louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04455373: Long-term Outcome in Pediatric Surgical Bypass Grafting After Traumatic Injury and Tumor Resection
Official title: Long-term Outcome in Pediatric Surgical Bypass Grafting After Traumatic Injury and Tumor Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Health
Bypass Graft Occlusion
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 27
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study represents a retrospective cohort analysis of pediatric patients who underwent vascular bypass grafting by an experienced team of vascular surgeons at the Medical University Vienna between 2002-2017.

All data regarding demographics, operative techniques and outcome were collected from the in-hospital database registry in collaboration with the Department of Orthopedics and Trauma-Surgery. All patients ≤ 18 years who suffered a traumatic injury or vascular surgery due to a planned orthopedic extremity tumor resection were included in this study. 33 patients underwent vascular repair, a total of 15 patients fulfilling the criteria could be identified.

Brief summary: Introduction:

Vascular bypass surgery in children differs significantly from adults. It is a rarely performed procedure in the setting of trauma and tumor surgery to facilitate limb salvage. Beside the technical challenges to reconstruct the small and spastic vessels, bypass grafting should not impede growth of the extremity. The primary aim of this study was to assess long-term outcome after pediatric bypass grafting, in a single academic center, focusing on potential effects on limb development.

Methods:

In this retrospective cohort analyses we included all pediatric patients undergoing vascular bypass grafting at the Medical University of Vienna between 2002-2017. All patients ≤ 18 years suffered a traumatic injury or underwent a tumor resection of the lower or upper limb, respectively. The youngest female patient was 0.4 years, the youngest male patient was 3.5 years.


Eligibility criteria: Inclusion Criteria:

* age \<18 years
* planned vascular bypass grafting

Exclusion Criteria:

* age \>18 years
* no vascular intervention

Primary outcomes:
measure: bypass growth
timeFrame: 10 years
Secondary outcomes:
measure: autologous vs. PTFE graft
timeFrame: patency rate in 1 year
measure: revision surgery
timeFrame: <30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04161573: Irony Comprehension Ability of Chinese Speaking Patients With TBI
Official title: A Preliminary Study on Irony Comprehension Ability of Chinese Speaking Patients With Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Keywords: Irony comprehension
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NTUH

Brief summary: This study aims at understanding irony comprehension ability of Chinese speaking patients with TBI through a series of self-made stories. Each story contains two characters having a conversation, and one of them would give a figurative (which is, ironic) or literal statement at the end of the story. The participants are asked to figure out its meaning.

Detailed description: The investigator plans to recruit TBI patients and control group whose gender and age accord with them, 15 people in each group. They would be asked to read the materials mentioned above displaying by a computer. It may take 30 minutes per time, and every participants only do once.

Eligibility criteria: Inclusion Criteria:

* Above 20 years old
* Chinese speaking people
* Diagnosed as TBI patients for over 6 months
* Having no other neurological and mental related problems
* Able to read with or without assistive device like glasses

Exclusion Criteria:

* Addicted to alcohol or drug morbid and postmorbid
* Having any communication disorders

Primary outcomes:
measure: TBI group gets lower scores
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: Yu-Chun Chih, PhD
role: STUDY_CHAIR
References:
citation: Angeleri R, Bosco FM, Zettin M, Sacco K, Colle L, Bara BG. Communicative impairment in traumatic brain injury: a complete pragmatic assessment. Brain Lang. 2008 Dec;107(3):229-45. doi: 10.1016/j.bandl.2008.01.002. Epub 2008 Feb 11.
citation: Carlomagno S, Giannotti S, Vorano L, Marini A. Discourse information content in non-aphasic adults with brain injury: a pilot study. Brain Inj. 2011;25(10):1010-8. doi: 10.3109/02699052.2011.605097.
Clinical trial NCT01594073: Evaluation of Novel Biomarkers to Improve Risk Stratification and Patient Selection in Implantable Cardioverter-defibrillator (ICD) Therapy
Official title: Evaluation of Novel Biomarkers to Improve Risk Stratification and Patient Selection in ICD Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Arrhythmias
Cardiac Death
Keywords: implantable defibrillator
ventricular arrhythmias
cardiac death
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients reveicing or having received an implantable cardioverster-defibrillator in the Dept. of Cardiovascular Medicine of the Hanover Medical School.

Brief summary: Implantable cardioverter-defibrillator (ICD) therapy reduces mortality in patients with chronic heart failure and reduced left ventricular ejection fraction (LVEF) \<36%. Nevertheless, patient selection for ICD therapy based on LVEF and NYHA functional class alone seems to have a low specificity and sensitivity: In 100 patients treated, the SCD-HeFT study prevented 7 deaths in 5 years. Therefore 93 patients have a risk of adverse effects, such as operation risk, infection, pneumothorax, lead dislocation, and inadequate icd therapy. On the other hand, patients with advanced or end stage heart failure might rather die off progressive heart failure death and thus not benefit from ICD therapy.

It therefore seems appropriate and necessary to improve the individualized risk stratification in these patients. The aim of this study is to evaluate multiple cardiac biomarkers in a model predicting ventricular arrhythmias in patients on ICD therapy.

Detailed description: Patients having or getting an ICD in the Dept. of Cardiovascular Medicine of the Hannover Medical School will be recruited in the next 2 years. Blood samples of all patients will be obtained at inclusion and at 6 months follow-up. Patients will be followed-up for 1-2 years after inclusion.

Eligibility criteria: Inclusion Criteria:

* Patient meeting the current indications for primary or secondary prophylactic ICD/CRT-D therapy
* age 18 years or older

Exclusion Criteria:

* Patient unwilling to participate.

Primary outcomes:
measure: ICD therapy
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life
timeFrame: 2 years
measure: Depression scale
timeFrame: 2 years
measure: 6-Minute-walk-test
timeFrame: 6 months
measure: all-cause mortality
timeFrame: 2 years
measure: Heart Failure Events
timeFrame: 2 years
measure: Risc Scores for Heart Failure events/ICD therapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: David Duncker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01539473: A Phase 1 TR-701 FA Study of Blood Pressure Response Post Tyramine Challenge
Official title: A Phase 1, Blinded, Placebo-Controlled, Crossover TR-701 FA Study of Blood Pressure Response Post-Tyramine Challenge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered with tyramine

Detailed description: This is a Phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to determine the effect of 200 mg oral TR-701 FA on SBP response when administered with tyramine in healthy adult male and female volunteers.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects between 18 to 45 years of age, inclusive
* Body mass index between 19 kg/m2 and 31 kg/m2, inclusive
* Healthy subjects with no clinically significant abnormalities identified by a detailed medical history,

Exclusion Criteria:

* Systolic blood pressure \>130 mmHg or \<90 mmHg measured after 10 minutes in the supine position at Screening or at admission to the study center
* Heart rate \>90 bpm or \<45 bpm measured after 10 minutes in the supine position
* Electrocardiogram (ECG) finding of QTc interval \>500 msec, or other clinically significant ECG abnormality at the Screening Visit

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Trius Investigator Site 001
state: Indiana
Study officials:
affiliation: Trius Therapeutics
name: Philippe G Prokocimer, MD
role: STUDY_CHAIR
References:
citation: Flanagan S, Bartizal K, Minassian SL, Fang E, Prokocimer P. In vitro, in vivo, and clinical studies of tedizolid to assess the potential for peripheral or central monoamine oxidase interactions. Antimicrob Agents Chemother. 2013 Jul;57(7):3060-6. doi: 10.1128/AAC.00431-13. Epub 2013 Apr 22.
Clinical trial NCT05239273: Effects of Complex Decongestive Therapy Applied on Patients With Lower Extremity Lymphedema
Official title: Investigation of the Effects of Complex Decongestive Therapy Applied on Patients With Lower Extremity Lymphedema on Body Awareness, Functionality and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphedema
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of complex decongestive therapy applied to patients with lymphedema in the lower extremities on body awareness, functionality and quality of life.

Detailed description: Lymphedema is a chronic condition characterized by the permanent accumulation of protein-rich fluid in certain body regions as a result of the dysfunction of the lymphatic system, in which skin and subcutaneous changes are added to the picture. Pain in the affected extremity and other accompanying lymphedema symptoms can negatively affect functionality and quality of life, and swelling in the extremity can negatively affect the body image of individuals. Today, Complex Decongestive Therapy (CDT) is accepted as the gold standard in the treatment of lymphedema. It has been shown in the literature that CDT has positive effects on parameters such as functionality, quality of life, and balance in patients with upper limb lymphedema. There are few studies investigating the effects of CDT on body awareness, functionality and quality of life in patients who developed lymphedema in the lower extremities.

Eligibility criteria: Inclusion Criteria:

* Be between the ages of 18-65
* Having unilateral lymphedema in the lower extremity
* Volunteer to participate in the study

Exclusion Criteria:

* Having bilateral lower extremity lymphedema
* Having an active infection
* Having a mental cognitive disorder
* Being unable to communicate and cooperate
* Conditions where manual lymphatic drainage is contraindicated (such as severe heart failure and/or uncontrolled rhythm disturbance, uncontrollable hypertension, being pregnant, presence of thrombus, active infection ect.)
* Presence of metastases

Primary outcomes:
measure: Body Awareness
timeFrame: change from baseline at 3 weeks
Secondary outcomes:
measure: Lower Extremity Functionality
timeFrame: change from baseline at 3 weeks
measure: Life quality
timeFrame: change from baseline at 3 weeks
measure: Edema evaluation
timeFrame: change from baseline at 3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05661773: Digital Ischemia Reduction in Critically Ill Patients
Official title: Assessing the Effect of Vacuum Suction on Digital Ischemia in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypovolemic Shock
Cardiogenic Shock
Digital Ischemia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patient will act as their own control. By applying the vacuum assisted warmer to one hand, results can be compared to the contralateral hand. In this way, patient outcomes can be assessed between patients and indexed to each patient.
Primary purpose: PREVENTION

Brief summary: Patients requiring high dose pressors (minimum 2) who are unlikely to be weaned off them over 1 day will be identified. Patients will have the device applied to one hand while expectant medical management will continue to the contralateral hand.

Detailed description: The proposed study offers no foreseeable risk to patients. The device relies on a wound vac system for vacuum generation which is industry standard and approved for creating safe suction applied to wounds. In this application, the same suction and device would be used to apply suction to an enclosure through which the hand is placed. Similarly, a heat exchanger would be used to run lukewarm water through a warming bad, which is technology that is routinely used in surgery. Heater coolers are used in every bypass surgery, and warming fluid blankets are common for helping to rewarm patients on the operating room table.

Eligibility criteria: Inclusion Criteria:

* Patients in the cardiac critical care unit/cardiovascular intensive care unit with cardiac pathologies on vasopressor support

Exclusion Criteria:

* Patients who are not on vasopressor support
* Patients under the age of 18

Primary outcomes:
measure: Incidence of digital ischemia
timeFrame: Day 14
Secondary outcomes:
measure: extent of digital ischemia - number of digits involved
timeFrame: Day 14
measure: extent of digital ischemia - length of digits involved
timeFrame: Day 14
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Bartlomiej Imielski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03637673: The Possible Role of Thyroxine in Keratoconus Development
Official title: The Possible Role of Thyroxine in Keratoconus Development
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Keratoconus
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will enroll all patients who meet the inclusion criteria and signed a written informed consent form.

Brief summary: Keratoconus (KC) is a corneal ectatic disorders, with incidence rate 1 per 50,000 among the population. Hormonal imbalances may be associated with KC as it affects the corneal metabolism. In this study, we aim to examine this clinical association between thyroid gland dysfunction (TGD) and KC.

Detailed description: Keratoconus (KC) is a corneal ectatic disorders, with incidence rate 1 per 50,000 among the population. Moreover, the pathophysiological processes underlying KC have not been fully elucidated with proposed mechanisms to include proteolytic degradation in the corneal stroma, oxidative damage, epithelial mechanical injury, immunological factors, and genetic factors. However, Hormonal imbalances may be associated with KC as it affects the corneal metabolism. Furthermore, thyroid gland dysfunction (TGD) can frequently associated with eye diseases such as Graves disease. Previous studies investigated the association between TGD and KC. Interestingly, thyroxine (T4) is important for corneal dehydration and transparency during embryonic development and regulates the synthesis of keratin sulfate proteoglycan in the chicken. T4 receptors (T4Rs) have been found in the lacrimal gland, confirming that the tear producing gland is a target organ of T4. T4 level was elevated in the tears of patients with KC. Hence, in this study, we aim to investigate the clinical association between TGD and KC.

Eligibility criteria: Inclusion Criteria:

* Patients with KC.

Exclusion Criteria:

* Patients who cannot give an informed consent.
* Patients who cannot provide needed samples for any reason

Primary outcomes:
measure: measuring the serum concentrations of free T4 (fT4) and thyroid-stimulating hormone (TSH)
timeFrame: We will recruit patients who meet the inclusion criteria during the study period of 3 months (June- August 2018). We will take only one blood sample from each patient recruited after the recrutiement and during this period
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Medicine
Study officials:
References:
Clinical trial NCT05868473: Effectiveness Of MM & Kinesotaping In The Female Patients Of KO To Improve Pain & Functional Mobility RCT
Official title: Effectiveness Of Mobilization With Movement And Kinesotaping In The Female Patients Of Knee Osteoarthritis To Improve Pain And Functional Mobility: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 56
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: to find out the Effectiveness Of Mobilization With Movement And Kinesotaping In The Female Patients Of Knee Osteoarthritis To Improve Pain And Functional Mobility


Eligibility criteria: Inclusion Criteria:

* · Female patients of age ranging from age above 50 years suffering from knee Osteoarthritis will be included

Exclusion Criteria:

* · Patients suffering from any type of Cancer effecting area at which treatment will be applied.

  * Patients having joint replacement or knee disease effecting the performance.
  * Having skin allergies to taping.

Primary outcomes:
measure: KOOS
timeFrame: 6 Months
measure: Li Scale
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudary Muhammad Akram Teaching Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT02465073: The Clinical Efficacy of Next Science Wound Gel (NXTSC) in the Healing of Chronic Wounds
Official title: The Clinical Efficacy of Next Science Wound Gel (NXTSC) in the Healing of Chronic Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Infection
Lead sponsor: Southwest Regional Wound Care Center
Sponsor class: OTHER
Collaborators: name: Next Science TM
First posted: 2015-06-08
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel (NXTSC) for the treatment of infected wounds as the sole topical treatment of microbial infection at the wound site.

Detailed description: 1. Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel (NXTSC) for the treatment of infected wounds as the sole topical treatment of microbial infection at the wound site.
2. Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel for the treatment of infected wounds when this gel is used in conjunction with the current standard of care infection controls to treat microbial infection at the wound site.
3. Determine the effect on wound treatment outcomes using standard of care treatment. (SOC).

Eligibility criteria: Inclusion Criteria:

1. The subject must have a full-thickness chronic wound for greater than one month.
2. The subject must be at least 18 years of age.
3. The ulcer to be biopsied must be greater than 1 centimeter in area.
4. The subject must be able to give informed consent.

Exclusion Criteria:

1. Medical or emotional risk associated with the potential biopsy that outweighs the risk of not taking a biopsy as determined by the investigator.
2. Those patients that have significant contributions from other disease processes such as arterial disease (Ankle Brachial Index \[ABI\] less than .7, OR Transcutaneous Partial Oxygen Pressure \[TCpO2 \] less than 20) will be considered to have mixed vascular disease producing their wound and will be excluded from the study.

Primary outcomes:
measure: The Percentage of Patients Who Had a 50% or Greater Wound Size Volume Reduction After 4 Weeks of Treatment With the Next Science Wound Gel, as Compared to Wounds Treated With Standard of Care
timeFrame: Percentage after 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Southwest Regional Wound Care Center
state: Texas
Study officials:
affiliation: Southwest Regional Wound Care Center
name: Randall D Wolcott, M.D.
role: PRINCIPAL_INVESTIGATOR
References: