louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06745830: Lymph Node Pathologic Grading Strategy
Official title: Lymph Node Pathologic Grading Strategy: Under the Backdrop of the IASLC Grading System for Invasive Lung Adenocarcinoma - a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Adenocarcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 2998
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2011 to September 2021, we consecutively collected patients with invasive LUAD who underwent surgical resection at the Department of Thoracic Surgery, Fudan University Shanghai Cancer Center.Exclusion criteria were the following: (1) adenocarcinoma in situ, minimally invasive adenocarcinoma, invasive mucinous adenocarcinoma, and other variants of adenocarcinoma; (2) incomplete common driver mutation data; and (3) unavailable pathologic slides.

Brief summary: The percentage of high-grade patterns in metastatic LNs (mLNs) that can predict poor outcomes has yet to be determined. Additionally, the potential implications of other histologic patterns in metastatic lymph nodes on patient outcomes warrant further investigation.

We conducted a retrospective cohort study to investigate the prognostic value of pathologic pattern in metastatic lymph nodes.


Eligibility criteria: Inclusion Criteria:

From January 2011 to September 2021, we consecutively collected patients with invasive LUAD who underwent surgical resection at the Department of Thoracic Surgery, Fudan University Shanghai Cancer Center.

Exclusion Criteria:

1. adenocarcinoma in situ, minimally invasive adenocarcinoma, invasive mucinous adenocarcinoma, and other variants of adenocarcinoma;
2. incomplete common driver mutation data;
3. unavailable pathologic slides.

Primary outcomes:
measure: 5-year RFS
timeFrame: 5 years
Secondary outcomes:
measure: 5-year OS
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT02080130: Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea
Official title: Efficacy of Two Probiotic Preparations in Children With Acute Viral Diarrhoea, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastroenteritis
Keywords: Gastroenteritis
diarrhea
Lead sponsor: Sinaloa Pediatric Hospital
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which of two different preparations of probiotics is effective in the treatment of acute viral diarrhoea in children.

Detailed description: Children and infants, aged 1 month to 5 years, with acute diarrhoea, will be randomised to receive either saccharomyces boulardii, a combination probiotic (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium infantis, Streptococcus thermophillus) or placebo, to determine if one shortens the duration of diarrhoea.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute viral gastroenteritis

Exclusion Criteria:

* Moderate or severe dehydration
* Malnutrition
* Immunodeficiencies
* Sepsis or bacterial infection
* Previous use of antibiotics, antidiarrheal drugs, or probiotics, in the last four weeks.
* Hospitalisation
* No phone number
* Illiteracy

Primary outcomes:
measure: Duration of diarrhoea in hours
timeFrame: Up to 7 days
Secondary outcomes:
measure: Percentage of children requiring hospitalisation
timeFrame: Up to 7 days
measure: Adverse effects
timeFrame: Up to 7 days
measure: Number of liquid stools
timeFrame: Up to seven days
Other outcomes:
Locations:
city: Culiacan
country: Mexico
facility: Sinaloa Pediatric Hospital
state: Sinaloa
Study officials:
affiliation: Sinaloa Pediatric Hospital
name: Giordano Pérez-Gaxiola, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06051630: Effects of Perioperative Administration of Intravenous Lidocaine in Children Operated on for Acute Generalized Peritonitis
Official title: Effects of Perioperative Administration of Intravenous Lidocaine in Children Operated on for Acute Generalized Peritonitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pain
Keywords: Peritonitis
Postoperative pain
Lidocaine
Burkina Faso
Lead sponsor: Université NAZI BONI
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 62
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a randomized, double-blind clinical trial conducted at University hospital Charles De Gaulle of Ouagadougou, comparing the results of intravenous administration of lidocaine perioperatively versus administration of saline
Primary purpose: OTHER

Brief summary: Intravenous administration of lidocaine perioperatively after laparotomy for peritonitis could be an interesting alternative by reducing the duration of postoperative ileus, the intensity of pain and the patient's hospital stay, as well as the cost of management in our context of lack of financial, technical and human resources, hence the present study.


Eligibility criteria: Inclusion Criteria:

* All patients aged 6 to 15, Classified according to the American Society of Anaesthesiologists (ASA) (I, II and III) admitted for peritonitis and whose parents have given informed consent

Exclusion Criteria:

* State of shock
* Severe renal insufficiency (creatinine clearance less than 30 ml/min)
* History of allergy to lidocaine
* Refusal to participate in the study

Primary outcomes:
measure: Resumption of transit
timeFrame: Up to 7 days during the postoperative period. From the date of randomization to the first postoperative gas and/or the presence of postoperative bowel sounds in the patient
Secondary outcomes:
measure: Analog visual scale
timeFrame: Postoperative pain scores at 24 hours
measure: Concentration of C-reactive protein
timeFrame: Hours 24 postoperative
measure: Hospitalisation
timeFrame: Up to 30 days during the postoperative period. From the date of randomization to the patient's discharge from hospital or date of death
measure: Postoperative mortality
timeFrame: Up to 30 days during the postoperative period. From date of randomization to date of death
Other outcomes:
Locations:
Study officials:
affiliation: JOSEPH KI-ZERBO University
name: Nazinigouba OUEDRAOGO, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00410930: Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients
Official title: Double-Blind Placebo-Controlled Study of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Allergy
Keywords: Immunotherapy, major allergen, birch
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
First posted: 2006-12-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare versus placebo the efficacy and safety of recombinant Bet v1, natural purified Bet v1 and birch pollen licenced extract used for subcutaneous immunotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-50 with seasonal rhinoconjunctivitis for at least 2 years, and/or mild asthma range 1 and 2 GINA.
* Positive history of birch pollen allergy (clinical history, positive skin prick test, birch specific IgE, presence of birch pollen)
* Compliant patients
* Written consent.

Exclusion Criteria:

* Perennial rhinoconjunctivitis and/or asthma due to cosensitization with: animal danders, mites, alternaria cladosporium
* Uncontrolled seasonal asthma : severe asthma permanent or not range 3 and 4 of GINA.
* Patients treated with beta-blockers or under continuous oral corticosteroids.
* Pregnant women

Primary outcomes:
measure: Reduction of symptom and medication scores.
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Pr Gabrielle PAULI
Study officials:
affiliation: Hôpital Liautey - Strasbourg, France
name: Gabrielle PAULI, MD, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04894630: Infective Keratitis in Minia Governate
Official title: Epidemiology, Clinical Profile and Treatment Outcomes of Bacterial and Fungal Keratitis in Minia Governate, Egypt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infective Keratitis
Keywords: infective keratitis
Bacterial keratitis
Fungal keratitis
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the microbiological aetiology, epidemiological factors, and clinical profile and treatment outcomes of infective keratitis in Ophthalmology department, Minia University. Egypt

Detailed description: Prospective, non-randomized, observational clinical series of cases, including 150 patients clinically diagnosed as infective corneal ulcer, attending the Ophthalmology Department - Faculty of Medicine. Minia University, Minia, Egypt. From 2018 to 2020.

Detailed history taking and all clinical findings were collected. Corneal scrapings were obtained from patients and subjected to staining and culture for bacterial and fungal pathogens; Bacterial and fungal growth were identified by standard laboratory procedures.

Eligibility criteria: Inclusion Criteria:

* clinically diagnosed as infective corneal ulcer, attending the Ophthalmology Department - Faculty of Medicine - Minia University, Minia, Egypt

Exclusion Criteria:

* healed keratitis

Primary outcomes:
measure: Positive smear and culture
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
Study officials:
affiliation: Minia University
name: Ahmed Abdelghany, ASS PROF
role: STUDY_DIRECTOR
References:
citation: Mabrouk NA, Abdelkader MF, Abdelhakeem MA, Mourad KM, Abdelghany AA. Epidemiology, clinical profile and treatment outcomes of bacterial and fungal keratitis. Int Ophthalmol. 2022 May;42(5):1401-1407. doi: 10.1007/s10792-021-02128-x. Epub 2021 Nov 28.
Clinical trial NCT06312930: Transcranial Pulse Stimulation on Motor Cortex
Official title: Neuromodulation of Transcranial Pulse Stimulation on Primary Motor Cortex in Adults: A Randomized, Cross-over, Single-blind, Sham-controlled, Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Adults
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Transcranial pulse stimulation (TPS) is a newly developed non-invasive brain stimulation (NIBS) technique from Austria \&amp; Germany with highly promising applicability in neuropsychiatric disorders. Clinical trials have shown a beneficial effect of TPS in patients with Alzheimer\&#39;s disease and depression. However, the mechanism of action of TPS treatment is unknown. There is a lack of controlled studies with sufficient sample size to draw reliable conclusions on the modulatory effect of TPS. The primary motor cortex is a common target when investigating the neuromodulation effect of NIBS techniques. Here, a randomized, cross-over, single-blind, sham-controlled clinical trial is proposed to probe the effects of TPS over the primary motor cortex on modulating motor response and motor behavior.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 65
* No physical, neurological or psychiatric disorder
* Right-handedness

Exclusion Criteria:

* Background with neuroscience
* TPS and TMS contraindications, including metal implants, pregnancy, coagulation disorders, thrombosis, brain tumor, cortisone therapy up to 6 weeks before first stimulation, pacemakers or cochlear implants.

Primary outcomes:
measure: Change in movement time in nine-hole peg test after TPS
timeFrame: Immediately after the completion of the single session TPS, 10 minutes after the single session TPS, 20 minutes after the single session TPS, 30 minutes after the single session TPS, 40 minutes after the single session TPS
measure: Change in reaction time in Deary-Liewald reaction time task after TPS
timeFrame: Immediately after the completion of the single session TPS, 10 minutes after the single session TPS, 20 minutes after the single session TPS, 30 minutes after the single session TPS, 40 minutes after the single session TPS
Secondary outcomes:
measure: The influence of motor excitability measured by resting motor threshold (RMT) on post-TPS motor performance
timeFrame: 30 minutes before TPS session, immediately after the completion of the single session TPS, 10 minutes after the single session TPS, 20 minutes after the single session TPS, 30 minutes after the single session TPS, 40 minutes after the single session TPS
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Georg Kranz, PhD
state: Hung Hom, Kowloon
Study officials:
affiliation: The Polytechnic University
name: Georg S. Kranz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01772030: Atrial Fibrillation Recurrence After Cryoballoon Ablation
Official title: Mechanisms and Patterns of Atrial Fibrillation Recurrence After Cryoballoon Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Cryoballoon Ablation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2013-01-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to evaluate the mechanisms of recurrent atrial fibrillation after cryoballoon ablation using the Arctic Front Ablation System. For those with pulmonary vein reconnection, specific sites of reconnection will be evaluated with left atrial intracardiac echo (ICE) guidance. The Achieve mapping catheter will be evaluated head-to-head with our current method of ICE-guided recordings from a conventional mapping catheter with high output pulmonary venous pacing.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing re-do catheter ablation procedure after index procedure with cryoballoon ablation
* At least 18 years old
* Able to read and understand informed consent

Exclusion Criteria:

* Unable to give informed consent

Primary outcomes:
measure: Presence or absence of pulmonary vein isolation or reconnection
timeFrame: During repeat cryoballoon ablation procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Shadyside
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Passavant
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sandeep K Jain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00312130: A Study to Evaluate the Effects of Vildagliptin on the Insulin Response to Glucose in Subjects With Pre-diabetes
Official title: A Single-blind, Single-treatment Study to Evaluate the Effects of Vildagliptin on Response to an Intravenous Glucose Load in Pre-diabetic Subjects With Impaired Fasting Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pre-diabetes
Keywords: Vildaglptin
Pre-diabetes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-04-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an exploratory study to assess whether vildagliptin, an unapproved drug, can increase insulin secretion in subjects with pre-diabetes who have a defect in the insulin response and elevated levels of fasting glucose.


Eligibility criteria: Inclusion Criteria:

* BMI in the range 22-45 and with a stable weight for the last 6 months
* Blood glucose criteria must be met
* Written informed consent

Exclusion Criteria:

* Pregnancy or lactation
* Previous diagnosis of type 2 diabetes or treatment with hypoglycemic agents
* Type 1 diabetes
* Evidence of cardiovascular complications as defined by the protocol
* Evidence of diabetic complications as defined by the protocol

Primary outcomes:
measure: Change from baseline in acute insulin response to an iv glucose load at 6 weeks
Secondary outcomes:
measure: Change from baseline in glucose disappearance rate at 6 weeks
measure: Change from baseline in glucose disappearance rate at 8 weeks
measure: Change from baseline in insulin sensitivity at 6 weeks
measure: Change from baseline in insulin sensitivity at 8 weeks
measure: Change from baseline in acute insulin response to an iv glucose load at 8 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Utzschneider KM, Tong J, Montgomery B, Udayasankar J, Gerchman F, Marcovina SM, Watson CE, Ligueros-Saylan MA, Foley JE, Holst JJ, Deacon CF, Kahn SE. The dipeptidyl peptidase-4 inhibitor vildagliptin improves beta-cell function and insulin sensitivity in subjects with impaired fasting glucose. Diabetes Care. 2008 Jan;31(1):108-13. doi: 10.2337/dc07-1441. Epub 2007 Oct 1.
Clinical trial NCT02875730: A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium Enhancement
Official title: A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Cryoablation
Lead sponsor: Aspire Foundation
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective trial investigating the effectiveness of a modified MRI preparatory pulse sequence to improve pulmonary vein isolation visualization.


Eligibility criteria: Inclusion Criteria:

* Men or non-pregnant women
* A diagnosis of symptomatic paroxysmal or recently persistent atrial fibrillation with a documented successful cardioversion within 4 months of the procedure
* Documented treatment failure or intolerance of at least 1 anti-arrhythmic medication used to control atrial fibrillation.

Exclusion Criteria:

* Contraindication to MRI, such as implanted incompatible metal prosthesis, or subject size exceeds bore or table limits
* Allergy to gadolinium-based contrast agent
* Previous atrial fibrillation ablation
* Renal dysfunction (estimated GFR \<60 mL/min/1.73m2) within 6 months
* Unwilling to provide informed consent for this protocol

Primary outcomes:
measure: Blood Pool Corrected Signal Intensity
timeFrame: Through study completion, an average of 1 year
measure: Imaging Failure Rate
timeFrame: Through study completion, an average of 1 year
measure: Extent of Detected LGE Signal Correlate to the Respiratory Navigator Scheme
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Health System
state: Missouri
Study officials:
References:
Clinical trial NCT04525430: Childbirth Education and Birth Plan on Birth Self Efficacy in Pregnant Women
Official title: Comparison of Childbirth Education and Birth Plan With Childbirth Education Alone on Childbirth Self-Efficacy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Self Efficacy
Keywords: pregnancy
childbirth education
birth plan
self efficacy
midwifery
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 153
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The pregnant women constituting the sample were divided into 3 groups. Group 1 was given only childbirth education (Group-ED), group 2 was given childbirth education and was subjected to a birth plan (Group-ED\&P), and group 3 was the control group, each including 51 pregnant women.

Detailed description: Aim: The purpose of this study was to investigate how pregnant women's childbirth self-efficacy was affected by childbirth education and birth plans applied with the education.

Methods: The research was carried out at seven Family Health Centers in Turkey as a randomized controlled trial. The pregnant women constituting the sample were divided into 3 groups. Group 1 was given only childbirth education (Group-ED), group 2 was given childbirth education and was subjected to a birth plan (Group-ED\&P), and group 3 was the control group, each including 51 pregnant women.

Eligibility criteria: inclusion criteria:

* pregnant women who was in the third trimester (28-40 gestational weeks),
* who was literate or had a relative/helper who would write a birth plan to be prepared,
* who were not involved in any diagnosed risk at the present pregnancy (such as preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios and multiple pregnancy)
* who did not have any diagnosed problems with the health of fetus (such as fetal anomaly and intrauterine growth retardation).

exclusion criteria:

• who had previous cesarean section were not included in the research.

Primary outcomes:
measure: Change in birth self-efficacy level at 2 weeks (after intervention).
timeFrame: CBSEI was administered as a pretest to all pregnant women in the three groups. After two weeks CBSEI was administered as a posttest to the pregnant women in all three groups.
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: İnönü University
Study officials:
affiliation: munzur üniversitesi
name: zeliha sunay, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aragon M, Chhoa E, Dayan R, Kluftinger A, Lohn Z, Buhler K. Perspectives of expectant women and health care providers on birth plans. J Obstet Gynaecol Can. 2013 Nov;35(11):979-985. doi: 10.1016/S1701-2163(15)30785-4.