louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04670497: Perioperative Analgesia for Total Hip Arthroplasty
Official title: Perioperative Analgesia for Total Hip Arthroplasty: Lumbar Plexus Block Using Shamrock Technique Versus Fascia Iliaca Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Anesthesia
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is comparing the effect of Lumbar plexus block and fascia iliaca block with general anesthesia to provide perioperative pain control and compare their effects on hemodynamics.
Primary purpose: TREATMENT

Brief summary: This study is comparing the effect of lumbar plexus block and fascia iliaca block with general anesthesia to provide perioperative pain control and compare their effects on hemodynamics

Detailed description: Different groups receive different interventions at same time during study. patients were randomly allocated in two groups :

Group A: lumbar plexus block using shamrock technique by 0.3 ml/kg of 0.5% bupivacaine with 1:200000 adrenaline.

Group B: Fascia iliaca block by 0.3 ml/kg of 0.5% bupivacaine with 1:200000 adrenaline.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II and scheduled for elective total hip arthroplasty

Exclusion Criteria:

* Patients who refuse to participate.
* Local infection.
* Patients with coagulation defects

Primary outcomes:
measure: Assessment of postoperative analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: Compare effects of both groups on mean arterial blood pressure
timeFrame: intraoperative and 24 hours
Other outcomes:
measure: compare their effects on heart rate (beat\minute)
timeFrame: intraoperative and 24 hours
measure: Complication rate for procedures in the form of local anesthetic toxicity
timeFrame: Intraoperative monitoring
Locations:
city: Cairo
country: Egypt
facility: Ahmed hashem
state: Assistant Lecturer
Study officials:
affiliation: faculty of medicine, anesthesia department
name: ahmed abd elraof, professor
role: STUDY_CHAIR
affiliation: faculty of medicine, anesthesia department
name: Ezz elden saleh, professor
role: STUDY_CHAIR
affiliation: faculty of medicine, anesthesia department
name: sadek abdelmasih, lecturer
role: STUDY_DIRECTOR
References:
Clinical trial NCT04587297: Food Collection From Type 1 Diabetic Patients Practicing Insulin Functional Therapy
Official title: Food Collection From Type 1 Diabetic Patients Practicing Insulin Functional Therapy : GLUCAL2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Type 1
Keywords: Diabetes
Functional insulin therapy
carbohydrate counting
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 diabetic patients

Brief summary: a food collection will be performed in this study with type 1 diabetic patients trained to carbohydrate counting, to collect data on the meals consumed daily and their quantities for a period of 1 month.


Eligibility criteria: Inclusion criteria:

* type 1 diabetic patients
* Using carbohydrate counting and functional insulin therapy
* Patient with Social security or beneficiary
* Patient able to read and understand the procedure, and able to express consent for the study protocol

Exclusion criteria:

* Patient abusing substances
* person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure -- Patient having a psychological conditions making him unable to follow and understand study protocol

Primary outcomes:
measure: number of meals
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Eric RENARD, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01798797: Integrated Diagnostic for Heart Failure
Official title: Integrated Diagnostic for Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
HFRS
OptiVol
ICD
CRT-D
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2013-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with heart failure who have been implanted with an ICD or a CRT-D wirless device for at least 3 months

Brief summary: A prospective post-market study to evaluate the performance and clinic usability of heart failure risk status (HFRS) feature on CareLink.

Detailed description: Patients with systolic heart failure (HF) implanted with Medtronic wireless implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy device with defibrillation capabilities (CRT-D) devices will be enrolled in the study. The purpose of the study is to evaluate the usability of CareLink HFRS to manage a patient's heart failure.

Eligibility criteria: Inclusion Criteria:

* Patient is 18 years of age or older
* Patient ( or patient's legally authorized representative) is willing and able to provide written informed consent
* Patient is willing and able to comply with the required study follow up visits
* Patient is implanted with a Medtronic wireless ICD or CRT-D device capable of OptiVol fluid monitoring feature
* Patient is on Medtronic CareLink network or is willing to be enrolled on the CareLink network
* Patient is being managed, or has been managed, by a HF clinician
* Patient has signed an informed consent for CareLink Network Services
* Patient is implanted with device for at least three months
* Patient is willing and able to transmit data using the CareLink home monitor (2490C).

Exclusion Criteria:

* Patient is participating in another study that may interfere with TRIAGE-HF protocol required procedures
* Patient with an implantable cardiac device that is indicated to reach ERI in less than 12 months

Primary outcomes:
measure: Heart Failure Risk Status Performance Characterization
timeFrame: from baseline until a subject completes 8 months of follow up
Secondary outcomes:
measure: Heart Failure Risk Status and medical management
timeFrame: from baseline for each subject until they complete 8 months of follow up
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
Study officials:
affiliation: Vancouver General Hospital, Vancouver, British Columbia, Canada
name: Sean Virani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06360497: The Effect of Mindfulness Meditation and Loving-kindness and Compassion Meditation on Psychological Distress
Official title: The Effect of Mindfulness Meditation and Loving-kindness and Compassion Meditation on Psychological Distress: The Perspective of Reinforcement Sensitivity Theory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MM Group
LKCM Group
Waitlist Group
Keywords: mindfulness, loving-kindness and compassion
Lead sponsor: Beijing Normal University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to explore the effect of of mindfulness meditation and loving-kindness and compassion meditation on psychological distress (i.e., anxiety, depression, stress), and explore the mechanism from the perspective of reinforcement sensitivity theory.

Detailed description: Participants were randomly assigned to three groups: mindfulness meditation group (MM, n = 51), loving-kindness and compassion meditation group (LKCM, n = 51), and waitlist group (n = 50). Participants in MM group and LKCM group received four weeks intervention, and data was collected before the intervention and after the intervention.

Eligibility criteria: Inclusion Criteria:

(1) have not attended structured meditation intervention; (2) have not diagnosed psychiatric diseases; (3) not currently receiving or has never received psychological counseling; (4) not currently taking or has never taken psychotropic medication; (5) age is less than 18.

Exclusion Criteria:

(1) have attended structured meditation intervention; (2) have diagnosed psychiatric diseases; (3) receiving or have received psychological counseling; (4) taking or have taken psychotropic drugs; (5) age is more than 18.

Primary outcomes:
measure: The Depression Anxiety Stress Scale
timeFrame: 2 months
measure: The Philadelphia Mindfulness Scale
timeFrame: 2 months
measure: The Sensitivity to Punishment and Sensitivity to Reward Questionnaire
timeFrame: 2 months
Secondary outcomes:
measure: The Emotional Word Lists
timeFrame: 2 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xianglong Zeng
state: Beijing
Study officials:
References:
Clinical trial NCT00181597: Trilostane for Androgen-Independent Prostate Cancer
Official title: A Phase II Study of Trilostane for Androgen-Independent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Keywords: Trilostane
Androgen-independent prostate cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 24
Sex: MALE
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 main purpose of this study is to test the safety of trilostane by looking at what effects, good and bad, it has on patients with androgen-independent prostate cancer.

Detailed description: * Patients will take trilostane orally once a day for three days, then twice a day thereafter.
* Patients will complete a daily drug log recording the date, time and number of capsules taken.
* Trilostane may moderately decrease the production of steroids by the adrenal glands. In order to prevent any symptoms related to decreased steroid production, patients will also take hydrocortisone at the same time as the trilostane.
* While the patients are on treatment blood work will be done after 2 weeks and then every 4 weeks to test the levels of PSA in the blood. On weeks 4 and 8 of treatment additional blood work will be done to check hormone levels. Blood pressure and pulse rate will also be taken every 4 weeks.
* Depending upon disease status, radiological testing (CT scan, x-rays, and/or bone scan) may be repeated every 12 weeks.
* Patients will remain on study treatment as long as their disease responds and they do not experience any severe side effects.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed prostate adenocarcinoma
* Disease progression despite androgen depravation therapy and antiandrogen withdrawal
* Progressive measurable disease or bone scan progression or PSA progression
* Serum total testosterone \< 50ng/ml
* Creatinine \< 2.0 mg/dl
* ALT \< 2 x ULN
* CALGB performance status of 0,1, or 2

Exclusion Criteria:

* Radiation therapy within 4 weeks
* Antiandrogen within 8 weeks
* Other secondary hormonal therapy or investigational agents within 4 weeks
* Prior chemotherapy for androgen-independent prostate cancer
* History of adrenal insufficiency
* Known brain metastases
* Severe liver or renal disease

Primary outcomes:
measure: activity of trilostane in men with androgen-independent prostate cancer.
timeFrame: 4 years
Secondary outcomes:
measure: serum levels of gonadal and adrenal steroids
timeFrame: 4 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01790997: Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke
Official title: The Role of DLBS1033 in Evaluating Bleeding Profile and Clinical Outcome in Patients With Acute Ischemic Stroke: Comparison With Aspirin and Clopidogrel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Ischemic Stroke
Keywords: DLBS1033
Lumbrokinase
Acute ischemic stroke
Bleeding profile
Clinical outcome
Aspirin
Clopidogrel
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2013-02-13
Enrollment: 126
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3 months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical outcome in patients with acute ischemic stroke compared with aspirin and clopidogrel, as active controls.

Detailed description: There will be 3 groups of treatment; each group will consist of 43 subjects with the treatment regimens :

* Treatment I : 1 tablet of DLBS1033 490 mg thrice daily, after meal
* Treatment II : 1 tablet of aspirin 80 mg once daily, after meal
* Treatment III : 1 tablet of clopidogrel 75 mg once daily, after meal

Bleeding profile (by measuring INR value, PT, and aPTT) and clinical outcome (by measuring Gadjah Mada Stroke Scale and Barthel Index) to evaluate the efficacy of the investigational drug will be performed at baseline and end of study (Month 3rd). General condition of the subjects will be followed-up every month over three months of study medication.

Physiotherapy will be provided to the subjects by the assigned Physiotherapist.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged 20-80 years old
* Having non-bleeding stroke in CT scan examination
* Having stroke attack onset ≤ 96 hours
* Living in 100 km from RSUP Dr Sardjito Jogjakarta

Exclusion Criteria:

* Having recurrence stroke
* Having Transient Ischemic Attack (TIA)
* Have been regularly taking anti-aggregation agent
* Having intracerebral and subarachnoid bleeding stroke
* Subjects and their family do not know when the stroke symptoms appeared
* History of haemostasis disorder
* History of or will have surgery within 6 months prior to screening

Primary outcomes:
measure: Change in INR value
timeFrame: 3 Months
Secondary outcomes:
measure: Change in PT
timeFrame: 3 Months
measure: Change in aPTT
timeFrame: 3 Months
measure: Change in Gadjah Mada Stroke Scale
timeFrame: 3 Months
measure: Change in Barthel Index
timeFrame: 3 Months
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital
state: Jogjakarta
Study officials:
affiliation: Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital, Jogjakarta, Indonesia
name: Ismail Setyopranoto, dr., SpS(K)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05386797: Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis
Official title: Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Embolization
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA) is a highly prevalent degenerative joint disease that contributes to chronic pain and disability in approximately 10% of people over the age of 55. With 25% of Canadians expected to be aged 55 or older by 2036, an increasing number of Canadians will be impacted by knee OA. In affected individuals the risk of medical co-morbidities is increased which can lead to adverse cardiovascular outcomes, depression, and poorer quality of life. Current conservative therapy includes oral analgesia, lifestyle modification, corticosteroid injection, and viscosupplementation. These current conservative measures have variable responses. In patients who would prefer to avoid surgery or are not surgical candidates safe and consistently effective treatment options are lacking.

Geniculate artery embolization (GAE) is a minimally invasive alternative with low risk of complications that has shown promise in exploratory studies. GAE provides benefit by disrupting angiogenesis in the knee which can contribute to chronic inflammation of the affected joint, and helps prevent the growth of new sensory nerve fibers which can reduce the pain associated with osteoarthritis.


Eligibility criteria: Inclusion Criteria:

1. VAS score of at least 50 mm for knee pain
2. Pain resistant to at least 3 months of conservative therapy (including medical therapy, physiotherapy, intra-articular cortisone or viscosupplement injection).
3. Age \> 40 years
4. Radiographs demonstrating knee osteoarthritis on same side as pain
5. Patient not a surgical candidate or declines surgical management

Exclusion Criteria:

1. Radiographically severe knee osteoarthritis (Kellgren-Lawrence grade \>2)
2. Severe non-knee related lower limb pain with VAS \> 50 mm.
3. Local infection and inflammatory arthritis.
4. Malignancy
5. Previous knee surgery
6. Bleeding risk - known hematologic disease increasing risk of bleeding, pre-procedure INR \> 1.4, pre-procedure PTT \> 40 seconds or pre-procedure platelets \< 50,000/uL
7. Known chronic renal failure or eGFR \< 45
8. ECOG grade \> 2
9. Patient weight \> 300 lbs
10. Patient unreliable for follow up

Primary outcomes:
measure: Pain Reduction
timeFrame: 3 months
Secondary outcomes:
measure: Procedure related complications
timeFrame: 30 days
measure: Pain Reduction
timeFrame: 1 month and 6 months
measure: Pain, stiffness and physical function
timeFrame: 1, 3 and 6 months
measure: Pain medication required
timeFrame: 1, 3, and 6 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Hospital
Study officials:
References:
Clinical trial NCT00926497: Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis
Official title: Use of Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis: Prospective Randomized Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: antibiotic therapy
early-onset sepsis
interventions study
procalcitonin
term and near-term neonates
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 121
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neonatal bacterial sepsis is a major cause of mortality and morbidity and early antibiotic therapy is crucial for treatment success.

Objective: To evaluate the effect of Procalcitonin-guided decision making on duration opf antibiotic therapy in suspected neonatal early-onset sepsis.

Detailed description: This single-centre, prospective randomized intervention study was conducted in a tertiary neonatal and paediatric intensive care unit in the Children's Hospital of Lucerne, Switzerland between June 1, 2005 and December 31, 2006. All term and near term infants with suspected early-onset sepsis were randomly assigned either to standard treatment based on conventional laboratory parameters (standard group) or to Procalcitonin-guided treatment (Procalcitonin-group). Minimum duration of antibiotic therapy was (48)-72 hours in the standard group, whereas in the Procalcitonin group antibiotic therapy was discontinued when two consecutive Procalcitonin values were below predefined age-adjusted cut-off values.

Eligibility criteria: Inclusion Criteria:

* Term and near-term infants with a gestational age of more than 34 weeks
* Admitted to the Children's Hospital of Lucerne, Switzerland
* Suspected neonatal early-onset sepsis
* Antibiotic therapy
* Parental consent

Exclusion Criteria:

* Surgery in the first 3 days of life
* Severe congenital malformations
* Chromosomal abnormalities

Primary outcomes:
measure: Antibiotic Treatment for More Than 72 Hours
timeFrame: 1 month
measure: Absolute Duration of Antibiotic Therapy
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: children's Hospital of Lucerne
Study officials:
affiliation: Children's Hospital Lucerne, Switzerland
name: Martin Stocker, MD
role: PRINCIPAL_INVESTIGATOR
References: