louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02700633: Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI
Official title: Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: TAVI
Lead sponsor: Royal Sussex County Hospital
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients post TAVI

Brief summary: Pacemaker requirement in the immediate post procedure phase following TAVI is approximately 20% depending on device type and patient characteristics. There is a signal from recent studies suggesting increased risk of sudden cardiac / unexplained death in the first 30-60 days. This study aims to address whether there is a mortality advantage to having a pacemaker in the short term


Eligibility criteria: Inclusion Criteria:

* All patients post TAVI

Exclusion Criteria:

* Nil

Primary outcomes:
measure: 30 day mortality
timeFrame: 30 dyas
Secondary outcomes:
measure: 60 day mortality
timeFrame: 60 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03888833: Risk Factors of Bleeding Under Veno Arterial Membrane Oxygenation
Official title: Risk Factors of Bleeding in Patients Undergoing Peripheral Veno Arterial Extra Corporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extracorporeal Membrane Oxygenation
Bleeding
Complication
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veno arterial extracorporeal membrane oxygenation

Brief summary: Veno arterial extracorporeal membrane oxygenation (VA ECMO) is used, for cardiogenic shock, refractory cardiac arrest and post cardiotomy cardiac failure. Bleeding is frequent complications during VA ECMO and is associated with increased mortality. The aim of our study was to identify early factors associated with major bleeding in patients supported by VA ECMO


Eligibility criteria: Inclusion Criteria: Patients over 18 years treated by peripheral veno arterial membrane oxygenation

Exclusion Criteria: None

Primary outcomes:
measure: Rate of major hemorrhagic episodes defined as follows: loss of over 2g dl-1 of hemoglobin in 24 h, bleeding rate over 20 ml kg-1 day-1 or blood transfusion over 10 ml kg-1 day-1
timeFrame: Through study completion, an average of 10 years
Secondary outcomes:
measure: Rate of mortality
timeFrame: 30 day
measure: Duration of life support
timeFrame: Through study completion, an average of 10 years
measure: Length of stay
timeFrame: Through study completion, an average of 10 years
measure: Ischemic and thrombotic complications
timeFrame: Through study completion, an average of 10 years
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT05078333: Dry Needling and High Intensity Laser Therapy in Treatment of Myofascial Pain Syndrome
Official title: Comparison of Effectiveness of Dry Needling and High Intensity Laser Therapy in Treatment of Myofascial Pain Syndrome: A Randomized Single-blind Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Keywords: Myofascial pain syndrome
high-intensity laser therapy
dry needling
exercise
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 108 myofascial pain syndrome (MPS) diagnosed patients will be randomly divided into 3 groups. To groups; exercise, exercise+high-intensity laser therapy (HILT) and exercise+dry needling will be applied. Visual anolog scale (VAS) scores and neck range of motion (ROM) of the patients before-after treatment will be recorded and will be evaluated statistically.

Detailed description: Myofascial pain syndrome (MPS) is a very common disease in the population that seriously affects the quality of life. Although many modalities are used in its treatment, there is still no common protocol. In this study, the investigators aim to compare the effectiveness of high-intensity laser therapy (HILT), which has been popular in recent years, with exercise and dry needling options that have been used for years.

In our study 108 myofascial pain syndrome (MPS) diagnosed patients will be randomly divided into 3 groups. To groups; exercise, exercise+high-intensity laser therapy (HILT) and exercise+dry needling will be applied. Visual anolog scale (VAS) scores and neck range of motion (ROM) of the patients before-after treatment will be recorded and will be evaluated statistically.

Eligibility criteria: Inclusion Criteria:

* diagnosed with neck and / or back pain
* diagnosed with MPS
* had a taut band on the trapezius muscle and at least one active trigger point

Exclusion Criteria:

* Diagnosed with fibromyalgia,
* had systemic disease,
* significant cervical disc lesion / radiculopathy / myelopathy,
* had trigger point injection in the last 6 months,
* had neck or shoulder surgery in the year before being included in the study,
* was pregnant,
* received anticoagulant therapy,
* used aspirin in the last three days, and
* with the cognitive dysfunction patients

Primary outcomes:
measure: Visual anolog scale (VAS)
timeFrame: 10 seconds
Secondary outcomes:
measure: neck range of motion (ROM)
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Private Medar Hospital
Study officials:
affiliation: private medar hospital
name: emine dundar ahi, assoc prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05100433: Effect of Passive Ultrasonic Irrigation on Bacteria That Persist After Root Canal Preparation
Official title: Effect of Passive Ultrasonic Irrigation on Bacteria That Persist After Root Canal Preparation in Teeth With Apical Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Infections
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effectiveness of ultrasonic irrigation in improving root canal disinfection after chemomechanical procedures.

Detailed description: Although chemomechanical procedures promote a drastic bacterial reduction, many root canals remain infected, which points to the need for complementary procedures to improve root canal disinfection. Thus, this clinical study aims to evaluate the effect of passive ultrasonic irrigation as a supplementary disinfection procedure after root canal preparation. Microbiological samples of the root canals of 30 single-rooted teeth with apical periodontitis will be taken at different stages of the endodontic treatment: before preparation (S1), after chemomechanical procedures (S2) and after passive ultrasonic irrigation (S3). The samples will be submitted to the quantitative polymerase chain reaction for bacterial quantification and to the reverse transcription quantitative polymerase chain reaction for bacterial activity analysis. Data will be analyzed using the Wilcoxon test for paired samples (p \< 0.05).

Eligibility criteria: Inclusion Criteria:

* Teeth with necrotic pulps and asymptomatic apical periodontitis

Exclusion Criteria:

* patients who had received antibiotics during the previous 3 months or had any general disease,
* teeth that could not be properly isolated with rubber dam,
* non-restored teeth,
* periodontal pockets depths greater than 4 mm,
* previous endodontic treatment,
* open apex,
* crown/root fracture
* root resorption or calcifications.

Primary outcomes:
measure: Bacterial Activity
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: Bacterial Levels
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
state: SP
Study officials:
References:
Clinical trial NCT00051233: Treatment of Schizophrenia Through Internet-Based Psychoeducation
Official title: Schizophrenia Patient and Family Continuity of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness of a Web-based psychoeducational program in helping people with schizophrenia and their families manage the disease.

Detailed description: This study will provide a comprehensive psychoeducational program which includes education, social support, information, coping strategies, and guidance from mental health, social services, and medical professionals. This study will work to reduce relapse, facilitate patient rehabilitation, decrease family distress, and improve family well being.

Patients and their families participate in an in-person Psychoeducational Survival Skills Workshop that is designed to provide patients and their families with basic information about schizophrenia and its treatment. After the workshop, participants are provided with 6 Web-based modules that are designed to increase mental health and schizophrenia knowledge. Patient relapse, family distress, family knowledge of schizophrenia, and data on user's acceptance and utilization are measured to determine the intervention's effectiveness.

Eligibility criteria: Inclusion Criteria

* DSM-IV diagnosis of schizophrenia or schizoaffective disorder
* At least 4 hours/week in-person contact with a family member
* Primary caregiver with a telephone
* Patient and primary caregiver speak and read English

Exclusion Criteria:

* Enrolled in another clinical trial
* Evidence of organic brain syndrome
* Current alcohol or substance abuse that could explain the presenting index psychotic episode
* DSM-IV diagnosis of psychoactive substance dependency

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Armando J Rotondi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01546233: Multidisciplinary Education in Lung Cancer Patients Who Receiving Chemotherapy Treatment
Official title: Outcome of Multidisciplinary Education Programme in Self-care in Fatigue Lung Cancer Patients Who Receiving Chemotherapy Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung cancer
Chemotherapy
Multidisciplinary self care programme
Fatigue
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2012-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fatigue Lung Cancer Patients

Brief summary: The purpose of this study is to compare the fatigue in lung cancer patients receiving chemotherapy treatment, between the education programme in self-care a multidisciplinary with the group who received standard care.

Detailed description: Educate of self-care by Oncology nurses to relieve and prevent the fatigue of cancer chemotherapy, and provide the manual to read at home, take about 15 minutes. By using home exercise program, 30 minutes of physical education. Teaching and demonstration exercises of the muscles to breath and conservation of energy during exercise and record the exercise/walking diary, the nutritional education nutrition counseling, psychiatric assessment,self-care prevention of depression.

Eligibility criteria: Inclusion Criteria:

1. Aged 45-65 years.
2. Has been diagnosed lung cancer stages 3-4 must be chemotherapy is platinum-based, and had received chemotherapy for at least one time, must be in the range of 2-4 cycles of chemotherapy.
3. Performance status: ECOG 0-1
4. No problem hearing it.
5. Read and write Thai.
6. Be willing to cooperate in research. And signed a joint research

Exclusion Criteria:

1. The complications include: high fever, severe nausea and vomiting.
2. Injection drug use in diabetes treatment.
3. Ischemic heart disease with heart arrhythmia and the drug continuously.
4. Is unable to daily living. Caused by defects in movement, and severe osteoarthritis, muscle atrophy, paralysis or walking flat less than 10 meters.

Primary outcomes:
measure: Measure fatigue by questionnaires
timeFrame: August 2011 to august 2012 (up to 1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Chemotherapy Unit, Rajavithi Hospital
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Kotchukorn Wnagnum, Msc (nurse)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04340687: Combination of Rectal Indomethacin and Pancreatic Duct Stenting Versus Indomethacin Alone in Preventing PEP
Official title: Combination of Rectal Indomethacin and Pancreatic Duct Stenting Versus Indomethacin Alone in Preventing Post-ERCP Pancreatitis in Patients With Difficult Cannulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Indomethacin
Double-guidewire technique
Adverse events
PEP
PD stenting
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent ERCP and received administration of rectal indomethacin.

Brief summary: Rectal indomethacin and pancreatic duct (PD) stenting (PDS) are recommended for the prevention of post-ERCP pancreatitis (PEP). However, the effects of the combination of the two methods on preventing PEP are controversial. We hypothesized that some group of patients with difficult cannulation might benefit from the combination of indomethacin plus PDS (IP) compared with indomethacin alone (IN).


Eligibility criteria: Inclusion Criteria:

1. Patients underwent diagnostic or therapeutic ERCP
2. With native papilla
3. With difficult cannulation (cannulation time \>10min or cannulation attempts \>5 times or inadvertently PD cannulation ≥1)
4. Receiving post-ERCP rectal indomethacin

Exclusion Criteria:

1. Patients with indications of PD cannulation
2. No attempt of cannulation due to inaccessible papilla
3. Non-difficult cannulation

Primary outcomes:
measure: Overall PEP
timeFrame: 30 days
Secondary outcomes:
measure: Overall ERCP related complication
timeFrame: 30 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
References:
citation: Dumonceau JM, Andriulli A, Elmunzer BJ, Mariani A, Meister T, Deviere J, Marek T, Baron TH, Hassan C, Testoni PA, Kapral C; European Society of Gastrointestinal Endoscopy. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014. Endoscopy. 2014 Sep;46(9):799-815. doi: 10.1055/s-0034-1377875. Epub 2014 Aug 22.
citation: Akbar A, Abu Dayyeh BK, Baron TH, Wang Z, Altayar O, Murad MH. Rectal nonsteroidal anti-inflammatory drugs are superior to pancreatic duct stents in preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a network meta-analysis. Clin Gastroenterol Hepatol. 2013 Jul;11(7):778-83. doi: 10.1016/j.cgh.2012.12.043. Epub 2013 Jan 30.
Clinical trial NCT02805387: Bicarbonate Given During Dystocic Labor
Official title: Bicarbonate, a New Treatment of Labour Dystocia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrested Labor
Keywords: labor dystocia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dystocic deliveries and the use of bicarbonate

Detailed description: A randomized controlled trial of 200 primiparous women in active labour.If cervical dilation crossed the action line in the partogram or if labour progress was arrested for two hours or more the delivery was considered to be dystocic, and Oxytocin was suggested for stimulation. Inclusion criteria were: primiparity, singleton pregnancy, with an arrested labour progress with a need for oxytocin. Gestational age was between 37-42 weeks, and no maternal /fetal chronic and/or pregnancy-related conditions. Excluded were multiparous women, deliveries with non-cephalic presentation, multiples, deliveries with fetal chronic and/or pregnancy-related conditions, IUFD (Intra Uterine Fetal Death) or premature \< 37 weeks of gestation. A randomization into two groups was performed. One group was treated with two bags of Samarin® (=Samarin® group, 5g bicarbonate) one hour before stimulation with oxytocin started. The other group (=nonSamarin® group) received no bicarbonate and started oxytocin immediately, according to local clinical guidelines. Maternal and fetal data was collected from medical files after delivery and analysed according to group.

Eligibility criteria: Inclusion Criteria:

* primiparity, singleton pregnancy
* with an arrested labour progress according to the partogram with a need for oxytocin
* Gestational age was between 37-42 weeks
* and no maternal /fetal chronic and/or pregnancy-related conditions.

Exclusion Criteria:

* multiparous women
* deliveries with non-cephalic presentation
* multiples
* deliveries with fetal chronic and/or pregnancy-related conditions
* IUFD (Intra Uterine Fetal Death) or premature \< 37 weeks of gestation

Primary outcomes:
measure: Frequency of spontaneous vaginal delivery
timeFrame: during labor
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Eva Wiberg-Itzel
Study officials:
affiliation: Karolinska Institutet
name: Per Tornvall, professor
role: STUDY_CHAIR
References:
Clinical trial NCT00292487: Patients With Renal Impairment Undergoing CT
Official title: Isovue and Visipaque in Renally Impaired Patients Undergoing CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contrast Induced Nephropathy
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2006-02-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with mild to moderate renal impairment who undergo a clinically indicated IV contrast-enhanced (multidetector computed tomography) MDCT of the liver or MDCT angiography of the lower extremities. Serum Creatinine (SCr) will be measured before and up to 48-72 hours post dose.


Eligibility criteria: Inclusion Criteria:

* referred for MDCT of liver or peripheral CTA
* stable baseline SCr of 1.5 - 2.5 mg/dL and/or calculated CrCl of 10-60 mL/min

Exclusion Criteria:

* unstable renal function
* required prophylactic drugs to receive contrast (other than hydration)
* uncontrolled diabetes
* currently on dialysis

Primary outcomes:
measure: Increase in SCr at 48-72 hours post dose
Secondary outcomes:
measure: Compare incidence of delayed hypersensitivity type reactions
measure: Compare changes in heart rate
measure: Compare efficacy of key vessels
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bracco Diagnostics, Inc
state: New Jersey
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Marie Morris
role: STUDY_DIRECTOR
References:
Clinical trial NCT02342587: Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer
Official title: Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer: A Phase II Single Arm Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HER2-positive Refractory Advanced Cancer
Keywords: Lapatinib
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-01-21
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Although anti-HER2 (human epidermal growth factor receptor 2) therapy is currently approved for breast, gastric, and gastroesophageal cancers overexpressing the HER2 protein or amplified for the HER2 gene, HER2 aberrations (gene amplification, gene mutations, and protein overexpression) are reported in other diverse malignancies. Indeed, about 1-37% of tumors of the following types harbor HER2 aberrations: bladder, cervix, colon, endometrium, germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct.

Lapatinib is an orally active, reversible, small molecule TKI that potently inhibits both ErbB1 and ErbB2 tyrosine kinase activity. Data suggest that a dual ErbB1 and ErbB2 inhibitor may provide improved therapeutic benefit compared with inhibitors that target only one or the other receptor.

Therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients with HER2-positive refractory cancer.


Eligibility criteria: Inclusion Criteria:

* Age \> 19
* Written informed consent
* ECOG 0-2,
* Histologically confirmed HER2-positive Refractory solid tumor(IHC 3+ alone, or IHC 2+ with FISH amplification) and/or specific sensitivity to Lapatinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
* The presence of measurable disease as defined by the Response (Evaluation Criteria in Solid Tumors (RECIST) version 1.1)
* Adequate organ function

Exclusion Criteria:

* Uncontrolled symptomatic brain metastasis,Uncontrolled active infection
* Uncontrolled systemic illness (DM, CHF, unstable angina, hypertension or arrhythmia)
* Prolonged QT interval in ECG (QTc \>450 msec)
* Pregnant, lactating women
* Prior treatment with lapatinib,Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication
* Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer

Primary outcomes:
measure: overall response rate
timeFrame: 4 weeks after treatment of lapatinib
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: