louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06073145: Transcranial Doppler Using Wearable Ultrasound Patch
Official title: Non-invasive Monitoring of Blood Flow in the Brain by Using a Wearable Ultrasound Patch
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Device Complication
Brain Injuries
Brain Diseases
Stroke
Vasospasm
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants without any serious medical conditions.

Brief summary: The main objective of this research is to measure the Doppler signal by the ultrasonic patch. Blood flow measurement is critical for vasospasm, stroke, and embolism monitoring on patients in the ICU or understanding the neurovascular coupling on different subjects. Currently, A conventional transcranial Doppler (TCD) probe is widely used for these applications. A headset design must be applied and fixed on the participants to obtain stable blood flow spectra. However, the TCD headset is operator dependent. The operator needs to be a trained expert and hold the ultrasound probe to get accurate blood flow velocity information. The stretchable and wearable non-invasive ultrasonic patch can not only free the operator's hands but can also provide long-term continuous monitoring, which is not possible by using the current operator-dependent ultrasound machine. The device can be conformal to the skin and attached to the skin surface.


Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent.
* In relatively good health with no serious medical conditions.

Exclusion Criteria:

* Inability to sign the informed consent.
* History of the following conditions: Heart attack, low blood pressure, aortic stenosis/carotid artery stenosis (also known as heart valve disease), glaucoma (a group of eye conditions that damage the optic nerve) or retinopathy (a disease of the eye retina).

Primary outcomes:
measure: Device comparison to standard monitoring (conventional transcranial Doppler)
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Structural and Materials Engineering (SME) building Room 310
state: California
Study officials:
affiliation: University of California, San Diego
name: Sheng Xu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01664845: Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance
Official title: Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Chronic Hepatitis c
Insulin Resistance
Keywords: hepatitis c
metformin
pegylated interferon
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2012-08-14
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic hepatitis C virus (HCV).

Detailed description: Current standard of treatment for HCV with pegylated interferon(Peg-IFN)-alpha and ribavirin can achieve sustained virological response (SVR) in only 60-90% of patients. Insulin resistance is an important factor of non-response to combination therapy. Metformin is a insulin sensitizer and can effectively reduce insulin resistance. The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic HCV.

Eligibility criteria: Inclusion Criteria:

* HCV RNA (+) and ALT \> 40 U/L
* Compensated liver
* HOMA-IR \> 2

Exclusion Criteria:

* neutrophil \<1500/mm3
* male: Hb \< 13 g/dl, female: Hb \< 12 g/dl
* platelet \< 80,000 /mm3
* Cr \> 2.5 mg/dl
* Alcohol use \> 20 gm per day
* uncontrolled depression, thyroid disease, autoimmune disease
* Pregnancy
* Hepatocellular carcinoma
* allergy to interferon or ribavirin
* Diabetes
* HBV/HIV co-infection

Primary outcomes:
measure: sustained virological response
timeFrame: 24 weeks after treatment is stopped
Secondary outcomes:
measure: change of HOMA-IR
timeFrame: Serial change of HOMA-IR at baseline, 4 weeks and 12 weeks after treatment
Other outcomes:
measure: RVR
timeFrame: HCV RNA At 4 weeks
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Department of Gastroenterology, Kaohsoung Veterans General Hospital
name: Wei-Lun Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02911545: Non-vitamin K Oral Anticoagulants in Cardioversion
Official title: Non-vitamin K Oral Anticoagulants in Cardioversion of Atrial Fibrillation. FinCV3
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Anticoagulation
Cardioversion
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Turku
First posted: 2016-09-22
Enrollment: 1000
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: AF patients undergoing cardioversion.

Brief summary: Non-vitamin K oral anticoagulants (NOAC) have been shown to be safe and effective alternatives to warfarin for stroke prevention in patients with nonvalvular AF (NVAF). There are yet limited real life data on outcomes following elective cardioversion in AF patients treated with NOACs. The aim of this study is to investigate the complications and the use of NOACs in AF patients undergoing cardioversion.


Eligibility criteria: Inclusion Criteria:

* AF patients undergoing cardioversion

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence and predictors of thromboembolic complications
timeFrame: 31 days after cardioversion of persistent AF
measure: Incidence and predictors of bleeding
timeFrame: 31 days after cardioversion of persistent AF
Secondary outcomes:
measure: Number of recurrence of AF
timeFrame: 31 days after cardioversion of persistent AF
measure: Hemodynamic complications of cardioversion
timeFrame: 31 days after cardioversion of persistent AF
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Mika Lehto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05778045: Examination of Trends in Non-Small Cell Lung Cancer Patients' Medical Study Experiences
Official title: Investigating Patients' Medical Study Experiences in Non-Small Cell Lung Cancer Clinical Trials to Identify Influencing Trends
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-Small Cell Lung Cancer
Keywords: non-small cell lung cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non-small cell lung cancer patients who are actively considering involvement in an observational clinical trial, but have not yet completed enrollment and registration.

Brief summary: Medical study participation percentages haven't always been fully representative of a given demographic.

The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through.

Participating in an observational clinical trial may help patients with non-small cell lung cancer since it advances medical knowledge and may improve treatment choices in the future.


Eligibility criteria: Inclusion Criteria:

* Participant has a diagnosis of non-small cell lung cancer
* Patient has self-identified as planning to enroll in a clinical trial for non-small cell lung cancer
* Patient is at least 18 years of age

Exclusion Criteria:

* Inability to perform regular electronic reporting
* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
* Pregnant or lactating woman

Primary outcomes:
measure: Rate of patients who decide to enroll in a non-small cell lung cancer clinical study.
timeFrame: 3 months
measure: Number of non-small cell lung cancer patients who remain in clinical trial until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Kayser G. [Non-small cell lung cancer. New biomarkers for diagnostics and therapy]. Pathologe. 2015 Nov;36 Suppl 2:189-93. doi: 10.1007/s00292-015-0084-1. German.
citation: Dufraing K, Van Casteren K, Breyne J, D'Haene N, Van Campenhout C, Vander Borght S, Zwaenepoel K, Rouleau E, Schuuring E, von der Thusen J, Dequeker E. Molecular pathology testing for non-small cell lung cancer: an observational study of elements currently present in request forms and result reports and the opinion of different stakeholders. BMC Cancer. 2022 Jul 6;22(1):736. doi: 10.1186/s12885-022-09798-5.
citation: Simeone JC, Nordstrom BL, Patel K, Klein AB. Treatment patterns and overall survival in metastatic non-small-cell lung cancer in a real-world, US setting. Future Oncol. 2019 Oct;15(30):3491-3502. doi: 10.2217/fon-2019-0348. Epub 2019 Sep 9.
Clinical trial NCT01917045: Different Lipid Soluble Opioids for Gynecologic Laparoscopic Surgery Postoperative Patient-controlled Analgesia
Official title: Different Lipid Soluble Opioids for Gynecologic Laparoscopic Surgery Postoperative Patient-controlled Analgesia --- a Double Blind Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain Management
Keywords: sufentanil
morphine
postoperative pain control
body fat percentage
gynecology laparoscopic surgery
lipid solubility
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators noticed that Body Fat Ratio might have great influence on the efficacy of different lipid soluble anesthetics. The objective of this clinical trial was to compare the effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics.

Detailed description: The objective of this clinical trial was to compare the effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists grade I-II
* adults aged over 20 and below 50 years old,
* non-smoker,
* with normal hepatic and renal function.

Exclusion Criteria:

* smoker ,
* any kind of mental disorder or
* history use of analgesics for more than 10 consecutive days,
* asthma; and
* those with digestion tract disorder who would get nausea or vomiting much more easily than normal people.

Primary outcomes:
measure: visual analogue pain scores
timeFrame: 24hour
Secondary outcomes:
measure: nausea & vomiting
timeFrame: 24hour
Other outcomes:
Locations:
Study officials:
affiliation: PKU 1st hospital
name: zhou yan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03570645: Comparison of the Duration of Ropivacaine Combined With Dexmedetomidine or Dexamethasone on Paravertebral Block
Official title: Comparison of the Duration of Ropivacaine Combined With Dexmedetomidine or Dexamethasone on Paravertebral Block in Patients Undergoing Video-assisted Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Cancer
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine or dexamethasone
Primary purpose: TREATMENT

Brief summary: This study was a prospective, randomized, controlled, and double-blind trial. Major assessments were made during the operation and 48 h postoperatively.

Detailed description: The prime outcomes were the time in minutes from leave the postoperative care unit to the first patient-controlled intravenous analgesia press.The secondary outcomes were to compare the following: (1)blood concentrations of ropivacaine was measured at 0.5 h, 1 h, 2 h, 3 h, and 24 h after paravertebral nerve block; and (2) the patient's intraoperative opioid use, phenylephrine use, fluid intake, urine output, dry mouth score, and 24 h and 48 h visual analogue scale.

Eligibility criteria: Inclusion Criteria:

* (1) age 18 to 65 years,
* (2) scheduled to undergo video-assisted thoracic surgery,
* (3) American Society of Anesthesiologists risk classification I-II.

Exclusion Criteria:

* (1) patient refusal;
* (2) known hypersensitivity to the study medication (ropivacaine);
* (3) long-term use of opioids;
* (4) liver or renal insufficiency;
* (5) a history of psychiatric or neurological disease;
* (6) deafness;
* (7) regular use of acetaminophen, nonsteroidal anti-inflammatory drugs, corticosteroids, or antiemetics; and
* (8) a preoperative Pittsburgh Sleep Quality Index (PSQI) global score higher than 6.

Primary outcomes:
measure: Change of thoracic paravertebral block analgesia duration
timeFrame: Change from Baseline to 2 days after surgery
Secondary outcomes:
measure: blood concentrations of ropivacaine
timeFrame: Change from Baseline to 2 days after surgery
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Anesthesiology, the First Hospital of China Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT05601245: High Voltage Pulsed Current and Microcurrent Stimulation Therapy in Treatment of Wounds.
Official title: High Voltage Pulsed Current Versus Microcurrent Stimulation Therapy in the Treatment of Chronic Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound
Ulcer
Keywords: High-voltage pulsed current
Micro-current therapy
Chronic wound
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sixty patients (male and female) with chronic wounds (pressure ulcers) does not heal within six weeks were involved in the study.

The diagnosis will be made clinically by the physician. The patients will be randomly assigned into two equal groups in number, two study groups (one for high-voltage pulsed galvanic current and the other for microcurrent therapy). Both groups will receive the same traditional physical therapy routine and conservative treatment for the wound for six weeks.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of high-voltage pulsed current (HVPC) and microcurrent stimulation therapy (MST) in treating chronic wounds and to compare their effects.

Detailed description: Sixty patients with chronic wounds (pressure ulcers) and their ages will be ranged from 45 to 60 years old. They will be recruited from the outpatient clinic at Kasr Al-Aini Hospitals and they will be randomly assigned into two groups of equal numbers, each one will contain thirty patients. High-voltage pulsed current group and microcurrent stimulation therapy groups. The change in wound surface area and wound volume will be measured before the intervention and after six weeks of intervention.

Eligibility criteria: Inclusion Criteria:

* Patients are of both sexes.
* Subject's age will be from 45 to 60 years.
* All patients will enter the study having their informed consent.
* All patients will be assessed by a physician before starting the study procedure.
* All patients suffer from a chronic wound not healed more than or within six weeks.

Exclusion Criteria:

* Patients with acute wounds.
* Patients with burn wound injuries.
* Malignancy in the wound.
* Necrotic tissue in the wound.

Primary outcomes:
measure: Change in wound surface area
timeFrame: Baseline and six weeks after the intervention.
measure: Change in wound volume
timeFrame: Baseline and six weeks after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Shaimaa Mohamed Ahmed Elsayeh
state: New Cairo
Study officials:
affiliation: Lecturer at Faculty of Physical Therapy, Cairo University
name: Shaimaa MA Elsayeh, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02993445: Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension
Official title: A Pilot Study on the Effect of Alternate Nostril Breathing and Foot Reflexology on Intraocular Pressure in Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ocular Hypertension
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 11
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of complementary and alternative therapies, specifically alternate nostril breathing and foot reflexology, on intraocular pressure in patients with ocular hypertension.

Detailed description: 11 patients were recruited from Temple Ophthalmology between 2014 and 2016. Patients had ocular hypertension and were between the ages of 48-74. Patients were excluded if they currently performed ANB or FR, were unable to perform the task, had previous eye surgery or laser, were receiving other CAM for ocular hypertension, or were unable to complete a washout period. After a 30-day drug washout, patients completed either ANB or FR. After instruction, the assigned task was performed for 5 minutes. FR was done on a commercially available foot reflexology board (JAPAN TSUBO HH-700) focused at the base of the second and third toes of both feet. Two weeks later, patients completed the alternate task. IOP was measured before the task, immediately after the task and then every 30 minutes for two hours. Sign rank tests were used to evaluate IOP changes within and between each group.

Eligibility criteria: Inclusion Criteria:

* patients with ocular hypertension

Exclusion Criteria:

* currently performed alternate nostril breathing or foot reflexology
* were unable to perform the task
* had previous eye surgery or laser,
* were receiving other CAM for ocular hypertension
* were unable to complete a washout period if they using glaucoma eye drops

Primary outcomes:
measure: Change From Baseline in Intraocular Pressure (mmHg)
timeFrame: 2 hours
measure: Change From Baseline in Intraocular Pressure (mmHg)
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Temple University
name: Jeffrey Henderer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03362645: Diagnostic Value of the Electrocardiogram in Fabry Disease
Official title: Diagnostic Value of the Electrocardiogram in Fabry Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fabry
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged \> 18 years, with genetically confirmed Fabry disease complicated by LVH.

Patients aged \> 18 years, with sarcomeric hypertrophic cardiomyopathy.

Brief summary: Cardiac complications occur in 78% of patients with Fabry disease and are mainly characterized by a high frequency of left ventricular hypertrophy resulting from an accumulation of GL3 in cardiomyocytes. Apart from family screening, left ventricular hypertrophy is an important factor in the diagnosis of Fabry disease. This left ventricular hypertrophy is more often concentric and homogeneous, but it can also be asymmetric and mimic the patterns seen in so-called familial hypertrophic cardiomyopathies caused by mutations in the sarcomere protein genes. Electrocardiogram has been suggested as a screening tool for Fabry disease. Analysis of the PQ interval would be of interest. An algorithm has even been proposed to differentiate Fabry disease from amyloidosis with excellent sensitivity and specificity. The only criterion of left ventricular hypertrophy used in all studies is the Sokolov-Lyon index, but this index has many limitations and does not appear to be discriminatory for Fabry disease. Other validated criteria for left ventricular hypertrophy, such as the Cornell, Lewis, Gubner index or the Romhilt-Estes point score, have never been tested in Fabry disease. The primary objective of our study is to evaluate the diagnostic value of different electrocardiographic scores of left ventricular hypertrophy in Fabry disease.


Eligibility criteria: Inclusion Criteria:

* Patients aged \> 18 years, with genetically confirmed Fabry disease complicated by LVH.
* Patients aged \> 18 years, with sarcomeric hypertrophic cardiomyopathy.

Exclusion Criteria:

* Patients aged \< 18 years. Sarcomeric hypertrophic cardiomyopathy for which Fabry disease has not been excluded by alpha-galactosidase A assay (in men) and genetic analysis (GLA gene mutation) in women.

Primary outcomes:
measure: Analysis of the PQ interval with a new algorithm
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: