louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03606109: Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid
Official title: Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tibial Tubercle Osteotomy
Keywords: Tibial Tubercle Osteotomy
Tranexamic Acid
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing high tibial osteotomy (HTO) and tibial tubercle osteotomy (TTO) to minimize hemarthrosis within the knee joint and post operative pain and swelling.

Detailed description: Not Provided

Eligibility criteria: Inclusion Criteria:

* Patients undergoing TTO
* Age 18-60
* Willing and able to provide consent

Exclusion Criteria:

* Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
* Younger than 18 years of age
* Older than 60 years of age
* Any patient considered a vulnerable subject
* Have bleeding or clotting disorder
* Preoperative anticoagulation therapy
* Abnormal coagulation profile
* Renal disorder or insufficiency
* Sickle cell disease

Primary outcomes:
measure: Perioperative Blood Loss
timeFrame: Perioperative, up to 2 hours
Secondary outcomes:
measure: Score on Visual Analogue Scale (VAS) for Pain
timeFrame: Day 1
measure: Score on Visual Analogue Scale (VAS) for Pain
timeFrame: Day 4
measure: Score on Visual Analogue Scale (VAS) for Pain
timeFrame: Day 7
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Michael Alaia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06181409: Diagnosing and Monitoring Portal Hypertension Non-invasively Using Spleen Stiffness Measurement in Patients With Advanced Chronic Liver Disease: a Prospective Cohort Study
Official title: Diagnosing and Monitoring Portal Hypertension Non-invasively Using Spleen Stiffness Measurement in Patients With Advanced Chronic Liver Disease: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Advanced Chronic Liver Disease
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 200
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: Adults with advanced chronic liver disease (defined as LSM ≥ 10kPa)

Brief summary: The goal of this observational study is to assess non-invasive tools' efficacy in predicting portal hypertension-related complications in individuals with advanced chronic liver disease. The main question it aims to answer are:

- what are the cut-off values for non-invasive tests (NITs) (including LSM, SSM) that predict the presence and occurrence of hepatic decompensation in individuals with advanced chronic liver disease?

Participants will undergo regular study visits involving non-invasive tests (LSM, SSM) and assessments to monitor hepatic decompensation over the study period.


Eligibility criteria: Inclusion Criteria:

* Age above 18years old
* Advanced chronic liver disease (defined as LSM ≥ 10kPa)
* Ability to provide informed consent

Exclusion Criteria:

* Transjugular intrahepatic portosystemic shunt
* previous liver transplantation
* Abnormality of the porto-mesenteric system (portal vein thrombosis, splenic vein thrombosis, splenectomy, portal cavernomatous transformation, porto-caval shunts)
* Hematological malignancy

Primary outcomes:
measure: Number of patients diagnosed with portal hypertension using elastography techniques
timeFrame: At baseline
Secondary outcomes:
measure: Identifying patients at high-risk of liver related events using elastography techniques
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00946309: Effects of Sulforaphane on Normal Prostate Tissue
Official title: In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: VA Puget Sound Health Care System
name: Seattle Institute for Biomedical and Clinical Research
name: Johns Hopkins University
name: University of Washington
name: Cedars-Sinai Medical Center
First posted: 2009-07-27
Enrollment: 45
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators proposed to identify the biological effects of a high-sulforaphane broccoli sprout extract in normal prostate tissue.

The investigators hypothesize that consumption of high-sulforaphane broccoli sprout extract every other day will inhibit growth of prostate cancer cells.


Eligibility criteria: Inclusion Criteria:

* Men aged 40-75 years
* Low or intermediate grade prostate cancer (as defined by Gleason sum less than or equal to 7) and clinical stage T1 or T2
* Serum Prostate specific antigen less than 20 ng/ml
* Have elected radical prostatectomy, Brachytherapy or active surveillance as their primary treatment

Exclusion Criteria:

* No current physician diagnosed disease (including but not limited to): kidney disease requiring dialysis, cognitive deficits, substance abuse
* BMI \< 18.5 kg/m2 or \> 40 kg/m2
* Use of any hormonal treatments, including but not limited to testosterone
* Any previous cancer diagnosis or treatment within the previous five years, excluding non-melanoma skin cancer
* Inability or unwillingness to eat a diet that is free of Brassica vegetables for the duration of the study
* Use of any dietary supplements other than a multivitamin (including herbal preparations)
* Allergy to cruciferous vegetables or any of the specific fillers used in the placebo
* Usual consumption of \> 5 servings per week of Brassica vegetables

Primary outcomes:
measure: Gene Expression of Phase II Enzymes
timeFrame: Baseline and 5 weeks
measure: Lipid Oxidation
timeFrame: Baseline and 5 weeks
measure: DNA Oxidation
timeFrame: Five weeks
measure: DHT Levels
timeFrame: Baseline and 5 weeks
measure: Testosterone Levels
timeFrame: Baseline and 5 weeks
measure: 3-alpha-diol Gluconate Levels
timeFrame: Baseline and 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Daniel W Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05112809: Noninvasive Cochlear Stimulation System
Official title: Noninvasive Cochlear Stimulation System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Normal hearing
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 98
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to develop a portable wearable hardware headset using a computer-based software that can establish the optimal stimulation parameters appropriate for medical and consumer environments for individuals with hearing impaired and normal hearing individuals.


Eligibility criteria: Inclusion Criteria:

- Employee of Mayo Clinic.

Exclusion Criteria:

* Pregnant.
* Cochlear implants.
* History of fluctuating sensorineural hearing loss.
* Skin diseases of the head.
* History of acute paroxysmal tachycardia.
* History of trigeminal neuralgia.
* Recent of paralysis of the facial nerve.
* Recent cerebrovascular stroke.

Primary outcomes:
measure: Perception threshold
timeFrame: Baseline, approximately 2 hours
measure: Speech Intelligibility
timeFrame: Baseline, approximately 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Michael J Cevette, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01533909: Development of a Screening Tool to Detect and Stage Cachectic Cancer Patients
Official title: Development of a Screening Tool to Detect and Stage Cachectic Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cachexia
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population from which the groups or cohorts will be selected (e.g., primary care clinic, community sample, residents of a certain town). (Limit: 1000 characters)

Brief summary: The aim of the study is to develop a screenings tool that will enable hospital nurses to detect and stage cancer cachectic patients. The early detection and staging of cancer cachexia will assist the oncology team in providing the cachectic cancer patient tailor-made patient care.

Detailed description: In this cross-sectional study, the participants will complete 4 times a set of questionnaires and measurements. The data that will be collected is:

age; sex; height; weight; type of tumour; classification of malignant tumours (TNM); progression of tumour and used therapy; blood sample to analyse albumin, creatine, hemoglobin, LDH and CRP; use of parental nutrition; dietary assessment; use of nutritional supplements; Quality of Life by using the EORTC-QlQ; Subjective Global Assessment; presence of Percutaneous endoscopic gastrostomy; use of enteral or parenteral nutrition; body composition based on a Bio Impedance Assessment; hand grip strength and mid upper arm circumference. Based on all these data points a easy to use tool/score for a hospital setting will be created. During the first assessment the measurements will be done in the morning and the evening to test the reproducibility.

Eligibility criteria: Inclusion Criteria:

* New Diagnosed Patients With Primary Head and Neck Cancer Neoplasms
* New Diagnosed Patients With Metastatic Pancreatic Neoplasms
* New Diagnosed Patients With Metastatic Colonic Neoplasms

Exclusion Criteria:

* Patients With Other Primary Neoplasms
* Patients Already in Therapy
* Patients With Non-metastatic Colonic or Pancreatic Neoplasms

Primary outcomes:
measure: Nutritional Assessment
timeFrame: 4 times in 6 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 4 times in 6 months
measure: Anthropometric measurements
timeFrame: 4 times in 6 months
measure: Markers of inflammation/metabolic disturbance
timeFrame: 4 times in 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
state: Vlaams Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Ignace Vergote, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01877109: Samsung Medical Center-Lymphoma Cohort Study-II
Official title: Prospective Observation Cohort Study of Malignant Lymphoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: Lymphoma
Prognosis
Biomarker
Quality of life
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 1358
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly visited lymphoma patients at the Samsung Medical Center

Brief summary: The purpose of this study is to establish a model which can predict the treatment outcome and the risk of treatment-related morbidity in patients with lymphoma.

Detailed description: Although the cure rate of lymphoma has been increased due to the development of newer effective drugs, a substantial portion of patients is still suffered from relapse. Furthermore, the treatment-related morbidity is another factor which can make the treatment outcome worse in patients with lymphoma, especially elderly patients. Thus, this study is going to assess factors which may affect the treatment outcome and the risk of treatment-related morbidity.

1.Biologic factors associated with the aggressiveness of lymphoma

* molecular markers in serum, cytogenetic markers 2.Factors associated with the risk of treatment-related morbidity
* comorbidity, nutrition status, performance status, quality of life at diagnosis

Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed as lymphoma
* Over 19 years old
* Patients who agreed the enrollment of study
* Informed consent for sampling

Exclusion Criteria:

•Patients who do not want to join the study

Primary outcomes:
measure: All cause mortality
timeFrame: 5 years
Secondary outcomes:
measure: Treatment response
timeFrame: 1 year
measure: Rate of occurrence of toxicity
timeFrame: 2 years from the start of the 1st therapy
measure: Quality of life
timeFrame: 5 years
measure: Biomarker development
timeFrame: 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Cho I, Lee H, Yoon SE, Ryu KJ, Ko YH, Kim WS, Kim SJ. Serum levels of soluble programmed death-ligand 1 (sPD-L1) in patients with primary central nervous system diffuse large B-cell lymphoma. BMC Cancer. 2020 Feb 13;20(1):120. doi: 10.1186/s12885-020-6612-2.
citation: Kim SJ, Hong M, Do IG, Lee SH, Ryu KJ, Yoo HY, Hong JY, Ko YH, Kim WS. Serum survivin and vascular endothelial growth factor in extranodal NK/T-cell lymphoma, nasal type: implications for a potential new prognostic indicator. Haematologica. 2015 Mar;100(3):e106-9. doi: 10.3324/haematol.2014.116087. Epub 2014 Dec 5. No abstract available.
Clinical trial NCT03517709: Feasibility of Home Telehealth Monitoring for Improvement in Management of Hypertension for Secondary Stroke Prevention
Official title: Feasibility of Home Telehealth Monitoring for Improvement in Management of Hypertension for Secondary Stroke Prevention
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Hypertension
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is being done to determine how home blood pressure monitoring, using a commercially available blood pressure monitor with the capability of transmitting readings to stroke doctors can help manage blood pressure in the optimal range after a stroke. High blood pressure is the leading risk factor for stroke. It is important to control high blood pressure after a stroke to prevent another one from happening. We will use the Withings Smart Blood Pressure Monitor for daily blood pressure measurements.

Tracking of blood pressure measurements will be done via iPod Touch equipped with internet connectivity. We hope to learn if this method of managing blood pressure is more effective than the standard way of having patients visit primary care physicians (the control group for this study). We will also get feedback from participants who will receive the Withings Smart Blood Pressure Monitor about the ease of use and overall satisfaction with this blood pressure device. People 18-100 years old who have had a stroke in the past 6 months may join. You will be excluded from the study if you are pregnant or plan on becoming pregnant in the near future.


Eligibility criteria: Inclusion Criteria:

* People 18-100 years old who have had a stroke in the past 6 months may join.

Exclusion Criteria:

* You will be excluded from the study if you are pregnant or plan on becoming pregnant in the near future.

Primary outcomes:
measure: Blood pressure
timeFrame: 3 months
measure: Stroke in 90 days
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
References:
Clinical trial NCT04405609: Usability Study of "ArmAssist 2.0." Robot: Homecare Arm Rehabilitation in Stroke Patients
Official title: Usability Study of "ArmAssist 2.0." Robot: Homecare Arm Rehabilitation in Acute, Subacute and Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Rehabilitation
Upper Limb Rehabilitation
Telerehabilitation
Robot-assisted Therapy
Keywords: Stroke
Cerebrovascular Disorders
Robotic
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: TECNALIA Research & Innovation
name: GMV Innovating Solutions
First posted: 2020-05-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to validate the usability of ArmAssist medical device, a robotic system for the rehabilitation of upper limbs in stroke patients (based on serious games). This study evaluate the usability of the system in a home environment, taking into account the ease-to-use, consistency and others; and will pretend demonstrate the feasibility of including or no, robotic therapy in home like complement of daily rehabilitation program. Finally this study investigate the acceptance from patients and therapists.


Eligibility criteria: Inclusion Criteria:

* Subjects over 18,
* Upper limb hemiparesis after stroke,
* Unilateral paresis and cognitive ability to understand,
* Accept and actively participate in the usability study.

Exclusion Criteria:

* Bilateral motor deficit,
* Severe spasticity,
* Psychiatric illness,
* and/or cognitive impairment.

Primary outcomes:
measure: Quebec User Evaluation of Satisfaction with assistive Technology: QUEST scale
timeFrame: Through study completion, an average of 3 weeks
measure: System Usability Scale: SUS
timeFrame: Through study completion, an average of 3 weeks
measure: Intrinsic Motivation Inventory: IMI
timeFrame: Through study completion, an average of 3 weeks
measure: Usability questionnaire specifically designed for the use of ArmAssist 2.0
timeFrame: Through study completion, an average of 3 weeks
measure: Structured interviews: Willingness-to-pay questionnaire
timeFrame: Through study completion, an average of 3 weeks
Secondary outcomes:
measure: Fugl-Meyer Assessment (FMA) scale
timeFrame: Baseline, 3 weeks
measure: Modified Asworth Scale (MAS)
timeFrame: Baseline, 3 weeks
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía de Córdoba
Study officials:
affiliation: Hospital Universitario Reina Sofia de Córdoba
name: Fernando Jesus Mayordomo Riera, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guillen-Climent S, Garzo A, Munoz-Alcaraz MN, Casado-Adam P, Arcas-Ruiz-Ruano J, Mejias-Ruiz M, Mayordomo-Riera FJ. A usability study in patients with stroke using MERLIN, a robotic system based on serious games for upper limb rehabilitation in the home setting. J Neuroeng Rehabil. 2021 Feb 23;18(1):41. doi: 10.1186/s12984-021-00837-z.
Clinical trial NCT05541809: Peppermint Aroma and Physiological Parameters
Official title: Effect of Peppermint Aroma on Physiological Parameters of Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Three drops of peppermint oil will be dropped on a cotton ball that will be fixed in the patient's collar. In the placebo group, peppermint oil will be replaced with water.

Detailed description: Mechanical ventilathetion increases the anxiety of critically ill patients. The physiological parameters of those patients are affected by stress. Peppermint inhalation reduces stress and improves physiological parameters in many studies, but none of these studies used peppermint inhalation on mechanically ventilated patients.

Patients who are conscious on mechanical ventilation via endotracheal via tube will be randomly assigned to two groups. Patients will be kept intubated and mechanically ventilated. Nothing will be changed in patients' mechanical ventilation data. The intervention group will receive peppermint inhalation intervention, and the placebo group received water inhalation intervention. Patients in both groups will be assessed for their smell ability by Sniffin Sticks-test before starting the interventions.

Three drops of undiluted peppermint oil will be dropped on a cotton ball. Then it will be placed about 20 cm from the patient's nose. It will be fixed on the patient's collar. In the placebo group, the cotton ball will be soaked in water. Then, patients will be monitored for one hour.

Eligibility criteria: Inclusion Criteria: Patients with

* (1) endotracheal tube (ETT)
* (2) mechanical ventilation with spontaneous breathing modes which are CPAP, PIPAP and PSV
* (3) FOUR score equal to or more than 13,
* (4) RASS score from -1 to +4.

Exclusion Criteria: Patients with

* (1) respiratory asthma
* (2) chronic obstructive pulmonary disease
* (3) acute respiratory distress syndrome,
* Sniffin' Sticks-test score of smell less than 17

Primary outcomes:
measure: Heart rate
timeFrame: Change from baseline heart rate at one hour.
measure: Respiratory rate
timeFrame: Change from baseline respiratory rate at one hour.
measure: Mean blood pressure
timeFrame: Change from baseline mean blood pressure at one hour.
measure: Pain score
timeFrame: Change from baseline pain score at one hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University, Faculty of nursing
Study officials:
References: