louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04454112: Pre and Post-gastrostomy Evaluation of GER in Children Using 24-hour pH Monitoring
Official title: Pre and Post-gastrostomy Evaluation of Gastroesophageal Reflux in Children Using 24-hour pH Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: to compare the results of pre- and postoperative 24-hour pH monitoring in patients who underwent gastrostomy only and who underwent fundoplication concurrently with gastrostomy and to evaluate influence of gastrostomy/ LNF+ gastrostomy on GER.
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to evaluate 24-hour pH monitoring results before and after gastrostomy in neurological impaired (NI) children who underwent gastrostomy or Nissen fundoplication (NF) concurrently with gastrostomy.

Detailed description: Gastrointestinal (GI) problems causing malnutrition may develop quite frequently in patients with neuromotor developmental delay. Diagnosis of GERD in patients with neurological impairment (NI) might be more difficult due to the absence of characteristic features in many cases. One of the best methods for the diagnosis of GER is the 24-hour esophageal pH monitoring.Even though there are some statements in the literature advocating that gastroesophageal reflux may develop in the late period in patients undergoing only gastrostomy, there are also reports supporting that gastrostomy does not contribute to the development of reflux.Regardless of whether the patient received anti-reflux surgery or not, the long-term follow-up is necessary in patients feeding with gastrostomy.The aim of this study is to compare the results of pre- and postoperative 24-hour pH monitoring in patients who underwent gastrostomy only and who underwent fundoplication concurrently with gastrostomy and to evaluate influence of gastrostomy/ LNF+ gastrostomy on GER.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of neurological damage Must be able to apply gastrostomy or Nissen fundoplication concurrently with gastrostomy.

exclusion Criteria: to use anti-reflux medications long period of time gastroesophageal reflux disease

Primary outcomes:
measure: Pre and post-gastrostomy evaluation of gastroesophageal reflux in children using 24-hour pH monitoring
timeFrame: 2 month
Secondary outcomes:
measure: Pre and post-gastrostomy evaluation of gastroesophageal reflux in children using 24-hour pH monitoring
timeFrame: 7 month
Other outcomes:
Locations:
city: Kurupelit/
country: Turkey
facility: Ondokuz Mayıs University Faculty of Medicine, Department of Pediatric Gastroenterology, Hepatology and Nutrition,
state: Samsun
Study officials:
affiliation: she underwent gastrostomy to patients with neurological damage
name: Berat Dilek Demirel
role: STUDY_CHAIR
References:
Clinical trial NCT02870712: Randomized Controlled Trial of the Effectiveness of Perineal Pain and Security of the Suture Led by the Result of Hemostasis Versus Manual Compression Routine Suture Perineal Tears of First Degree During Childbirth
Official title: Randomized Controlled Trial of the Effectiveness of Perineal Pain and Security of the Suture Led by the Result of Hemostasis Versus Manual Compression Routine Suture Perineal Tears of First Degree During Childbirth, ImSOLENCE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parturition
Delivery, Obstetric
Keywords: perineal tear of first degree
suture
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During childbirth, the recommendations have evolved to a restriction of episiotomy. This reduction results in an increase of superficial vaginal and perineal tears. These lesions are usually routinely sutured which often causes the onset of discomfort and pain in the immediate postpartum period. Gordon showed, in 1998, improved comfort and pain when the skin was not sutured perineal tears during the second degree. Others have compared different techniques in the same indications (separated points running suture, biological adhesive) without demonstrated impact. These studies were not interested in isolated perineal tears or first degree or the application of a simple manual compression with or without a suture according to the result of hemostasis.

Our objective is to evaluate the possibility of not suture the perineum of the first degree. The use of suture only result of bleeding not yielding to manual compression.

Our approach is guided by the principles of "primum non nocere" and discerning about the dogmatic systematization.


Eligibility criteria: Inclusion Criteria:

* single Pregnancy
* primiparae
* delivery by spontaneous vaginal delivery
* forward Delivery (≥ 37 weeks)
* cephalic presentation
* children living
* perineal tear or isolated first-degree vaginal tear

Exclusion Criteria:

* Known haemostatic anomaly
* Premature birth (before 37)
* caesarean
* Instrumental delivery
* Placenta and / or uterine revision
* episiotomy
* perineal tear ≥ 2nd degree

Primary outcomes:
measure: Composite Outcome Measure for success defined by : - a negligible pain, - satisfactory healing, - no bleeding and infection of the perineum
timeFrame: ten day after childbirth
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References:
Clinical trial NCT06216912: Gastric Volume in Paralyzed Obese Patients After High-flow Nasal Oxygen Therapy
Official title: Ultrasound Assessment of Gastric Volume in Paralyzed Obese Patients After High-flow Nasal Oxygen Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Undefined
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2024-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese patients undergoing surgery under general anesthesia

Brief summary: Preoperative preoxygenation is performed using High-flow nasal oxygen therapy, and the gastric volume before and after High-flow nasal oxygen therapy is measured by ultrasound and compared in obese patients undergoing surgery under general anesthesia.

Detailed description: Preoperative preoxygenation is performed using High-flow nasal oxygen therapy, and the gastric volume before and after High-flow nasal oxygen therapy is measured by ultrasound and compared in obese patients undergoing surgery under general anesthesia.

Eligibility criteria: Inclusion Criteria:

* Adult patients with a BMI of 30 kg/m2 or more, undergoing surgery under general anesthesia

Exclusion Criteria:

* Nasotracheal intubation
* History of a surgery or anatomical anomaly in the head and neck
* History of Inability to breathe through nose
* History of difficult airway
* Severe cardiac or respiratory disease
* Gastric reflux disease, diabetes, pregnancy
* Previous gastric surgery

Primary outcomes:
measure: gastric volume measured by gastric ultrasound
timeFrame: immediately before HFNOT, immediately after HFNOT, immediately after tracheal intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG - SNU Boramae Medical Center
Study officials:
References:
Clinical trial NCT00996112: Primary Care Management of Community-Acquired, Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections
Official title: Management by Primary Care Clinicians of Patients Suspected of Having Community-Acquired, Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Methicillin-Resistant Staphylococcus Aureus
Keywords: primary health care
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: American Academy of Family Physicians National Research Network
First posted: 2009-10-16
Enrollment: 4518
Sex: ALL
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises primary care patients in ambulatory clinics from two health care systems.

Brief summary: The goal of this study is to further the investigators' understanding of community acquired methicillin-resistant Staph Aureus (CA-MRSA) and treatment of it by developing real-world sustainable strategies consistent with existing guidelines on treatment of CA-MRSA from the Centers for Disease Control and Prevention (CDC) and test these strategies in busy primary care settings.


Eligibility criteria: Inclusion Criteria:

* All patients presenting at a primary care clinic who have a skin or soft tissue infection.

Exclusion Criteria:

* None

Primary outcomes:
measure: Physician Behavior Change
timeFrame: Throughout study participation
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: Department of Family Medicine, University of Colorado Denver
name: David R West, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03971812: Organoids Derived From Induced-Pluripotent Stem Cells (iPS) From Patients With High Grade Astrocytoma
Official title: Organoids Derived From Induced-Pluripotent Stem Cells (iPS) From Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients managed for a brain tumor for whom a blood sample collected routinely will be recovered

Brief summary: The objective of this study research proposal is to model human gliomagenesis using 3-Dimensional (3D) brain organoids derived from human induced pluripotent stem cells (hiPSCs).

The working hypothesis is that 3D brain organoids can develop glioma-like structures and recapitulate phenotypic traits of gliomas when generated from hiPSCs expressing genetic mutants associated with glioma predisposition.

Methodology : To develop this pioneer study on the use of hiPSC-based brain organoids as a strategy to model gliomagenesis and study the impact of genetic mutants, it will be collect the peripheral blood mononuclear cell from 20 patients with high grade astrocytoma with or without IDH mutation. iPS will be generated from these PBMC and will be genetically modified according to different mutations. Then, it will be generate brain organoids according to standard protocols. Brain organoids generated from all different cells will be collected at different time points and analyzed for the presence of glioma-like structures and phenotypic hallmarks of gliomas.

From the proposed experiments, it will be expect that brain organoids will develop glioma-like features upon the presence of genetic mutations. Thus, it will be expect to demonstrate that brain organoids can be used as a reliable strategy to test the impact of genetic mutants, including the possible synergistic cooperation between different mutations on early gliomagenic events.


Eligibility criteria: Inclusion Criteria:

* Patient, male or female, aged 18 years or older
* Astrocytoma grades 3 or 4, confirmed by anatomopathological diagnosis
* Patient having signed an informed consent

Exclusion Criteria:

* Person in emergency situation, a legal person of legal age (guardianship, guardianship or legal guardianship), or unable to express his / her consent
* No affiliation to a social security scheme (beneficiary or beneficiary)
* Pregnant or lactating woman

Primary outcomes:
measure: Characterize the level of proliferation of organoids
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Jean-Olivier ARNAUD, Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01110512: Comparative Efficacy of Two Preparations of the Association Diosmin (450 mg) + Hesperidin (50 mg) in the Treatment of Chronic Venous Insufficiency (CVI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Venous Insufficiency
Keywords: Improvement of CVI parameters
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2010-04-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is hoped that with the use of medication, occurs improvement of the CVI parameters, such as edema, pain, night cramps, functional discomfort, heavy feeling and that the drug test is non-inferior than the comparator.


Eligibility criteria: Inclusion Criteria:

* Subjects who agree to the terms described in IC;
* Subjects of both genders, aged ≥ 18 and ≤ 75 years with IVC framework of the lower limbs;
* Subjects with CVI ranked 3 to 5, according to CEAP scale;
* Patients complaining of pain and swelling in the lower limbs secondary to IVC;
* Subjects with good mental health that can respond adequately to the study questionnaires;
* Subjects who agree to make any return visits for evaluation;

Exclusion Criteria:

* Patients with CVI classified as 0, 1, 2 or 6, according to CEAP;
* Subjects who have received treatment for varicose veins as laser, medication use topical or oral (eg: brown India, coumarin, and etc.). And surgery in the 03 months preceding the study;
* Patients with other diseases that may interfere with the study results: thrombosis, coagulation disorders and other diseases that the medical criteria, are important to be excluded;
* Pregnant or nursing women;
* Presence of any medical condition that, according to the investigator, should prevent the patient from the study;
* Participation in clinical trials in the twelve months preceding the study;
* Patients with serious illnesses and uncontrolled that need multidrug treatment;
* Patients on diuretics of any kind, regardless of pathology (hypertension, renal or liver disease);
* Values of laboratory tests appropriate security; the Hemoglobin \<10 mg / mL the creatinine\> 1.5 mg / mL; AST, ALT, GGT ≥ 2 times normal values; the platelet count below 90.000/ml; Total Bilirubin and the fractions ≤ 1.5 times the normal range.
* past medical history of hypersensitivity to drugs of the same pharmacological classes of substances under investigation;

Primary outcomes:
measure: Improvement of the parameters of CVI, such as edema of lower members.
timeFrame: 90 days.
Secondary outcomes:
measure: Improvement of the parameters of CVI.
timeFrame: 90 days
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: Lal Clínica Pesquisa e Desenvolvimento Ltda
state: SP
Study officials:
affiliation: LAL Clinical Reseach e Development Ltda
name: Alexandre Frederico, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05469412: Comparison of Pharmacological and Non-Pharmacological Interventions For Alleviating Preoperative Anxiety In Children
Official title: To Compare Pharmacological and Non-Pharmacological Interventions (Use of Technology) For Alleviating Preoperative Anxiety In Children Undergoing General Anesthesia In A Tertiary Care Hospital Of Pakistan: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety and Fear
Keywords: Preoperative Anxiety
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 84
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to find out any beneficial effects of electronic devices over preoperative pharmacological intervention in the preoperative period.

Detailed description: Preparation for surgery with the induction of general anesthesia can be a stressful experience for a child. Preoperative anxiety can prolong induction of anesthesia and postoperative recovery, as well as increasing the risk of postoperative delirium, pain, and analgesic use.

Pharmacological interventions are associated with increased cost to the hospital, potential surgical delay while waiting for the medication to take effect, and delayed discharge from the recovery room. Non-pharmacological modalities comprise education, behavioral techniques, parental presence at induction of anesthesia, and using technology including cellular phones and tablets/iPad, with each category including an array of effective strategies for reducing anxiety.

Eligibility criteria: Inclusion Criteria:

1. Children aged between 2 and 12 years old
2. ASA I and II
3. Informed consent signed by parents or legal guardians

Exclusion Criteria:

1. Previous exposure to surgery
2. Contraindication to midazolam
3. Patients with developmental delay
4. Patients with significant visual/hearing problems

Primary outcomes:
measure: modified Yale Preoperative Anxiety Scale
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
References:
citation: Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD006447. doi: 10.1002/14651858.CD006447.pub3.
citation: Agbayani CG, Fortier MA, Kain ZN. Non-pharmacological methods of reducing perioperative anxiety in children. BJA Educ. 2020 Dec;20(12):424-430. doi: 10.1016/j.bjae.2020.08.003. Epub 2020 Oct 21. No abstract available.
citation: Cheng X, Chen Z, Zhang L, Xu P, Qin F, Jiao X, Wang Y, Lin M, Zeng L, Huang L, Yu D. Efficacy and Safety of Midazolam Oral Solution for Sedative Hypnosis and Anti-anxiety in Children: A Systematic Review and Meta-Analysis. Front Pharmacol. 2020 Mar 18;11:225. doi: 10.3389/fphar.2020.00225. eCollection 2020.
Clinical trial NCT05677412: Sleep, Pain and Stress in Adolescents With Persistent Pain
Official title: Sleep, Pain and Stress in Adolescents With Persistent Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Chronic
Sleep
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2023-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Experimental within-subject study design
Primary purpose: TREATMENT

Brief summary: The main aim is the gain information of sleep structures in adolescents with persistent pain. Also to study simple interventions to support their sleep and pain management. The main aim of this study is to test the efficacy and feasibility of suggestive presleep relaxation technique in improving sleep quality and sleep-related emotional memory processing.


Eligibility criteria: Inclusion Criteria:

* Patients aged 15-17 years with persistent (\> 3months) pain reporting average pain intensity over 3/10 on the Numerical Rating Scale (NRS).

Exclusion Criteria:

* ongoing medication for sleep or pain.

Primary outcomes:
measure: Sleep quality
timeFrame: one night
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: New Childrens Hospital
Study officials:
References:
Clinical trial NCT06357312: Influence of Static Distal Locking of a Short Proximal Femoral Nail
Official title: Influence of Static Distal Locking on Outcomes of Unstable Intertrochanteric Fracture Treated With a Short Proximal Femoral Nail
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Fracture
Keywords: hip
fracture
intertrochanteric
elderly
screw
Lead sponsor: Elda University Hospital
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, comparative, randomized and double-blind study
Primary purpose: TREATMENT

Brief summary: Prospective, comparative, randomized, double-blind study to evaluate the outcomes of trochanteric nailing in unstable hip fractures with and without a distal interlocking screw.

Detailed description: Due to the lack of first-level evidence, this study aims to evaluate the effectiveness and safety of surgical treatment for unstable hip fractures, with or without the inclusion of a distal interlocking screw in the hip nail.

Eligibility criteria: Inclusion Criteria:

* Patient over 50 years old
* With unstable intertrochanteric hip fracture
* Operated in the first 48 hours after hospital admission

Exclusion Criteria:

* Simultaneous associated fractures
* Fractures with subtrochanteric line
* Non-acute fractures

Primary outcomes:
measure: Evaluation of functional status using the Barthel index
timeFrame: 12 months
Secondary outcomes:
measure: Postoperative mechanical complications
timeFrame: 12 months
measure: Parker mobility scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Elda
country: Spain
facility: Elda University Hospital
state: Comunidad Valenciana
Study officials:
affiliation: Elda University Hospital
name: Carlos De la Pinta Zazo
role: PRINCIPAL_INVESTIGATOR
References: