louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00163644: RCT to Investigate Whether an Exercise Programme Improves the Physical Performance and QOL After BMT
Official title: Randomised Controlled Trial to Investigate the Effects of an Exercise Programme on Physical Performance and Quality of Life After a Bone Marrow Transplant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematological Malignancies
Keywords: Hematological malignancies.
Bone- marrow/ haemopoetic transplant
Exercise
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: The Alfred
name: The Leukaemia Foundation of Victoria
First posted: 2005-09-14
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The hypothesis is that exercise will improve the physical performance and quality of life of bone marrow/ haemopoietic stem cell transplants.The aim of the trial is to provide definite clinical evidence as to which( if any) type of exercise is most beneficial for this patient population. It is also aimed at improving the provision of physiotherapy services to this group of patients.

Detailed description: A three group, single blinded, randomised trial was designed to compare the effects of

1. aerobic plus active exercise and
2. aerobic plus resistance exercise to
3. control group of bone marrow/haemopoietic recipients not recieving exercise.

The hypotheses being tested is that

1. Exercise improves the physical performance of transplants recipients.
2. Exercise improves the quality of life of these patients;
3. resisted exercise added to aerobic exercise increases muscle strength or lean muscle mass and
4. There are no adverse events during either form of exercise

Eligibility criteria: Inclusion Criteria:

Recipient bone marrow transplant Alfred Hospital, Platelets \>= 20 x 10E9 / l Provide written consent, 30 days after a bone marrow transplant have an absolute neutrophil count of 1x10E9/l be in a stable medical condition

Exclusion Criteria:

febrile neutropenia Have active graft versus host disease Have cardiomyopathy (ejection fraction \< 20%) require \> 28% oxygen

Primary outcomes:
measure: Physical performance.
timeFrame: At 6 weeks
measure: Quality of Life.
timeFrame: At 6 weeks
measure: Anthropometry and Grip strength
timeFrame: At 6 weeks
Secondary outcomes:
measure: Heart Rate.
timeFrame: At 6 weeks
measure: No adverse events during treatment.
timeFrame: At 6 weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred hospital Physiotherapy dept,
state: Victoria
Study officials:
affiliation: Bayside Health
name: Catherine M Walsh, dip. physio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00297544: Effect of Sildenafil on Endothelial Function
Official title: Effect of Sildenafil on Endothelial Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Impotence
Keywords: impotence
endothelial function
autonomic nervous system
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2006-02-28
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: We are investigating the chronic effect of daily assumption of Viagra on the blood vessels function in patients with impotence. The study will include 2 groups: 1- patients with multiple risk factors, e.g. hypertension 2- patients with no cardiovascular risk factors

Detailed description: We are investigating the chronic effect of daily assumption of Viagra on the blood vessels function in patients with impotence. The study will include 2 groups: 1- patients with multiple risk factors, e.g. hypertension 2- patients with no cardiovascular risk factors

Eligibility criteria: Inclusion Criteria:

* age 40-70
* impotence
* with and without hypertension, Hypercholesteremia or DM

Exclusion Criteria:

* CHF: NYHA \> II
* Stable angina: CCS \> II
* Nitrate treatment

Primary outcomes:
measure: Improvement of endothelial function following Viagra treatment, according to platismographia.
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center, Recanati Autonomic Dysfunction CTR
Study officials:
affiliation: Rambam Health Care Campus
name: Giris Jacob, Prof, MD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dayan L, Greunwald I, Vardi Y, Jacob G. A new clinical method for the assessment of penile endothelial function using the flow mediated dilation with plethysmography technique. J Urol. 2005 Apr;173(4):1268-72. doi: 10.1097/01.ju.0000152290.71948.bf.
citation: Vardi Y, Appel B, Ofer Y, Greunwald I, Dayan L, Jacob G. Effect of chronic sildenafil treatment on penile endothelial function: a randomized, double-blind, placebo controlled study. J Urol. 2009 Dec;182(6):2850-5. doi: 10.1016/j.juro.2009.08.025. Epub 2009 Oct 17.
Clinical trial NCT02731144: Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients
Official title: The Impact of Optimized Caloric-proteic Nutrition on Clinical Outcome and Physical Component Summary (PCS) of Quality of Life in Septic and Septic Shock Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Sepsis
Septic Shock
Keywords: Loss of Physical Function
Lead sponsor: Hospital Sao Domingos
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this pilot randomized prospective controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and high protein intake with nutritional regimen based on 25 Kcal / kg / day and protein intake usually recommended for critically ill patients (1.4 to 1.5 grams / kg / day of protein).


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the ICU with sepsis and septic shock according to 3rd International Sepsis Consensus Conference Definitions for sepsis and septic shock
* Mechanically ventilated
* Expected length of stay in ICU ≥ 4 days
* Written informed consent obtained from authorized surrogates

Exclusion Criteria:

* Pregnancy
* Requirement for inspired oxygen content (FIO2) \> 0.60
* High output bronchopleural fistula

Primary outcomes:
measure: Physical function measured through the tool Physical Component Summary - PCS of Short Form 36
timeFrame: Three months after randomization
Secondary outcomes:
measure: Hospital mortality
timeFrame: Up to 1 year
measure: Length of ICU stay
timeFrame: Up to 1 year
Other outcomes:
Locations:
Study officials:
affiliation: COORDINATOR ICU HOSPITAL SAO DOMINGOS
name: JOSE R AZEVEDO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02462044: Contrast Enhancement on Coronary Computed Tomographic Angiography
Official title: Contrast Enhancement on Coronary Computed Tomographic Angiography : Effects on Intra-Coronary Attenuation Using Low Iodine Concentrations While Maintaining Identical IDR (EICAR-Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Coronary Stenosis
Keywords: Computed tomography
Coronary CTA
Contrast media
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2015-06-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Computed tomographic angiography (CTA) is an important prognostic tool with regard to the detection of coronary artery stenoses. Both iodine delivery rate (IDR; the amount of iodine delivered to the patient per second) and iodine concentration are decisive factors in the opacification of arterial vessels.

There remains to be some debate in the literature about whether the use of high iodine concentration contrast media is beneficial compared to lower iodine concentrations.

To date, there have not been any studies comparing intracoronary attenuation using concentrated contrast media lower than 300 mg I/ml at coronary CTA. For a reliable comparison of CM with different iodine concentrations, adapted injection protocols insuring an identical IDR (in g iodine per second) are mandatory. The investigators hypothesize that usage of lower iodine concentrations, while maintaining identical IDR and total iodine load, will result in comparable diagnostical intra-vascular attenuation in CTA.

Detailed description: To evaluate intravascular contrast enhancement and image quality in coronary CTA using different iodine concentrations ranging from 240 to 370 mg iodine per ml, administered with an identical IDR and total iodine load.

To describe the effect of iodine concentration and flow rates on contrast bolus characteristics, eg time to peak, bolus homogeneity, injection pressure and patient comfort.

Eligibility criteria: Inclusion Criteria:

* Atypical or typical chest pain

Exclusion Criteria:

* Unstable angina
* Hemodynamic instability
* History of CAD
* Pregnancy
* Renal insufficiency (defined as glomerular filtration rate (GFR) \<45ml/min or \<60ml +diabetes
* HR \> 90 bpm and the inability to receive beta-blockers and iodine allergy

Primary outcomes:
measure: intravascular contrast enhancement
timeFrame: two years
Secondary outcomes:
measure: time to peak
timeFrame: two years
measure: bolus homogeneity
timeFrame: two years
measure: patient comfort
timeFrame: two years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
References:
Clinical trial NCT04297644: mCVI Pilot Study: Algorithm Verification
Official title: A Single-Center, Prospective Pilot Study to Verify the Algorithm of mCVI® to Accurately Capture Pulse Rate and Respiratory Rate in 10 Healthy Subjects in Comparison to Commercially-Available Masimo Pulse Oximeter Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Algorithm Verification
Lead sponsor: Intelomed, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-05
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: This single center pilot study is to verify the algorithm of mCVI® to accurately capture pulse rate and respiratory rate in 10 healthy subjects in comparison to commercially-available Masimo pulse oximeter devices. This is a non significant risk device.

Detailed description: In this pilot study the mCVI device is a mobile application used to simply verify the algorithm when the mobile video reads a patients pulse rate and respiratory rate while spontaneously breathing. There is no facial recognition technology. There is no immediate feedback given to the research team to act upon or provide for further clinical care decisions. In real time, the mCVI device will be compared to two commercially available pulse oximeter devices in a single visit.

Eligibility criteria: Inclusion Criteria:

* Healthy adult patients between the ages of 21 - 70

Exclusion Criteria:

* Medical conditions that could compromise a patient's ability to provide for all breathing samples, pedal the Cubii Pro elliptical, or follow instructions
* Medications that could compromise a patient's ability to participate in the study
* Documented medical history of respiratory or cardiovascular disease
* Excessive facial hair, facial deformities, or obstructions that could compromise the recording of pulse rate and respiratory rate of the mCVI®
* Missing digits or fingers on one or more hand that would prevent proper recording of Masimo pulse oximeter devices
* Patients wearing nail polish, acrylic nails, or rings on the ring finger of either hand that would prevent the proper use of Masimo pulse oximeter device
* Recent (≤ 1 month) surgical procedure of any kind
* Current participation in another investigational clinical trial
* Inability to provide informed consent

Primary outcomes:
measure: Primary Objective
timeFrame: 2 months
Secondary outcomes:
measure: Secondary Objective
timeFrame: 2 months
Other outcomes:
Locations:
city: McMurray
country: United States
facility: Primary Care Research South, INC
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06095544: Enhanced Recovery After Surgery for SPK Transplantation Recipients
Official title: A Clinical Study on the Application of Enhanced Recovery After Surgery for Simultaneous Pancreas-kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transplant Complication
Diabetic Nephropathy
Perioperative/Postoperative Complications
Keywords: enhanced recovery after surgery, SPK transplantation
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled tiral
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 108 patients underwent elective SPK surgery were randomly divided into ERAS group (E) and routine care group (T). The ERAS group was consisted of evidenced-based systematic optimization approaches, while the control group received routine care.

Detailed description: Primary results: the postoperative length of stay (LoS) and hospitalization costs; second results: post-operative analgesia score (NRS) , the incidence of post-operative nausea and vomiting (PONV) , urinary catheter removal time by 7 days , post-operative gastric tube indwelling time, the incidence of ambulation within 6 days . the dosage of dobutamine using , the dosage of norepinephrine using, and the total amount of fluid and urine volume . MAP and lactate level . Peak systolic velocity (PSV) and (resistance index) RI of grafts were checked between two groups.

Eligibility criteria: Inclusion Criteria:

1. Patients were aged 20-62 years
2. Body mass index (BMI) of 18.5-32.9 kg/m2
3. Voluntary participation for elective SPK surgery
4. ERSD and DN patients waiting for SPK transplantation surgery.

Exclusion Criteria:

1. History of allergy to narcotic drugs
2. cardiopulmonary insufficiency
3. congestive heart failure
4. myasthenia gravis
5. neurological disease
6. mental illness
7. severe liver dysfunction
8. hyperkalaemia
9. malignant hyperthermia
10. unwilling to participate in the study for any reason, or had participated in another study within the 3 months

Primary outcomes:
measure: Length of hospital stay (LoS)
timeFrame: Record all the period time from the day of admiting to hospital to the day of discharge from hospital(days).
measure: Hospital costs (US dollar)
timeFrame: Total costs(dollar) of the patients spended from the day of admiting to hospital to the day of discharge from hospital(days).
Secondary outcomes:
measure: Perioperative complications
timeFrame: After the surgery acomplishment(see detail above)：record the NRS within 40hours after the surgery, occurrence rate of the PPCs within 2 weeks after the surgery, ocurrence rate of the ambulation within 6 days after the surgery, etc.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Second affiliated hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT04285944: Operator Radiation Protection During Cardiac Catheterization Using Mavig X-ray Protective Drapes®.
Official title: Operator Radiation Protection During Cardiac Catheterization Using Mavig X-ray Protective Drapes®.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiation Exposure
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 1000
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: Interventional cardiologists are exposed to significant doses of scatter radiation during cardiac catheterization and percutaneous coronary intervention. Traditional methods of reducing the radiation dose for operators in the cardiac catheterization laboratory include limiting the use of radiation, radiation protection aprons and shields, and the use of lead eye glasses. Despite these measures several parts of the operators body, including the head and neck, are poorly screened from scatter radiation. Radiation protection drapes have been developed for use in cardiac catheterization but no randomized controlled study has yet been performed with the commercially available Mavig X-ray Protective Drapes®. The aim of this study is to evaluate operator radiation protection using Mavig X-ray Protective Drapes®.


Eligibility criteria: Inclusion Criteria:

1. Patient undergoing the procedure is older than 18 years and is planned for a coronary angiogram, cardiac catheterization and/or percutaneous coronary intervention.
2. The coronary angiogram/cardiac catheterization/PCI procedure is elective.
3. The patient undergoing the procedure is male, or if female, has no childbearing potential or is not pregnant.

Exclusion Criteria:

1. The procedure is an emergency and/or the patient is unstable. -

Primary outcomes:
measure: Operator radiation dose
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Cardiovascular Disease, University Hospitals Leuven
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Keir Mccutcheon
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCutcheon K, Vanhaverbeke M, Dabin J, Pauwels R, Schoonjans W, Desmet W, Bennett J. Efficacy of MAVIG X-Ray Protective Drapes in Reducing CTO Operator Radiation. J Interv Cardiol. 2021 Dec 14;2021:3146104. doi: 10.1155/2021/3146104. eCollection 2021.
citation: McCutcheon K, Vanhaverbeke M, Pauwels R, Dabin J, Schoonjans W, Bennett J, Adriaenssens T, Dubois C, Sinnaeve P, Desmet W. Efficacy of MAVIG X-Ray Protective Drapes in Reducing Operator Radiation Dose in the Cardiac Catheterization Laboratory: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2020 Nov;13(11):e009627. doi: 10.1161/CIRCINTERVENTIONS.120.009627. Epub 2020 Oct 23.
Clinical trial NCT00180544: Safety and Effectiveness Study of the HERCULINK 14 Stent to Treat Renal Artery Disease
Official title: A Prospective, Non-Randomized, Multicenter, Single-Arm, Clinical Trial to Assess the Safety and Efficacy of the RX HERCULINK 14 Peripheral Stent System for Treatment in de Novo or Restenotic Renal Artery Stenosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Renal Artery Obstruction
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the RX HERCULINK 14 Peripheral Stent System in treating atherosclerotic renal artery stenosis.

Detailed description: A prospective, non-randomized, multi-center, single-arm clinical trial to evaluate the safety and efficacy of the RX HERCULINK™ 14 Peripheral Stent System in the treatment of suboptimal post- procedural percutaneous transluminal angioplasty (PTA) results in de novo or restenotic atherosclerotic renal artery stenoses.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of renal artery atherosclerosis; candidate for renal artery angioplasty and stenting; blood pressure \>160/90

Exclusion Criteria:

* Totally occluded renal artery on the opposite side; only one functioning kidney; target lesion is in a transplanted kidney; renal insufficiency

Primary outcomes:
measure: Primary patency .
timeFrame: at 9-months
Secondary outcomes:
measure: Acute procedural success
timeFrame: Acute
measure: Access site events requiring surgical repair or intervention
timeFrame: Acute
measure: Major adverse events (e.g. death, nephrectomy, target lesion revascularization (TLR)
timeFrame: at 30 days
measure: TLR
timeFrame: at 9 months
measure: Renal function
timeFrame: measured at 1, 6, 9, and 12-month follow-up, and every three months thereafter until approximately May 2003 or until patient 169 completes 12 month follow-up.
measure: Changes in blood pressure
timeFrame: 9 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Alton Ochsner Medical Foundation
state: Louisiana
Study officials:
affiliation: Alton Ochsner Medical Foundation
name: Stephen Ramee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06583044: Bruxism Awareness in Dental Students
Official title: Bruxism Awareness and Self-assessment in Dental Clinical Students: A Questionnaire Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bruxism
Keywords: awareness
bruxism
dental students
questionnaire
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included 4th and 5th dental students.

Brief summary: Clinical students in the Faculty of Dentistry were diagnosed with bruxism according to the bruxism assessment consensus 2018. A total of 128 students with (64) and without (64) bruxism, were asked 33 questions about their knowledge and self-awareness about bruxism.

Detailed description: This study included systemically healthy individuals aged 18 to 27. Intraoral and extraoral examinations were performed on 128 students with (64) and without bruxism (64), 4th and 5th-grade dental students at Bolu Abant İzzet Baysal University who met the inclusion criteria. The diagnosis of bruxism was based on the 2018 International Consensus and data collected through a validated 33-item questionnaire covering general information and bruxism awareness. The questionnaire included questions on bruxism's types, risk factors, symptoms, and impact on periodontal tissues, with multiple-choice responses. Statistical analyses were performed using IBM SPSS Statistics, and p\<0.05 was accepted as statistical significance

Eligibility criteria: Inclusion Criteria:

* Systemically healthy individuals

Exclusion Criteria:

* Individuals with mental retardation,
* Individuals with suicidal tendencies,
* Individuals with dementia,
* Individuals with psychosis

Primary outcomes:
measure: Bruxism Awareness Survey
timeFrame: Baseline
measure: Bruxism Knowledge Level Survey
timeFrame: Baseline
Secondary outcomes:
measure: Bruxism symptoms Survey
timeFrame: Baseline
measure: Treatment and Follow-up Survey
timeFrame: Baseline
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant İzzet Baysal University
Study officials:
affiliation: Abant Izzet Baysal University
name: TUGBA SAHIN
role: PRINCIPAL_INVESTIGATOR
References: