louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03450590: Heart Rate Variability and Cardiorespiratory Complications During Ophthalmic Arterial Chemotherapy for Retinoblastoma
Official title: Relation Between Heart Rate Variability and Cardiorespiratory Complications During Ophthalmic Arterial Chemotherapy for Retinoblastoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parasympathetic Cardiovascular Function Disorder
Keywords: heart rate variability
intraarterial chemotherapy
ophthalmic arterial chemotherapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 38
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing ophthalmic arterial chemotherapy for retinoblastoma

Brief summary: A patient undergoing ophthalmic arterial chemosurgery may experience a sudden, profound decrease in lung compliance when the microcatheter is in the ICA or ophthalmic artery. However, underlying pathophysiology of the respiratory complication is unknown. In this study, the investigators are going to investigate the relation between underlying balance of parasympathetic and sympathetic tone and the respiratory complications by analyzing heart rate beat-to-beat variability.

Detailed description: A patient undergoing ophthalmic arterial chemosurgery may experience a sudden, profound decrease in lung compliance when the microcatheter is in the ICA or ophthalmic artery. However, underlying pathophysiology of the respiratory complication is unknown. In this study, the investigators are going to investigate the relation between underlying balance of parasympathetic and sympathetic tone and the respiratory complications by analyzing heart rate beat-to-beat variability. Also, the investigators are going to investigate whether baseline heart rate variability can predict respiratory complications during the procedures.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing ophthalmic arterial chemotherapy

Exclusion Criteria:

* None

Primary outcomes:
measure: Heart rate variability
timeFrame: 5 min after microcatheter enters ophthalmic artery
Secondary outcomes:
measure: Heart rate variability
timeFrame: 5 min after anesthesia induction
measure: Heart rate variability
timeFrame: 5 min before end of anesthesia
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Tae Kyong Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02107690: The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration
Official title: The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Needlestick Injuries
Keywords: Injections
Temperature
Pain
Healthy volunteers
Lidocaine
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2014-04-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will investigate the influence of lidocaine temperature on pain during injection of lidocaine. Each participant will receive three injections subcutaneously on the abdomen with different temperatures. After each injection, participants will be asked to evaluate the pain on a Visual analog scale (0-100 mm). It is anticipated that the pain decreases with increasing temperature. The aim of the study is to find a simple method for pain reduction that can be used in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years

Exclusion Criteria:

* Kidney, heart or liver disease
* Eczema or psoriasis on injection site
* Neuropathy
* Regular use of painkillers
* Hypersensitivity of Lidocaine
* Pregnancy
* Diabetes

Primary outcomes:
measure: pain
timeFrame: 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Neuroscience, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Vilhjalmur Finsen, prof md
role: STUDY_DIRECTOR
References:
citation: Lundbom JS, Tangen LF, Wago KJ, Skarsvag TI, Ballo S, Hjelseng T, Foss OA, Finsen V. The influence of Lidocaine temperature on pain during subcutaneous injection. J Plast Surg Hand Surg. 2017 Apr;51(2):118-121. doi: 10.1080/2000656X.2016.1194281. Epub 2016 Jun 17.
Clinical trial NCT06068790: Incontinence Analysis After HoLEP Using 28Fr Versus 22Fr Sheath
Official title: 28Fr Versus 22Fr HoLEP, a Randomized Controlled Trial Indiana University School of Medicine, Department of Urology
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana University
First posted: 2023-10-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We hypothesize there will be lower rates of immediate urinary incontinence, and urethral stricture formation in patients undergoing HoLEP with smaller 22Fr sheaths compared to 28 Fr.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The rationale for this study is to assess whether there is a difference in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.

Detailed description: This study will be a randomized controlled trial in which patients who meet inclusion criteria will be randomized to one of two groups, HoLEP performed with either 1) 22Fr sheath set or 2) 28Fr sheath set. After HoLEP, data will be analyzed using chi-square test for incontinence vs no incontinence between 22Fr and 28Fr groups at 1 week, 4 weeks and 12 weeks post operatively.

Eligibility criteria: Inclusion Criteria:• Age \>18 years old Undergoing HoLEP for benign prostatic enlargement Eligible for same day catheter removal

Exclusion Criteria:

* Age \< 18 years old
* Existing stress or urge urinary incontinence
* Planned overnight admission or overnight catheterization

Primary outcomes:
measure: Assessing differences in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.
timeFrame: M-ISI survey completed at 1,4,12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Physicians Urology
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
References:
Clinical trial NCT05672290: Comparison of the Effects of External Electrical Stimulation Protocols in Women With Overactive Bladder
Official title: Comparison of the Effects of External Electrical Stimulation Protocols in Women With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 40
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: The aim of our study is a comparison of the effects of external electrical stimulation protocols in women with overactive bladder (OAB).

Detailed description: OAB is a condition defined by the International Continence Society as the presence of urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. External electrical stimulation has positive effects on OAB. However, there are not enough studies on how often this stimulation is applied. Studies are needed on this subject.

Eligibility criteria: Inclusion Criteria:

* Being in the age range of 18-65 ,
* Having diagnosed with OAB,
* Being a volunteer

Exclusion Criteria:

* Being pregnant,
* presence of severe pelvic organ prolapse,
* malignant disease,
* urinary infection,
* neurological disease,
* have electronic and metal implant,
* loss of sensation,
* lumbosacral peripheral nerve lesion

Primary outcomes:
measure: Overactive bladder symptoms
timeFrame: change from baseline at 3 weeks and 6 weeks
Secondary outcomes:
measure: Urgency severity
timeFrame: change from baseline at 3 weeks and 6 weeks
measure: Bladder functions
timeFrame: change from baseline at 3 weeks and 6 weeks
measure: Life quality
timeFrame: change from baseline at 3 weeks and 6 weeks
measure: Strength of pelvic floor muscle
timeFrame: change from baseline at 3 weeks and 6 weeks
measure: Perception of recovery
timeFrame: change from baseline at 3 weeks and 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01461590: Study of Safe Blood Transfusion Volumes to Correct Acute Severe Anaemia
Official title: Phase II Trial of Transfusion Volumes in Children With Acute Severe Anaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Severe Anaemia
Lead sponsor: KEMRI-Wellcome Trust Collaborative Research Program
Sponsor class: OTHER
Collaborators: name: Imperial College London
First posted: 2011-10-28
Enrollment: 160
Sex: ALL
Minimum age (years): 60
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Greater volume of whole blood(30mls/kg compared to 20mls/kg) following standard calculations, given to children with severe anaemia will be beneficial in haematological correction and can be given safely since respiratory distress and haemodynamic changes result from acidosis and compensation in these children rather than from biventricular failure.

Detailed description: Severe anemia (SA, hemoglobin \<6 g/dl) is a leading cause of pediatric hospital admission in Africa, with significant in-hospital mortality. The underlying etiology is often infectious, but specific pathogens are rarely identified. Guidelines developed to encourage rational blood use recommend a standard volume of whole blood (20 ml/kg) for transfusion, but this is commonly associated with a frequent need for repeat transfusion and poor outcome. Evidence is lacking on what haemoglobin threshold criteria for intervention and volume are associated with the optimal survival outcomes.

We evaluated the safety and efficacy of a higher volume of whole blood (30 ml/kg; Tx30: n = 78) against the standard volume (20 ml/kg; Tx20: n = 82) in Ugandan children (median age 35.5 months (interquartile range (IQR) 12.5 to 52.5)) for 24-hour anemia correction (hemoglobin \>6 g/dl: primary outcome) and 28-day survival.

Eligibility criteria: Inclusion Criteria:

* Severe anaemia(HB less than 6g/dl)at admission
* Guardian or parent willing/able to provide consent

Exclusion Criteria:

* Malignancy
* Surgery
* Acute trauma
* Severe malnutrition

Primary outcomes:
measure: Correction of severe anaemia.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mbale
country: Uganda
facility: Mbale Regional Referral Hospital
city: Soroti
country: Uganda
facility: Soroti Regional Hospital
Study officials:
affiliation: Soroti Regional Hospital, Uganda
name: Charles Engoru, MMed, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olupot-Olupot P, Engoru C, Thompson J, Nteziyaremye J, Chebet M, Ssenyondo T, Dambisya CM, Okuuny V, Wokulira R, Amorut D, Ongodia P, Mpoya A, Williams TN, Uyoga S, Macharia A, Gibb DM, Walker AS, Maitland K. Phase II trial of standard versus increased transfusion volume in Ugandan children with acute severe anemia. BMC Med. 2014 Apr 25;12:67. doi: 10.1186/1741-7015-12-67.
Clinical trial NCT00494390: Evaluation Study for a Non-Contact Biometer
Official title: Neuartige Kontaktlose Biometrische Messungen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Pseudophakia
Myopia
Hyperopia
Aphakia
Keywords: Biometry
corneal opacity
astigmatism
refraction
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Haag-Streit AG
First posted: 2007-06-29
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE

Brief summary: The purpose of this study is to determine whether a new non-contact biometer, is as accurate as the the available gold-standard.

Detailed description: The features of a not yet commercial available new biometer will be compared to available contact and non contact biometers in different patient groups.

Eligibility criteria: Inclusion Criteria:

1. 18 year or older
2. Normal eye
3. Cataract
4. Corneal abnormality (scar, opacity, transplant)
5. refractive corneal surgery
6. Pseudophakia
7. Aphakia
8. Silicon oil
9. refractive IOL

2.-9. (at least one yes)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Ophthalmology, University Hospital
Study officials:
affiliation: www.insel.ch
name: David Goldblum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02628990: Lipid-lowering Effect of Plant Stanol Ester Yoghurt Drinks
Official title: The Effect of Plant Stanol Ester Yoghurt Drinks With or Without Added Camelina Oil on Serum Lipids in Comparison to Placebo in Subjects With Mildly to Moderately Elevated Serum Cholesterol Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lead sponsor: Raisio Group
Sponsor class: INDUSTRY
Collaborators: name: University of Turku
First posted: 2015-12-11
Enrollment: 155
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol ester either with or without added camelina oil on the serum cholesterol levels in moderately hypercholesterolemic subjects


Eligibility criteria: Inclusion Criteria:

* BMI \< 30 kg/m2
* moderate hypercholesterolemia (fasting total cholesterol between 5-8 mmol/l)
* serum triglycerides \< 3 mmol/l.
* normal liver, kidney and thyroid function
* subjects must voluntarily sign the informed consent

Exclusion Criteria:

* use of cholesterol lowering foods or dietary supplements within 21 days before the start of the intervention
* lipid lowering medication
* history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, hyperglycemia, temporal ischemic attack and malignant diseases
* pregnancy or lactation
* alcohol abuse
* subjects with intolerance to any ingredient of the test products

Primary outcomes:
measure: Percentual change in serum LDL-cholesterol
timeFrame: 4 weeks
measure: Absolute change in serum LDL-cholesterol
timeFrame: 4 weeks
Secondary outcomes:
measure: Percentual change in serum total cholesterol
timeFrame: 4 weeks
measure: Absolute change in serum total cholesterol
timeFrame: 4 weeks
measure: Percentual change in serum non-HDL cholesterol
timeFrame: 4 weeks
measure: Absolute change in serum non-HDL cholesterol
timeFrame: 4 weeks
measure: Percentual change in serum triglycerides
timeFrame: 4 weeks
measure: Absolute change in serum triglycerides
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Salo P, Kuusisto P. Cholesterol Lowering Effect of Plant Stanol Ester Yoghurt Drinks with Added Camelina Oil. Cholesterol. 2016;2016:5349389. doi: 10.1155/2016/5349389. Epub 2016 Feb 21.
Clinical trial NCT03832790: Sleep, Glycemic Control, and Insulin Resistance in Adolescents With Type 1 Diabetes
Official title: Sleep, Glycemic Control, and Insulin Resistance in Adolescents With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type1diabetes
Adolescent Behavior
Sleep
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: Colorado Clinical &amp; Translational Sciences Institute
name: Ludeman Family Center for Women&#39;s Health Research
First posted: 2019-02-06
Enrollment: 23
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with type 1 diabetes

Brief summary: Despite advancements in care, most adolescents with T1D have higher BMI and significantly higher HbA1c than recommended and are markedly IR, placing them at increased risk for CVD1,2. Thus, alternative approaches to improve and maintain glycemic control, IR, and BMI for adolescents with T1D are urgently needed. This proposal moves beyond the current insulin and carbohydrate counting-focused lifestyle change paradigm to focus on sleep and circadian misalignment, which will allow for identification of new mechanisms that can be directly translated into future intervention and prevention trials. The goal of the current study is to utilize multiple objective measures of sleep duration, timing (actigraphy), and circadian rhythm (melatonin) in adolescents with type 1 diabetes (T1D; N = 40) and examine relationships with glycemic control, IR, vascular health, and BMI. Further, qualitative methodology will be used to identify barriers and facilitators to healthy sleep in adolescents with T1D.


Eligibility criteria: Inclusion Criteria:

* attending high school
* diagnosis of type 1 diabetes \>1 year

Exclusion Criteria:

* current diagnosis of a sleep disorder (e.g., insomnia, OSA) or abnormal scores on sleep disorders screening measures
* regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin, other sleep aids)
* HbA1c ≥11 or \>14% for the previous 2+ measurements
* IQ\<70 or severe mental illness

Primary outcomes:
measure: HbA1c
timeFrame: at 60 days
measure: glycemic variability
timeFrame: at 2 weeks
measure: insulin sensitivity from hyperinsulinemic euglycemic clamp
timeFrame: at study entry (baseline)
measure: BMI
timeFrame: at study entry (baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus/Children's Hospital Colorado
state: Colorado
Study officials:
References:
Clinical trial NCT06655090: Fibrotic Interstitial Lung Disease Early Recognition and Strategic Therapy Study in China
Official title: Fibrotic Interstitial Lung Disease Early Recognition and Strategic Therapy Study in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Disease (ILD)
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Guangzhou Medical University
name: Nankai University
name: Jilin University
name: Shanghai Pulmonary Hospital, Shanghai, China
name: Shanghai Chest Hospital
name: Institute of Basic Medical Sciences CAMS
name: Tongji Hospital
name: National Institute for Occupational Health and Poison Control
name: Infervision Medical Technology Company Limited
First posted: 2024-10-23
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were selected during hospitalization from medical organization.

Brief summary: This project aimed to: 1) construct a cohort of no less than 10000 cases of f-ILD (including pneumoconiosis ≥3000 cases) with continuous regular follow-up to reveal the clinical phenotypes closely related to the development, progression and prognosis of pulmonary fibrosis; 2) systematically evaluate the safety and effectiveness of frozen lung biopsy, surgical lung biopsy/thoracoscopic lung biopsy and other techniques, and to optimize the histological diagnosis method of f-ILD; 3) construct a set of artificial intelligence (AI) evaluation system for quantitative evaluation of pulmonary fibrosis and its severity, and develop application software; 4) excavate and verify important molecular targets for the formation of pulmonary fibrosis and identify biomarkers; 5) combined with clinical phenotype, imaging, pathology and biomarkers to establish f-ILD early recognition and progress model, intervention strategies, guidelines and consensus, and applicated nationwide.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as ILD

Exclusion Criteria:

* Lack of chest CT
* Patients refused to participant

Primary outcomes:
measure: Clinical diagnostic protocol of ILD tissue biopsy
timeFrame: 3 years
measure: Predict model
timeFrame: 3 years
measure: Severity of fibrosis in HRCT assessed by AI system in patients with ILD
timeFrame: 3 years
measure: F-ILD cohort
timeFrame: 6 years
measure: Important molecular targets and biomarkers identified by multi-omics
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Huaping Dai, M.D. Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03215290: Trans-parenchymal Compressing Suture in Major Liver Resection
Official title: Application of Trans-parenchymal Compressing Suture in Major Liver Resection to Decrease Cutting Surface Related Complication.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Carcinoma Resectable
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 382
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Non-anatomical liver resection with appropriate resection margin was regarded as a potential curative treatment for selected major hepatic carcinoma due to preserving maximal normal liver, especially in cirrhotic patients. But occurrence of cutting surface related complications become a main challenge.

Detailed description: In order to better manage the cutting surface after liver resection, we further applied trans-parenchymal compressing suture to "not good" cutting surface in hope of decreasing cutting surface related complication. A majority of studies investigating cutting surface management are limited to non-surgical treatments, such as the application of hemostasis agents including fibrin sealants, oxidized cellulose, and absorbable gelatin sponge13-15 . But there is no consensus regarding the necessity of the hemostatic agent application to the liver cutting surface. Up to date, few studies investigate surgical suture management of the cutting surface in liver resection.

Eligibility criteria: Inclusion Criteria:

1. tumor size more than 5cm
2. non-anatomical liver resection;

Exclusion Criteria:

1. intravascular infiltration with tumor embolus;
2. previous liver surgical treatment (e.g. microwave ablation; preoperative transcatheter arterial chemoembolization (TACE);
3. other concomitant extrahepatic procedures (e.g. splenectomy).
4. exposed Glisson Shealth, main hepatic veins or (and) retro-hepatic inferior vena cava.

Primary outcomes:
measure: Cutting surface related complications
timeFrame: 90 days
Secondary outcomes:
measure: Interventions for cutting surface related complications
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
References: