louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03259945: Retrospective Observational Study of Patients With a Sutureless Aortic Valve Implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU
Official title: Retrospective Observational Study of Patients With a Sutureless Aortic Valve Implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients With a Sutureless Aortic Valve
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with a sutureless aortic valve implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU

Brief summary: The incidence of aortic valve disease is increasing steadily because of the ageing of the population. At a certain stage, replacement of the aortic valve improves symptoms and thus the quality of life of patients.

Surgical aortic valve replacement is the " gold standard ". The procedure involves stopping the heart and setting up cardiopulmonary bypass (CPB) to ensure the oxygenation of tissues.

The reference technique consists in suturing a prosthetic valve to the aortic annulus so as to restore normal function. This technique has very good results in the long term. The elective approach is sternotomy, which has certain drawbacks: post-operative pain, risk of infection, psychological trauma of a major incision. In recent years an alternative approach, right minithoracotomy, has been proposed. The drawback to this approach is that it increases aortic cross-clamp time and CPB time.

More recently, new prosthetic valves, so-called "sutureless" or "rapid deployment" valves have become available. The main advantage of these valves is that they are easy to implant, as they do not require or need just a few sutures. As a result heart-arrest time is shorter, post-operative inflammatory syndrome is less frequent and transfusion needs are reduced.

However, these valves have a metallic stent to fix the valve in place by pressing against the aortic annulus, which may give rise to intra-cardiac conduction disorders. Yet, very few studies have been conducted on this subject.

The investigators wish to evaluate these conduction disorders in a cohort of patients operated on in this Department with this sutureless or rapid deployment valve technique.


Eligibility criteria: Inclusion Criteria:

All patients who underwent implantation of a Suturless valve since 2015 (Intuity Elite Edwards or Perceval S Liva Nova)

Exclusion Criteria:

* patients with a pacemaker
* patients who underwent double valve replacement

Primary outcomes:
measure: presence of conduction disorders on postoperative ECGs
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT00744445: Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity
Official title: Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemodialysis
Chronic Renal Failure
Anemia
Keywords: hemodialysis
erythropoietin
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2008-09-01
Enrollment: 46
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: The purpose of this research study was to determine if the activity of erythropoietin (r-HuEPO) is time dependent when given to chronic renal failure patients at three different times of day.

Detailed description: This phase-II crossover study was designed to test if the activity of erythropoietin is time dependent. Patients with chronic renal failure on hemodialysis requiring r-HuEPO to maintain adequate levels of hematocrit are eligible for the study. Patients were administered r-HuEPO subcutaneously three times per week, 50 U/kg, rounded to the nearest 2000 units. r-HuEPO will be administered until the hematocrit rises from the baseline level of 20-24% to the target level of 30-34%. This will be repeated three times, each at different times of day, either 0800, 1500 or 2200 hrs and the order of these will be randomly determined. Each patient will complete all three of the phases.

Eligibility criteria: Inclusion Criteria:

* Chronic renal failure patients requiring hemodialysis and requiring r-HuEPO to maintain adequate hematocrit levels
* Serum ferritin level \> 200 micrograms/L and transferrin saturation \> 15%
* Serum erythropoietin level less than 500 mu/ml (when off r-HuEPO)
* Prior therapy with r-HuEPO
* An adequate program of dialysis established
* Informed consent signed

Exclusion Criteria:

* Adocumented cause of anemia other than chronic renal disease
* Symptoms of unstable coronary artery disease
* Poorly controled hypertension
* Known seizure disorder
* Other active inflammatory or infective disorders
* Other disorders that may diminish the response of the bone marrow to r-HuEPO

Primary outcomes:
measure: Time for hematocrit to rise
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Georg Bjarnason, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06139445: Manual Lymphatic Drainage for Pain, Muscle Strength, and Sensation
Official title: Effect of Manual Lymphatic Drainage on Pressure Pain Threshold, Pain Tolerance, Grip and Pinch Strength, and Two-point Discrimination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Manual Lymphatic Drainage Effects
Keywords: Manual lymphatic drainage
pain threshold
pain tolerance
two-point discrimination
muscle strength
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the acute effect of MLD on pressure pain threshold (PPT), pain tolerance, tactile sensation, and muscle strength in healthy young adults.

healthy young adults were included in the study. Before and after MLD and plasebo touchs, the same physiotherapist performed PPT and pain tolerance measurements, muscle strength measurements with a hand dynamometer (Jamar®) and pinchmeter (Baseline®), and two-point discrimination (2PD) evaluation with an esthesiometer.


Eligibility criteria: Inclusion Criteria:

* Being aged 18-30 years
* Volunteering to participate in the study

Exclusion Criteria:

* Having any skin disease
* Having a history of neurological and/or orthopedic disease
* Having a significant scar or burn tissue in the upper extremity
* Having any condition that would prevent communication

Primary outcomes:
measure: pressure pain threshold (PPT)
timeFrame: 5 minutes
measure: pain tolerance
timeFrame: 5 minutes
measure: Evaluation of Hand Grip Strength
timeFrame: 5 minutes
measure: Evaluation Finger Pinch Strength
timeFrame: 5 minutes
measure: Two-point discrimination (2PD)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
References:
Clinical trial NCT05083845: The Effect of Different Local Anesthetic Volumes on Postoperative Analgesia for Thoracotomy Patients With Erector Spinae Plane Block
Official title: The Effect of Different Local Anesthetic Volumes for Thoracotomy Patients With Erector Spinae Plane Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erector Spinae Plane Block
Local Anesthetic
Thoracotomy
Postoperative Analgesia
Lead sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 60
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: TREATMENT

Brief summary: It is widely accepted that thoracotomy causes severe acute pain. This increases the frequency of postoperative pulmonary complications and postoperative morbidity. Many analgesic methods have been proposed for thoracotomy pain, including thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), intercostal nerve blocks (ICSB), erector spinae plane block (ESPB), serratus anterior plane block (SAPB). Among these methods, ultrasound-guided TPVB and ESPB are the most used methods. TPVB has left its place to newer techniques such as ESPB due to its proximity to the pleura and its deeper location. ESPB is more superficial, easy to access, and less likely to have complications. In addition, ESPB application is increasing in patients who underwent thoracotomy and VATS. There is no consensus on the dose of analgesia in these studies. There are studies on volumes between 10 ml and 40 ml in the literature. In this study, it was aimed to compare the volumes of 20 ml and 30 ml containing local anesthetic at the same concentration (0.25% bupivacaine) of ESPB block to be performed with USG in patients who underwent thoracotomy.


Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old
* ASA physical status I-II-III
* BMI 18 to 30 kg/m2
* Elective thoracotomy surgery

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* History of chronic opioid or analgesic used

Primary outcomes:
measure: Pain Scores
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Morphine Consumption
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Kecioren
country: Turkey
facility: Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
state: Ankara
Study officials:
References:
Clinical trial NCT04558645: Evaluation of Quality of Life in Patients With Type 1 Diabetes Mellitus During the Covid-19 Pandemic
Official title: Evaluation of Quality of Life, Physical Activity and Depression in Patients With Type 1 Diabetes Mellitus During the Covid-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Covid19
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 1 diabetes mellitus and healthy controls between 18-65 years

Brief summary: During the COVID-19 pandemic, the time spent at the home of patients has increased because of national quarantine policies and patients' fear of getting sick. For this reason, in this ongoing process, patients have been unable to go to work regularly due to their chronic diseases (being on administrative leave) and their fear of going out. These reasons have prevented being physically active. The aim of the study is to evaluate the physical activity level, quality of life, glucose control, anxiety, depression, fear of hypoglycemia and loneliness perceptions of patients with type 1 diabetes mellitus during the COVID-19 pandemic period and compared with healthy controls.


Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with Type 1 Diabetes Mellitus
* Willing to participate in the study
* Participants whose native language is Turkish

Exclusion Criteria:

* Unwilling to participate in the study
* Having a cognitive disorder
* Not being literate
* Individuals who do not have sufficient knowledge and functional levels to fill out the online form

Primary outcomes:
measure: Physical activity level
timeFrame: Five minutes
measure: General Quality of life
timeFrame: Ten minutes
Secondary outcomes:
measure: Depression
timeFrame: Three minutes
measure: Anxiety
timeFrame: Three minutes
measure: Self-reported hypoglycemia
timeFrame: Last seven day
measure: Loneliness
timeFrame: Three minutes
measure: Hypoglisemia fear
timeFrame: Five minutes
measure: Dyspnea
timeFrame: Two minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zeliha ÇELİK
state: Çankaya
Study officials:
affiliation: Gazi University
name: Zeliha ÇELİK, MSc
role: STUDY_CHAIR
affiliation: Gazi University
name: Meral BOŞNAK GÜÇLÜ, Prof
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Füsun BALOŞ TÖRÜNER, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05382845: Screening for Pregnancy Related Pelvic Girdle Pain
Official title: Are There Associations Between the Outcomes of Pain Provocation Tests Early in Pregnancy and the Development of Pregnancy Related Pelvic Girdle Pain?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Girdle Pain
Lead sponsor: Blekinge County Council Hospital
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2022-05-19
Enrollment: 360
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prediction modelling, where risk factors such as earlier trauma to the pelvis, earlier low back pain, earlier pregnancy related pelvic girdle pain, physically demanding job, contraception and the outcomes of the pain provocation tests will predict to what degree a woman is at risk of developing symptoms.
Primary purpose: SCREENING

Brief summary: To perform clinical manual pain provocation tests of the pelvic joints in pain free pregnant women early in pregnancy, follow them until delivery, and compare those who develop PPGP with those who don't.

Detailed description: One arm study:

Pregnant women are informed about the study at their first visit in Maternity care. Those that are interested in participating sign an informed consent, and book an appointment with a manual therapist. During the appointment five pain provocation tests are performed to the pelvic joints, and about 13 questions regarding previous low back pain, trauma to the pelvic, or pelvic pain during previous pregnancies, number of previous pregnancies, number of years with contraception, any presence of lactosis intolerance, profession, degree of physical exercises, gestational week, age, and BMI are asked by the therapist. Each participant is given a telephone call after delivery, to ask whether any pelvic pain ocurred or not, and whether sick-leave was necessary.

Eligibility criteria: Inclusion Criteria:

* Pregnant women before gestational week 20 without any ongoing symptoms of pain from their pelvic joints.

Exclusion Criteria:

* Fibromyalgia
* sick-leave
* working at home
* treatment of the pelvic joints during the pregnancy

Primary outcomes:
measure: Correlation between pain provocation tests, different risk factors and full time sick-leave.
timeFrame: Approximately six months for each participant
Secondary outcomes:
Other outcomes:
Locations:
city: Karlskrona
country: Sweden
facility: The Region Hospital of Blekinge County
state: Blekinge
Study officials:
affiliation: Karolinska Institutet
name: Stina Lilje, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00750945: Treadmill and Music Cueing for Gait Training in Mild to Moderate Parkinson's Disease
Official title: Treadmill and Music Cueing for Gait Training in Mild to Moderate Parkinson's Disease: a Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Cueing training
Treadmill training
Music
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2008-09-11
Enrollment: 30
Sex: MALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Sensory and motor cueing have been demonstrated as useful ambulation training techniques for Parkinson's disease (PD). This study is aimed to evaluate the effectiveness of treadmill training program with music cueing for mild to moderate PD patients.


Eligibility criteria: Inclusion Criteria:

1. Male PD patients aged 60-80 years with Hoehn and Yahr stage 2-3 diagnosed by attending neurologist
2. Good cognitive function with Thai Mental State Examination \>23
3. Stable medication without freezing
4. No prior exercise program within the last 2 months
5. No contraindication for exercise

Exclusion Criteria:

1. Medication change during the study program
2. Inability to walk on treadmill (in treadmill groups)
3. Cannot complete 80% of the prescribed program

Primary outcomes:
measure: Walking performance evaluated with Timed Up and Go test, walking speed, step length, and cadence.
timeFrame: within 1 week after training, and at 4 weeks follow up
Secondary outcomes:
measure: Balance (single leg stance time) and fall rate
timeFrame: within 1 week after training, and at 4 weeks follow up
measure: Aerobic endurance (6 minute walk test)
timeFrame: AA) within 1 week after training, and at 4 weeks follow up
measure: Mentation, mood, behavior, Motor and ADL subscale of UPDRS
timeFrame: within 1 week after training, and at 4 weeks follow up
measure: Patient's satisfaction
timeFrame: within 1 week after training, and at 4 weeks follow up
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Dootchai Chaiwanichsiri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06617845: Optimizing Brain Stimulation Parameters
Official title: Optimizing Brain Stimulation Parameters
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy; Seizure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A primary purpose of this study is to better understand what stimulation parameters work best for patients. For example, for Deep Brain Stimulation (DBS) of the Anterior Nucleus of the Thalamus (ANT), it is not clear what stimulation frequency leads is most effective. This study will help assess the effectiveness of low frequency or high frequency stimulation.


Eligibility criteria: Inclusion Criteria:

* Patients who are implanted with a brain stimulation device targeting the anterior nucleus of the thalamus per Mayo Clinic standard of care

Exclusion Criteria:

* Patients for whom clinical follow-up is not expected during the initial 6-8 months following implant

Primary outcomes:
measure: Seizure burden
timeFrame: Baseline, 4 months, 7 months, 12 months
Secondary outcomes:
measure: Change in Mayo Post-Stimulation Activation score
timeFrame: Baseline, 4 months, 7 months, 12 months
measure: Change in Mayo Epilepsy Short Assessment (MESA) score
timeFrame: Baseline, 4 months, 7 months, 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
References:
Clinical trial NCT05836545: Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy
Official title: A Randomized, Single-Blind, Investigator Initiative Trial Study of Remimazolam Versus Midazolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Healthy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to compare the efficacy of remimazolam with midazolam in patients undergoing gastrointestinal endoscopy. The main questions it aims to answer are:

* Superiority of total procedure time in remimazolam compared to midazolam
* The success of sedation time

This is the single blind study.; Patients will not know what they are given as the sedation drug If there is a comparison group: Researchers will compare patients with midazolam group to see if remimazolam group is superior to midazolam group


Eligibility criteria: Inclusion Criteria:

* Patients who agreed for this clinical trials
* Patients who want diagnostic endoscopy under sedation
* The total procedure time which is predicted within 15 minutes
* ASA \>=2
* BMI more than 18.5kg/m2, less than 30kg/m2

Exclusion Criteria:

* Patients who have stomach illness
* Patients with respiratory disease
* Mallampati Score\>=3
* Systolic BP \>160mmHg or \<90mmHg
* Refractory Hypertension
* Uncontrolled glaucoma
* Severe liver failure or chronic kidney disease
* Patients with drug abuse or alcohol abuse within 1 year
* Patients who are sensitive for certain medication (such as benzodiazepine, remimazolam)
* Obstructive sleep dyspnea patients
* Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Pregnant, breast feeding patient

Primary outcomes:
measure: Total procedure time
timeFrame: begin when the drug is give to when the endoscopy is withdrawn
Secondary outcomes:
measure: The success rate of sedation
timeFrame: Completion of the whole endoscopy procedures, No requirement for an alternative and/or rescue sedative, Administered up to a maximum of five supplemental doses within 15 mnutes after the initial dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Taejun Kim
role: STUDY_DIRECTOR
References:
Clinical trial NCT01901445: Quality of Life in Children and Adolescents With Chronic Functional Constipation: Educational Action Effects
Official title: Quality of Life in Children and Adolescents With Chronic Functional Constipation: Educational Action Effects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Functional Constipation
Keywords: Quality of life
Constipation
Focus groups
Health education
Problem-based learning
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 11
Sex: ALL
Minimum age (years): 6
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if the quality of life in children and adolescents diagnosed with chronic functional constipation improves after educational activity in focus group composed by these patients' mothers.

Detailed description: The present research will be conducted on the specific constipation clinic in Hospital das Clínicas at Universidade Federal de Pernambuco.

Eligibility criteria: Inclusion Criteria:

* Children (6 to 9 years-old) and adolescents
* Diagnostic of chronic functional constipation

Exclusion Criteria:

* Patients using calcium and/or heme
* Patients with organic diseases that causes constipation

Primary outcomes:
measure: The improvement in the quality of life on participants after the intervention
timeFrame: 3 months
Secondary outcomes:
measure: The improvement in clinical parameters of chronic functional constipation
timeFrame: 3 months
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Gabriela CS Sette, MSc
role: PRINCIPAL_INVESTIGATOR
References: