louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03514030: Clinic Registry Study of Optic Neuromyelitis Spectrum Disease in China
Official title: Clinic Registry Study of Optic Neuromyelitis Spectrum Disease in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NMO Spectrum Disorder;Registry Study
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 400
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are clinically suspected of being NMOSD

Brief summary: In 1894, Devic first proposed the concept of neuromyelitis optica(NMO). NMO is an inflammatory demyelinating disease that selectively affects the central nervous system of the optic nerve and spinal cord.In 2004, Lennon and other persons found highly specific AQP4（aquaporin 4）antibodies in NMO patients'sera, and further differentiated between NMO and MS, confirming that NMO is an independent disease.At present, NMO has been widely recognized as an idiopathic and severe demyelinating disease of the central nervous system.In 2015, the international NMO diagnostic team developed the diagnostic criteria based on highly specific AQP4 antibodie.Up to now, in China, there is no data on the number of NMOSD patients, the rate of misdiagnosis, the treatment methods, and the prognosis.This study is committed to build China's NMOSD big data platform to provide the basis for diagnosis, treatment and prognosis of the disease.


Eligibility criteria: Inclusion Criteria:

1. more than 14 years old
2. Compliance with the diagnostic standard by the NMO International Diagnostic team in 2015

Exclusion Criteria:

1. less than 14 years old
2. NOT Compliance with the diagnostic standard by the NMO International Diagnostic team in 2015

Primary outcomes:
measure: misdiagnosis rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital,Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT01727830: Hemodilution and Coagulopathy With 3 Colloids
Official title: Influence of Hemodilution on Coagulation, pH, Platelet Function, Laboratory Values and ROTEM in Volunteers Using HES 6%, Gelatine and Balanced Gelatine and the Reversal of Coagulopathy With F XIII and Fibrinogen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dilutional Coagulopathy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: volunteers

Brief summary: Aim of this in vitro trial is to assess the effect on blood coagulation after 60 % dilution with different colloids (HES 130/0.42, Gelatin and Gelatin balanced) and investigate reversibility by replacement of fibrinogen (FBG), factor XIII (F XIII), and the combination of FBG and FXIII.

In blood of 12 volunteers the following measurements are performed at baseline and 60% dilution with HES 130/0.42, Gelatin or Gelatin balanced: Blood gas analyses, coagulation factor concentrations (F II,F VII,F VIII,F XIII), impedance aggregometry and rotational thrombelastometry (ROTEM®). Then FBG, F XIII and a combination of both was added, in concentrations corresponding to 6 g FBG and 1250 IU F XIII in adults. ROTEM® measurements and determination of factor concentrations are again performed.

* Trial with medical device


Eligibility criteria: Inclusion criteria:

* signed informed consent from before blood withdrawal

Exclusion criteria:

* known coagulation disorders,
* any form of anticoagulation therapy,
* use of acetyl-salicylic acid within the past five days,
* use of non-steroidal anti-inflammatory agents within the past 24 hours,
* known renal disease or plasma concentrations of aspartate aminotransferase (\>50 U l -1) or alanine aminotransferase (\>50 U l-1)
* patients incapable of understanding the German language

Primary outcomes:
measure: Reversibility of in vitro induced coagulopathy
timeFrame: Same day when blood was drawn
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Anaesthesiology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Anaesthesiology
name: Oliver Theusinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06556225: Isolated Maxillary Sinus Lesions in Sohag University Hospital
Official title: Isolated Maxillary Sinus Lesions in Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Maxillary Sinus Disease
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with the isolated maxillary sinus lesions were subjected to

1. Detailed history, general clinical examination \& ENT examination, routine investigations, diagnostic nasal endoscopy.
2. CT scan PNS
3. The surgical approaches and intraoperative findings were recorded either endoscopicallay or combined approach .
4. The pathological diagnoses were reviewed postoperatively.

Brief summary: Aim of the study:

Identify variants of maxillary sinus pathologies, its clinical presentations, radiological findings and surgical managements.

Detailed description: Maxillary sinus diseases are common and numerous disorders that affect this anatomical area. As lesions are frequently allowed to grow to a significant size before becoming symptomatic, patients often present late, which can make management options more limited and difficult. Proper evaluation both clinically and with appropriate imaging allows accurate diagnosis, and lesions can often be successfully managed endoscopically

Eligibility criteria: Inclusion Criteria:

* Only patients with isolated maxillary sinus lesions , with varying degrees of sinus opacity who were indicated for surgery.

Exclusion Criteria:

* Patients who had pan sinuses lesions or those with significant involvement of the other paranasal sinuses than maxillary sinus were excluded.

Primary outcomes:
measure: Identify variants of maxillary sinus pathologies, its clinical presentations, radiological findings and surgical managements.
timeFrame: will be at Sohag University Hospital, a tertiary care academic center in Egypt, from 2023 to 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Universty
Study officials:
affiliation: sohag universty
name: arafat mahmoud
role: STUDY_CHAIR
References:
Clinical trial NCT00181025: Isolated Pelvic and Limb Perfusion in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs' Girdle
Official title: Isolated Pelvic and Limb Perfusion With 1mg TNFa in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs' Girdle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sarcoma of Pelvis
Keywords: Limbs' girdle
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 33
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study looks at isolated pelvic perfusion and limbs' girdle with 1 mg tumor necrosis factor alpha (TNFa) in the treatment of locally advanced sarcoma of the pelvis and limbs' girdle.


Eligibility criteria: Inclusion Criteria:

* Soft tissue or bone sarcomas locally advanced of the pelvis or limbs' girdle

Exclusion Criteria:

* Resectable tumor without mutilation

Primary outcomes:
measure: Complete response rate on MRI
Secondary outcomes:
measure: Histological response
measure: Objective responses
measure: Rate of conservative treatments
measure: Overall survival and disease free survival
measure: Local and systemic toxicity
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave-Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Sylvie Bonvalot, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04095325: Transversus Abdominis Plane Block Versus Erector Spina Plane Block
Official title: Ultrasound Guided Transversus Abdominis Plane Block Versus Erector Spina Plane Block in Pediatric Lower Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraoperative Pain Control
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Regional anesthesia and analgesia techniques are frequently used to provide pain control in pediatric surgical applications. The main advantages of these techniques include ease of application, good analgesic efficacy and low risk of complications (1). It reduces the need for parenteral opioids and increases the quality of postoperative pain control and the satisfaction of the patient and family (2). The aim of this study was to compare the contribution of TAP block and ESP block combined with sedation in pediatric surgery to anesthesia and analgesia during surgery without general anesthesia.


Eligibility criteria: Inclusion Criteria:

* ASA I-II,
* undergo elective lower abdominal surgery
* 2-6 years

Exclusion Criteria:

* Psychiatric patients,
* weight\> 40 kg,
* those with cardiac-pulmonary-neurological disease,
* those with bleeding disorders,
* infection or wound scarring at the injection site,
* known allergy to local anesthetics

Primary outcomes:
measure: Visual analogue scale
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan University
Study officials:
References:
citation: Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andres J. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019 Jun;72(3):209-220. doi: 10.4097/kja.d.19.00012. Epub 2019 Mar 19.
citation: Tanaka M, Mori N, Murakami W, Tanaka N, Oku K, Hiramatsu R, Nakagawa M, Yasumoto K. [The effect of transversus abdominis plane block for pediatric patients receiving bone graft to the alveolar cleft]. Masui. 2010 Sep;59(9):1185-9. Japanese.
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
citation: Hernandez MA, Palazzi L, Lapalma J, Cravero J. Erector spinae plane block for inguinal hernia repair in preterm infants. Paediatr Anaesth. 2018 Mar;28(3):298-299. doi: 10.1111/pan.13325. Epub 2018 Jan 17.
citation: Stuart-Smith K. Hemiarthroplasty performed under transversus abdominis plane block in a patient with severe cardiorespiratory disease. Anaesthesia. 2013 Apr;68(4):417-20. doi: 10.1111/anae.12108. Epub 2012 Dec 17.
citation: Tekelioglu UY, Demirhan A, Sit M, Kurt AD, Bilgi M, Kocoglu H. Colostomy with Transversus Abdominis Plane Block. Turk J Anaesthesiol Reanim. 2015 Dec;43(6):424-6. doi: 10.5152/TJAR.2015.89410. Epub 2015 Dec 1.
Clinical trial NCT01590030: Ovarian Mesial Incision: a New Safe and Fertility-sparing Technique
Official title: Mesial Incision for Laparoscopic Dermoid Cystectomy: a New Safe and Fertility-sparing Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermoid Ovarian Cysts
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety and efficacy in terms of spillage risk and fertility-sparing of mesial incision for laparoscopic dermoid cystectomy.


Eligibility criteria: Inclusion Criteria:

* reproductive age
* pre-operative findings suggestive for benign tumor
* regular menstrual cycles at least six months before surgery

Exclusion Criteria:

* previous pelvic surgery
* known endocrine disease
* estrogen-progestin use before surgery

Primary outcomes:
measure: Spillage of intracystic content rate
timeFrame: Intraoperative
measure: Operative times
timeFrame: Immediately at the end of the laparoscopy
measure: Chemical peritonitis rate
timeFrame: 1 week after surgery
measure: Intraoperative blood loss
timeFrame: The morning after laparoscopy
Secondary outcomes:
measure: Ovarian reserve
timeFrame: 3 months and 1 year after surgery
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Chair of Obstetrics and Gynecology
state: CZ
Study officials:
affiliation: University Magna Graecia
name: Fulvio Zullo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morelli M, Mocciaro R, Venturella R, Imperatore A, Lico D, Zullo F. Mesial side ovarian incision for laparoscopic dermoid cystectomy: a safe and ovarian tissue-preserving technique. Fertil Steril. 2012 Nov;98(5):1336-40.e1. doi: 10.1016/j.fertnstert.2012.07.1112. Epub 2012 Aug 11.
Clinical trial NCT01562925: Effect of Red Wine, White Wine and Beer on Contrast-Medium Induced Acute Kidney Injury
Official title: Randomized Controlled Study for Evaluation of the Impact of Red Wine, White Wine and Beer Intake on Contrast-Medium Induced Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Renal Failure/ Kidney Disease
Contrast-medium Induced Acute Kidney Injury
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2012-03-26
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with impaired renal function are at elevated risk for development of contrast-medium induced acute kidney injury (CI-AKI). CI-AKI is associated with increased risk for cardiovascular morbidity and mortality. Effective CI-AKI prevention strategies are needed.

The RenPro-II-WINE Trial was designed to test the hypothesis whether moderate red wine consumption prior to contrast-medium use is effective in CI-AKI prevention.

Consecutive patients with impaired renal function undergoing elective coronary angiography will be assigned in one of four treatment arms: a. control patients receiving standard care b. patients receiving standard care plus red wine c. patients receiving standard care plus white wine d. patients receiving standard care plus beer This study will give important answers on how to prevent CI-AKI in patients with impaired renal function undergoing contrast media exposure.


Eligibility criteria: Inclusion Criteria:

* age \>= 18 years
* impaired renal function (baseline estimated glomerular filtration rate of \<60 ml/min)
* at least three of following comorbidities: hypertension, diabetes mellitus without insulin therapy, heart failure NYHA III and/or left ventricular ejection fraction \<35%, peripheral artery disease, coronary artery disease

Exclusion Criteria:

* known alcohol addiction
* severe renal impairment (estimated glomerular filtration rate \<15 ml/min and/or in chronic dialysis program
* Recent (\<=30 days) contrast media exposure
* insulin therapy
* Patients enrolled in concomitant studies
* fertile women

Primary outcomes:
measure: CI-AKI incidence
timeFrame: <48 hours after contrast-medium exposure
Secondary outcomes:
measure: Biomarkers assessing acute kidney injury
timeFrame: <48 hours
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Herzzentrum der Universität zu Köln
Study officials:
References:
Clinical trial NCT02834325: Predicting Success of HFNC: The Utility of the ROX Index
Official title: Predicting Failure of High Flow Nasal Cannula in Pneumonia Patients With Hypoxemic Respiratory Failure: The Utility of ROX Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Failure
Pneumonia
Keywords: high flow nasal cannula
success
failure
ROX index
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with acute respiratory failure admitted to intensive care unit receiving high-flow nasal cannula treatment.

Brief summary: The purpose of the study was to describe early predictors and to develop a prediction tool that accurately identifies the need for mechanical ventilation in pneumonia patients with acute respiratory failure treated with High Flow nasal cannula.

Detailed description: Purpose The purpose of the study is to describe early predictors and to develop a prediction tool that accurately identifies the need for mechanical ventilation (MV) in pneumonia patients with hypoxemic acute respiratory failure (ARF) treated with high-flow nasal cannula (HFNC).

Materials and methods This is a 4-year prospective observational 2-center cohort study including patients with severe pneumonia treated with HFNC. High-flow nasal cannula failure was defined as need for MV. ROX index was defined as the ratio of pulse oximetry/fraction of inspired oxygen to respiratory rate.

Eligibility criteria: Inclusion Criteria:

* diagnosis of acute respiratory failure secondary to pneumonia receiving HFNC therapy

Exclusion Criteria:

* younger than 18 years old
* indication for mechanical ventilation at ICU admission
* limitation of therapeutic effort

Primary outcomes:
measure: prediction of need for mechanical ventilation using ROX index
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04684225: Telerehabilitation on Hand-Affected Scleroderma
Official title: Telerehabilitation Approach on Individuals With Hand-Affected Scleroderma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma
Scleroderma, Systemic
Scleroderma Associated Digital Ulcer
Hand Rheumatism
Physiotherapy
Rehabilitation
Keywords: Scleroderma
Systemic sclerosis
Telerehabilitation
Hand therapy
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Telerehabilitation Approach on Individuals with Hand-Affected Scleroderma

Detailed description: The effects of exercises performed by telerehabilitation on individuals with hand-affected scleroderma on range of motion, grip strength, function, sensation, daily life activities and general health will be compared with the effects of home-exercises.

Firstly, the evaluation results will be published; and after all data are collected, the results will be published.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with scleroderma
* Stability of medical treatments
* To be able to adapt to the exercises

Exclusion Criteria:

* The patient has a history of neurological disease or trauma that may affect his symptoms
* Systemic involvement that affects the treatment process
* Being in the active phase of the disease

Primary outcomes:
measure: Hand Mobility in Scleroderma (HAMIS)
timeFrame: change from baseline at 8 weeks
Secondary outcomes:
measure: 9-Hole Peg Test
timeFrame: change from baseline at 8 weeks
measure: Scleroderma Health Assessment Questionnaire (SHAQ)
timeFrame: change from baseline at 8 weeks
measure: Semmes Weinstein Monofilaman Test
timeFrame: change from baseline at 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Tugba Civi Karaaslan
state: Buyukcekmece, Cerrahpasa Medical Faculty
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: TUGBA CIVI KARAASLAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06200025: Virtual Reality in Aphasia Rehabilitation
Official title: The Virtual Reality Rises; The Fall of The Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Aphasia
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 102
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups with a conventional control group
Primary purpose: TREATMENT

Brief summary: Virtual reality-based aphasia rehabilitation has been shown to improve the language skills of individuals with aphasia in the chronic period after stroke. However, non-immersive or semi-immersive rehabilitation methods have often been adopted in the studies. Considering the importance of the visual given to the patient for naming, it can be thought that full immersive therapy may be more effective. Therefore, the aim of this study was to investigate the effect of cue-based aphasia naming therapy in a fully immersive virtual reality environment on aphasia severity and aphasia-related quality of life and to compare it with standard cue treatments.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with non-fluent aphasia by a neurologist
* at least 4 months after stroke
* A score of 29 and above on the language score sub-item of the GAT scale

Exclusion Criteria:

* severe sensory impairments (vision, hearing) that prevent participation in therapies
* severe motor dysfunction
* apraxia
* neglect
* dementia
* psychiatric disorders
* 3D vision problems

Primary outcomes:
measure: Gülhane Aphasia Test
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Faculty of Health Sciences Bolu Abant Izzet Baysal University
state: Merkez
Study officials:
affiliation: Abant Izzet Baysal University
name: Ramazan Kurul, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: