louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06866418: Phagenyx® Registry Study
Official title: Phagenyx® Registry Study Evaluating Swallowing Therapy OutcomEs in the US
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dysphagia
Lead sponsor: Phagenesis Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-10
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 600 patients total, comprised of 300 evaluable adult patients with severe dysphagia post stroke will be treated with PES with an additional 300 subjects enrolled as historical controls.

Brief summary: A retrospective, open-label, matched-control registry study designed to characterize the effectiveness of Pharyngeal Electrical Stimulation (PES) to improve swallowing in patients with severe dysphagia post stroke when delivered using the Phagenyx® System in real-world clinical settings in hospitals in the United States of America (US).

Detailed description: The study will consist of a Treatment Group and a Control Group. The Treatment Group will include patients who have undergone PES treatment for severe dysphagia. The Control Group will consist of patients that qualify for PES treatment but are not treated with PES in the time period prior to implementing PES. Patients will be treated per standard of care at each institution. Each Treatment patient will receive treatment with PES in addition to other standard of care dysphagia therapies. Control subjects will receive standard of care dysphagia therapies only (no PES or other electrical stimulation therapies for dysphagia are permitted). Performance of the Phagenyx® System will be analyzed by comparing treatment outcomes for patients in the PES Group compared to patients in the Control Group.

The study will include patients with severe dysphagia post stroke. The main clinical outcomes will be assessed using the participating sites' standard of care methodology and will evaluate improvements in swallowing and reduction in associated treatments and complications.

Eligibility criteria: Inclusion Criteria:

1. Phagenyx® System Group Patients: Patients underwent treatment with the Phagenyx® System for a minimum of 3 treatments.
2. Control Group Patients: Patient requires a nasogastric feeding tube for severe dysphagia and required dysphagia treatment.
3. Willing and able to provide appropriate informed consent (if required).

Exclusion Criteria:

1. Primary endpoint outcome data not collected or not available.
2. In the investigator or sponsor's opinion the patient is not considered suitable.
3. Participation in another interventional study (medicinal or device) that could influence the outcomes of PES.
4. Treatment of dysphagia with other forms of electrical stimulation.

Primary outcomes:
measure: Swallowing safety
timeFrame: 2 (+1 days) post PES treatment
measure: Nutritional Management
timeFrame: 7 ± 2 days (or discharge) post last PES treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04660318: Assessment of Physiological Parameters Measurements (Heart Rate, Respiratory Rate, and Oxygen Saturation) by Standard Acquisition System Compared Remote Photoplethysmography Imaging System l
Official title: Assessment of Physiological Parameters Measurements (Heart Rate, Respiratory Rate, and Oxygen Saturation) by Standard Acquisition System Compared Remote Photoplethysmography Imaging System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plethysmography
Remote Photoplethysmography Imaging
Physiological Parameters
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 1045
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Introduced in 1930, photoplethysmography techniques presented the possibility of measuring SpO2 and HR using the absorption of light by the blood to define these signals In recent years, a new approach to photoplethysmography to measure physiological parameters without contact has been developed. This technique, called remote Photoplethysmography Imaging (rPPG), uses the different Red - Green - Blue color spectra at a skin captured by the camera video to determine a plethysmography signal.

Although these systems have been technically valid, they have not been clinically evaluated in a health setting. This clinical trial is to assess parameters measurements by rPPG compared standard acquisition system in real conditions


Eligibility criteria: Inclusion Criteria:

* Patients requiring a Pulmonary function testing.

Exclusion Criteria:

* Patients with stable clinical status.
* Pregnant woman or Woman of childbearing potential without effective contraception

Primary outcomes:
measure: Concordance of rPPG heart rate readings
timeFrame: 30-120 seconds.
measure: Concordance of rPPG respiratory rate readings
timeFrame: 30-120 seconds.
measure: Concordance of rPPG oxygen saturation readings
timeFrame: 30-120 seconds.
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre les nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy.
Study officials:
References:
citation: Allado E, Poussel M, Moussu A, Saunier V, Bernard Y, Albuisson E, Chenuel B. Innovative measurement of routine physiological variables (heart rate, respiratory rate and oxygen saturation) using a remote photoplethysmography imaging system: a prospective comparative trial protocol. BMJ Open. 2021 Aug 13;11(8):e047896. doi: 10.1136/bmjopen-2020-047896.
Clinical trial NCT01834118: Reintervention-study After Previous Renal Denervation in Non-responding Patients With Severe Hypertension
Official title: Reintervention After Previous Renal Denervation in Non-responding Patients With Severe Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Resistant to Conventional Therapy
Lead sponsor: Cardiovascular Center Frankfurt
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 10
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 with treatment-resistant hypertension, who already underwent renal denervation with no therapeutic avail.

Brief summary: The purpose of this study is to determine the effect of repeated renal denervation in non-responding patients with severe hypertension. Therefore ultrasound technique will be used.

Detailed description: Renal Denervation is a CE-certified opportunity for treating patients with therapy-refractory hypertension. In some patients it doesn't show a significant lowering of the blood pressure, so a repeated renal denervation is an option.

In this study repeated renal denervation will be performed with the Recor Paradise Ultrasound Catheter.

For the study no specific procedures are required which would exceed the standard renal denervation procedure with the CE-certified Recor Paradise Ultrasound Catheter System.

There are no additional risks for the patient in consequence of participating in the study or the follow up procedures.

Eligibility criteria: Inclusion Criteria:

* Individual is ≥18 years old
* Individual received renal denervation ≥12 months prior to study participation to no therapeutical avail and is scheduled for reintervention.
* Systolic Office based blood pressure ≥140mmHg
* Individual receives 3 or more antihypertensive drugs including one diuretic
* Individual is willing to provide written informed consent to participate in this study

Exclusion Criteria:

* Individual has hypertension secondary to an identifiable and treatable cause
* Individual has any serious medical condition which in the opinion of the investigator may adversely affect the participation.
* Individual is pregnant, nursing or planning to be pregnant
* Renal artery abnormalities which may affect the procedure

Primary outcomes:
measure: Office Blood pressure measurement
timeFrame: up to1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: CardioVascular Center Frankfurt
state: Hessen
Study officials:
affiliation: Cardiovascular Center Frankfurt
name: Horst Sievert, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02742818: Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models
Official title: Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Keywords: forced-air warming
hypothermia
endovascular surgery
blanket
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 50
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: Prospective randomized trial comparing effectiveness of two different forced-air warming blankets in patients undergoing lower extremity angioplasty (LEA) and endovascular abdominal aortic aneurysm repair (EVAR).

Detailed description: Fifty patients undergoing LEA and EVAR will be randomized into two groups: Group upper body blanket and Group underbody blanket. All patients will receive general anesthesia and body temperature will be measured and registered by an esophageal thermometer with 15 minutes interval beginning immediately after tracheal intubation up to tracheal extubation. The warming unit used (Bair Hugger 750 warming unit, Arizant Healthcare) will be the same for both groups and the blankets tested will be: upper body blanket (Bair Hugger 522 upper body blanket, 3M) and underbody blanket (Bair Hugger 635 full acess underbody blanket, 3M). Surgical and anesthetic complications will be noted. Only surgeries with minimum 45 minutes duration will be accepted for the purposes of this study.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing LEA and EVAR
* American Society of Anesthesiologists physical status (ASA) : 1-4

Exclusion Criteria:

* Non-endovascular surgery
* pregnant patients
* patient refusal
* less than 45 minutes duration of surgery

Primary outcomes:
measure: Values of Body Temperature ( in Celsius Degree ) in Two Groups of Patients Undergoing EVAR and LEA That Will Use Two Different Types of Bair Hugger 3M Body Warming Blankets, Namely: 522 Upper Body Blanket and 635 Full Access Underbody Blanket.
timeFrame: Across duration of surgery (up to 210 minutes)
Secondary outcomes:
measure: Age ( in Years)
timeFrame: At time of surgery ( in minutes)
measure: Gender
timeFrame: At time of surgery ( in minutes)
measure: Type of Surgery ( LEA and EVAR )
timeFrame: At time of surgery ( in minutes)
measure: Duration of Surgery ( in Minutes)
timeFrame: Across duration of surgery ( in minutes)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06658418: Erector Spinae Plane Block with Dexmedetomidine and Bupivacain Versus Dexamethasone and Bupivacain for Postoperative Analgesia in Patients Undergoing Abdominal Surgeries
Official title: Erector Spinae Plane Block with Dexmedetomidine and Bupivacain Versus Dexamethasone and Bupivacain for Postoperative Analgesia in Patients Undergoing Abdominal Surgeries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Analgesia, Postoperative
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 90
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: PREVENTION

Brief summary: To compare the analgesic effect of dexmedetomidine combined with bupivacaine versus dexamethasone combined with bupivacaine for ultrasound-guided ESPB for postoperative pain control in patients scheduled for abdominal surgeries


Eligibility criteria: Inclusion Criteria:

Age :18 years old and older. Patients undergoing open abdominal surgery.

Exclusion Criteria:

1. Patient refusal
2. known sensitivity or contraindication to any of study drugs
3. contraindications for local anesthesia
4. Patients with local infection at site of puncture
5. uncooperative patients
6. history of psychological disorders or chronic pain and significant liver or renal disease.

Primary outcomes:
measure: VAS score
timeFrame: at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperative.
Secondary outcomes:
measure: the time for requirement of first morphine dose
timeFrame: at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperative.
Other outcomes:
Locations:
Study officials:
References:
citation: Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.
Clinical trial NCT01416818: Treatment of Depression in Parkinson's Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of "Xiaoyao Pill" Treatment of Depression in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Depression in Parkinson's Disease
Keywords: Depression;
Parkinson's disease;
antidepressant
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2011-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the efficacy of Traditional Chinese Medicine-"Xiaoyao Pill" (Herb extracts)on depression, compared to placebo and "Bupleurum+Ginkgo" in patients with Parkinson's disease.

Detailed description: Depression as the most common non-motor comorbidity of Parkinson's disease (PD), have a negative impact on disability and quality of life.

Traditional Chinese Medicine has shown effects on several depression. It is not known if TCM also is effective for depression in PD. This study is to investigate "Xiaoyao Pill", an antidepressant in TCM, on depression in PD.

A total of 60 patients with depression in PD will be randomized to each of the three arms.

Eligibility criteria: Inclusion Criteria:

* Parkinson's disease without dementia
* Depression
* Males or females
* Willing and able to give informed consent

Exclusion Criteria:

* cognitive dysfunction
* other serious diseases

Primary outcomes:
measure: Hamilton Depression Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: the responder rate (defined as score reduction of HAMD-17>=50%)
timeFrame: 12 weeks
measure: the Geriatric Depression Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Piu Chan, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02031718: Comparison Between Interactive Internet-based Education and Counseling for the Management of Acne With That of Internet-based Education Alone
Official title: Comparison Between Interactive Internet-based Education and Counseling for the Management of Acne With That of Internet-based Education Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 98
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will develop and evaluate the efficacy of an Internet-based education program incorporating virtual coaching. For this study, the virtual coach will consist of online videos aimed at providing acne education and promoting behaviors that support healthy skin. The use of Web-based technologies and virtual coaching in acne-related patient education is novel, and may significantly improve clinical outcomes and quality of life in acne patients. We hypothesize that an interactive Internet-based education and counseling program will be more effective than Internet-based education alone in improving clinical outcomes and quality of life in acne patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of mild to moderate acne vulgaris
* 13 years of age or older at time of assent, may be men or women.
* Able read and understand English.
* Able to hear and see the educational videos.
* Access to computer with Internet access.
* Capable of giving informed consent.
* Not currently using any prescription acne treatment.

Exclusion Criteria:

* Non-English speaking individuals.
* Self-reported exposure to environmental or chemical comedogenic agents
* Women with self-reported hyperandrogenism (e.g., PCOS)
* Women self-reporting current use of any form of specific acne-directed hormonal therapy
* Men or women with self-reported history of Cushing syndrome or congenital adrenal hyperplasia

Primary outcomes:
measure: Acne Lesion Counts (Inflammatory and Non-inflammatory)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Dermatology Life Quality Index
timeFrame: Up to 12 weeks
Other outcomes:
measure: Knowledge
timeFrame: Up to 12 weeks
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Audrey Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: April W Armstrong, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tuong W, Wang AS, Armstrong AW. Effect of Automated Online Counseling on Clinical Outcomes and Quality of Life Among Adolescents With Acne Vulgaris: A Randomized Clinical Trial. JAMA Dermatol. 2015 Sep;151(9):970-5. doi: 10.1001/jamadermatol.2015.0859.
Clinical trial NCT05822518: Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy
Official title: Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Bladder
Cystostomy; Complications
Keywords: radical cystectomy
complications
immune-nutrition
immune enhancing nutrition
bladder cancer
muscle invasive bladder cancer
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the outcome of perioperative immune-nutrition with glutamine, arginine and fish oil in patients undergoing radical cystectomy as regards to enhancement of healing, increasing immunity and improving overall health status.


Eligibility criteria: Inclusion Criteria:

1. Patients with CT showing bladder mass with radiological staging of T2 or T3.
2. Patients pathologically proven to have cancer bladder.
3. Patients undergoing radical cystectomy with ileal conduit.
4. The American Society of Anesthesiologists Physical Status classification system (ASA PS) of 1, 2 or 3.

Exclusion Criteria:

1. Coagulopathy.
2. Distant metastasis.
3. Body mass index less than 18.5.
4. Relevant food allergies.
5. Severe renal and hepatic insufficiency.

Primary outcomes:
measure: Postoperative complications
timeFrame: 30 days
measure: Wound healing
timeFrame: 30 days
measure: infectious complications
timeFrame: 30 days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 30 days
measure: Length of ICU stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Shibin Al Kawm
country: Egypt
facility: Menoufia Faculty of Medicine
state: Menoufia
Study officials:
References:
Clinical trial NCT02676518: AMH, Glucose Intolerance and Metabolic Syndrome in PCOS
Official title: Anti-Müllerian Hormone and Its Association With Glucose Intolerance and Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycystic Ovary Syndrome
Keywords: polycystic ovary syndrome
Serum anti-Mullerian hormone
glucose intolerance
metabolic syndrome
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2016-02-08
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Thai women with PCOS diagnosed by Rotterdam criteria 2003 who visit at Gynecological Department, King Chulalongkorn Memorial Hospital, Bangkok,Thailand

Brief summary: Association between serum anti-Mullerian hormone (AMH) level and prevalence of glucose intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS)

Detailed description: * To study the association between serum anti-Mullerian hormone (AMH) level and glucose intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS).
* Glucose intolerance is detected by 2-hours 75 gram oral glucose tolerance test (OGTT).
* Metabolic syndrome is diagnosed by using the Harmonized criteria; the presence of any 3 of 5 following risk factors constitutes a diagnosis of metabolic syndrome.

  1. Elevated waist circumference (\> 80 cm in Asian women)
  2. Elevated triglycerides (\> 150 mg/dL)
  3. Reduced HDL-cholesterol (\< 50 mg/dL)
  4. Elevated blood pressure )systolic \> 130 and/or diastolic \> 85 mmHg)
  5. Elevated fasting glucose ( \> 100 mg/dL)
* Percentage of glucose intolerance and metabolic syndrome in PCOS women as well was any differences in parameters between PCOS patients with and without glucose intolerance and metabolic syndrome will be analysed.

Eligibility criteria: Inclusion Criteria:

* PCOS diagnosed by Rotterdam criteria 2003

Exclusion Criteria:

* Pregnancy
* Previous any hormonal uses in the last 3 months
* Previous hypoglycemic drugs or insulin-sensitising agents use in the last 3 months
* Previous chemotherapy, ovarian surgery, pelvic irradiation
* Menopause

Primary outcomes:
measure: Differences between serum AMH level between PCOS women with and without glucose intolerance and metabolic syndrome
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of glucose intolerance in PCOS women
timeFrame: 6 months
measure: Percentage of metabolic syndrome in PCOS women
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University
name: Dhirapong Charoenvidya, MD
role: STUDY_CHAIR
References: