirrhotic esophageal and gastric varices after endoscopic treatment, so as to further clarify the optimal time for patients to eat after endoscopic treatment.

Eligibility criteria: Inclusion Criteria:

* Patients with cirrhosis of gastroesophageal varices undergoing endoscopic therapy

Exclusion Criteria:

* Endoscopic treatment of uncontrollable bleeding
* Accompanied with other endoscopic treatments that need to be fasting
* With obvious hepatic encephalopathy and liver failure
* Did not sign the informed consent form and refused to participate

Primary outcomes:
measure: rebleeding
timeFrame: 2 to 30days
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital , Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Gao Yanjing, PhD.MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01931280: A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring
Official title: A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Pregnancy
Keywords: Gestational diabetes
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-08-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study includes a behavioral educational intervention that focuses on healthy eating, physical activity and glucose management during pregnancy and post partum among women newly diagnosed with gestational diabetes mellitus (GDM).

Detailed description: This is a pilot trial in which 50 women newly diagnosed with gestational diabetes are randomized to either one of two groups: 1) active internet intervention or 2)Usual Care (Self-directed) educational intervention. The primary pregnancy outcome is change in A1C. The primary postpartum outcome is weight.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with gestational diabetes Confirmed singleton pregnancy 24-32 weeks gestation age Planning to deliver within the study area

Exclusion Criteria:

* Pre-existing diabetes (type 1 or 2) Non-english speaking Not planning to deliver in the study area

Primary outcomes:
measure: Change in glycosylated hemoglobin
timeFrame: Baseline and 36 weeks gestation
Secondary outcomes:
measure: Change in weight after pregnancy
timeFrame: 6 weeks postpartum to 30 weeks postpartum
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Wanda K. Nicholson, MD MPH MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Setse R, Grogan R, Cooper LA, Strobino D, Powe NR, Nicholson W. Weight loss programs for urban-based, postpartum African-American women: perceived barriers and preferred components. Matern Child Health J. 2008 Jan;12(1):119-27. doi: 10.1007/s10995-007-0211-6. Epub 2007 Jun 7.
Clinical trial NCT01360580: Swallowing Disorders After Prolonged Mechanical Ventilation
Official title: Current Care Study of Incidence and Consequences of Swallowing Disorders After Invasive Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Larynx Disease
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2011-05-25
Enrollment: 138
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: More than 7d of invasive mechanical ventilation

Brief summary: Epidemiology study for evaluation of incidence of swallowing disorders (SD) after prolonged invasive ventilation (more than seven days), using a clinical statement. All consecutive patients are screened, and clinical evaluation is performed during 48h after patient's extubation. If a SD exist, a new evaluation is realized 48h after. Three groups will be created (1.no SD, 2.transitory SD and 3.persistent SD (eg persistent after 48h)). Data complementary are notified at day 28 (pneumonia? nutritional status?)


Eligibility criteria: Inclusion Criteria:

* More than 7 days of invasive mechanical ventilation

Exclusion Criteria:

* Age \< 18 years old
* Preexistent swallowing disorders, stroke, tracheostomy
* Failure of patient's agreement

Primary outcomes:
measure: Prevalence of swallowing disorders after prolonged invasive ventilation
timeFrame: 48 hours after extubation
Secondary outcomes:
measure: Nutritional status at day 28
timeFrame: day 28
Other outcomes:
Locations:
city: Angers
country: France
facility: Service de Réanimation Médicale
city: Rouen
country: France
facility: service de Réanimation médicale
Study officials:
affiliation: Service de Réanimation médicale Hôpitaux de Rouen
name: Gaetan Beduneau, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beduneau G, Souday V, Richard JC, Hamel JF, Carpentier D, Chretien JM, Bouchetemble P, Laccoureye L, Astier A, Tanguy V, Mercat A, Beloncle F, Tamion F. Persistent swallowing disorders after extubation in mechanically ventilated patients in ICU: a two-center prospective study. Ann Intensive Care. 2020 Oct 14;10(1):138. doi: 10.1186/s13613-020-00752-x.
Clinical trial NCT02930980: Micra Accelerometer Sensor Study 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradyarrhythmia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2016-10-12
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the MASS2 is to characterize accelerometer signals of Micra implantable device during different postures and activities and to understand the source of the sensed motion, in order to test feasibility for future enhancements in device functionalities.


Eligibility criteria: Inclusion Criteria:

* Subject is ≥ 18 years old
* Subject is implanted with a Micra device
* Subject or witness (if applicable as per local regulation) is able and willing to provide Informed Consent

Exclusion Criteria:

* Subject is in atrial fibrillation
* Subject is not able to perform study requirements

Primary outcomes:
measure: Waveform and Components of Accelerometer Signal
timeFrame: For approximately two hours after software download
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Pessac
country: France
facility: Hôpital cardiologique du Haut-Lévêque
city: Tours
country: France
facility: CHRU Tours - Hopital Trousseau
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References:
citation: Chinitz L, Ritter P, Khelae SK, Iacopino S, Garweg C, Grazia-Bongiorni M, Neuzil P, Johansen JB, Mont L, Gonzalez E, Sagi V, Duray GZ, Clementy N, Sheldon T, Splett V, Stromberg K, Wood N, Steinwender C. Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results from the Micra atrioventricular feasibility studies. Heart Rhythm. 2018 Sep;15(9):1363-1371. doi: 10.1016/j.hrthm.2018.05.004. Epub 2018 May 11.
Clinical trial NCT00822380: Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children
Official title: Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: Anemia
Iron
Children
Micronutrients
Lead sponsor: Universidad Autonoma de Queretaro
Sponsor class: OTHER
Collaborators: name: Procter and Gamble
First posted: 2009-01-14
Enrollment: 680
Sex: ALL
Minimum age (years): 6
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anemia continues to be a major public health problem in many regions of the world and it is still not clear which strategy is more effective in children population in terms of adherence and efficacy. The objective was to evaluate the efficacy and acceptance of several strategies that have been recently recommended to treat anemia on anemic children (6 to 43 mo):Iron supplement, iron+folic acid supplement, a multiple micronutrients supplement a micronutrient fortified complementary food in the form of porridge powder or zinc+iron+ascorbic acid fortified water.


Eligibility criteria: Inclusion Criteria:

* Hemoglobin less than 11.7g/dL and above 7.0g/dL

Exclusion Criteria:

* Breastfeeding
* Chronic gastroenteritis
* Any other severe illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Rosado JL, Gonzalez KE, Caamano Mdel C, Garcia OP, Preciado R, Odio M. Efficacy of different strategies to treat anemia in children: a randomized clinical trial. Nutr J. 2010 Sep 23;9:40. doi: 10.1186/1475-2891-9-40.
Clinical trial NCT01721980: Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects
Official title: Double-blind, Randomized, Placebo-controlled Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of GLPG0974 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2012-11-06
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability after multiple ascending oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to placebo.

Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood and stool samples (pharmacodynamics) will be characterized compared to placebo.

Also, the effect of the compound on glucose tolerance will be explored as well as the potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.


Eligibility criteria: Inclusion Criteria:

* Healthy male, age 18-50 years
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking

Primary outcomes:
measure: Safety and tolerability
timeFrame: Between screening and 7-10 days after the last dose
Secondary outcomes:
measure: The amount of GLPG0974 in plasma and urine over time after multiple oral dose
timeFrame: Between Day 1 predose and Day 14
measure: Inhibition of CD11b on neutrophils in blood after multiple oral doses of GLPG0974
timeFrame: Day 1 and Day 13, predose until 24h post dose
Other outcomes:
measure: Ratio of 6b-hydroxycortisol/cortisol in urine
timeFrame: Predose and postdose on Day 1 and Day 13 for 24h
measure: Levels of faecal calprotectin in stool
timeFrame: Prior to first dosing and postdose (between Day 12 and 15)
measure: Glucose and insulin concentrations after glucose loading
timeFrame: Day -1 (predose) and Day 14 (postdose)
Locations:
city: Antwerp
country: Belgium
facility: SGS LSS Clinical Pharmacology Unit Antwerp
Study officials:
affiliation: Galapagos NV
name: Frédéric Vanhoutte, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03323580: Effects of Intraoperative GDFT on the Postoperative Brain Edema
Official title: Effects of Intraoperative Goal-directed Fluid Therapy (GDFT) on the Postoperative Brain Edema in Neurosurgical Patients With Malignant Supratentorial Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Therapy
Brain Edema
Brain Tumor
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 480
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: SUPPORTIVE_CARE

Brief summary: Whether a fluid protocol aiming for protecting vital organ perfusion or fluid restriction is favorable to post-craniotomy outcomes such as brain edema remains uncertain. To our knowledge, there has been no extensive and quantitative analysis of brain edema following SVV-based GDFT in neurosurgical patients with malignant supratentorial glioma. So the study aims to observe the effect of the stroke volume variation-based GDFT on the postoperative brain edema and decrease the incidence of postoperative complications in neurosurgical patients with malignant supratentorial gliomas.


Eligibility criteria: Inclusion Criteria:

1. Preoperative brain image indicating high-grade glioma (HGG), verified by postoperative histology of the World Health Organization (WHO) as grade III or IV tumors.
2. Age 18-65 years, and American Society of Anaesthesiologists (ASA) physical status I to III.
3. Signed informed consent.

Exclusion Criteria:

1. Renal insufficiency or the creatinine clearance is \< 30 mL/kg.
2. Heart disease, New York Heart Association Functional Classification (NYHA) class II or higher heart failure, or if their cardiac ejection fraction is \< 20%.
3. Chronic obstructive pulmonary disease.
4. Extensive peripheral arterial occlusive disease.
5. Coagulopathy.
6. Surgery in the prone position.
7. Recurrent carcinoma or tumor in the brain ventricular.
8. Body Mass Index \<18.5 kg·m-2 or \>30.0 kg·m-2.
9. Awake craniotomy.

Primary outcomes:
measure: Quantitative analysis of brain edema
timeFrame: Within 24 hours postoperatively
Secondary outcomes:
measure: The incidence of delirium
timeFrame: During the first 3 postoperative days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References:
citation: Liu X, Zhang X, Fan Y, Li S, Peng Y. Effect of intraoperative goal-directed fluid therapy on the postoperative brain edema in patients undergoing high-grade glioma resections: a study protocol of randomized control trial. Trials. 2022 Nov 19;23(1):950. doi: 10.1186/s13063-022-06859-9.
Clinical trial NCT01421680: The Effects of Preoperative and Postoperative Oral Nutritional Supplements in Malnourished Post-gastrectomy Patients
Official title: A Prospective Randomized Controlled Trial Evaluating the Effects of Preoperative and Postoperative Oral Nutritional Supplements (ONS) in Malnourished Post-gastrectomy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnourished
Stomach Neoplasms
Gastrointestinal Stromal Tumors
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2011-08-23
Enrollment: 144
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to evaluate the effect of a perioperative nutrition strategy using oral nutritional supplements (ONS) on postoperative complications and improvement in body weight in malnourished patients who underwent gastrectomy.


Eligibility criteria: Inclusion Criteria:

* Patients older than 20 years
* Patients who undergo distal, total, proximal, or pylorus-preserving gastrectomy
* Patients who are assessed as moderate or severe malnourished according to PG-SGA or patients with BMI lower than 18.5 kg/m2
* Patients who can take oral meals
* Patients who agree on the informed consent

Exclusion Criteria:

* Emergent operation
* Patients who received preoperative chemotherapy or radiation therapy within 6 months
* Pregnant patients
* Patients who cannot consume the Ensure powder
* Patients who enrolled another clinical trials

Primary outcomes:
measure: Postoperative complication rate
timeFrame: 7weeks
Secondary outcomes:
measure: Body weight
timeFrame: 7weeks
measure: Body composition indices
timeFrame: 7weeks
measure: Length of hospital stay
timeFrame: 7weeks
measure: Quality of life
timeFrame: 7weeks
measure: Postoperative 30-day mortality
timeFrame: 7weeks
measure: Biochemical assessment of nutritional status
timeFrame: 7weeks
measure: Readmission rate
timeFrame: 7weeks
measure: Patient compliance of oral nutritional supplements
timeFrame: 7weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Seoul National University Hospital
Study officials:
affiliation: Department of Surgery, Seoul National University Hospital
name: Han-Kwang Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03483480: Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease
Official title: Randomized Controlled Trial of Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pilonidal Disease
Pilonidal Sinus
Lead sponsor: The National Children's Hospital, Tallaght
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pilonidal Disease is disease of young patients with significant morbidity and is difficult to treat. Currently multiple methods are practiced for the treatment of the disease, two of them are preferred over others and practice extensively. First one involves excision of pilonidal sinus and dressings while the second one is excision of the pilonidal sinus with application of negative pressure wound therapy. None of these approaches is considered superior to the other, as not enough comparison studies of the two procedures have been done. In order to clarify this and find the best option for our patients, investigators are taking opportunity to compare these two modalities. If participants choose to participate in this study they will be randomly selected to one of these groups and the progress of wound healing will be monitored after surgery with the measurement of wound weekly and photographs. Investigators are hoping to find out which procedure is superior. This will allow investigators to provide the best treatment option for their patients in future.


Eligibility criteria: Inclusion Criteria:

* Adult patient suffering from Pilonidal Disease willing to participate in study.

Exclusion Criteria:

* Patients below the age of 16 years (not able to consent).
* Not consenting to participate in study.
* Patient with less than 3 cm between inferior opening of sinus and anus.

Primary outcomes:
measure: Time to complete wound healing
timeFrame: Wound will be assessed for healing at 1 week to 6 weeks
Secondary outcomes:
measure: VAS score (Visual Analogue Scale)
timeFrame: VAS for pain will be recorded at 1 week to 6 weeks at weekly intervals
measure: Wound size ratio
timeFrame: Wound size ratio will be recorded at 1 week to 6 weeks at weekly intervals
measure: Time to resume daily activities
timeFrame: Assessment will be done at 1 week to 6 weeks at weekly intervals
measure: Recurrence
timeFrame: Patient will be assessed at 6 months from surgery
measure: Analgesia Requirement
timeFrame: Recording will be done at 1 week to 6 weeks at weekly intervals
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Tallaght Hospital
Study officials:
References: