louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05334134: COVID-19: Immunological Mechanisms in Multisystem Inflammatory Syndrome in Children
Official title: Immunological Mechanisms in Multisystem Inflammatory Syndrome in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multisystem Inflammatory Syndrome in Children
COVID-19
SARS-CoV-2 Infection
Keywords: Multisystem Inflammatory Syndrome in Children
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients fulfilling the diagnostic critieria of MIS-C, according to the CDC

Brief summary: This study seeks to explore immunological mechanisms in patients with Multisystem Inflammatory Syndrome in Children (MIS-C) to improve the understanding of this pathogenesis of this disease.

In a cohort of MIS-C patients diagnosed during the Wild type, Alpha, Delta and Omicron waves, research samples will be analyzed for whole-blood RNA expression, proteomics, inflammatory cytokines, cellular immune populations, autoantibodies, as well as host genetic markers.

Detailed description: BACKGROUND Multisystem inflammatory syndrome in children (MIS-C) is a rare severe complication to SARS-CoV-2 infection in children. Thousands of children worldwide have been hospitalized with this new disease. Yet, the immunological mechanisms are sparsely described.

AIM The project seeks to explore immunological mechanisms in patients with MIS-C.

METHOD From a prospective nationwide cohort of patients with MIS-C from Denmark (May 2020-March 2022), research samples will be investigated for whole-blood RNA expression, proteomics, inflammatory cytokines, metabolomics, cellular immune populations, autoantibodies, as well as host genetic markers allowing for detailed mapping this disease. Samples from MIS-C patients will be compared to patients with bacterial and viral disease, and other inflammatory diseases.

TIME FRAME Sample identification: February 1 2022 to April 1, 2022. Sample analysis: April 1, 2022 to December 31, 2022

PERSPECTIVES New molecular-based tools may lead to improved understanding of the pathogenesis of MIS-C. This could form basis for development of novel diagnostic markers, identification of severe phenotype and therapeutic interventions.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with MIS-C, according to the CDC criteria aged 0-17 years

Exclusion Criteria:

* Patients from whom patient/parent/legal guardian signed consent is not received

Primary outcomes:
measure: Immunological mechanisms in MIS-C
timeFrame: Day 0-3 and up to during 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Ulrikka Nygaard
Study officials:
affiliation: Rigshospitalet, Denmark
name: Ulrikka Nygaard, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01578434: Role of Calcium And Vitamin D In Nutritional Rickets And It's Management
Official title: Role of Calcium And Vitamin D In Nutritional Rickets And It's Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nutritional Rickets
Keywords: Nutritional Rickets
Calcium
Vitamin D
Lead sponsor: Lady Hardinge Medical College
Sponsor class: OTHER_GOV
First posted: 2012-04-17
Enrollment: 67
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rickets, a common nutritional disorder, is usually considered to be due to vitamin D deficiency. However, in the last few decades many studies have shown that in tropical countries, with abundance of sunshine, calcium deficiency may play a more important role in the causation of rickets. Studies from adults in India have also shown that calcium intake of our population is much below the recommended allowance. The calcium deficiency gets compounded by the high level of phytates in the conventional vegetarian diet consumed by the majority of the population. There are few studies on children in India / other Asian countries on assessment of dietary calcium intake.

However, recent studies from many nations of the world have also shown a wide spread prevalence of vitamin D deficiency in adolescent and adult population. A study done at our own hospital has shown a high prevalence of vitamin D deficiency in lactating mothers and their infants.

Since both Calcium and Vitamin D deficiency are likely to be present in children, it is not clear what plays a more important role in the etiology of rickets in India or other Asian countries.

The present study is therefore planned with the following objectives:

1. To study the dietary calcium intake, sun exposure and serum vitamin D levels in children with and without rickets.
2. To compare the role of Calcium Carbonate, Vitamin D and a combination of the two in the treatment of nutritional rickets.


Eligibility criteria: Inclusion Criteria:

* children aged 6 months to 5 years with rickets

Exclusion Criteria:

* Non nutritional cause of rickets
* taken vitamin D or calcium supplements in last 6 months
* children presenting with convulsions

Primary outcomes:
measure: Healing of rickets
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03341234: Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection
Official title: Analgesic Efficiency of Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Analgesia
Pain, Postoperative
Opioid Consumption
Keywords: Superficial Serratus Plane Block
Modified Radical Mastectomy
Axillary Lymph Node Disection
bupivacaine
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast cancer is the most common type of cancer in women. Mastectomy and axillary lymph node disection are commonly performed as part of the cancer management. This surgery can cause significant postoperative pain. The serratus plane block (SPB) has been described for analgesia of the hemithorax and reported for many cases such as thoracoscopy, shoulder arthroscopy, breast surgery and axillary lymph node dissections. Serratus plane block may be a viable alternative to current regional anaesthetic techniques such as thoracic paravertebral and central neuraxial blockade.

The aim of this study is to determine effectiveness of ultrasound guided superficial serratus plane block in patients undergoing modified radical mastectomy and axillary lymph node dissection surgery.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients undergoing Modified Radical Mastectomy and Axillary Lymph Node Disection

Exclusion Criteria:

* chronic pain, bleeding disorders, renal or hepatic insufficiency,patients on chronic non-steroidal anti-inflammatory medications

Primary outcomes:
measure: Opioid Consumption
timeFrame: First 24 hours total opioid consumption
Secondary outcomes:
measure: Visual analog pain score
timeFrame: postoperative first hour
measure: Visual analog pain score
timeFrame: postoperative second hour
measure: Visual analog pain score
timeFrame: postoperative 4th hour
measure: Visual analog pain score
timeFrame: postoperative 8th hour
measure: Visual analog pain score
timeFrame: postoperative 12th hour
measure: Visual analog pain score
timeFrame: postoperative 24th hour
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Regional Training and Research Hospital
Study officials:
References:
citation: Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
citation: Ahiskalioglu A, Alici HA, Yayik AM, Celik M, Oral Ahiskalioglu E. Ultrasound guided serratus plane block for management of acute thoracic herpes zoster. Anaesth Crit Care Pain Med. 2017 Oct;36(5):323-324. doi: 10.1016/j.accpm.2017.01.008. Epub 2017 Mar 21. No abstract available.
Clinical trial NCT01270334: Effect of Vaginal PH on Treatment Effectiveness With Misoprostol for First Trimester Missed Abortions
Official title: Effect of Vaginal PH on Treatment Effectiveness With Misoprostol for First Trimester Missed Abortions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MISED ABORTION- Vaginal PH
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2011-01-05
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women dignosed with missed abortion in the first trimester

Brief summary: vaginal PH has an effect on the effectiveness of treatment with misoprostol given vaginally for missed abortions in the first trimester


Eligibility criteria: Inclusion

* missed abortion under 8 weeks by sac diameter over 18 years old informed concent given

Exclusion Criteria:

* missed abortion over 8 weeks hypersensitivity for PG vaginal bleeding suspected EUP IUD heart disease, HTN, cerebral vascular disease, epilepsy intrauterine infection clooting disorder under 18

Primary outcomes:
measure: treatment failure- need for D&C
timeFrame: 2 weeks
Secondary outcomes:
measure: side effects, need foe analgetics, time for compliting abortion
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemel Medical Center
Study officials:
References:
Clinical trial NCT01357434: Comparing Calories at Fast Food Restaurants
Official title: Rating Fast Food on Healthiness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2011-05-20
Enrollment: 97
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents in a community in South Los Angeles.

Brief summary: Rating systems are intended to guide consumer choices. This project will determine if a previously developed scale that evaluates the "healthiness" of a restaurant is correlated with the actual choices consumers make when they patronize the restaurants. The study will also assess whether a restaurant marketed as "healthy" (Subway) rates higher on this scale than another restaurant that makes no such claims (McDonald's). Finally, the investigators will compare the calorie purchases from these two restaurants among youths and their families who eat at each of the restaurants.


Eligibility criteria: Inclusion Criteria:

* 12-21 Year Olds that live in local area
* Like to eat at Subway and McDonald's

Primary outcomes:
measure: Calories Consumed at each Restaurant
timeFrame: Calories will be recorded at two time points within 1-2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: University of California, Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
References:
citation: Lesser LI, Kayekjian KC, Velasquez P, Tseng CH, Brook RH, Cohen DA. Adolescent Purchasing Behavior at McDonald's and Subway. J Adolesc Health. 2013 Oct;53(4):441-5. doi: 10.1016/j.jadohealth.2013.02.014. Epub 2013 May 6.
Clinical trial NCT02656134: Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis (FAP)
Official title: Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis: A Prospective Clinical, Immunopathologic and Molecular Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Familial Adenomatous Polyposis
Keywords: Familial Adenomatous Polyposis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 55
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Familial Adenomatous Polyposis with colectomy, or scheduled for surgery.

Brief summary: Background and study aim The relative risks of duodenal adenocarcinoma and ampullary carcinoma in Familial Adenomatous Polyposis (FAP) have been estimated 100 to 330 times higher than in general population. However risk factors, including a genotype-phenotype association for duodenal cancer in FAP has not been fully understood. The aim of this study is to determine risk factors associated with the development of advanced duodenal polyposis and ampullary adenomas in colectomized patients with FAP.


Eligibility criteria: Inclusion Criteria:

* Patients with Familial Adenomatous Polyposis with colectomy, or scheduled for surgery.

Exclusion Criteria:

* Pregnancy, lactation

Primary outcomes:
measure: Genetic profile in FAP patients
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo Medical School
Study officials:
affiliation: PhD
name: Marianny Sulbaran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campos FG, Sulbaran M, Safatle-Ribeiro AV, Martinez CA. Duodenal adenoma surveillance in patients with familial adenomatous polyposis. World J Gastrointest Endosc. 2015 Aug 10;7(10):950-9. doi: 10.4253/wjge.v7.i10.950.
citation: Spigelman AD, Talbot IC, Penna C, Nugent KP, Phillips RK, Costello C, DeCosse JJ. Evidence for adenoma-carcinoma sequence in the duodenum of patients with familial adenomatous polyposis. The Leeds Castle Polyposis Group (Upper Gastrointestinal Committee). J Clin Pathol. 1994 Aug;47(8):709-10. doi: 10.1136/jcp.47.8.709.
citation: Groves CJ, Saunders BP, Spigelman AD, Phillips RK. Duodenal cancer in patients with familial adenomatous polyposis (FAP): results of a 10 year prospective study. Gut. 2002 May;50(5):636-41. doi: 10.1136/gut.50.5.636.
citation: Mathus-Vliegen EM, Boparai KS, Dekker E, van Geloven N. Progression of duodenal adenomatosis in familial adenomatous polyposis: due to ageing of subjects and advances in technology. Fam Cancer. 2011 Sep;10(3):491-9. doi: 10.1007/s10689-011-9433-2.
Clinical trial NCT06003296: Calcaneocuboid Arthrodesis in Triple Arthrodesis by Plate Versus Screw: Randomized Controlled Trial
Official title: Calcaneocuboid Arthrodesis in Triple Arthrodesis by Plate Versus Screw: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Calcaneocuboid Osteoarthritis Secondary to Trauma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigators aim to compare clinical and radiological outcome of use of plate versus screw fixation for calcaneocuboid arthrodesis in adult population.

Detailed description: The calcaneocuboid joint is stable, even although multiple conditions might affect the joint, ranging from osteoarthritis to fracture, subluxation, and dislocation. Calcaneocuboid arthrodesis is more commonly performed as an adjunct procedure with other rearfoot procedures such as triple arthrodesis and is less used as isolated fusion.\[1\],\[2\],\[3\] What the most effective and least cost method for calcaneocuboid arthrodesis?! Many conditions that may affect foot that cause pain ; and there are many methods for relieve that pain , one of these is arthrodesis , and calcaneocuboid joint one of the most affected joints , and commonly we do calcaneocuboid arthrodesis as a part of triple arthrodesis ( subtalar , talonavicular , calcaneocuboid ); The traditional fixation for a calcaneocuboid (CC) arthrodesis in triple arthrodesis is with a 6.5-mm cancellous screw. This procedure can be technically challenging. Fixation with a locking compression plate (LCP) may be easier to perform while achieving compression perpendicular to the fusion site. Investigators suppose that plate is more powerful than screw in calcaneocuboid arthrodesis. The purpose of this study was to compare the load to failure and the stiffness for each fixation method. \[4\],\[5\],\[6\] literature reveal that: More stability to the fusion site can be applied by using plate fixation. Rationale of the research that: calcaneocuboid arthrodesis with screw is effective and least cost compare to plate fixation? \[7\]

Eligibility criteria: Inclusion Criteria:

all patients who will be operated by calcaneocuboid fusion for any indication age range 18-65 no paralytic patients

Exclusion Criteria:

* age \< 18 , \> 65 acute calcaneal fracture infection non union bone defect that need bone graft refusing to participate in the study neuropathic patients

Primary outcomes:
measure: Assess calcaneocuboid arthrodesis union
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Abdelrazik Talaat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02714296: Evaluating the Effectiveness of Colon Preparation for Endoscopy Using Specialized Clinical Nutrition
Official title: Phase IV Prospective Sinle Center Randomised Three-arm Controlled Study Evaluating the Effectiveness of Colon Preparation for Endoscopy Using Specialized Clinical Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Keywords: colon preparation for endoscopy
enteral feeding
sip feeding
nutridrink
nutridrink compact protein
Lead sponsor: Nutricia Advanced
Sponsor class: INDUSTRY
First posted: 2016-03-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is an open, prospective, comparative diagnostic studies aimed at improving the colonoscopy results, by optimizing the way of preparation for endoscopy

Detailed description: Objective: to improve the quality of bowel preparation for endoscopy.

Research objectives:

1. Compare the three methods of colon preparation for endoscopy
2. To develop a rational strategy of preparing patients for endoscopy on the basis of the data obtained.

Eligibility criteria: Inclusion Criteria:

1. Patients older than 18 years with the recommendation to conduct a diagnostic colonoscopy
2. Absence of contraindications to the use of specialized clinical nutrition products

Exclusion Criteria:

1. Conditions which are contraindicated for colonoscopy:

   * The acute phase of cerebrovascular accident
   * Acute myocardial infarction
   * severe cardiovascular, pulmonary insufficiency and mixed
   * Violations of the cardiac rhythm (paroxysmal bradyarrhythmia, atrial fibrillation with atrial fibrillation or paroxysmal atrial fibrillation, severe transverse heart block)
   * Severe clinical forms (fulminant) inflammatory diseases of the colon (ulcerative colitis, Crohn's disease, ischemic colitis, radiation colitis, diverticulitis)
   * Aortic aneurysm or heart
   * Acute inflammatory infiltrates abdominal cavity (including diverticulitis)
   * Suspicion of abscess of the abdominal cavity
   * Peritonitis
   * Hepatosplenomegaly
   * Tense ascites
   * hydrothorax, hydropericardium
   * Severe blood coagulation
   * Hemorrhagic vasculitis
2. Pregnancy
3. The patient's refusal to participate in the study
4. Intolerance of specialized clinical nutrition products

Primary outcomes:
measure: the degree of preparation in the colonoscopy (Chicago or Boston scale).
timeFrame: before colonoscopy
Secondary outcomes:
measure: tolerability
timeFrame: before colonoscopy
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: ГНЦ колопроктологии
Study officials:
name: Elena Volkova
role: STUDY_CHAIR
References:
Clinical trial NCT03160196: Efficacy of an Electronic System to Support Clinical Decisions in Adults With Type 2 Diabetes Mellitus.
Official title: Efficacy of an Electronic System to Support Clinical Decisions Based on an Evidence-based Clinical Practice Guide for Metabolic Control of Adults With Type 2 Diabetes Mellitus: Clinical and Cluster-randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Hemoglobin A, Glycosylated
Lead sponsor: Sanitas University
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 1768
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of an electronic system to support clinical decisions based on an evidence-based clinical practice guide for metabolic control of adults with Type 2 Diabetes Mellitus through Clinical and cluster-randomized controlled trial in a Colombian population.


Eligibility criteria: Inclusion Criteria:

* No prior exposure to the tool (through development and beta testing)
* Access to an organized diabetes pathway consistent with the Sanitas EPS (Entidad Promotora de Salud) diabetes mellitus 2 guideline.

Exclusion Criteria:

* Terminally ill

Primary outcomes:
measure: Proportions of participants with normal Hb1Ac
timeFrame: 6 months and a year of enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03544996: Transdermally Delivered Human Insulin Product
Official title: A Comparison of Injected Insulin Replacement Therapy With A Novel Transdermally Delivered Human Insulin Product
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoinsulinemia
Keywords: Insulin, needle-less, transdermal
Lead sponsor: Transdermal Delivery Solutions Corp
Sponsor class: INDUSTRY
First posted: 2018-06-04
Enrollment: 1
Sex: MALE
Minimum age (years): 60
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Single patient, brittle T1D patient

Brief summary: An Early Feasibility Study of a device formulation to deliver human insulin across intact skin

Detailed description: An attempt was made to formulate an insulin product that would complex human insulin in a stable anhydrous solution and when applied to the skin enable the uptake and release of insulin in a brittle T1D patient.

A series of formulations were produced at varing dose strengths and in conjunction with injected insulin products, applied and serum glucose measured to ascertain response and optimize a fomrula to be submitted for IND approval.

Eligibility criteria: Inclusion Criteria:

* Brittle T1D patient with poor insulin sensitivity requiring more than 3,000 IUs on insulin a day

Exclusion Criteria:

* High insulin sensitivity
* well managed serum glucose

Primary outcomes:
measure: Insulin response
timeFrame: 8-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Palm Beach Gardens
country: United States
facility: Langford Research Institute
state: Florida
Study officials:
affiliation: Sentry Data Systems
name: William D Kirsh, D.O.
role: PRINCIPAL_INVESTIGATOR
References: