louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02073981: Observational Study for Non-motor Symptoms and Treatment in Parkinson's Disease Patients
Official title: Japan-First-in Large Scale Observational Study for Non-motor Symptoms and Treatment in Parkinson's Disease Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-02-28
Enrollment: 1021
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson Disease

Brief summary: This study is implemented to identify factors having an impact on improvement or exacerbation of non-motor symptoms, to provide information contributing to development of medical care in this field and improvement of patients' QOL, and to clarify the association between the use of istradefylline and non-motor symptoms or QOL.


Eligibility criteria: Inclusion Criteria:

* Patients who have wearing off under treatment with levodopa-containing drugs administered at least three times daily
* Patients who have at least one non-motor symptom as a complication
* Patients at least 20 years of age at the time of consent
* Patients who have given written consent
* Patients who are receiving outpatient care

Exclusion Criteria:

* Patients with dementia or a score of 23 or less on the Mini-Mental State Examination (MMSE)
* Patients, in the opinion of the investigator or subinvestigator, having conditions impairing the proper assessment of the MDS-UPDRS or PDQ-8 (e.g., patients who are receiving treatment for malignant tumor)

Primary outcomes:
measure: Changing of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: 52 weeks
measure: Changing of Parkinson's Disease Questionaire-8 (PDQ-8) score.
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
Study officials:
References:
Clinical trial NCT03445481: Clinical Pilot Study of New Prosthesis for Trans-femoral Amputated Patients
Official title: Pilot Study of New Prosthesis for Trans-femoral Amputated Patients Clinical Study Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trans-femoral Amputated Patients
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with a trans-femoral amputation who experienced problems, complications pain due to the ischial weight bearing and discomfort with conventional socket prosthesis will be proposed to implant a new developed prosthesis.

Detailed description: The patients will undergo a surgical operation to implant a femoral prosthesis according to the hospital's protocol. The surgical intervention will be performed under general or spinal anesthesia with a tourniquet at the root of the lower limb. Under sterile conditions, the incision of the stump will be done at the level of the previous surgical scar. Preserving the soft tissue, the distal femoral bone is reached. Then, the medullary canal is opened and prepared with reamers of increasing diameter. A femoral cemented stem of appropriate dimensions correlated to the size of the canal and 105 mm of height is implanted. To the above-mentioned stem, the Medacta prosthesis will be fixed with a blocking screw. The prosthesis is then covered with the soft tissue and layered suturing of the stump is performed.

Eligibility criteria: Inclusion Criteria:

* Age \>18 and \<75 years
* Patients with Trans-femoral Amputations since at least 2 years and suffering from pain and discomfort with the current standard socket prosthesis, i.e., with a baseline VAS score for pain between 3 and 10 or a health-related quality of life (Eq-5D) score \< 60 or an SF-36 result below the 50th percentile
* Amputation due to:

  1. Trauma
  2. Oncologic disease
* Written informed consent

Exclusion Criteria:

* Trans-femoral amputation due to infection
* Patients affected by

  1. metabolic disease
  2. neurologic degenerative disease
  3. vascular disease proximal to the amputation
  4. body weight \>100 kg
  5. Hip arthritis of the amputated limb

Primary outcomes:
measure: Quality of Life
timeFrame: Two years
Secondary outcomes:
measure: Adverse Events
timeFrame: Two years
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano Civico e Italiano
Study officials:
affiliation: EOC
name: Christian Candrian, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00469781: Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystoid Macular Edema,
Retinal Thickening
Lead sponsor: Center For Excellence In Eye Care
Sponsor class: OTHER
First posted: 2007-05-07
Enrollment: 95
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: The objective of this study is to determine if twice-daily dosing of prednisolone (Pred Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly with twice-daily bromfenac.


Eligibility criteria: Inclusion Criteria:

* · Male or female \> 18 years of age scheduled to undergo cataract surgery

  * Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
  * Expected visual outcome of 20/25 or better.
  * Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

* · Known contraindication to any study medication or any of their components

  * Uncontrolled systemic disease
  * Required use of ocular medications other than the study medications during the study
  * Abnormal pre-operative OCTs
  * Diabetic patients with a history of macular edema or diabetic retinopathy
  * AMD, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease
  * Only one eye of each patient can be enrolled

Primary outcomes:
measure: Cystoid Macular Edema
timeFrame: 11 months
Secondary outcomes:
measure: Retinal Thickening
timeFrame: 11 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: The Center for Excellence in Eye Care
state: Florida
Study officials:
affiliation: The Center for Excellence in Eye Care
name: Carlos Buznego, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00231881: Functional and Molecular Characterisation of Oesophageal Distal Epithelium: Correlations With Acid and Non Acid Reflux
Official title: Functional and Molecular Characterisation of Oesophageal Distal Epithelium: Correlations With Acid and Non Acid Reflux
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroesophageal Reflux
Keywords: GORD - Oesophageal sensitivity- Oesophageal permeability
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2005-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: This study aims to characterize the permeability as well as some protein involved in the cell junction in the oesophageal epithelium in patients with GORD symptoms. In addition these patients will be characterized for their reflux especially by pH-impedancemetry, Bilitec and oesophageal acid perfusion test. Correlations between the characteristics of the reflux and the biological results will be calculated.

Detailed description: This study aims to characterize the permeability as well as some protein involved in the cell junction in the oesophageal epithelium in patients with GORD symptoms. In addition these patients will be characterized for their reflux especially by pH-impedancemetry, Bilitec and oesophageal acid perfusion test. Correlations between the characteristics of the reflux and the biological results will be calculated.

Eligibility criteria: Inclusion Criteria:

Main inclusion criteria :

* Digestive symptoms suggestive of GORD (heartburn, regurgitation, epigastric pain), or dyspeptic syndrome (nausea, belch, bloating, epigastric discomfort).
* Need of upper GI endoscopy and pH monitoring.
* Normal propagation of oesophageal persitaltic waves (manometry \< 6 months).
* Age 18 -70 yrs
* Signed informed consent
* Normal coagulation

Exclusion Criteria:

* Barrett's oesophagus
* Previous oesophageal bleeding
* Need of NSAID treatment.
* Previous sus mesocolic surgery
* Alcool consumption \> 40g/d, smoking \> 10 cig/j
* Pregnancy or lack of contraceptive disposal, breast feeding.
* Allergy to Xylocaïne

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Centre Hospitalier et Universitaire de Nantes
name: Stanislas Bruley des Varannes, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04043481: Modified Allen's Test and Peripheral Perfusion Index
Official title: Relation of the Peripheral Perfusion Index Derived From Pulse Oximetry to Modified Allen's Test in Evaluation of Hand Perfusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Perfusion
Keywords: Perfusion index
modified Allen's test
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients

Brief summary: to detect the relation between results of the peripheral perfusion index and modified Allen's test.

Detailed description: The modified Allen's test (MAT) is commonly used to assess hand perfusion. Other non-invasive methods including plethysmography, pulse oximetry and duplex ultrasonography are used nowadays. The perfusion index is calculated as the ratio of the pulsatile blood flow to non- pulsatile blood flow in peripheral tissue.

In this study, we will try to detect the relation between results of the peripheral perfusion index and modified Allen's test.

Eligibility criteria: Inclusion Criteria:

* Adult patients or healthy volunteers

Exclusion Criteria:

-

Primary outcomes:
measure: Perfusion of the hand using the perfusion index
timeFrame: Preoperative
measure: Perfusion of the hand using the modified Allen's test
timeFrame: Preoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT04859881: Risk Factors for Barotrauma in COVID-19
Official title: Risk Factors Associated With Barotrauma in COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barotrauma
Covid19
Keywords: Barotrauma
COVID-19
Lead sponsor: Hospital General Ajusco Medio
Sponsor class: OTHER
Collaborators: name: Horacio Marquez-Gonzalez
name: Carlos Torruco-Sotelo
name: Sebastian Rodriguez-Llamazares
First posted: 2021-04-26
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of severe SARS-COV2 infection and mechanical ventilation, admitted in a single-center community Hospital in Mexico City.

Brief summary: Barotrauma in mechanical ventilation (MV) is defined as lung damage attributable to the application of high airway pressure and is one of the potential mechanisms of ventilator-induced lung injury (VILI). Previous studies have shown an increased mortality in patients with barotrauma under MV; pneumothorax (PTX) being the most common presentation, but it can also present as pneumomediastinum (PM) with or without PTX, with extension to soft tissue as subcutaneous emphysema or even as pneumo-retroperitoneum and pneumo-scrotum.

Traditionally, underlying lung disease or age are known risk factors for non-trauma related barotrauma. However, in patients with novel coronavirus disease (COVID-19), the incidence of this complication is more common than in non-infected patients, as recently reported. Since little is known regarding which are the main risk factors for these events to develop, most pathophysiological mechanisms remain unexplained.

The aim of this study was to determine the risk factors for developing barotrauma in patients under MV with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS). Secondary objectives were to determine the incidence of barotrauma and its association with mortality.


Eligibility criteria: Inclusion Criteria:

* Patients under MV fulfilling the Berlin definition for ARDS, with positive SARS-COV2 real time polymerase chain reaction

Exclusion Criteria:

* Incomplete clinical records and other causes of extrapulmonary air

Primary outcomes:
measure: Barotrauma development
timeFrame: During patient hospitalization, an average of one month
Secondary outcomes:
measure: Mortality
timeFrame: During patient hospitalization, an average of one month
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Hospital General Ajusco Medio
Study officials:
References:
Clinical trial NCT06172881: Novel Multifocal Soft Contact Lens Study
Official title: Novel Multifocal Soft Contact Lens Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Myoptechs
First posted: 2023-12-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single site, open label protocol will be used to evaluate the safety and quality of vision of a novel soft contact lens. Habitual contact lens wearers will be asked to come to the study site for one visit. Ocular health assessments and visual acuity will be completed with both the study lens and without.


Eligibility criteria: Inclusion Criteria:

1. Ability to give informed consent
2. Any gender
3. Any racial or ethnic origin
4. 18 - 40 years of age
5. Distance visual acuity with best corrected visual acuity of 20/25 with each eye
6. Habitual soft contact lens wearer with myopia
7. Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the investigator).

Exclusion Criteria:

1. Current or active ocular inflammation or infection as determined by the Investigator.
2. Astigmatism \> 0.75 D in either eye
3. History of previous eye surgery
4. Demonstration or history of corneal ectasia or keratoconus.
5. Pregnant or lactating.

Primary outcomes:
measure: Distance Visual Acuity
timeFrame: 1 day (This is a single visit study)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
Study officials:
affiliation: The Ohio State University College of Optometry
name: Jennifer Fogt, OD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01361581: Metabolic Aspects of Citrate Anticoagulation in Renal Replacement Therapy
Official title: Metabolic Aspects of Citrate Anticoagulation in Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Renal Failure
Critical Illness
Keywords: Acute renal failure
Anticoagulation
Citrate
Haemodiafiltration
Haemofiltration
Renal replacement therapy
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Czech Republic
First posted: 2011-05-27
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: critically ill intensive care patients

Brief summary: Citrate anticoagulation is associated with metabolic side effects which are linked to a portion of citrate reaching systemic circulation. Data on significance of systemic gain of citrate and its relationship to method configuration are missing. Patient might also receive certain dose of lactate as a buffer and a dose of glucose if acid-citrate-dextrose solution is used. The authors test variable methods of indirect estimate of systemic dose of citrate which would allow to quantify the metabolic input without mostly unavailable measurements of citrate levels.


Eligibility criteria: Inclusion Criteria:

* Acute renal failure on continuous renal replacement therapy for more than 24 hours (CVVH or CVVHDF).

Exclusion Criteria:

* Absence of consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Prague 2
country: Czech Republic
facility: Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University
Study officials:
References:
citation: Zakharchenko M, Los F, Brodska H, Balik M. The Effects of High Level Magnesium Dialysis/Substitution Fluid on Magnesium Homeostasis under Regional Citrate Anticoagulation in Critically Ill. PLoS One. 2016 Jul 8;11(7):e0158179. doi: 10.1371/journal.pone.0158179. eCollection 2016.
citation: Balik M, Zakharchenko M, Leden P, Otahal M, Hruby J, Polak F, Rusinova K, Stach Z, Tokarik M, Vavrova J, Jabor A, Oudemans-van Straaten HM. Bioenergetic gain of citrate anticoagulated continuous hemodiafiltration--a comparison between 2 citrate modalities and unfractionated heparin. J Crit Care. 2013 Feb;28(1):87-95. doi: 10.1016/j.jcrc.2012.06.003. Epub 2012 Aug 27.
Clinical trial NCT04212481: RCT of Uniport VATS for Lung Cancer
Official title: Randomized Controlled Trial of the Comparison of Uniport VATS and Non- Uniport VATS for Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Single-port Video-assisted Thoracoscopic Surgery
Keywords: Non Small Cell Lung Cancer
Perioperative Efficacy
multi-port
Lead sponsor: The Second Hospital of Shandong University
Sponsor class: OTHER
First posted: 2019-12-27
Enrollment: 300
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Video-assisted thoracoscopic surgery (VATS) has been widely used for non-small cell lung cancer (NSCLC) for nearly two decades. Usually, it was applied through three ports with at least one drainage after surgery, which often lead to acute chest pain. Therefore, fewer, smaller ports, and wider intercostal space for surgery has been required.

Uniport VATS became a feasible option with the development of surgical techniques and instruments, with potentially less postoperative pain and shorter hospital stays. However, there may be some complications, or with a longer time of operation, even more difficult in lymph nodes resection during learning curve.

In our study, a Randomized Controlled Trial was designed to study the operation time, perioperative blood loss, conversion rate, duration of postoperative drainage, length of hospital stay, visual analogue score of postoperative pain, complications, and survival.


Eligibility criteria: Inclusion Criteria:

patients with cT1-3N0-1M0 NSCLC; good cardiopulmonary function; prepared to undergo radical resection;

Exclusion Criteria:

patients with N3 or M1 NSCLC; poor cardiopulmonary function; not be prepared to undergo radical resection;

Primary outcomes:
measure: operative time
timeFrame: 1 day
measure: perioperative blood loss
timeFrame: 1 day
measure: conversion rate
timeFrame: 1 day
measure: duration of postoperative drainage
timeFrame: within 5-7 days
measure: length of hospital stay
timeFrame: within 5-7 days
measure: visual analogue score of postoperative pain
timeFrame: within 5-7 days
measure: complications
timeFrame: up to 3 months
Secondary outcomes:
measure: overall survival
timeFrame: up to 5 years
measure: progression- free survival
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
Study officials:
affiliation: The Second Hospital of Shandong University
name: Xiaogang Zhao, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04559581: Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
Official title: Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases, Interstitial
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-09-23
Enrollment: 425
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: Non-interventional study in patients in Japan with chronic fibrosing ILDs with the progressive phenotype who are prescribed with Ofev and have never been treated with Ofev before; except patients with a diagnosis of idiopathic pulmonary fibrosis or patients with other chronic fibrosing ILDs with the progressive phenotype due to systemic sclerosis as the underlying disease. No limitations are set up on background factors and their concomitant drugs in use of actual medical practice.

Brief summary: The primary objective is to evaluate the incidence of adverse drug reactions (focus on hepatic function disorders) of Ofev Capsules under the real world setting in patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype (PF-ILD).


Eligibility criteria: Inclusion Criteria:

* Patients in Japan with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included.

Exclusion Criteria:

* Diagnosis of Idiopathic Pulmonary Fibrosis
* Patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype due to systemic scleroderma as the underlying disease

Primary outcomes:
measure: Incidence of adverse drug reactions (ADRs)
timeFrame: up to 104 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Nippon Boehringer Ingelheim Co., Ltd.
Study officials:
References: