louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02154659: The Difference of Reflux Pattern Between the Patients Who Have Postprandial Reflux Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 81
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Gastroesophageal reflux disease is increasing worldwide. The causes of reflux symptoms are not found exactly. especially, the postprandial reflux symptoms are more common than the all day reflux symptoms. One of the causes of reflux symptoms is the relaxation of the lower sphincter of the esophagus. But, the sphincter relaxation also occur in normal people. But, there is a difference in postprandial reflux pattens between the patients and the normal people. So, in this study, we want to compare the difference of reflux pattern between the patients who have postprandial reflux symptoms and normal people though the 24hr pH monitoring.


Eligibility criteria: Inclusion Criteria:

1. over 19 years old, male and female
2. normal people (control group, who has no postprandial reflux symptoms
3. patients who have postprandial reflux symptoms (postprandial reflux symptom means that within the last 6 months, postprandial reflux symptoms more than once a week for more than 1 month)

Exclusion Criteria:

1. patients who have nasoesophageal stricture
2. patients who have bleeding tendency
3. patients who have esophageal varix
4. patients who have cardioverter implantation
5. patients who had surgery for esophagus, stomach or duodenum
6. patients who are taking medications, gastrointestinal motility drugs

Primary outcomes:
measure: The difference of reflux pattern at postprandial period between the patients who have postprandial reflux symptoms and the normal people
timeFrame: Within the 24 hours after the 24hr pH monitoring
Secondary outcomes:
measure: The difference of esophageal reflux pH between the patients who have postprandial reflux symptoms and the normal people
timeFrame: Within the 24 hours after the 24hr pH monitoring
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei university College of Medicine
Study officials:
References:
Clinical trial NCT01665859: Risk Factors for Poor Outcome After Epigastric and Umbilical Hernia Repair
Official title: Nationwide Prospective Study of Surgical Risk Factors for Poor Outcome After Epigastric and Umbilical Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Umbilical Hernia
Epigastric Hernia
Keywords: readmission
recurrence
umbilical
epigastric
hernia
outcome
morbidity
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2012-08-15
Enrollment: 6783
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All elective umbilical or epigastric hernia repairs registered in tha Danish National Hernia Database from January 1st 2007 to December 31st 2010

Brief summary: Umbilical and epigastric hernia repairs are common and performed by numerous surgical techniques. Considering that the hernia repairs in general are relatively small and simple procedures there are disproportionate poor results.

The aim of present study is to determine surgical risk factors for readmission after umbilical and epigastric hernia repair and to report risk factors for later reoperation for recurrence.

Detailed description: All elective umbilical or epigastric hernias registered in the Danish Ventral Hernia Database are included in the study. The included patients will be followed in up to 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.

Eligibility criteria: Inclusion Criteria:

* Umbilical or epigastric hernia repair

Exclusion Criteria:

-

Primary outcomes:
measure: readmission
timeFrame: 30 days
Secondary outcomes:
measure: reoperation for recurrence
timeFrame: up to 4 years
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Køge Hospital
Study officials:
affiliation: dept. surgery, Køge sygehus, Denmark
name: Frederik Helgstrand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03751059: NSAID vs Steroid in Trabeculectomy Wound Management
Official title: An Investigator-Initiated Multicenter Prospective Clinical Trial to Examine the Efficacy of Peri-operative NSAID vs Steroid Treatment in Trabeculectomy Wound Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Glaucoma
Lead sponsor: Ivey Eye Institute
Sponsor class: OTHER
Collaborators: name: Glaucoma Research Society of Canada
First posted: 2018-11-23
Enrollment: 150
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: This study will examine the efficacy of steroid vs NSAID treatment in relation to trabeculectomy wound management. Eligible study participants will be randomized to receive either steroid or NSAID topical treatment one week post-trabeculectomy. Each group will dose with their assigned study treatment until three months post-trabeculectomy. Study participants will be followed for twelve months post-trabeculectomy.


Eligibility criteria: Inclusion Criteria:

* Adult patients over the age of 18 years
* Uncontrolled open angle glaucoma
* Scheduled to undergo stand-alone trabeculectomy
* No previous incisional glaucoma surgery
* No ocular surgery of any kind in prior 6 months

Exclusion Criteria:

* steroids and/or NSAIDs contraindicated
* poor corneal epithelial health

Primary outcomes:
measure: Target IOP
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ivey Eye Institute
name: Cindy Hutnik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04108559: Comparison of The Surgical Drain Placement With Use of Kinesiologic Tape
Official title: Comparison of The Surgical Drain Placement With Use of Kinesiologic Tape on Postoperative Pain, Swelling and Trismus in Impacted Mandibular Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impacted Third Molar Tooth
Keywords: Kinesiology tape
Surgical drain
Pain
Swelling
Trismus
Lead sponsor: Konya Necmettin Erbakan Üniversitesi
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The investigator's purpose was to compare the effects of the surgical drain and kinesiologic tape applications on postoperative morbidity after mandibular third molar surgery.

Detailed description: A total of 90 patients will be scheduled for impacted third molar surgery. The patients will be divided into 3 groups.All surgeries will be carried out by the same surgeon. Group A will be treated with kinesiologic tape, Group B will be treated with a surgical drainage tube and Group C will be control group. After surgery in control group, routine surgical extraction will be performed.The investigators will compare postoperative pain, swelling, trismus and patients' comfort.

The duration of each procedure from the start of the incision to the time of last suture placement will be noted.

Patients are recalled on days 2, 7, 14 postoperative pain, facial swelling, maximum mouth opening, wound dehiscence. For the assesment of the pain, visual analog scale will be used. For the swelling evaluation, measurement will be done from the different three region on the face:

* Tragus-Pogonion
* Tragus-Labial Commissura
* Angulus Mandible-Lateral canthus

Maximum mouth opening will be noted before and after (one week later) the surgery.

Eligibility criteria: Inclusion Criteria:

* Older than 18 of age,
* Asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B)
* Fully covered with mucosa and bone

Exclusion Criteria:

* Alcohol abuse,
* Smoking,
* Pregnancy,
* No allergy
* Presence of acute severe periodontitis.

Primary outcomes:
measure: Swelling will be assessed using paper ruler. Tragus-Pogonion Tragus-Labial Commissura Angulus Mandible-Lateral canthus.
timeFrame: Up to 1week
measure: Pain will be assessed using a visual analogue scale.
timeFrame: Up to 1week
measure: Trismus will be evaluated using a caliper at maximum mouth opening.
timeFrame: Up to 1week
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
state: Karatay
Study officials:
affiliation: Necmettin Erbakan University
name: Dilek Menziletoglu, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Necmettin Erbakan University
name: Bozkurt Ku Isik, Prof Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT06661759: Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy
Official title: Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sleep problems are more common and more severe in children with epilepsy. The purpose of this study is to develop and evaluate the effect of a clinic-based and technology-supported sleep intervention for improving sleep and health in children with epilepsy and their parents.

Detailed description: Participants in the intervention group will receive a standard pediatric neurology care plus a hybrid in-person and digital sleep education program.

Eligibility criteria: Inclusion Criteria:

* Children aged between 1.5 and 9 years with a confirmed diagnosis of epilepsy.
* Parents with sufficient Chinese language skills to fully comprehend the trial and complete questionnaires.

Exclusion Criteria:

* Children with cerebral palsy or those who are bedridden.
* Children with a documented sleep disorder, such as obstructive or central sleep apnea and sleep-related movement disorders
* Children born with a congenital, genetic, or orthopedic abnormality that limit their activities of daily living or impair their physical activity.

Primary outcomes:
measure: Objective sleep parameter by actigraphy
timeFrame: Baseline, 3 , 6 , and 12 months after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Shao-Yu Tsai
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05456659: Renal Replacement Therapy in Neonates
Official title: Renal Replacement Therapy in Neonates : a Retrospective Monocentric Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Failure
Keywords: Neonatal
Dialysis
Extra-renal purification
Neonatal resuscitation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 72
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor under 28 days old, having benefited from a renal purification technique in the pediatric intensive care unit of the University Hospital of Strasbourg

Brief summary: The circumstances for setting up dialysis in the neonatal period are multiple: congenital anomaly of the kidney and urinary tract (CAKUT), secondary acute renal failure whose etiologies are multiple (sepsis, hypovolemia, respiratory distress syndrome, neonatal asphyxia, Arterial or venous renal thrombosis, nephrotoxic drugs, etc.), metabolic diseases (mainly hyperammonemia and leucinosis) and post-operative management of heart disease: analysis of the characteristics of the patients in our study and comparison with existing epidemiological data in the literature.

The decision to set up dialysis in a newborn whose recovery of renal function is uncertain or in a context of acute multi-visceral failure is not always obvious and must be discussed carefully. multidisciplinary in connection with neonatologists, resuscitators and nephrologists as well as families with the consideration of the future quality of life of the child.


Eligibility criteria: Inclusion criteria:

* Minor under 28 days old
* Having benefited from a renal purification technique in the pediatric intensive care unit of the University Hospital of Strasbourg
* Holders of parental authority who do not object to the reuse of their child's data for scientific research purposes.

Exclusion criteria:

- Holders of parental authority who have expressed their opposition to the reuse of their child's data for scientific research purposes.

Primary outcomes:
measure: Description of clinical characteristics of patients, survival and technical modalities of dialysis in children undergoing neonatal dialysis at the Strasbourg University Hospital
timeFrame: Files analysed retrospectively from January 01, 2010 to December 31, 2021 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pédiatrie 1 - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT00417859: Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings
Official title: Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2007-01-04
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to provide gait parameters as a new objective method to assess total knee arthroplasty outcome between patients with fixed- and mobile-bearing, using an ambulatory device with minimal sensor configuration.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from a primary unilateral knee osteoarthritis and requiring a knee replacement
* Informed consent

Primary outcomes:
measure: Gait Stride Length
timeFrame: 5years
measure: EuroQoL Quality of Life Scale (EQ-5D)
timeFrame: 5years
Secondary outcomes:
measure: Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures
timeFrame: 5years
measure: Number of Participants With Dislocation
timeFrame: 5years
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: HOSR
Study officials:
affiliation: HOSR
name: B Jolles, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04524559: Feasibility Of Oral Sensorimotor Stimulation On Oropharyngeal Dysphagia In Children With Spastic Cerebral Palsy
Official title: Feasibility Of Oral Sensorimotor Stimulation And Sequenced Trunk Co-Activation On Oropharyngeal Dysphagia In Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Therapy
Keywords: Spastic Quadriplegia
Cerebral Palsy
Oropharyngeal Dysphagia
Oral Sensorimotor Stimulation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 64
Sex: ALL
Minimum age (years): 12
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children with CP encounter swallow and feeding impairments, especially in infancy and childhood with long meal times with late development of oral motor skills resulting in poor growth.

Detailed description: this study will be conducted to explore the feasibility of oral sensorimotor stimulation combined with sequenced trunk co-activation on oropharyngeal dysphagia in children with spastic quadriplegic CP.

Eligibility criteria: Inclusion criteria

* Diagnosed as spastic quadrilepgic CP
* Both genders
* Aged from 12 to 48 months
* Scored ≤ 10 on an initial evaluation of Oral Motor Assessment Scale.
* Having at least a problem of oral motor functions (drooling, swallowing, and/or sucking); independent feeding
* Grade ≥ 2 spasticity according to the MAS
* Level IV and V motor function according to the GMFCS-R\&E.
* Partial head and trunk control. Exclusion criteria
* Gum and/or dental problems
* Congenital problems of mouth and soft plate
* Uncontrolled seizures
* Any metabolic disorders
* Cardiopulmonary disorders
* Significant mental problems.

Primary outcomes:
measure: Oral motor skills
timeFrame: period of the treatment was 4 successive months
Secondary outcomes:
measure: - Physical growth
timeFrame: period of the treatment was 4 successive months
measure: - Segmental trunk control
timeFrame: period of the treatment was 4 successive months
measure: - Gross motor function
timeFrame: period of the treatment was 4 successive months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of physical therapy, Cairo university
Study officials:
affiliation: MTI university, Egypt
name: sara s saad-Eldeen
role: STUDY_DIRECTOR
References:
Clinical trial NCT00528359: β-Cell Function in Schizophrenic Subjects on Atypical Antipsychotic drugS
Official title: Phase 1 Study of Insulin Sensitivity, Adjusted β-Cell Function and Adiponectin Among Lean Drug-naïve Schizophrenic Subjects Treated With Atypical Antipsychotic Drugs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: antipsychotic drugs
schizophrenia
β-cell function
insulin resistance
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2007-09-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to determine whether atypical antipsychotic drugs (commonly prescribed for treating schizophrenia) induce changes in anthropometry and metabolism, including alteration in insulin sensitivity and/or insulin secretion by the pancreas, when given to lean, non-diabetic, individuals who are antipsychotic drug(s)-naïve, and free of metabolic syndrome at enrollment.

Detailed description: Atypical antipsychotic drugs (AADs) induce weight gain, truncal adiposity and may engender a metabolic syndrome which may progress to IFG/IGT or DM. AADs effects in lean schizophrenic patients without metabolic syndrome are not documented, especially the relationship between weight gain and changes in insulin sensitivity (S), beta-cell function (β), and circulating adiponectin. We prospectively determined the outcome of 9-month therapy with AADs on anthropometrics, metabolism and adiponectin, including HOMA-modeling of S, β, and βxS (hyperbolic product, assessing individual β adjusted for S)in 36 schizophrenic subjects (M:F 24:12; Caucasian n=23; North-African n=12; South-Asian n=1) aged 35±9 years (mean±1SD) free of MetS (NCEP-ATPIII).

Eligibility criteria: Inclusion Criteria:

* age 18-55 years
* body mass index \<25.0 kg/m²
* waist circumference \<102 (men) and \<88 cm (women)
* absence of a metabolic syndrome according to NCEP ATPIII criteria
* normoglycaemic (fasting plasma glucose levels \<100 mg/dl)

Exclusion Criteria:

* previous use of antipsychotic drugs
* concomitant therapy with drugs known to possess an inherent potential to increase weight and/or to alter glucose metabolism (including antihistaminic drugs, glucocorticoids, β-blockers, antiepileptic drugs and mirtazapine)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Sanatia Hospital
Study officials:
affiliation: Université Catholique de Louvain
name: Philippe M ORIOT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03055559: Trial Protocol GlobiFer - Oral Iron Repletion
Official title: Oral Iron Repletion With Globifer Forte® After 12 Weeks of Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Deficiency
Keywords: Iron, Hemoglobin, Feritin, erytrocyty. transferin
Lead sponsor: Gedeon Richter Slovakia, s.r.o.
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female , ≥ 18 ≤ 60 years of age

Brief summary: The haemoglobin level of the patients with iron deficiency should be increased clinical relevant after 12 weeks treatment with GlobiFer Forte.


Eligibility criteria: Inclusion Criteria:

1. ≥ 18 ≤ 60 years of age
2. Signed written informed consent
3. Hb ≥ 8 ≤ 10g/dl for
4. Female

Exclusion Criteria:

1. History of acquired iron overload, known haemochromatosis or first relatives with haemochromatosis, and allergic disorders (asthma, eczema, and anaphylactic reactions).
2. Known hypersensitivity to oral iron preparations.
3. Diseases, which an iron supplementation is not allowed or contraindicated.
4. Patients on current oral or intravenous iron supplementation
5. History of erythropoietin therapy in previous 30 days or scheduled for erythropoietin therapy or blood transfusion during duration of the study.
6. Patients who have had iron supplementation within the last 30 days.
7. Other reasons which in the investigator's judgment argue against inclusion of the patient into the trial.
8. Inability to comprehend study protocol
9. Participation in another clinical trial (currently or within the last 30 days)

Primary outcomes:
measure: Proportion of patients with a clinical relevant increase of the haemoglobin level treatment with GlobiFer Forte
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Martin
country: Slovakia
facility: Prof. MUDr. Ján Danko, PhD.
Study officials:
affiliation: Comenius University's Jessenius Faculty of Medicine
name: Ján Danko, PhD.
role: PRINCIPAL_INVESTIGATOR
References: