louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04358198: AI in GIM Diagnosis
Official title: Usefulness of Artificial Intelligence (AI) for Gastric Intestinal Metaplasia Diagnosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: GIM Diagnosis
Artificial Intellegence
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The surveillance EGD in patients with GIM will be done as scheduled and then pictures at GIM lesions and normal mucosa was done and sending to AI for learning. Then AI will be used for diagnosing GIM by using pathology as a gold standard
Primary purpose: DIAGNOSTIC

Brief summary: This study will use artificial intelligence (AI) for diagnosing gastric intestinal metaplasia.

Detailed description: The patients with previously diagnose gastric intestinal metaplasia (GIM) and have the surveillance gastroscopy will be enrolled. The routine surveillance program will be performed additional to taking photo at both GIM and normal mucosa at least 5 pictures in each. Biopsy will be done to confirm the diagnosis of GIM and normal mucosa. All pictures will be inserted to AI algorithm based on the convolutional neural network (CNN). Then, the AI program will be validated in daily endoscopy compared with pathology. Accuracy, sensitivity and specificity can be calculated by 2x2 table.

Eligibility criteria: Inclusion Criteria:

* More than 18 years of age
* Able to sign a consent form

Exclusion Criteria:

* History of gastric surgery
* Coagulopathy
* Pregnancy/Breast feeding

Primary outcomes:
measure: Accuracy of AI for GIM diagnosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: Rapat Pittayanon
state: Bangkok
Study officials:
References:
Clinical trial NCT04533698: Impact of Fluid Resuscitation Protocol on the Incidence of Reoperation for Bleeding After Emergency Cardiopulmonary Bypass Grafting
Official title: Impact of Fluid Resuscitation Protocol on the Incidence of Reoperation for Bleeding After Emergency Cardiopulmonary Bypass Grafting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resternotomy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that underwent elective or emergency aortocoronary bypass.

Brief summary: This is a retrospective data analysis of patients that underwent elective or emergency cardiopulmonary bypass. Resternotomy due to bleeding is frequent after sternotomy. Also due to implementation of Argipressin into clinical practice fluid resuscitation protocol has changed to more vasopressors and less fluid within the past five years. The investigators want to explore the influence of volume resuscitation protocol on incidence of rethoracotomy during the past twenty years.


Eligibility criteria: Inclusion Criteria:

* All patients that underwent elective or emergency aortocoronary bypass at the University Hospital Basel between 2009 and 2020.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Resternotomy
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06278298: Different Level of ECSWT in Post Mastectomy Lymphedema
Official title: Different Levels of Energy of Extracorporeal Shock Wave Therapy in Post Masrectomy Lymphedema
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lymphedema of Upper Limb
Keywords: Lymphedema, Shock wave, Breast Cancer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 45
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to investigate the effectiveness of different dosages of ECSW in the treatment of post mastectomy lymphedema volume and quality of life (Qol)

Detailed description: The treatment program included two sessions per week for eight weeks. This study was approved by the ethical committee faculty of Physical Therapy Cairo University. All patients signed a consent form involves their agreement to participate in this study.

Eligibility criteria: Inclusion Criteria:

- Criteria of selecting the patients from hospital included the following;

1. Their ages ranged from 30 to 50 years.
2. All patients were examined carefully by physician before the study procedure.
3. All patients were free from any other pathological conditions or histories of other health abnormalities except arm lymphedema.
4. They had undergone radical or modified radical mastectomy with axillary lymph node dissection with or without radiotherapy intervention.
5. Only ambulant subjects without any aides will be selected.
6. The degree of lymphedema in all subjects was grade 2 to 3 according to the classification of Foldi.(Foldi et al., 2006), (Appendix II ).
7. All patients will be medically stable.
8. Each patient will sign a consent form which in that insures her eligibility in the study.
9. All patients were treated by the same doctor and physiotherapist.

Exclusion Criteria:

* The subjects had been excluded from the study if they met one of the following criteria;

  1. The patients had recurrent malignancy, active infection, and clinical evidence of obstructive venous diseases.
  2. Patients contraindicated to ESWT due to bilateral, acute, and chronic inflammation as well as due to metastasis and poor skin condition were excluded.
  3. The patients had neurological or orthopedic problems, and diabetes.
  4. Patients with primary lymphedema.
  5. Cardiopulmonary disease which decrease the patient activites.

Primary outcomes:
measure: lymphedema volume
timeFrame: two months
measure: skin thickness of the arm
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
state: Dokki
Study officials:
affiliation: faculty of physical therapy
name: Haytham M Elhafez
role: STUDY_DIRECTOR
References:
Clinical trial NCT05924698: Blood Flow Restriction Therapy Combined With Neuromuscular Electrostimulation in Amateur Female Soccer Players
Official title: Effects of Blood Flow Restriction Therapy Combined With Neuromuscular Electrostimulation in Amateur Female Soccer Players: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to know the effects of Neuromuscular Electrical Stimulation (NMES) and its combination with Blood Flow Restriction (BFR) Therapy in healthy amateur female soccer players.

Detailed description: The objective is to know the effects of Neuromuscular Electrical Stimulation (NMES) and its combination with Blood Flow Restriction (BFR) Therapy in healthy amateur female soccer players.

For this purpose, a randomized clinical trial will be performed: 20 amateur female soccer players were distributed in two groups (control group n=10; experimental group n=10). In the control group, NMES (symmetrical biphasic rectangular pulse, 350 μs and 80Hz) combined simultaneously with active exercise in knee extension (75 repetitions in 4 sets, 20% 1RM, 30 seconds rest between sets) was applied. The experimental group performed the same intervention combined with blood flow restriction (BFR) therapy (80% of arterial occlusion pressure). The variables measured were muscle strength, muscle volume and static proprioception.

Eligibility criteria: Inclusion Criteria:

* Be federated in a sports club playing 11-a-side soccer for at least the last two seasons.
* Be between 16 and 28 years of age.
* Be physically active players at the time of the study with a regular practice of at least 5 hours per week during the last 2 months,
* Have been playing soccer for at least 5 hours per week during the last 2 months.
* Have been playing soccer for at least 2 years

Exclusion Criteria:

* Those who presented at the time of the study any lesion classified according to the Munich consensus and diagnosed by a doctor.
* Those with systemic lupus erythematosus.
* Hemophilia.
* Unregulated hypertension.
* History of pulmonary thromboembolism or stroke.
* Impaired blood coagulation.
* Contraceptive intake.
* Spinal radicular lesions.
* Previous surgeries related to the circulatory system.

Primary outcomes:
measure: Muscular Strenght
timeFrame: During the intervention, at day 1
measure: Muscle volume
timeFrame: During the intervention, at day 1
Secondary outcomes:
measure: Knee joint repositioning
timeFrame: During the intervention, at day 1
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: University of Extremadura
Study officials:
affiliation: University of Extremadura
name: Luis Espejo-Antúnez, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01336998: Administration of Arginine Supplementation in Preterm Infants
Official title: Administration of Arginine Supplementation in Preterm Infants and Measurement of Fecal Calprotectin as an Inflammatory Marker of the Intestine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Necrotizing Enterocolitis
Keywords: necrotizing enterocolitis
arginine supplementation
calprotectin
Lead sponsor: Alexandra Hospital, Athens, Greece
Sponsor class: OTHER
Collaborators: name: University of Athens
First posted: 2011-04-18
Enrollment: 80
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Calprotectin is a cytosolic component of neutrophils .Fecal calprotectin(FC) is a useful marker for exacerbation of inflammatory bowel disease in children .FC may be a useful marker for necrotizing enterocolitis (NEC).

NEC is one of the most common ,deadliest and enigmatic intestinal problems encountered mostly in premature infants. The precise pathophysiology of NEC is unclear ,but major factors thought to play an important role include an immature intestine ,an inflammatory response to intestinal microbes,enteral feedings and intestinal ischemia-reperfusion injury.Diagnosis of NEC is not easy clinically and up to now there is not a simple laboratory test to differentiate NEC at an early stage from other conditions in the neonate.

Arginine is the substrate for NO production in the gut and its deficiency may cause vasoconstriction and gut injury and thus predispose to NEC. In previous studies arginine supplementation was found to reduce the incidence of NEC in premature infants but more studies are needed for the use of arginine supplementation for the prevention of NEC.

The investigators aim is to measure the fecal calprotectin in very low birth weight (VLBW) infants during the first month of life as an inflammatory marker of the bowel and evaluate whether premature infants receiving arginine supplements had lower calprotectin values compared to the premature infants that did not .

The investigators hypothesize that arginine supplementation in preterm infants reduces the inflammation of the gut which will be shown by the lower fecal calprotectin values of the premature infants receiving arginine supplementation.


Eligibility criteria: Inclusion Criteria:

* preterm neonates born at Alexandra hospital during the study period
* \< 34 weeks gestational age
* \< 1500gr birth weight

Exclusion Criteria:

* major congenital abnormalities
* inborn errors of metabolism
* parents not consent

Primary outcomes:
measure: fecal calprotectin levels
timeFrame: first 28 days of life
Secondary outcomes:
measure: necrotizing enterocolitis
timeFrame: first 3 months of life
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Alexandra Hospital
Study officials:
affiliation: Alexandra Hospital neonatal intensive care unit
name: Kostalos Chistos, MD Phd
role: STUDY_CHAIR
References:
Clinical trial NCT04488198: Acupuncture in Pediatrics and Adolescents with Chronic Inflammatory Bowel Diseases
Official title: Acupuncture in Pediatrics and Adolescents with Chronic Inflammatory Bowel Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Morbus Crohn
Colitis, Ulcerative
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic inflammatory bowel disease (CIBD) with its prevalence of 2.6 million people in Europe is diagnosed in 25% before the age of 18 years. Early remission is intended to improve child growth, quality of life and reduce psychological comorbidities. Additionally to conventional drugs one third of pediatric CIBD patients use alternative treatment strategies. However, there is a lack of evidence of acupuncture as complementary medicine in pediatric CIBD on the disease activity and inflammation. Therefore, the main aim of this study is to evaluate the effect of acupuncture in children with CIBD on the Pediatric Ulcerative Colitis Activity Index (PUCAI) and the Weighted Pediatric Crohn's Disease Activity Index (sPCDAI), which are non-invasive validated instruments to measure the disease activity. Furthermore, this study aims to investigate the effect of acupuncture on chronic pain, quality of life and parameters of inflammation.


Eligibility criteria: Inclusion Criteria:

* mild/moderate CIBD
* stable pharmacological treatment at least for 8 weeks

Exclusion Criteria:

* complementary alternative medicine

Primary outcomes:
measure: Disease Activity Index
timeFrame: At beginning vs 8 weeks
measure: Disease Activity Index
timeFrame: At beginning vs 4 weeks
Secondary outcomes:
measure: Quality of Life in Children and Adolescents measured by KINDL(R)
timeFrame: At beginning vs 4 weeks
measure: Quality of Life in Children and Adolescents measured by KINDL(R)
timeFrame: At beginning vs 8 weeks
measure: Quality of Life in Children and Adolescents measured by ILK
timeFrame: At beginning vs 4 weeks
measure: Quality of Life in Children and Adolescents measured by ILK
timeFrame: At beginning vs 8 weeks
measure: Pain assessment
timeFrame: At beginning vs 4 weeks
measure: Pain assessment
timeFrame: At beginning vs 8 weeks
measure: C reactive protein
timeFrame: At beginning vs 4 weeks
measure: C reactive protein
timeFrame: At beginning vs 8 weeks
measure: Leukocytes
timeFrame: At beginning vs 4 weeks
measure: Leukocytes
timeFrame: At beginning vs 8 weeks
measure: Erythrocyte sedimentation rate
timeFrame: At beginning vs 4 weeks
measure: Erythrocyte sedimentation rate
timeFrame: At beginning vs 8 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna
Study officials:
affiliation: MedUniVienna
name: Gisela Scharbert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03060798: The Change of Tissue Oxygen Saturation Following Volatile Anesthesia
Official title: The Change of Tissue Oxygen Saturation Measured by Dynamic Near Infrared Spectroscopy Following Volatile Anesthesia in Healthy Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Aging
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2017-02-23
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: PROBABILITY_SAMPLE
Study population: Adult male and female patients over 18 years of age undergoing general surgery under general anesthesia. American anesthesiologists association patient (ASA) category I or II.

Brief summary: General anesthesia can affect tissue oxygen saturation and microcirculatory reactivity. However, the differences in microcirculation caused by anesthetic methods have not been well studied. Near-infrared spectroscopy (NIRS) measures peripheral tissue oxygen saturation noninvasively and can be used in conjunction with vascular occlusion (VOT) experiments. The purpose of this study was to examine the changes in NIRS derived tissue oxygen saturation (StO2) and microcirculatory reactivity by VOT after inhalation anesthesia in healthy population.

This prospective, observational study will be performed on 60 healthy patients who had undergone elective surgery under volatile general anesthesia. The investigators measure StO2 and microvascular reactivity using NIRS combined with vascular occlusion test (VOT). The parameters were performed twice per patient, before and after the induction of anesthesia.

Occlusion slope and recovery slope during VOT will be compared before and after anesthesia. Moreover, the changes depend on the age will be analyzed.

Detailed description: This prospective observational study was performed on 60 patients without comorbidities who underwent elective surgery under general anesthesia. Before and after the induction of anesthesia, StO2 monitoring and VOT were performed to investigate the effect of anesthesia on microcirculation. To investigate the effect of age on microcirculation, the patients were divided into two different groups, young (\< 65 yrs) and old (\> 65 yrs) groups, and the VOT-derived parameters and hemodynamics between two groups were compared.

Eligibility criteria: Inclusion Criteria:

* Adult Over 18 years of age undergoing general surgery under general anesthesia.

Exclusion Criteria:

* ASA category III or IV, Diabetes, Chronic Kidney Disease, Vascular Disease

Primary outcomes:
measure: Changes in Tissue Oxygen Saturation after General Anesthesia
timeFrame: before and 30 minutes after anesthetic induction
Secondary outcomes:
measure: Age-related changes in microcirculation
timeFrame: before and 30 minutes after anesthetic induction
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Hyeon Jeong Lee
Study officials:
affiliation: Pusan National University Hospital
name: Hyeon-Jeong Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005098: Study of Genotype and Phenotype in Patients With Alpha 1-Antitrypsin Deficiency
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alpha 1-Antitrypsin Deficiency
Keywords: alpha 1-antitrypsin deficiency
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of Pittsburgh
First posted: 2000-04-07
Enrollment: 160
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES:

I. Establish cell lines from patients with alpha 1-antitrypsin deficiency in order to examine genetic traits that predispose to liver injury.

Detailed description: PROTOCOL OUTLINE:

Patients undergo blood draw and skin biopsy. Cells are isolated from patients' blood and skin, cell lines are established, and genetic traits are examined.

Eligibility criteria: * Alpha 1-antitrypsin deficiency

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David H. Perlmutter
role: STUDY_CHAIR
References:
Clinical trial NCT03098498: Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy
Official title: Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Periodontal Attachment Loss
Periodontal; Lesion
Keywords: periodontitis
scaling
attachment gain
air polishing
periodontal lesion
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: controlled prospective parallel group intervention trial
Primary purpose: TREATMENT

Brief summary: This study compared the gain of periodontal attachment after concomitant one-stage removal of bacterial biofilms and subgingival calculus with a two-stage procedure removing subgingival calculus 6 weeks after the initial removal of soft subgingival bacterial biofilms.

Detailed description: The concomitant removal of subgingival calculus and soft bacterial biofilms in a one-stage procedure might impair periodontal healing in deep infrabony pockets due to the mechanical disruption of demineralized bone sections at the bottom of periodontal lesions. This randomized controlled clinical trial therefore aims at comparing the resulting attachment gain 6 months after one-stage antiinfective periodontal therapy comprising the concomitant subgingival removal of soft bacterial biofilms and calculus with a two-stage approach removing subgingival calculus only 6 weeks after the initial removal of soft subgingival bacterial biofilms.

Eligibility criteria: Inclusion Criteria:

* presence of periodontal disease
* minimum of 1 tooth with an infrabony periodontal lesion and pocket depth ≥ 6mm
* minimum of 15 natural teeth

Exclusion Criteria:

* systemic disease interfering with periodontal healing (e.g. diabetes)
* antibiotic therapy ≤ 12 month prior to study participation
* necessity for preventive antibiotic therapy during dental interventions
* inability to comply with the study protocol

Primary outcomes:
measure: Change in Clinical Attachment Loss
timeFrame: 168 days (24 weeks)
Secondary outcomes:
measure: Change in Bleeding on Probing
timeFrame: 168 days (24 weeks)
measure: Change in Probing Pocket Depth
timeFrame: 168 days (24 weeks)
measure: Change in Gingival Index (GI)
timeFrame: 168 days (24 weeks)
measure: Change in Plaque Index
timeFrame: 168 days (24 weeks)
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: Dept. of Periodontology, University Hospital Wuerzburg
Study officials:
affiliation: Chairman Dept. of Periodontology, University Hospital Wuerzburg, Germany
name: Ulrich Schlagenhauf, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: