louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05647525: The Etiology of New-onset Status Epilepticus
Official title: Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Status Epilepticus
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were selected strictly according to the inclusion and exclusion criteria from January 2021 to December 2022 at Sichuan Academy of Medical Sciences. Inpatient NOSE patients at Sichuan Provincial People's Hospital

Brief summary: This study will help to identify the causes of new epilepsy and provide a basis for the development of a rational and standardized diagnosis and treatment plan to reduce the rate of disability and death.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Status Epilepticus
* Sign the informed consent form

Exclusion Criteria:

* Patients with previous epilepsy
* Missing information such as basic information and treatment history
* Long-term smoking, alcohol and drug abuse
* Pregnant and breastfeeding women

Primary outcomes:
measure: Death
timeFrame: 2021-12--2022-12
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Jie Liu
state: Sichuan
Study officials:
References:
Clinical trial NCT05384925: Prior Abdominal Surgery: A Potential Risk Factor for Colonic Diverticulosis or Diverticulitis
Official title: Prior Abdominal Surgery: A Potential Risk Factor for Colonic Diverticulosis or Diverticulitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diverticulosis, Colonic
Abdominal Adhesion
Diverticulitis
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2022-05-20
Enrollment: 359
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: patients 18 years of age and older presenting for a colonoscopy at Shamir Medical Center between 2020 and 2021

Brief summary: Background \& Aims:

Abnormal colonic pressure profiles have been associated with an increased risk of colonic diverticulosis. A surgical history is a known risk factor for abdominal adhesions, and these may lead to increased intraluminal colonic pressure. We assessed whether previous abdominal surgery is associated with colonic diverticulosis or diverticulitis.

Methods:

The investigators analyzed data from a prospective study of patients undergoing colonoscopy for different indications from 2020 through 2021. Patients completed a structured questionnaire concerning previous abdominal surgeries, dietary and lifestyle exposures including smoking and alcohol use, and co-morbidities.


Eligibility criteria: Inclusion Criteria:

* patients \> 18 years old who are going through colonoscopy in shamir medical center for any reason

Exclusion Criteria:

* inadequate preparation (Boston Bowel Preparation Quality Scale \<6);
* previous colonic resection based on history and colonoscopy;
* previous colon cancer.

Primary outcomes:
measure: correlation between prior abdominal surgery and the development of diverticulosis
timeFrame: in the end of the study (estimated in 1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Asag Harofeh Medical Center
Study officials:
References:
Clinical trial NCT06486025: Protocols for Magnesium Sulfate Maintenance Dose in Overweight and Obese Women Diagnosed With Preeclampsia
Official title: ALTERNATE DOSING PROTOCOL FOR MAGNESIUM SULFATE IN OVERWEIGHT AND OBESE WOMEN WITH PREECLAMPISA: A RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Severe Preeclampsia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is still no evidence of the appropriate dose to be used. Serum magnesium sulfate concentration is not measured regularly, thus we may be using sub-therapeutic level or reaching a toxic level.Overweight and obese women have different pharmacokinetics and different drug distribution, therefore, they may need higher doses of magnesium sulfate to reach therapeutic level.

Detailed description: Magnesium sulfate is used in pre-eclampsia to prevent seizures, it is administered in the form of a loading dose and maintenance dose. Maintenance dose of magnesium sulfate in pre-eclampsia varies in literature (1-3gms/hour). There is still no evidence of the appropriate dose to be used. Serum magnesium sulfate concentration is not measured regularly, thus we may be using sub-therapeutic level or reaching a toxic level.Overweight and obese women have different pharmacokinetics and different drug distribution, therefore, they may need higher doses of magnesium sulfate to reach therapeutic level. This study will evaluate whether overweight and obese women need higher maintenance doses to reach therapeutic level of magnesium sulfate in serum.Preeclampsia is a serious pregnancy complication characterized by hypertension, proteinuria and signs of damage to another organ system, often the kidneys, occurring after 20 weeks of gestation

Eligibility criteria: Inclusion Criteria:

Women diagnosed with SPET as per criteria of NICE, 2023 guidance

* Age 20-40 years
* BMI \>25kg/m2
* Gestational age \> 28 weeks

Exclusion Criteria:

* Intrauterine Fetal Death (IUFD)
* Hemolysis - Elevated liver enzymes - Low platelets syndrome (HELLP)
* Contraindication to Magnesium Sulfate such as myasthenia gravis, severe renal failure, cardiac ischemia, and heart block
* Serum creatinine levels greater than 1.1 mg/dL.
* Women refusing to participate in the study.

Primary outcomes:
measure: serum magnesium level
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02708225: The Influence of Medical Clowns on the Performance of Pulmonary Function Tests Among Preschooler Children
Official title: The Influence of Medical Clowns on the Performance of Pulmonary Function Tests Among Preschooler Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Pneumonia
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-03-15
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Medical clowns are known to assist in relaxing children and allowing better cooperation during performance of medical procedures.

The ability of medical clowns to improve the motivation of children to perform active tasks was never examined to date.

The investigators would like to examine the influence of the clowns' presence on the performance of pulmonary function test.

Detailed description: The investigators would like to evaluate the performance of pulmonary function tests among preschool children aged 3-6 years.

Overall 200 children will participate.

The children will perform pulmonary function test without a clown present.

About an hour later half of them will perform the exam again with a medical clown assistance and the second half will repeat the examination without a clown present the differences between the performance will be evaluated.

Eligibility criteria: Inclusion Criteria:

* children visiting the pediatric pulmonology clinic
* parents signed informed consent

Exclusion Criteria:

* medical or neurological diseases not allowing performance of pulmonary function tests
* parents refusal

Primary outcomes:
measure: length of experium (seconds)
timeFrame: through study completion; estimate 1 year
measure: FEV1 (%predicted)
timeFrame: through study completion; estimate 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hillel Yaffe Medical Center
name: vers NIR, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06142825: Developing, Implementing and Evaluating Effective Community-facility Interactions to Improve Blood Availability and Transfusion in Three Distinct County Settings in Kenya
Official title: Developing, Implementing and Evaluating Effective Community-facility Interactions to Improve Blood Availability and Transfusion in Three Distinct County Settings in Kenya (CoBAnK): A Type III Hybrid Effectiveness-implementation Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Blood Transfusion
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Strathmore University
name: University of Pittsburgh
name: Center for Public Health and Development, Kenya (CPHD)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-11-22
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Type III hybrid effectiveness-implementation trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The strategy of the CoBAnK study is to establish and enable the function of Community-Facility Transfusion Committees (CFTCs) incorporating diverse representation involving hospital, community, and county leadership, to improve blood availability and transfusion at the point-of-care.

Detailed description: The strategy of the CoBAnK study is to establish and enable the function of Community-Facility Transfusion Committees (CFTCs) incorporating diverse representation involving hospital, community, and county leadership, to improve blood availability and transfusion at the point-of-care. The CFTC strategy will be evaluated across nine transfusing facilities across three counties in Kenya (two intervention and one control site in each county). While the intervention will be tested in "beta" facilities (i.e., facilities without a co-located blood bank) in each county, blood availability will also be measured in "alpha" facilities (i.e., facilities with co-located blood banks) in the three counties, which supply blood to the beta facilities.

Eligibility criteria: Eligibility criteria for study sites (beta hospitals):

* Transfusing hospital at level 3 or higher
* Has conducted at least 20 blood transfusions in the preceding year
* Does not have a KTTA-approved blood bank (regional or satellite) in the facility premises
* Receives blood from a blood bank at an Alpha Facility in the same county

Primary outcomes:
measure: Met blood need
timeFrame: The time required for the hospital laboratory to process a request for blood for transfusion, up to two weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT00838825: Continuous Quality Improvement for Diabetes
Official title: Continuous Quality Improvement for Diabetes: Unique Care Delivery Design's Effect on Quality of Care and Utilization of Resources
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Keywords: diabetes
chronic care management
resource utilization
outcome
glycohemoglobin
hospitalization
Lead sponsor: Santa Clara Valley Health & Hospital System
Sponsor class: OTHER
First posted: 2009-02-06
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare health care delivery outcomes and costs achieved by two different approaches to health care delivery. The investigators will compare health outcomes for groups of adult patents with diabetes. One group will be managed by our traditional approach to diabetes care. The second group's care delivery is structured according to a design consistent with the Chronic Care Model (CCM).

Detailed description: The study is comparing the effect of an intervention targeting a subset of the diabetic patients within a primary care practice on the resource utilization of resources and disease outcomes on the entire population of patients with diabetes in that practice. The effect will also be compared across the entire panel of patients assigned to the physicians in the 2 arms of the study.

Eligibility criteria: Inclusion Criteria:

* Primary care physicians practicing in a designated site with \> 200 patients assigned to their panel who have been diagnosed with diabetes

Exclusion Criteria:

* Refusal to give informed consent

Primary outcomes:
measure: resource utilization
timeFrame: baseline compared to 2 years intervention
Secondary outcomes:
measure: compliance with process measures
timeFrame: 3 years
measure: metabolic outcome
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Santa Clara Valley Health & Hospital System
name: Patrick J Kearns, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kearns P. Diabetes Care Management Teams Did Not Reduce Utilization When Compared With Traditional Care: A Randomized Cluster Trial. Manag Care. 2017 Oct;26(10):33-40.
Clinical trial NCT00004825: Short Term Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperinsulinism
Keywords: endocrine disorders
hyperinsulinism
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2000-02-25
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Confirm the inhibitory effect of recombinant human insulin-like growth factor I (IGF-I) on insulin secretion in children with hyperinsulinism.

II. Define the effects of short term IGF-I therapy on postprandial blood sugar levels in this patient population.

III. Characterize the effects of short term IGF-I therapy on fasting behavior, and other insulin dependent parameters, in this patient population.

Detailed description: PROTOCOL OUTLINE: Octreotide and/or diazoxide are discontinued on day 1, and fasting blood glucose is monitored. Patients receive test meals of Sustacal on days 3 and 4 and are assessed for insulin response.

Beginning on day 5, patients are given recombinant human insulin-like growth factor I subcutaneously every 12 hours for a total of 3 doses. The first dose (on day 5) is given 30 minutes before a Sustacal challenge, the second dose is followed by a bedtime snack, and the third dose (on day 6) is followed by a supervised fast.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of hyperinsulinism (i.e. evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action)

Suboptimal control of blood sugar (i.e. inability to fast at least 10 hours with a blood sugar of 60 mg/dL or greater)

No suspected insulinoma

Must be currently managed on a regimen of diazoxide, octreotide and/or frequent feedings to control hypoglycemia

--Prior/Concurrent Therapy--

See Disease Characteristics

--Patient Characteristics--

Hematopoietic: No anemia or other concerns of blood volume depletion

Renal: No renal dysfunction

Other:

* No known malignancy
* No other major medical conditions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Pinchas Cohen
role: STUDY_CHAIR
References:
Clinical trial NCT02878525: Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure
Official title: Study the Effectiveness and Safety of Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure, in Comparison to Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 150
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: The purpose of this study is to study the effectiveness of laparoscopic internal gastric banding as a treatment for morbid obesity in comparison to laparoscopic sleeve gastrectomy

Detailed description: In this study 190 morbidly obese patients will be included and will randomly assign into 2 groups, group 1 will be operated by laparoscopic internal gastric banding and group 2 by laparoscopic sleeve gastrectomy, the patients will be followed up for 1 year to evaluate the effectiveness and drawbacks of laparoscopic internal gastric banding in comparison to laparoscopic sleeve gastrectomy, the investigators preparing to submit our study protocol to our institution ethical committee for approval to start the study

Eligibility criteria: Inclusion Criteria:

* BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* Approval to share in the study
* Patients fit for laparoscopic surgery

Exclusion Criteria:

* Patient age less than 18 or more than 50 years old
* Refusal to share in the study
* Unfit for surgery
* patients with gastroesophageal reflux disease clinically or by investigation

Primary outcomes:
measure: safety of the technique
timeFrame: 4 weeks
Secondary outcomes:
measure: operative time
timeFrame: 12 hours
measure: Hospital stay
timeFrame: 30 days
measure: total cost
timeFrame: 16 weeks
measure: Metabolic effect
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medicine
city: Minya
country: Egypt
facility: Minia university hospital
Study officials:
References:
Clinical trial NCT01382225: Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome
Official title: A Phase 3 Multicenter, Randomized, Controlled, Double-Masked Study of Safety and Efficacy of Sodium Hyaluronate Ophthalmic Solution, 0.18% in Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndrome
Keywords: Dry eyes
Ocular discomfort
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 1936
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: The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in treating the signs and symptoms of dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Documented history of dry eyes for at least 3 months.
* Ocular discomfort due to dry eyes.
* Presence of corneal and conjunctival staining.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women who are pregnant or lactating.
* Contact lens wear within 1 week before Screening and during the study.
* Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
* Punctal plugs or punctal occlusion initiated within 3 months of screening
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7
timeFrame: Baseline, Day 7
measure: Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7
timeFrame: Baseline, Day 7
Secondary outcomes:
measure: Change From Baseline in LGS Total Score at Day 14
timeFrame: Baseline, Day 14
measure: Change From Baseline in GSF Total Score at Day 14
timeFrame: Baseline, Day 14
measure: Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score
timeFrame: Baseline, up to Day 14
measure: Percentage Change From Baseline in Schirmer I Score
timeFrame: Baseline, up to Day 14
measure: Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score
timeFrame: Baseline, up to Day 14
measure: Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score
timeFrame: Baseline, up to Day 14
measure: Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating
timeFrame: Baseline, Up to Day 14
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Michela Montecchi-Palmer, BS
role: STUDY_DIRECTOR
References:
Clinical trial NCT05787925: Adjunctive Oral Systemic Vitamin E Therapy on Salivary Nitric Oxide Level in Patients With Erosive Oral Lichen Planus
Official title: The Efficacy of Adjunctive Oral Systemic Vitamin E Therapy on Salivary Nitric Oxide Level In Patients With Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lichen Planus
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 52
Sex: ALL
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: Oral lichen planus (OLP) is a chronic inflammatory disease affecting the skin, mucous membranes,s and rarely scalp and nails. It is a T-cell-mediated autoimmune disease. Traditional treatment for OLP is topical steroids commonly used to treat mild to moderately symptomatic lesions. Recent treatment modalities for oral lichen planus include micronutrients such as antioxidants including vitamin E that modify the immune system function. The aim of this study is to evaluate the efficacy of adjunctive oral systemic vitamin E therapy on salivary nitric oxide levels in patients with erosive oral lichen planus.


Eligibility criteria: Inclusion Criteria:

* Patients who are clinically and histopathologically confirmed of having erosive OLP according to modified WHO criteria.
* Patients with erosive OLP patients who will agree to take supplied medications.
* Ability to complete this trial.

Exclusion Criteria:

* OLP patients receiving any systemic treatment such as systemic steroids, other immunosuppressive drugs, or non-steroidal anti-inflammatory drugs on past 3 months.
* Pregnant and breast-feeding females.
* Patients suffering from systemic diseases.
* Patients with lesions showing any dysplastic changes in the biopsy specimen.
* Patients who are smoking and tobacco users in any form, will not be included.
* Patients with both lichenoid contact reaction and lichenoid drug reactions.
* Patients with cutaneous lichen planus lesions

Primary outcomes:
measure: Change in oral lesion
timeFrame: At baseline,4th week and 8th week
measure: Change in pain score
timeFrame: At baseline,4th week and 8th week
Secondary outcomes:
measure: Change in salivary nitric oxide
timeFrame: At baseline,4th week and 8th week
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References: