louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00371202: Comparison of Penetrating Keratoplasty and Deep Lamellar Keratoplasty With the Big Bubble Technique for Keratoconus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Keratoconus
Keywords: keratoconus, penetrating keratoplasty,
deep lamellar keratoplasty
big bubble technique
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-09-01
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: it is a randomized clinical trial to compare deep lamellar keratoplasty (DLK) Using big bubble technique and Penetrating Keratoplasty (PK) in patients with keratoconus

Detailed description: In this randomized clinical trial 50 keratoconic eyes of 50 patients randomly assigned in two groups: 25 patients underwent DLK with the big bubble technique and the other 25 patients underwent PK with the standard technique using hessburg - Barron trephine. One surgeon performed all operations using a 16 bites separate 10-0 nylon sutures. We used A-scan ultrasonic biometry for measuring vitreous length (VL) before surgery. If VL≥15.50mm, a trephine 0.25mm larger than recipient and if VL was \<15.50mm, a trephine 0.50 mm larger than recipient were considered. Selective suture removal was started 3 months after operation. quality of vision endothelial cell changes and correlation between refractive outcome and VL in relation to donor-recipient disparity, were measured and analyzed in both PK and DLK 15 mos postoperatively.

Eligibility criteria: Inclusion Criteria:

* moderate to severe keratoconus
* contact lens intolerance
* low visual acuity due to anterior stromal scar
* age between 15 to 50 years

Exclusion Criteria:

* posterior stromal scar with descemets membrane involvement
* history of hydrops
* fuchs endothelial dystrophy
* glaucoma
* cataract
* history of intraocular surgery
* history of vernal keratoconjunctivitis
* intraoperative complications
* reoperation (resuturing- regraft)

Primary outcomes:
measure: Uncorrected visual acuity (UCVA), best corrected visual acuity(bcva), refractive astigmatism, endothelial cell density, mean cell area, polymegathism (CV), Contrast sensitivity, Root-mean-square (RMS) Wavefront error, Pearson correlation factor between
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Bahram Einollhi, MD
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Bahram Einollahi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02015702: Educational Intervention to Increase Physician Satisfaction and Effectiveness With a New Electronic Health Record
Official title: Interventions to Increase Physician Effectiveness and Acceptance of a Electronic Health Record System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attitude of Health Personnel
Keywords: Physicians
Electronic Health Record
Education
Lead sponsor: The Reading Hospital and Medical Center
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 44
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: OTHER

Brief summary: This study was intended to test the effects of adding a one-on-one educational intervention taught by a physician to a physician during their clinical work to improve their acceptance and satisfaction with a new inpatient electronic health record and ordering system.

Detailed description: This study was a randomized, parallel , non- blinded controlled trial of real-time, focused educational interventions in an intervention arm compared with usual training and support in the control arm. Improvement in performance, defined as the time between opening and closing a progress note, and number of notes completed after shift , were the primary outcomes. Physician satisfaction was a secondary outcome. Participants from one 550-bed Academic Independent Medical Center were invited to participate if they were full-time hospitalists or residents in internal medicine with no prior experience with the EPIC electronic health record.

Eligibility criteria: Inclusion Criteria:

* Internal Medicine physicians and resident physicians with inpatient clinical duties at the time of the EPIC electronic health record go-live (Feb 4, 2013)

Exclusion Criteria:

* Physicians whose duties did not include regular admissions and discharge of patients
* Physicians whose work was limited to teaching
* Physicians with prior experience in using EPIC systems for inpatient care .
* Physician assistants and nurse practitioners

Primary outcomes:
measure: Time to complete a progress note
timeFrame: within 1 week of note completion
Secondary outcomes:
measure: Number of notes completed after shift
timeFrame: within 1 week of posting note
measure: Physician Satisfaction with EPIC Electronic Health Record
timeFrame: at baseline, 15-20 shifts, and 35-40 shifts
Other outcomes:
Locations:
city: West Reading
country: United States
facility: Reading Health System
state: Pennsylvania
Study officials:
affiliation: Reading Health System
name: Leena Jalota, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Reading Health System
name: Anthony A Donato, MD MHPE
role: STUDY_DIRECTOR
References:
Clinical trial NCT03661502: Effect of Variable Volume Ventilation on Lung Compliance
Official title: Effect of Variable Volume Ventilation on Lung Compliance During Mechanical Ventilation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Injury
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled trial comparing low inspiratory and expiratory flow during variable volume ventilation with a constant volume decelerating flow (pressure controlled volume guarantee) ventilation.

Detailed description: Randomized controlled trial comparing low inspiratory and expiratory flow during variable volume ventilation (VVV) with a constant volume decelerating flow (PCV pressure controlled volume guarantee) ventilation.

After anesthesia induction patients are VVV or PCV ventilated with a positive end expiratory pressure (PEEP) of 10 cm H2O. Average tidal volume is set at 6 ml/kg and end tidal CO2 is kept between 30 and 50 mmHg in both groups by adapting breaths per minute between 10 and 16. I/E ratio is set at 1/1 in VVV and at the standard ½ in PCV.

Dynamic lung compliance is measured before and during pneumoperitoneum. If dynamic lung compliance is less than 40 or decreases below 40 a first lung recruitment (10 sec of 30 up to 40 cmH2O) is given till dyn compliance rises above 40.

Dynamic lung compliance is further monitored and when value decreases again below 40, a new lung recruitment (LRM) is given and the PEEP is increased to 15 cm H2O after the second LRM.

All patients get an opioid free general anesthesia with anti inflammatory agents and deep NMB with full reversal at end of surgery.

The moment and number of LRM performed after induction of anesthesia with the averaged reached lung compliance is used to compare both ventilation methods.

The oxygen saturation without oxygen at arrival of PACU and the need for oxygen when saturation drops below 95 % are compared between both groups.

Eligibility criteria: Inclusion Criteria:

* laparoscopic bariatric surgery requiring mechanical ventilation

Exclusion Criteria:

* lung disease requiring oxygen before anesthesia
* emergence procedure
* spontaneous or assisted ventilation

Primary outcomes:
measure: Number of lung recruitments required to keep dynamic lung compliance above 40.
timeFrame: during mechanical ventilation under general anesthesia between 1 and 3 hours. No outcome measurements are measured after 3 hours.
Secondary outcomes:
measure: Oxygen saturation at arrival of PACU without oxygen therapy.
timeFrame: during stay in PACU being between 1 and 4 hours post operative of the same day. No outcome measurements are measured after 4 hours.
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Azsintjan
Study officials:
affiliation: AZ Sint-Jan AV
name: Marc Lanckneus
role: STUDY_CHAIR
References:
Clinical trial NCT06373302: Peripheral Arterial Disease Biomarkers
Official title: Peripheral Arterial Disease Biomarkers: The Effect of Intervention on Biomarker Levels and Predictors of Restenosis or Deterioration
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Peripheral Arterial Disease
Keywords: Peripheral
Arterial
Disease
Claudication
Lead sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with peripheral arterial disease

Brief summary: The study aims to determine how expression levels of biomarkers for peripheral arterial disease change over time in response to exercise therapy, surgical or endovascular intervention, and whether they can be used to predict disease progression.

Detailed description: Several studies have identified markers in the blood (called biomarkers) that are associated with peripheral arterial disease, or clogging up of the blood supply to the leg. There is little understanding however regarding how these respond to intervention, and how they are related to walking distance.

This study will increase the understanding of the relationship between peripheral arterial disease state and biomarker expression and enable us to work towards the development of new targets for treatment.

Participants will be invited to undertake questionnaires and dedicated walking tests alongside regular blood tests to check their biomarker levels. These will be undertaken on a regular basis so the investigators can see what happens over time, such as after a surgical procedure, and see if these markers go back towards normal following intervention.

Eligibility criteria: Inclusion Criteria:

* Aged \> 50 years
* Symptomatic PAD
* ABPI \<0.8 or TBPI \<0.7

Exclusion Criteria:

* Aged \<50 years
* Current Malignancy
* Rheumatological Condition
* Previous surgical or endovascular intervention for PAD
* ABPI \>0.8 or TBPI \>0.7

Primary outcomes:
measure: Correlation between PAD biomarker levels and walking distance.
timeFrame: Baseline
measure: Change in PAD biomarker levels following exercise therapy.
timeFrame: 6 months up to 2 years
measure: Change in PAD biomarker levels following endovascular intervention
timeFrame: 48 hours
Secondary outcomes:
measure: To determine whether biomarker levels normalise with improved walking distance.
timeFrame: 2 years
measure: To determine whether biomarker levels can be used as a predictor of restenosis, occlusion or reintervention following endovascular intervention.
timeFrame: 2 years
measure: Levels of biomarkers and (Major Adverse Cardiovascular Events).
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01149902: Study of Chemo-Immunotherapy in Head and Neck Cancer Patients
Official title: Phase I Study of Chemo-Immunotherapy in Patients With Relapsed and Refractory Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Head and Neck Cancer
Lead sponsor: University of Yamanashi
Sponsor class: OTHER
First posted: 2010-06-24
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine safety and feasibility of Chemo-Immunotherapy using cyclophosphamide, docetaxel, OK-432, and autologous immature dendritic cells for patients with relapsed and refractory head and neck squamous cell carcinoma.


Eligibility criteria: Inclusion Criteria:

1. The patients with relapsed and refractory head and neck squamous cell carcinoma
2. 20 years and older
3. ECOG performance status 0-1
4. More than 4 weeks must have elapsed from the time of radiation therapy and the last dose of chemotherapy
5. Tumor lesions are accessible to intratumoral dendritic cells injection
6. Patients who are able to do oral ingestion
7. Patients must have normal organ and marrow functions as follows:

   * Hb\>9.0 mg/dl
   * Ht\>25%
   * WBC\>4000/mm3
   * Platelet count\>100,000/mm3
   * T-Bil\<1.5mg/dl
   * GOT\<x2.5 institutional upper limit of normal
   * GPT\<x2.5 institutional upper limit of normal
   * Creatinin\<1.5mg/dl
8. signed informed consent

Exclusion Criteria:

1. Less than 20 years
2. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.
3. Patients with clinically active infection
4. Patients with uncontrolled concurrent illness including cardiovascular disease, pulmonary disease, and bleeding tendency
5. Concomitant malignant diseases, brain metastases
6. Psychiatric illness
7. Treatment with steroids
8. Decision of unsuitableness by physician

Primary outcomes:
measure: The safety and feasibility of chemo-immunotherapy
timeFrame: 1 year
Secondary outcomes:
measure: The number and function of immune effector cells in treated patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Chuo
country: Japan
facility: Umiversity of Yamanashi Hospital
state: Yamanashi
Study officials:
References:
Clinical trial NCT03133702: Traumatic Characteristics of the Forensic Cases Admitted to Emergency Department and Errors in the Forensic Reports
Official title: Characteristics of the Traumatic Forensic Cases Admitted to Emergency Department and Errors in the Forensic Reports
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Trauma
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 4300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Traumatic forensic cases which applied to Emergency Department of Adıyaman University Tranining and Research Hospital, between January 01, 2014 and December 31, 2014.

Brief summary: Objectives: to detect the mistakes and deficiencies of the forensic reports which was written and to detect the injury characteristics of the forensic cases applied to emergency service of a tertiary hospital.

Detailed description: All patients who applied for reasons such as crushing, traffic accidents, firearms and explosive injuries, assault, all kinds of injuries, burns, electric shock, asphyxia, torture, child abuse, falls and other injuries, poisoning and suicide attempt are a forensic case.Traumatic forensic cases are often confronted in emergency departments, Aim to this study is to detect the mistakes and deficiencies of the forensic reports which was written and also aimed to detect the injury characteristics of the forensic cases applied to emergency department which is the most important center in region at a tertiary hospital.

Eligibility criteria: Inclusion Criteria:

* Traumatic forensic cases which written a forensic report were included in study.

Exclusion Criteria:

* The forensic cases which can not be reached the forensic report and patients' emergency department chart

Primary outcomes:
measure: Forensic cases admitted to Emergency department
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Adiyaman University Research Hospital
state: Central
Study officials:
affiliation: Adiyaman University of Medical Faculty
name: Umut Gulacti
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buchanan A, Norko M. The forensic evaluation and report: an agenda for research. J Am Acad Psychiatry Law. 2013;41(3):359-65.
Clinical trial NCT02942602: Effect of Lipid Modifying Drugs on HDL Function in Patients With Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 1) to test HDL function comprehensively in healthy and diseased individuals; 2) to evaluate if this test correlates with cardiovascular risk, independent of traditional risk factors; 3) and to differentiate effects of lipid-modifying or antiatherosclerotic drugs on HDL function and composition


Eligibility criteria: Inclusion Criteria:

* The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy
* Aged over 20
* Consent form signed

Exclusion Criteria:

* pregnant or lactating women
* subjects with familial hypercholesterolemia
* uncontrolled hypertension or DM
* Thyroid dysfunction
* Active liver disease (transaminase or bilirubin \> 1.5 x NL)
* Serum creatinine \> 2 mg/dL
* Included in other clinical trials within 3 months
* using of other medication: fish oil, fibric acid derivatives, niacin, systemic corticosteroid, thiazolidinedione

Primary outcomes:
measure: Cholesterol efflux capacity (%)
timeFrame: Change of HDL functions from baseline to 8 weeks
measure: Endothelial NO production (Arbitrary unit)
timeFrame: up to 8 weeks
measure: VCAM-1 expression (Arbitrary unit)
timeFrame: up to 8 weeks
measure: ROS generation (Arbitrary unit)
timeFrame: up to 8 weeks
Secondary outcomes:
measure: ApoA-I
timeFrame: Change of HDL associated proteins from each patient at baseline and at 8 weeks
measure: ApoA-II
timeFrame: Change of HDL associated proteins from each patient at baseline and at 8 weeks
measure: ApoC-I
timeFrame: Change of HDL associated proteins from each patient at baseline and at 8 weeks
measure: ApoC-II
timeFrame: Change of HDL associated proteins from each patient at baseline and at 8 weeks
measure: ApoC-III
timeFrame: Change of HDL associated proteins from each patient at baseline and at 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine,
Study officials:
References:
citation: Lee CJ, Choi S, Cheon DH, Kim KY, Cheon EJ, Ann SJ, Noh HM, Park S, Kang SM, Choi D, Lee JE, Lee SH. Effect of two lipid-lowering strategies on high-density lipoprotein function and some HDL-related proteins: a randomized clinical trial. Lipids Health Dis. 2017 Feb 28;16(1):49. doi: 10.1186/s12944-017-0433-6.
Clinical trial NCT05163002: Effectiveness of Nutrition Education in Carbohydrate Counting in People With Type 1 Diabetic
Official title: Effectiveness of Nutrition Education in Carbohydrate Counting, in a Group Context, on Glycemic Control in People With Type 1 Diabetic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Carbohydrates are the nutrient in the diet with the greatest impact on blood glucose. Inadequate carbohydrate counts are associated with higher A1c and greater variations in postprandial blood glucose. Clinical guidelines for the nutritional treatment of diabetes recommend that patients with DM1 learn carbohydrate counting or some similar systematic strategy that allows for better metabolic control. However, despite the recommendations, this is still not a reality for most healthcare services treating individuals diagnosed with DM1.

Detailed description: The study aims to assess the impact of a structured nutrition education programme for nutritional education and carbohydrate counting, in group sessions, on glycemic control and nutritional literacy in people with DM1. This will be achieved by evaluating the glycaemic control through A1c and daily glycaemic variability (time on target, mean glycaemia), as well as the level of knowledge before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* Adults aged ≥18 years old who have been diagnosed with type 1 diabetes or parents of children and adolescents (\< 18 years old) who have been diagnosed with type 1 diabetes;
* To be under intensive insulin therapy (basal/bolus system);
* To regularly use a continuous glucose monitoring system as primary method for glycaemic control;
* To be able to read and write.

Exclusion Criteria:

* None

Primary outcomes:
measure: Differences between baseline A1c (%) and 90 days after the last educational session.
timeFrame: 90 days
Secondary outcomes:
measure: Difference in the level of knowledge on nutrition and carbohydrate counting, assessed through a questionnaire collected at baseline and in the last educational session
timeFrame: 90 days
measure: Difference in time in range (%) between baseline and 90 days following the last educational session
timeFrame: 90 days
measure: Difference in the glucose coefficient of variation (%) between baseline and 90 days following the last educational session
timeFrame: 90 days
measure: Difference in mean glycaemia (mg /dL) between baseline and 90 days following the last educational session
timeFrame: 90 days
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Nova Medical School
Study officials:
References: