louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05452473: CDSS-assisted UGI Endoscopy vs. Routine Screening Endoscopy
Official title: Clinical Benefit in the CDSS-assisted Screening Upper Gastrointestinal Endoscopy vs. Routine Screening Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Individual
Keywords: Convolutional neural network
Deep learning
Endoscopy
Gastric neoplasms
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 1200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to find the CDSS-assisted upper GI endoscopy has clinical benefit compared to conventional routine screening upper GI endoscopy. Investigators will conduct a pilot randomized controlled study. Consecutive patients will be allocated either to CDSS-assisted upper GI endoscopy or conventional routine screening upper GI endoscopy. The lesion detection rate will be compared between both groups.

Detailed description: Artificial intelligence has been adopted in the field of gastrointestinal endoscopy. Investigators previously established deep-learning models to predict the histology and invasion depth of gastric lesions using endoscopic stillcut images. However, clinical benefit of this model has not been evaluated. This study aimed to find the CDSS-assisted upper GI endoscopy has clinical benefit compared to conventional routine screening upper GI endoscopy. Investigators will conduct a pilot randomized controlled study. Consecutive patients who visited Chuncheon Sacred Heart hospital will be allocated either to CDSS-assisted upper GI endoscopy or conventional routine screening upper GI endoscopy. The lesion detection rate will be compared between both groups. Expert endoscopists will conduct this randomized study.

Eligibility criteria: Inclusion Criteria:

* Participants who visited for routine screening upper gastrointestinal endoscopy

Exclusion Criteria:

* Participants who refuse to participate in this study
* Participants who showed paradoxical reaction prohibiting routine examination

Primary outcomes:
measure: Gastric lesion detection rate
timeFrame: Baseline (gold standard; ground truth is expert endoscopists' lesion detection)
Secondary outcomes:
measure: Lesion classification accuracy
timeFrame: Baseline (gold standard; ground truth is histologic diagnosis of detected lesions)
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart hospital
state: Gangwon
Study officials:
affiliation: Hallym University
name: Chang Seok Bang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06037473: The Efficacy and Safety of PEGylated GH for the Treatment of Short Stature in Chinese Children-GLOBE Reg
Official title: A Real-world Study of the Efficacy and Safety of PEGylated Recombinant Human Growth Hormone Injection in the Treatment of Short Stature in Chinese Children From the Global Registry for Novel Therapies For Rare Bone or Endocrine Conditions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Growth Hormone Treatment
Growth Disorders
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
Collaborators: name: Office for Rare Conditions Registries, University of Glasgow
First posted: 2023-09-14
Enrollment: 2600
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The height of the patients was below 2 stadard deviation below average. The patients were diagosesed as endogenous growth hormone deficiency, TS, SGA, ISS, etc. and treated with polyethylene glycol recombinant human growth hormone injection

Brief summary: In order to further observe the long-term safety and effectiveness of real-world polyethylene glycol-recombinant human growth hormone(PEG-rhGH) treatment of GHD, idiopathic short stature, and SGA in children, explore and analyze the factors affecting the efficacy of PEG-rhGH and the height prediction model after treatment, etc., collect and analyze more scientifically and rationally, and understand the situation of real-world PEG-GH treatment. A database registration study was developed.

Detailed description: A database registration study was developed to retrospectively analyze the efficacy and safety of polyethylene glycol recombinant human growth hormone injection in the treatment of slow growth in children caused by endogenous growth hormone deficiency, idiopathic short stature, Turner syndrome, etc., and to further prospectively follow up and monitor. In order to participate in the global real-world use of long-acting growth hormone, all data from this study were uploaded to the Global Registry of New Therapies for Rare Endocrine Diseases and Bone Disorders (GloBE-Reg) platform.

Eligibility criteria: Inclusion Criteria:

Patients with endogenous growth hormone deficiency, Turner Syndrome, SGA, idiopathic short stature, etc. treated with polyethylene glycol recombinant human growth hormone injection

Exclusion Criteria:

Patients with serious heart and lung, blood system, malignant tumors and other diseases or systemic infections, immune function is low and Persons with mental illness;

Primary outcomes:
measure: the change in height standard deviation score
timeFrame: 3-10years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Endocrinology, Genetics, Metabolism
state: Beijing
Study officials:
affiliation: Beijing Children's Hospital
name: Bingyan Cao, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05076773: TPVB, PECSB, ESPB for Postmastectmy Pain
Official title: A Comparative Study Between Ultrasound-guided Thoracic Paravertebral Block, Pectoral Nerves Block, and Erector Spinae Block for Pain Management in Cancer Breast Surgeries. A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim of the work The aim of the study is to compare between the effects of ultrasound guided thoracic paravertebral block, pectoral nerve block II, and erector spinae block in management of pain during cancer breast surgeries. The hypothesis of the study is that the three groups will give comparative results.


Eligibility criteria: Inclusion Criteria:

1. ASA physical status classification class I or II
2. Age group 18 - 60 years of the female gender
3. Patients undergoing breast cancer surgeries

Exclusion Criteria:

1. Patient refusal
2. History of hypersensitivity to local anesthetics
3. Bleeding disorders or patients receiving anticoagulants
4. Spine or chest wall deformities
5. Pregnancy
6. Local infection at the site of injection.

Primary outcomes:
measure: The primary outcome of the study will be duration of analgesia (time to first rescue analgesia after administration of the block).
timeFrame: 0-24o minutess
Secondary outcomes:
measure: Postoperative pain
timeFrame: 48 hours
measure: Total morphine consumption
timeFrame: 48 hours
measure: Postoperative nausea and vomiting (PONV)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Medicine Menofia University
state: Menofia
Study officials:
affiliation: assistant fellow, Ahmed Maher Hospital
name: kareem M mikhimer, m.sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01170273: Vitamin D in Vulnerable Adults (VIVA-VA)
Official title: Vitamin D in Vulnerable Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Frail Elderly
Vitamin d Deficiency
Keywords: aged
vitamin d deficiency
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-07-27
Enrollment: 130
Sex: MALE
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Vitamin D insufficiency is a problem of growing concern, given its prevalence in older persons and the association of low vitamin D with multiple major health problems, including mobility and balance deterioration and falls, cardiovascular disease, diabetes, and certain cancers. Sedentary persons are particularly vulnerable for these health problems and generally not adherent to prescribed physical activity. This study will investigate if treatment with vitamin D will benefit physical performance in male veterans age 65 to 95.


Eligibility criteria: Inclusion Criteria:

* male veterans
* 65 to 95 years of age
* independent
* sedentary
* vitamin D insufficiency

Exclusion Criteria:

* hypercalcemia
* renal failure
* living in a nursing home

Primary outcomes:
measure: Change in Short Physical Performance Battery Test Score
timeFrame: baseline and 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: VA Medical Center, Miami
state: Florida
Study officials:
affiliation: VA Medical Center, Miami
name: Silvina Levis-Dusseau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01817673: Creatine Supplementation on Kidney Function in Resistance-trained Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Persons
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-03-25
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: There is a claim that creatine supplementation might affect kidney function, especially in those consuming a high-protein diet. The aim of this study was to investigate the effects of creatine supplementation on kidney function in resistance-trained individuals ingesting a high-protein diet.


Eligibility criteria: Inclusion Criteria:

* participation in recreational resistance training
* consumption of a high-protein diet (≥ 1.2 g/Kg/d)

Exclusion Criteria:

* vegetarian diet
* use of creatine supplements in the past 6 months
* chronic kidney disease
* use of anabolic steroids.

Primary outcomes:
measure: kidney function
timeFrame: 3 months
Secondary outcomes:
measure: proteinuria
timeFrame: 3 months
measure: albuminuria
timeFrame: 3 months
measure: serum urea
timeFrame: 3 months
measure: serum creatinine
timeFrame: 3 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Univsersity of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Bruno Gualano, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lugaresi R, Leme M, de Salles Painelli V, Murai IH, Roschel H, Sapienza MT, Lancha Junior AH, Gualano B. Does long-term creatine supplementation impair kidney function in resistance-trained individuals consuming a high-protein diet? J Int Soc Sports Nutr. 2013 May 16;10(1):26. doi: 10.1186/1550-2783-10-26.
Clinical trial NCT02228473: Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort
Official title: Effect of Glycopyrrolate and Atropine as Adjuncts to Reversal of Non-Depolarizing Neuromuscular Blocking Agents on Postoperative Catheter-Related Bladder Discomfort
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Catheter Site Discomfort
Complications
Anesthesia
Urinary Bladder Neoplasms
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-08-29
Enrollment: 76
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We want to evaluate the efficacy of the glycopyrrolate and atropine for the prevention of catheter-related bladder discomfort.

Detailed description: The mechanism of catheter-related bladder discomfort is thought to be related to the muscarinic receptor. The adjuncts to reversal agents such as glycopyrrolate and atropine are known to block the muscarinic receptor in different ways.

We want to evaluate the efficacy of the glycopyrrolate and atropine for the prevention of catheter-related bladder discomfort.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for transurethral bladder excision under general anesthesia
* ASA I-III

Exclusion Criteria:

* Foley catheter less than 18 Fr.
* Patients with obstruction of urinary tract
* Patients with neurogenic bladder
* Patients with severe obesity
* Patients with neurologic disorder
* Patients with chronic pain
* Patients with allergic history to atropine or glycopyrrolate

Primary outcomes:
measure: Catheter-related bladder discomfort
timeFrame: 1 hour postoperatively
Secondary outcomes:
measure: Catheter-related bladder discomfort
timeFrame: 0, 6 and 24 hour postoperatively
measure: Hemodynamic parameters
timeFrame: 0, 1, 5, 10 minute postoperatively
measure: Nausea
timeFrame: 0, 1, 6 and 24 hour postoperatively
measure: Vomiting
timeFrame: 0, 1, 6 and 24 hour postoperatively
measure: Dry mouth
timeFrame: 0, 1, 6 and 24 hour postoperatively
measure: Flushing
timeFrame: 0, 1, 6 and 24 hour postoperatively
measure: Blurred vision
timeFrame: 0, 1, 6 and 24 hour postoperatively
measure: Dizziness
timeFrame: 0, 1, 6 and 24 hour postoperatively
measure: Analgesics
timeFrame: 0, 1, 6 and 24 hour postoperatively
Other outcomes:
Locations:
city: Seoul, Korea, Republic of
country: Korea, Republic of
facility: Seoul National University of Hospital
Study officials:
affiliation: Seoul National University of Hospital
name: Hee-Pyoung Park, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HC, Lim SM, Seo H, Park HP. Effect of glycopyrrolate versus atropine coadministered with neostigmine for reversal of rocuronium on postoperative catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor: a prospective randomized study. J Anesth. 2015 Dec;29(6):831-5. doi: 10.1007/s00540-015-2064-2. Epub 2015 Aug 9.
Clinical trial NCT06742073: Histiocytosis and Inflammatory Manifestations in Patients with H Syndrome
Official title: Histiocytosis and Inflammatory Manifestations in Patients with H Syndrome- a Multinational Collaboration
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: H Syndrome
Keywords: SLC29A3
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient with a genetically confirmed diagnosis of H syndrome (two pathogenic or likely pathogenic germline SLC29A3 variants)

Brief summary: H syndrome is a rare genetic disorder predisposing to histiocytosis. Our knowledge of the clinical spectrum of these patients is based on case reports and small patient series. Patients with H syndrome have been treated with a range of immunomodulatory and chemotherapeutic agents, with limited success. We aim to comprehensively assess the clinical manifestations and patterns of treatment response in a multinational cohort of patients with H syndrome.

Detailed description: H syndrome is a rare inflammatory genetic disorder predisposing to histiocytosis, caused by germline biallelic loss-of-function mutations in SLC29A3, encoding the protein equilibrative nucleoside transporter 3 (ENT3). ENT3 transports nucleosides from lysosomes to the cytoplasm following lysosomal degradation of nucleic acids. Results from our previous study (under review) suggest a model in which impaired nucleoside trafficking aberrantly activates nucleoside-sensing Toll-like receptors, leading to persistent activation of ERK, driving histiocytosis. This constitutes a novel signaling pathway leading to activation of ERK and histiocytosis, in the absence of somatic mutations in MAPK cascade genes. Our knowledge of the heterogenous clinical spectrum of these patients is based on case reports and small patient series. Patients with H syndrome have been treated with a range of immunomodulatory and chemotherapeutic agents, with limited success. Improvement following therapy with tocilizumab, an IL6-receptor antibody, has recently been reported in isolated case reports. There is a lack of data on MEK inhibitor therapy in these patients. We aim to comprehensively assess the clinical manifestations and patterns of treatment response in a multinational cohort of patients with H syndrome.

Eligibility criteria: Inclusion Criteria: Any patient with a genetically confirmed diagnosis of H syndrome -

Exclusion Criteria:

-

Primary outcomes:
measure: Response to therapy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Schneider Children's Medical Center
Study officials:
affiliation: Schneider Children'ds Medical Center
name: Sarah Elitzur, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01893073: Mindful Walking in Low Back Pain
Official title: Effectiveness of a a Mindful Walking Program in Patients With Chronic Low Back Pain - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-07-08
Enrollment: 48
Sex: ALL
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: The purpose of this study is to determine whether a mindful walking program is effective in the treatment of patients with chronic low back pain.


Eligibility criteria: Inclusion Criteria:

* male and female, 18-65 years
* chronic low back pain (disease duration \> 3 months)
* pain intensity on visual analogue scale at inclusion \> 40 mm (0-100 mm scale)
* only pharmacological treatment with NSAID or no treatment in the last 4 weeks
* undersigned informed consent form

Exclusion Criteria:

* active walking or jogging in the last 6 weeks (\< 60 minutes/week)
* regular meditation, relaxation exercise, mindfulness exercise in last 6 weeks (\> 30 minutes per week)
* use of complementary medicine therapies as acupuncture, homeopathy, herbal medicine in last 6 weeks or planned in the next 12 weeks
* use of other nonpharmacological therapies as physical therapy, manual therapy or osteopathy in the last 4 weeks
* participation in another trials within the last 3 months
* pathological neurological symptoms such as muscular paralysis or paraesthesia due to spinal disc herniation or other causes
* risk of falls and inability to walk
* angina pectoris in the last 3 months
* chronic respiratory disease with respiratory insufficiency
* intake of central nervous system-acting analgesics in the last 6 weeks
* Known renal and / or hepatic diseases
* Severe organic, psychological or psychiatric disorders that are not permitting a study participation
* applying for early retirement due to low back pain
* no undersigned informed consent form

Primary outcomes:
measure: Pain intensity on visual analogue scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Back function - FFbH-R-Questionnaire
timeFrame: 8 weeks, 12 weeks
measure: Pain intensity on visual analogue scale
timeFrame: 12 weeks
measure: Cohens perceived stress scale
timeFrame: 8 weeks, 12 weeks
measure: Quality of Life - SF 36
timeFrame: 8 weeks, 12 weeks
measure: Intake of paracetamol
timeFrame: 8 weeks
measure: Adverse events
timeFrame: 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Germany
Study officials:
References:
citation: Rotter G, Ortiz M, Binting S, Tomzik J, Reese F, Roll S, Brinkhaus B, Teut M. Mindful Walking in Patients with Chronic Low Back Pain: A Randomized Controlled Trial. J Integr Complement Med. 2022 Jun;28(6):474-483. doi: 10.1089/jicm.2021.0361. Epub 2022 Mar 30.
Clinical trial NCT05812573: A Retrospective Study for Multiple Endocrine Neoplasia
Official title: A Retrospective Study for Multiple Endocrine Neoplasia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Endocrine Neoplasia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with multiple endocrine neoplasia who age 18 to 99 years old

Brief summary: Retrospectively review the clinical characteristics of patients with multiple endocrine neoplasia type I in National Taiwan University Hospital.

Detailed description: The investigators will retrospectively review the clinical characteristics of patients with multiple endocrine neoplasia type I in National Taiwan University Hospital.

Eligibility criteria: Inclusion Criteria:

* Patients with multiple endocrine neoplasia

Exclusion Criteria:

* Patients younger than 18 years old

Primary outcomes:
measure: Number or endocrine organs involved
timeFrame: 2023/2/14-2033/2/14
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: