louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04680039: Early Warning of Intradialytic Hypotension in Hemodialysis Patients
Official title: Noninvasive Hemodynamic Parameters Measurements as a Tool for Early Warning of Intradialytic Hypotension in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension of Hemodialysis
Keywords: Hemodialysis
Intradialytic hypotension
Remote Monitoring
Lead sponsor: Biobeat Technologies Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 150 adult subjects (≥18 years) with end stage kidney disease (ESKD) undergoing chronic hemodialysis (HD) treatments in Hadassah Ein-Kerem medical center. A patient can participate more than once.

Brief summary: In this study, the investigators will monitor patients undergoing hemodialysis treatment with a non-invasive wearable PPG-based device. Measurements will include blood pressure, heart rate, oxygen saturation, stroke volume, cardiac output, cardiac index and systemic vascular resistance, among others. The aim is to diagnose intradialytic hypotension more rapidly than with current noninvasive methods and prevent related poor outcomes.


Eligibility criteria: Inclusion Criteria:

1. Patients with EKSD undergoing chronic hemodialysis treatments for \> 3 months.
2. Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
3. Patients must satisfy a medical examiner about their fitness to participate in the study.
4. Patients must provide written informed consent to participate in the study.

Exclusion Criteria:

1. Patients with an inability to communicate well with the Principal investigator (PI) and staff (i.e., language problem, poor mental development, or impaired cerebral function).
2. Withholding the dialysis session for any reason prior to initiation.
3. Minors under the age of 18.

Primary outcomes:
measure: Number of participants with intradialytic hypotension
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Determining the pathogenesis of intradialytic hypotension
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: The Hadassah Ein Kerem Medical Center
Study officials:
affiliation: The Hadassah Ein Kerem Medical Center, Jerusalem, Israel
name: Dean Nachman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01621139: A Pilot Clinical Trial to Evaluate the Effects of Acupuncture in Patients on Prolonged Mechanical Ventilation
Official title: A Pilot Prospective Randomized Study to Evaluate the Effects of Acupuncture in Patients on Prolonged Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Mechanical Ventilation Complication
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the role of acupuncture use on: 1) decrease the requirements for pharmacologic analgesic, 2) improve patient-reported pain, 3) expedite recovery process, and 4) improve the quality of life.


Eligibility criteria: Inclusion Criteria:

Consecutive male and post-menopausal female patients expected to require more than 24 hours of mechanical ventilation will be included.

Exclusion Criteria:

* Children \< 18 years of age
* Patients with active resuscitation (fluid boluses greater than 2 Liter per hour, rapid transfusions, titration of vasoactive medication)
* Patients with hemodynamic instability: heart rate less than 40/min or greater than 120/min, SBP \< 90 or \> 180 mm Hg for longer than 2 continuous hours
* Patients who are pregnant or pre-menopausal
* Patients with expected survival less than 6 3 months
* Major deformities of the upper or lower extremities and/or any active skin lesions or ulcers in acupuncture treatment areas.
* Patients with a pacemaker or other implanted electronic device

Primary outcomes:
measure: RASS (Richmond Agitation Sedation Scale)
timeFrame: baseline to six months
Secondary outcomes:
measure: ABPS (Aberdeen Back Pain Scale)
timeFrame: baseline to six months
measure: Pain Scale
timeFrame: baseline to six months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT00864539: Comparison of the Efficacy of Calcium-cholecalciferol Foodstuffs and Calcium-cholecalciferol Supplement
Official title: The Prevalence of Vitamin D Insufficiency in Primary School Children and Comparison of the Effect of Calcium-Vitamin D-Fortified Milk, -Orange Juice and Calcium-Vitamin D Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Vitamin D Status
Healthy
Keywords: vitamin D fortification
milk
orange juice
supplement
efficacy
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2009-03-18
Enrollment: 585
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is conducted in two phases. At the first phase, the prevalence of vitamin D insufficiency in primary school-children in Tehran is determined during the cold seasons of 2008. Then, the efficacy of calcium-vitamin D-fortified milk, -orange juice and supplement is compared in six selected primary schools.

Detailed description: At the first step, serum 25-(OH)D, PTH(parathyroid hormone), osteocalcin, bone alkaline phosphatase, calcium, phosphorous, and magnesium is evaluated. Anthropometric and dietary intake data is also collected. In the second phase, we have 6 experimental groups: (1) plain milk; (2) calcium-vitamin D-fortified milk (containing 500 mg Ca and 100 IU vitamin D/200 mL package); (3) plain orange juice; (4) fortified orange juice containing equal amounts of calcium and vitamin D as fortified milk; (5) calcium-vitamin D supplement (500 mg calcium and 200 IU vitamin D); and (6) placebo. Each group consists of 40-60 children (9-11 years) from both sexes. All above-mentioned biochemical, anthropometric and dietary intake data is collected both in the beginning and in the end of interventional period.

Eligibility criteria: Inclusion Criteria:

* Age: 9-11 years
* Being healthy (no apparent clinical disease)
* Informed consent signed by child's parent(s)

Exclusion Criteria:

* Subjects receiving vitamin D, calcium or omega-3 supplement
* Unwillingness to continue the study
* Subjects with type 1 diabetes, allergy, kidney disorders

Primary outcomes:
measure: Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Nutrition and Food Technology Research Institute, P.O. Box 19295-4741
name: Tirang R. Neyestani, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00356239: Implantable Cardioverter Defibrillators And Magnetic Resonance Imaging of the Heart at 1.5 Tesla
Official title: Evaluation of Safety and Feasibility Magnetic Resonance Imaging of the Heart at 1.5 Tesla In Patients With Implantable Cardioverter Defibrillators
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Defibrillators, Implantable
Heart Failure, Congestive
Keywords: Defibrillators, Implantable
Heart Failure, Congestive
Magnetic Resonance Imaging
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2006-07-25
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: To evaluate short-term and long-term effects by MR imaging on the technical and functional status of implantable cardioverter defibrillators.

Detailed description: The presence of an implantable cardioverter defibrillators (ICD) is currently considered an absolute contraindication to MR imaging, and most patients with PM are excluded from having MRI. As a result from studies such as MADIT I, MADIT II, SCDHeft etc. the number of patients with ICDs has been continuously growing over the past years, ans this development will continue.

The aim of this study is to develop a strategy for safe performance of MR imaging at 1.5T, which included restriction of specific absorption rate (SAR) values to minimize the risk of lead heating, and ICD reprogramming to avoid interference from time varying gradient fields. The safety of this approach is then evaluated in a large group of ICD patients including assessment of potential myocardial thermal injury by measuring serum troponin I and pacing capture thresholds, and performing a follow-up 6 weeks after MR imaging to evaluate long-term effects.

Eligibility criteria: Inclusion Criteria:

* Implantable Cardioverter Defibrillator
* congestive heart failure
* informed consent

Exclusion Criteria:

* Non-MRI-compatible implants

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn, Department of Cardiology
state: NRW
Study officials:
affiliation: University of Bonn, Department of Cardiology
name: Nikos Werner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naehle CP, Strach K, Thomas D, Meyer C, Linhart M, Bitaraf S, Litt H, Schwab JO, Schild H, Sommer T. Magnetic resonance imaging at 1.5-T in patients with implantable cardioverter-defibrillators. J Am Coll Cardiol. 2009 Aug 4;54(6):549-55. doi: 10.1016/j.jacc.2009.04.050.
Clinical trial NCT00861939: To Demonstrate the Relative Bioavailability of Bupropion HCI 300 mg Extended-Release Tablets Under Fasting Conditions
Official title: A Relative Bioavailability Study of Bupropion HCI 300 mg Extended-Release Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-03-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 300 mg ER Tablets under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B orc.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence according to US FDA timelines
timeFrame: 17 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: So R Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01718639: Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
Official title: Randomized, Controlled, Single-blind, Three-way Crossover Clinical Investigation to Evaluate Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postprandial Heartburn
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2012-10-31
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is a randomized, placebo-controlled, single-blind, three-way crossover clinical trial to evaluate safety and efficacy of IQP-LH-101 (tablet form and liquid form) in postprandial heartburn.

The null hypothesis is that there is no difference between IQP-LH-101 and the placebo in terms of efficacy for postprandial heartburn treatment.


Eligibility criteria: Inclusion Criteria:

* Post-prandial heartburn (e.g. after a high-fat meal) in at least 2 months prior to the study (at least 2 times a week)
* Not receiving prescribed treatment for heartburn, reflux or upper gastrointestinal disorders
* Written informed consent is a prerequisite for subject enrollment.

Exclusion Criteria:

* Gastrointestinal bleeding within 12 months prior to the study
* Difficulty swallowing (dysphagia)
* History of or symptoms suggestive of Zollinger-Ellison syndrome, oesophageal or gastric malignancy, gastric or duodenal ulcer, pernicious anaemia, Barrett's oesophagus or systemic sclerosis
* Participation in other studies within the last 30 days prior to entry or during the study

Primary outcomes:
measure: Difference in time to both onset of soothing and onset of cooling after intake of investigational product between study arms
timeFrame: Measured up to 30 minutes
Secondary outcomes:
measure: Duration of time until the first perception of recurring heartburn symptoms after intake of investigational product
timeFrame: Up to 4 hours
measure: Evaluation of efficacy
timeFrame: Up to 4 hours per crossover
measure: Adverse events
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Weißenseerweg 111
Study officials:
References:
Clinical trial NCT04819139: Position Sense, Force Control and Pain Intensity in Basal Thumb Osteoarthritis
Official title: Interaction Between Position Sense, Force Control and Pain Intensity in Basal Thumb Osteoarthritis. A Cross-sectional Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thumb Osteoarthritis
Proprioceptive Disorders
Pain, Chronic
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In practice, a single test is used to quantify thumb proprioception. Previous studies have found a decrease in joint position sense (JPS) and force sense (FS) in patients diagnosis of thumb carpometacarpal osteoarthritis, but no correlation have been stabilize between JPS, FS and pain intensity perceived by the patient during activity daily life (ADL).

The goal of the study is compared joint position error (JPE) with joint force sense error (JFSE) in subjects with carpometacarpal (CMC) joint osteoarthritis and investigated a possible correlation between thumb pain intensity and thumb proprioception in patients with CMC joint OA.

Detailed description: Forty-five subjects over 18 with thumb CMC joint OA in the dominant hand grade 1-3 according o the Eaton Classification Stage will be evaluated for thumb active joint position sense (JPS) test and Force sense test to measure proprioception function. For measurement of JPS, the subjects will blindfolded and repositioned their thumb to a target position, which will be determined by the examiner previously. For force sense, participants will should reproduce pinch force measure with dynamometer. The severity of pain with activity will be measured according to the visual analog scale (VAS).

Eligibility criteria: Inclusion Criteria:

* Over 18 years; Diagnosis of grade I, II or II thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage; A minimum pain rating of 4/10 on the Visual Analogue Scale (VAS) during activities of daily living (ADLs) at the time of the initial evaluation; Ability to read and understand the patient information sheets and exercises

Exclusion Criteria:

* Neurological disorder affecting the upper limb; Treatment for hand or thumb pain in the same limb in the last 6 months (including injections to the wrist, fingers, or thumb); Fracture or significant hand injury; Previous surgery to the wrist or hand; Hand/finger tenosynovitis; Dupuytren disease; Cognitive impairment that inhibited an understanding of the informed consent and exercise program; Fixed thumb adduction contracture or blindness.

Primary outcomes:
measure: Pain intensity
timeFrame: baseline - 2 days
Secondary outcomes:
measure: JPS
timeFrame: baseline - 2 days
measure: FS
timeFrame: baseline- 2 days
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Raquel Cantero-Téllez
state: Málaga
Study officials:
References:
Clinical trial NCT05687825: Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula
Official title: Operative Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy: A Prospective Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Fistula
Keywords: risk factors,
clinically relevant pancreatic fistula,
pancreaticoduodenectomy
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 107
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all consecutive patients who were treated with a pancreaticoduodenectomy

Brief summary: For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.

Detailed description: For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.

Eligibility criteria: Inclusion Criteria:

1. Patients with resectable distal CBD carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.
2. American Society of Anesthesiologists (ASA) scores I \& II.
3. Patients aged \> 20 years.
4. Agreement to complete the study.

Exclusion Criteria:

1. Patients with benign disease, trauma, and receive neoadjuvant therapy.
2. double primary cancers.

Primary outcomes:
measure: clinically relevant post operative pancreatic fistula
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Qena faculty of Medicine, South Valley University
Study officials:
affiliation: General Surgery Department, Faculty of Medicine, South Valley University
name: Mohammed A Omar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01055925: Clinical Comparative Trial of a Modified Polyurethane Dressing and Aquacel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reepithelialization of Skin Graft Donor Sites
Lead sponsor: Klinik Bogenhausen
Sponsor class: OTHER
First posted: 2010-01-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Primary purpose: TREATMENT

Brief summary: The almost single disadvantage of conventional polyurethane film dressings, an uncontrolled leakage, is probably as often described as its numerous advantages for split-thickness skin graft (STSG) donor sites. This shortcoming can be overcome by perforating the polyurethane dressing (MPD), which permits a controlled leakage into a secondary absorbent dressing. The study was conducted to compare the MPD-system and Aquacel® (ConvaTec), a hydrofiber wound dressing, which also seems to fulfill all criteria of an ideal donor site dressing.


Eligibility criteria: Inclusion Criteria:

* skin graft donor site anterolateral thigh
* men and women \> 18 years

Exclusion Criteria:

* informed consent missing
* repeated skin graft take or prior injury at the observed site
* Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
* History of hypersensitivity to the investigational products

Primary outcomes:
measure: reepithelialization rate
timeFrame: 10th day postoperative
Secondary outcomes:
measure: pain, scar formation, complications (e.g. infection), costs
timeFrame: pain until and during dressing removal, scar formation 60 days following surgery
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich Bogenhausen, Technical University Munich
state: Bavaria
Study officials:
References:
Clinical trial NCT02626325: Effect of High-carbohydrate or High-monounsaturated Fat on Blood Pressure: Meta-analysis of Randomized Clinical Trials
Official title: Effect of High-carbohydrate or High-monounsaturated Fatty Acids on Blood Pressure: a Meta-analysis of Randomized Clinical Trials
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Pressure
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy and unhealthy (T2DM, hyperlipidemic, hypertensive)

Brief summary: High saturated fat acids diets are associated with elevated blood pressure which is associated with cardiovascular morbidity and mortality. For this reason, a change of diet is recommended to manage blood pressure and prevent cardiovascular complications. To achieve this nutritional goal, a high-carbohydrate diet or high-monounsaturated fat diet can be advised in the replacement of a saturated fat diet.

Previous meta-analysis of Garg (1998) cited randomized articles with inconsistent blood pressure lowering after consumption of a high-monounsaturated-fat diet compared with a high-carbohydrate diet only in type 2 diabetes patients. Moreover, another meta-analysis of Shah et al. (2007) showed slightly high blood pressure on diets rich in carbohydrates than diets rich in cis-monounsaturated fat after randomized and nonrandomized articles.

For this reason, a new meta-analysis of a randomized clinical trial will be performed to clarify the effects of high-carbohydrate or high-monounsaturated fat diets on blood pressure. Results from this meta-analysis will help health professionals take important decisions on patient diet and minimize cardiovascular morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

* Randomized controlled trials
* Parallel or Crossover Design
* Duration: at least 3 weeks
* Isocaloric diet

Primary outcomes:
measure: Blood pressure
timeFrame: 3 weeks
measure: Mean arterial pressure
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Vladimir Vuksan
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Vladimir Vuksan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Elena Jovanovskie, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Any de Castro Ruiz Marques, MSc
role: STUDY_DIRECTOR
References:
citation: Jovanovski E, de Castro Ruiz Marques A, Li D, Ho HVT, Blanco Mejia S, Sievenpiper JL, Zurbau A, Komishon A, Duvnjak L, Bazotte RB, Vuksan V. Effect of high-carbohydrate or high-monounsaturated fatty acid diets on blood pressure: a systematic review and meta-analysis of randomized controlled trials. Nutr Rev. 2019 Jan 1;77(1):19-31. doi: 10.1093/nutrit/nuy040.