louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01909687: Assessment of Blood Glucose Monitoring Systems
Official title: Leistungsbewertung Von Blutzuckermesssystemen im Methodenvergleich
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: blood glucose monitoring systems
ISO 15197
system accuracy
Lead sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2013-07-26
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: System accuracy evaluation of different blood glucose monitoring systems with 3 lots of test strips per systems according to ISO 15197:2013


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Male or female subjects with type 1 or type 2 diabetes or healthy subjects
* For BG adjustment people with type 1 diabetes

Exclusion Criteria:

* Severe acute illness that, in the opinion of the Investigator, might pose additional risk to the patient
* Chronic illness that, in the opinion of the Investigator, might pose additional risk to the patient
* Current condition that, in the opinion of the Investigator, doesn't enable subject to participate in the study
* For BG adjustment people with type 1 diabetes without CHD, condition after myocardial infarction, PAOD, cerebral events or hypoglycaemia unawareness
* Legal incompetence or limited legal competence
* Age \< 18 years
* Dependency from the sponsor or the clinical investigator
* Mental incapacity or language barriers precluding adequate compliance with the study procedures

Primary outcomes:
measure: Analysis of system accuracy
timeFrame: for each subject, the experimental phase has an expected duration of up to 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm
Study officials:
References:
citation: Freckmann G, Link M, Schmid C, Pleus S, Baumstark A, Haug C. System Accuracy Evaluation of Different Blood Glucose Monitoring Systems Following ISO 15197:2013 by Using Two Different Comparison Methods. Diabetes Technol Ther. 2015 Sep;17(9):635-48. doi: 10.1089/dia.2015.0085. Epub 2015 Jun 25.
Clinical trial NCT05987787: Suture Reinforcement to Reduce the Leak Rate After Sleeve Gastrectomy
Official title: Staple-line Suture Reinforcement: Could it Help Contain the Leak?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Obesity, Morbid
Leak, Anastomotic
Bleeding
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity or BMI≥40kg/m2, age ≥ 18 years. Before surgery, patients underwent a standardized psychological and physical evaluation which includes blood chemistry tests, chest x-rays, electrocardiogram and cardiological examinations, nutritional evaluation, esophagogastroduodenoscopy, spirometry and psychiatric evaluation .

Brief summary: Staple line reinforcement (SLR) has been suggested as a mean of reducing the risk of sleeve leakage or bleeding. The aim of this study is to analyze if the suture reinforcement can be used to reduce the leakage rate after sleeve gastrectomy.


Eligibility criteria: Inclusion Criteria:

* BMI\>40 kg/m2
* BMI\>35 kg/m2with at least one associated major comorbidity

Exclusion Criteria:

* secondary obesity due to endocrine and psychological disorders
* patients under antiaggregant and anticoagulant therapy
* re-do surgery.

Primary outcomes:
measure: the importance of staple line reinforcement
timeFrame: 1 year
measure: the importance of staple line reinforcement
timeFrame: During Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: University of Foggia
Study officials:
References:
Clinical trial NCT00552487: Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis
Official title: Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hashimoto Disease
Adrenal Insufficiency
Keywords: isolated ACTH deficiency
Hashimoto disease
Hashimoto thyroiditis
autoimmune thyroiditis
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
First posted: 2007-11-02
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether patients with Hashimoto thyroiditis and impaired well-being may have a partial secondary adrenocortical insufficiency.

Detailed description: Many patients with Hashimoto thyroiditis who are correctly substituted with thyroid hormones have an impaired well-being. in some people an isolated ACTH deficiency was found.

In this study a 1 µg ACTH test is performed to evaluate the adrenocortical function.

Eligibility criteria: Inclusion Criteria:

* Hashimoto thyroiditis euthyreot thyroid function with levothyroxin therapy written informed consent

Exclusion Criteria:

* • hypothyroidism of other origin

  * pregnancy and lactation
  * oral contraception
  * glucocorticoid therapy during the last 2 months
  * History of malignancy or chronic infections (Hepatitis, HIV)

Primary outcomes:
measure: serum cortisol-peak 30 min after ACTH-stimulation
timeFrame: 30 minutes
Secondary outcomes:
measure: serum DHEA-peak 30 min. after ACTH-stimulation,DHEA-S, ACTH
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University of Wuerzburg, Department of Endocrinology
state: Bavaria
Study officials:
affiliation: University of Wuerzburg
name: Bruno Allolio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04067687: Home Visit Intervention in Pediatric Palliative Care
Official title: Palliative Intervention to Improve Quality of Life in Children With Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Palliative
Keywords: palliative
cancer
pediatric
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm of control group and intervention group
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized controlled trial to compare the quality of life between participants who were given palliative care (a 3-month home visit) and those who were not (intervention vs control group) was conducted. Participants consisted of children with cancer aged 2-18 years old. A two-way communication between a trained health worker and participants with or without their parents were conducted as the intervention (report by proxy or self-report). Interventions were given in 6 sessions (1 session every 2 weeks) focusing on problems solving education, symptoms management, self-care, communication, decision making, and long-term care plan assistance. In the first and twelfth week of the intervention, all participants were assessed with the Pediatric Quality of Life Inventory (PedsQLTM) questionnaire cancer module 3.0. Symptomps intensityof anorexia, sleep diturbance, and pain will be asessed in each visit. Participants were followed, Emergency Room (ER) admissions were recorded during follow up period. During the follow up period, ER admissions were recorded further.


Eligibility criteria: Inclusion Criteria:

* Child age 2-18 years old with malignancies who undergo treatments at the Department of Child Health of Cipto Mangunkusumo Hospital, during the study period.
* All participants who meet the criteria to get palliative care, participants with a total score ≥ 4 based on palliative screening form.
* Participants and or parents agree to be enrolled in study

Exclusion Criteria:

* Patients who live outside Jakarta and therefore unreachable to get palliative intervention

Primary outcomes:
measure: Quality of life cancer child
timeFrame: at the end of 3 months follow up
Secondary outcomes:
measure: Emergency room visits
timeFrame: during 3 months follow up
measure: Symptomps intensity
timeFrame: during 3 months follow up
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Hospital
Study officials:
affiliation: Indonesia University, Cipto Mangunkusumo Hospital Jakarta
name: Murti Andriastuti, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02867787: Study of the Treatment of Tendinopathy Unruptured of Rotator Cuff by Intramuscular Injection of Botulinum Toxin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tendinopathy Rotator Cuff
Keywords: Shoulder Joint
A02.835.583.748
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Botulinum toxin is used in musculoskeletal therapy routinely for 15 years. This is one of the most potent neurotoxins. It comes in 7 serotypes (A to G).Therapeutic application of botulinum toxin are mainly based on its ability to block the neuromuscular transmission by preventing the release of acetylcholine, creating paralysis muscle relative and reversible.

It has been used in the treatment of cervical dystonia, migraine headaches, and an antinociceptive effect. The analgesic effect occurred even prior to the release muscular. Several randomized studies have been published about it. The investigators assume that intramuscular injection of botulinum toxin is effective in the treatment of tendinopathy rotator cuff.


Eligibility criteria: Inclusion Criteria:

* Signed consent
* Active social care
* Compliant patient with protocol
* Patient more than 18 years
* Positive Neer Test

Exclusion Criteria:

* Prior study exclusion period
* Protected patient
* Study refusal
* Deficient patient
* Rheumatoid arthritis, osteoarthritis, chondrocalcinosis.
* Microcrystalline arthritis.
* Active infection .
* History of hypersensitivity reaction during a previous injection of botulinum toxin
* Bilateral involvement
* Neurological deficit
* Depression
* History of shoulder surgery
* Pregnant or breast feeding women
* Systemic disease (diabeta, vascularitis)
* Known neurological disease
* Intraarticular associate disease
* Acromioclavicular associate disease
* Myasthenia
* Botulinum toxin is not recommended in combination with aminoglycosides

Primary outcomes:
measure: Significant improvement in shoulder pain objectified by analogy Visual Scale (VAS) in patients with unruptured tendinopathy of the rotator cuff impingement, debilitating, lasting for more than 3 months and resistant to usual medical treatment.
timeFrame: 3 months
Secondary outcomes:
measure: Significant improvement in life quality : functional clinical scores (Constant, ASES, Oxford)
timeFrame: 24 months
Other outcomes:
Locations:
city: Le CHESNAY
country: France
facility: CH Versailles
Study officials:
affiliation: CH Versailles
name: Pujol Nicolas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04894487: The Effects of The Use of Baby Mobile Accompanied With Brahms Lullaby On The Infants During Sternum Dressing
Official title: The Effect of The Use of Baby Mobile Accompanied With Brhams Lullaby On The Infant's Physiologicak Parameters and Pain Level During Sternum Dressing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Procedural (During Sternum Dressing on Infants)
Physiological Parameters During Sternum Dressing in Babies
Keywords: Sternum Dressing
Infant
Brahms Lullaby
Baby Mobile
Pain
Physiological Parameters
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 76
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled two groups ( control group and experiment group)
Primary purpose: PREVENTION

Brief summary: The study was conducted experimentally in a randomized controlled manner in order to determine the effect of the use of baby mobile accompanied by Brahms Lullaby on physiological parameters and pain level during sternum dressing in babies. The research was carried out with 76 babies followed up in the Pediatric Cardiovascular Surgery Intensive Care Unit between August 2020 and February 2021 (Baby Mobile Group accompanied by Brahms Lullaby: 38, Control Group: 38). Data were collected by using the "Baby Monitoring Form" and "FLACC Pain Scale".


Eligibility criteria: Inclusion Criteria:

* Being 1-12 months
* Being volunteer for research
* Operated for Congenital Heart Disease
* Got Sternum incision
* No other chronic illness
* No similar surgical experiment before
* No visual impairment
* No hearing impairment
* No mental or neurological impairment
* Hospitalization experience

Exclusion Criteria:

-

Primary outcomes:
measure: The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's pain levels during sternum dressing
timeFrame: 30 minutes
measure: The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's heart beat during sternum dressing
timeFrame: 30 minutes
measure: The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's blood pressure sternum dressing
timeFrame: 30 minutes
measure: The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's body temperature during sternum dressing
timeFrame: 30 minutes
measure: The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's SpO2 during sternum dressing
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Küçükçekmece
country: Turkey
facility: Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Pediatric Cardiovascular Surgery Intensice Care Unit
state: Istanbul
Study officials:
References:
Clinical trial NCT00310687: Persistence of Immune Response After Vaccination With MCC
Official title: A Phase IV, Single Centre, Open-label Study to Evaluate the Persistence of Antibodies in Adolescents 14-16 Years of Age, Vaccinated With Chiron Meningococcal C Conjugate Vaccine During the 1999-2001 UK MenCC Immunization Campaign, at One Year After Either a Challenge Dose of Aventis Pasteur MSD Meningococcal A/C Polysaccharide Vaccine or a Booster Dose of MenC Vaccine, in Parallel to Subjects Aged 11-20 Evaluated at 4 Years After Vaccination During the 1999-2001 UK MenCC Immunization Campaign
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prevention of Meningococcal Infection
Keywords: Prevention of Meningococcal Meningitis
vaccines
conjugate
immunology
antibody persistence
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2006-04-04
Enrollment: 1244
Sex: ALL
Minimum age (years): 11
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Persistence of Immune response after vaccination with MCC


Eligibility criteria: Inclusion Criteria:

* healthy adolescents vaccinated with Meningococcal C Conjugate vaccine

Exclusion Criteria:

* ascertained or suspected disease caused by N. meningitidis
* household contact with individuals with proven N. meningitidis serogroup C infection
* significant acute or chronic infections
* any other serious disease

Primary outcomes:
measure: persistence of memory response to N. meningitidis serogroup C as measured by serum bactericidal activity at one year after either a challenge with 1/5 of a dose of Meningococcal A/C Polysaccharide vaccine or a booster dose of MenC Vaccine.
Secondary outcomes:
measure: Evaluation and comparison of the persistence of antibodies against N. meningitidis serogroup C as measured by hBCA
measure: Evaluation of the immunological response (ELISA) to N. meningitidis serogroup C
Other outcomes:
Locations:
city: Headington
country: United Kingdom
facility: Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
state: Oxfordshire
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Vaccines - Information Services
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05539287: Clinical Study Evaluating the Safety of Lactobacillus Probiotic in Children With Drug Resistant Epilepsy
Official title: Clinical Study Evaluating the Safety of Lactobacillus Probiotic in Children With Drug Resistant Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Drug Resistant Epilepsy
Keywords: Lactobacillus
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Animal and human studies have brought up evidence supporting Gut microbial disbalance, namely dysbiosis, as a causative factor of epilepsy, especially the refractory form. thus, probiotics might constitute a safe, low-cost, and effective supplementary therapy in patients with DRE.

The Lactobacillus population is probiotic bacteria that have a beneficial role in epilepsy. Lactobacillus can influence brain function through the modulation of GABA, as shown in rodent models. Moreover, it has been demonstrated in animal models of epilepsy and in human epileptic patients that probiotic treatment aimed at restoring gut microbiota equilibrium has beneficial effects on epileptic symptoms by increasing GABA in animals and the levels of Bifidobacteria and Lactobacillus in humans.

Detailed description: This study will be a placebo-controlled, double-blind, and parallel 6-month duration study

Eligibility criteria: Inclusion Criteria:

* Patients aged 3-18 years with intractable childhood-onset epilepsy.

  * All patients are diagnosed to have drug-resistant epilepsy (refractory epilepsy) according to the ILAE definition.
  * The subject is willing and able to comply with the study requirements

Exclusion Criteria:

* Any metabolic conditions that might increase the risks associated with trial participation or investigational product administration, such as hepatic enzyme elevation greater than twice normal and/or a GFR \< 60 mL/min/1.73 m2 or electrolyte imbalance.

  * Patients who are currently using or used antibiotics therapy in the preceding month
  * Patients who are currently using or used other probiotic products in the preceding two weeks
  * Patients scheduled to undergo GIT surgery or those who underwent GIT surgery
  * Patients with a Known allergy to probiotics.
  * Patients receiving artificial enteral or intravenous nutrition

Primary outcomes:
measure: effectivness of Lactobacillus probiotics for controlling epileptic seizures in children with drug resistant epilepsy
timeFrame: 6 months
Secondary outcomes:
measure: 1. the change in the concentration of measured biological parameters (NLRP3, and GAD-Ab)
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Amira
Study officials:
affiliation: Tanta University
name: tarek mostafa, professor
role: STUDY_DIRECTOR
affiliation: Tanta University
name: Amira Rashdan, Rashdan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04926987: The Research of Human Cortex Cell Atlas
Official title: The Research of Human Cortex Cell Atlas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aging
Epilepsy
Trauma, Brain
Keywords: Single-Cell Analysis
aging
epilepsy
trauma brain
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Craniocerebral injury patients needing operative treatment
2. Treatment-resistant epilepsy patients needing resection surgery.

Brief summary: In this study, the single-cell transcriptome sequencing technology was used to study the transcriptome differences at the single-cell level in normal human brain, aging human brain, and epileptic brain.

Detailed description: The human brain has about 100 billion cells and makes up neural networks.The abnormal activity of neurons can affect the operation of neural networks, leading to neurological diseases.With the coming of the age of global population aging, neurodegenerative diseases such as Alzheimer's, Parkinson's and Huntington's have become an increasing burden on human health.

Cells are the basic unit of brain. Understanding the mechanism of brain activities includes not only the mechanism of neural network, but also the self-regulation of its basic unit, that is, the regulation of gene expression based on brain activity.The abnormal expression and regulation of genes lead to the abnormal activities of the nervous system.Therefore, studying the regulation mechanism of gene expression at the cellular level is an important way to research brain diseases.The recent development of single-cell RNA-sequencing technology provides a possibility to understand the functioning mechanism of the brain at the cellular level.

Eligibility criteria: Inclusion Criteria:

* Craniocerebral injury patients needing operative treatment
* Treatment-resistant epilepsy patients needing resection surgery

Exclusion Criteria:

* Vital signs unstable
* Pregnancy
* Tumor
* Incomplete medical history, imaging and clinical diagnosis

Primary outcomes:
measure: single-cell RNA sequencing
timeFrame: 1 Day of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2ndAffiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Department of Neurosurgery
name: Jianmin Zhang, M.D
role: STUDY_CHAIR
affiliation: Department of Neurosurgery
name: Junming Zhu, M.D
role: PRINCIPAL_INVESTIGATOR
References: