louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04172623: Evaluating the Feasibility and Efficacy of a Real-time Smoking Intervention Using Wearable Technology
Official title: Evaluating the Feasibility and Efficacy of a Real-time Smoking Intervention Using Wearable Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Patterson Trust Mentored Research Award: Clinical, Health Services and Policy Research
First posted: 2019-11-21
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group randomized trial design comparing smoking outcomes when receiving standard treatment vs. standard treatment plus real-time smoking intervention.
Primary purpose: TREATMENT

Brief summary: This study will use wearable technology to test the feasibility and efficacy of delivering a novel real-time smoking intervention to improve standard tobacco treatment.

Detailed description: The goals of this project include evaluating the feasibility, acceptability, and helpfulness of the real-time smoking intervention and to assess the preliminary efficacy of the real-time intervention as an adjunct to standard tobacco treatment. Rates of adherence, participant satisfaction, and perceived usefulness will be evaluated through post-treatment interviews and ratings. Biochemically confirmed 7-day point prevalence abstinence will be compared between the experimental and control groups at the end of treatment (week 8).

Eligibility criteria: Inclusion Criteria:

* 18 or older
* Able to read English
* Cigarette smoker
* Seeking smoking cessation treatment

Exclusion Criteria:

* Serious psychiatric or medical condition
* Unable or unwilling to complete study protocol

Primary outcomes:
measure: Change in Cigarettes
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: % Days Abstinent From Cigarettes
timeFrame: Week 8
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Krysten Bold, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06799923: Possibilities of Use MRI-Guided Laser Interstitial Thermal Therapy in Medically Intractable Tremor
Official title: Possibilities of Use Magnetic Resonance Imaging (MRI)-Guided Laser Interstitial Thermal Therapy (LITT) in Treatment of Medically Intractable Tremor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laser Interstitial Thermal Therapy
Parkinson Disease
Essential Tremor
Movement Disorders
MRI
Keywords: laser interstitial thermal therapy
Parkinson Disease
Essential Tremor
Movement Disorders
MRI
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: University Hospital, Rouen
name: University Hospital, Caen
name: Central Hospital Saint Quentin
First posted: 2025-01-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Medically intractable tremors are a common difﬁcult clinical situation. Deep brain stimulation decreases Parkinson's disease tremor and essential tremor, but not all patients are candidates from a diagnostic, medical, or social standpoint, prompting the need for alternative surgical strategies. Less invasive lesional brain surgery (thalamotomy) procedures by radio-surgery or MRI-guided focused ultrasound have emerged and have proven to be effective in these third-line indications. Recently, a new technology has emerged allowing the performance of minimally invasive lesion surgeries by MRI-Guided Laser Interstitial Thermal Therapy (MRIg-LITT). MRIg-LITT has been shown to be effective and safe in management of epilepsies and brain tumors. However, no study has evaluated MRIg-LITT for performing thalamotomy in medically intractable tremor.In a pilot study, the investigators propose to evaluate the effect and safety of unilateral thalamotomy by MRIg-LITT in the management of medically intractable tremor of parkinsonian or essential origin.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years age or older with Parkinson\&#39;s disease or essential tremor and tremor resistant to medical therapy with a contraindication to deep brain stimulation or refusal deep brain stimulation

Exclusion Criteria:

* Contraindication to MRI
* Contraindication to general anesthesia
* Patient unable to give their free and informed consent because of cognitive or psychiatric disorders
* Brain anatomical abnormalities not allowing intervention
* Adults protected (guardianship, curators) or deprived of liberty.

Primary outcomes:
measure: Variation of total body weight from baseline
timeFrame: at 72 hours
Secondary outcomes:
measure: cumulative fluid balance
timeFrame: at 72 hours
Other outcomes:
Locations:
city: Salouel
country: France
facility: CHRU Amiens
Study officials:
References:
Clinical trial NCT06225323: Effect of Lidocaine Infusion on Neuraxial Opioid-induced Pruritus After Cesarean Section
Official title: Effect of Lidocaine Infusion on Neuraxial Opioid-induced Pruritus After Cesarean Section Double-blinded, Randomized Control Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lidocaine Infusion
Neuraxial Opioid
Pruritus
Cesarean Section
Lead sponsor: Aswan University
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 136
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess the efficacy and potency of lidocaine infusion as a preventive measure on pruritus response after injection of 200 micro gram morphine with bupivacaine subarachnoid block, spinal anesthesia, in cesarean section.

Detailed description: Neuraxial opioids (NO) are one of the most widely used methods for postpartum analgesia, for cesarean section analgesia, and many other surgical procedures.

The pruritus induced by NO is an unpleasant, subjective, and irritating sensation that causes scratching response.

Pruritus begins shortly after anesthesia, with the onset depending on the type, route and dosage of opioid used. Pruritus invoked by lipid-soluble opioids such as fentanyl and sufentanil is of shorter duration, and the use of the minimum or small dose from opioids in addition of local anesthetics seems to decrease the prevalence and the severity of itching. Pruritus invoked by intrathecal morphine is of longer duration and is difficult to treat. Intrathecal administration, of opioids reach peak concentrations in the cerebrospinal fluid almost immediately. \]. But, after epidural administration, there is a delay in the rise to peak concentration (10-20 min with fentanyl and 1-4 h with morphine).

Eligibility criteria: Inclusion Criteria:

* Age from 20 to 40 years.
* Weight from 50 to 90 kg.
* Women undergoing Cesarean section.

Exclusion Criteria:

* Patient with known allergies to lidocaine.
* Preexisting pruritus.
* Coexisting skin disorders.
* Contraindications to spinal anesthesia.
* Preeclampsia.
* Eclampsia.
* Major systemic diseases.
* Refusal to participate.
* Uses of any current drugs have potential effects on post-operative itching as steroidal ,nonsteroidal ,ondanstern, propofol, midazolam during study period.

Primary outcomes:
measure: The incidence of pruritis
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: The severity of pruritis
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
References:
Clinical trial NCT06112223: Preemptive Oral Gabapentin and Tramadol on Postoperative Pain After Knee Arthroscopy
Official title: Preemptive Oral Gabapentin Versus Tramadol on Postoperative Pain After Knee Arthroscopy Done Under Spinal Anesthesia: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gabapentin
Tramadol
Postoperative Pain
Knee Arthroscopy
Spinal Anesthesia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 50
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: PREVENTION

Brief summary: The aim of this study to evaluate the effect of preemptive oral gabapentin versus tramadol on postoperative pain after knee arthroscopy under spinal anesthesia.

Detailed description: Orthopedic surgeries are frequently associated with moderate-to-severe postoperative pain that can decrease mobility in the immediate postoperative period, interfere with postoperative rehabilitation, and delay hospital discharge. Pain may also become chronic.

Spinal anesthesia is the most popular anesthesia technique worldwide in orthopedic lower limb surgeries. However, its relatively short duration of action may limit the excellent postoperative analgesic effect. Thus, many adjuvants had been used to improve postoperative analgesia and decrease consumption of postoperative analgesics.

Gabapentin is a gamma aminobutyric acid analogue that is known as an anticonvulsant drug. This drug is tolerated well and has known effects on pain and anxiety.

Tramadol, a commonly used postoperative analgesic, is a synthetic centrally acting opioid analgesic. The various actions include inhibition of noradrenaline and serotonin reuptake, and also inhibition of M1 and M3 muscarinic receptors

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years old.
* Both sexes. American Society of Anesthesiologists (ASA) physical status I and II
* Undergoing knee arthroscopy procedures.
* under spinal anesthesia.

Exclusion Criteria:

* Cardiac patients.
* Patients with known allergy to drug of study.
* Prolonged administration of NSAIDS or other analgesics due to chronic pain of any reason.
* Cirrhosis.

Primary outcomes:
measure: The intensity of postoperative pain
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: The total amount of morphine consumption in the first 24-hour postoperative
timeFrame: 24 hours postoperatively
measure: The time first rescue analgesia
timeFrame: 24 hours postoperatively
measure: The incidence of side effects
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT05442723: Extensively Diseased Left Anterior Descending Coronary Artery: On Pump vs Off Pump CABG?
Official title: Extensively Diseased Left Anterior Descending Coronary Artery: On Pump vs Off Pump CABG?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CAD - Coronary Artery Disease
Keywords: On-pump
off-pump
CABG
LAD
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Diseased left Anterior descending coronary artery (LAD) is one of the most challenging conditions in Bypass surgery. we investigate whether on-pump coronary artery bypass grafting (CABG) is more beneficial in those critical patients or off-pump surgery.


Eligibility criteria: Inclusion Criteria:

* any patient with diffuse LAD disease indicated for open heart surgery

Exclusion Criteria:

* no concomitant valve disease
* any patient can be treated by medical treatment or PCI

Primary outcomes:
measure: mortality
timeFrame: 30 days post operative
measure: Morbidity
timeFrame: 60 days post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university heart hospital
Study officials:
References:
Clinical trial NCT02958423: tDCS Versus tsDCS for Endometriosis-related Chronic Pelvic Pain Treatment
Official title: Transcranial Direct Current Stimulation (tDCS) vs Trans-spinal Direct Current Stimulation (tsDCS) for Endometriosis-related Chronic Pelvic Pain Treatment: A Single Center, Prospective, Randomized, Controlled, Parallel Group Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Endometriosis
Pelvic Pain
Transcranial Direct Current Stimulation
Spinal Cord Stimulation
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the analgesic effect of 2 mA anodal direct current stimulation on the right primary motor cortex (M1) (tDCS) with a similar stimulation on the spine (D10) (tsDCS) in healthy volunteers (HV) followed by a pilot study in patients suffering of endometriosis-related chronic pelvic pain (CPP)

Detailed description: - 2 groups of 5 HV will receive tDCS or tsDCS (2mA, anodal, 20min) and the thermonociceptive threshold will be measured before and after the stimulation over the abdomen (hypogastric). The HAD scale and SF-36 will also be tested.

The treatment(s) that produces the greatest increase in pain thresholds will be chosen to treat 10 patients.

- 10 patients suffering from endometriosis-related chronic pelvic pain will be treated by the most efficient treatment (tDCS or tsDCS) for 4 weeks (5 daily 20-min sessions per week), or, if no treatment modality was superior in HV, 5 patients will be treated by tDCS and 5 by tsDCS. Patients will fill in daily a dedicated diary 2 weeks before treatment, during the4-week treatment period and after this period as long as their pain level remains below 80% of their baseline pain intensity (VAS). Analgesic intake will also be monitored as well as HAD and SF-36 scores.

Eligibility criteria: Inclusion Criteria:

* HV: good health.
* CPP patients: surgical diagnosis of endometriosis within the last 10 years; diagnosis of chronic pelvic pain (according to ACOG); mean VAS pain score \>4 during severe episodes.

Exclusion Criteria:

* HV: chronic pain disorder; no regular medication or illicit drug use.
* CPP patients: pregnancy; other medical or psychiatric condition interfering with pelvic pain assessment.

Primary outcomes:
measure: Antalgic effect of direct current stimulation by measuring Quantitative Sensory Testing (QST)
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Departments of Gynecology & Neurology. CHR Citadelle
Study officials:
affiliation: University of Liege
name: Michelle Nisolle, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00437723: A Study of NeoRecormon in Patients With Chronic Kidney Disease.
Official title: An Open-Label Study to Investigate the Effect of NeoRecormon on Hemoglobin Level and Renal Function in Patients With Chronic Kidney Disease, Stage 2-4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-02-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will compare the level of anemia, and the decline in renal function, between patients receiving NeoRecormon, and those not receiving it. Patients with chronic kidney disease, stage 2-4, and not receiving dialysis, will be randomized 2:1 to a group receiving NeoRecormon (at a dose determined by the investigator to achieve and maintain an Hb level of 120-135 g/L), or to a control group not receiving NeoRecormon. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients,18-75 years of age;
* end-stage renal disease, not on dialysis;
* Hb \<110g/L.

Exclusion Criteria:

* unstable hypertension;
* acute infections;
* use of i.v. NeoRecormon, or use of any other ESA beside NeoRecormon;
* myocardial infarction, unstable angina or venous thrombosis within 6 months before start of treatment.

Primary outcomes:
measure: Hb level, decline in renal function, 24h proteinuria, creatinine clearance.
timeFrame: Throughout study
Secondary outcomes:
measure: SAEs, AEs leading to withdrawal, AEs related to NeoRecormon.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Belgrade
country: Serbia
city: Novi Sad
country: Serbia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04037423: European Database on Catheter-directed Treatment of Pulmonary Embolism.
Official title: European Database on Catheter-directed Treatment of Pulmonary Embolism.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pulmonary Embolism
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients.

Brief summary: The main goals of EuroPE-CDT is to assess the currently applied catheter-directed treatment (CTD) techniques and strategies in pulmonary embolism (PE) patients and to determine the short term efficacy and safety of this invasive procedure.

Detailed description: This is a prospective (and retrospective, if required data are available), non-interventional, multicenter study. We intend to obtain data on basic patients characteristics, pulmonary embolism severity, catheter-directed treatment procedures and short term outcome. We are planning to include approximately 150-200 patients suitable for analysis by the end of 2020. Anonymized data of consecutive PE patients treated with CTD in European centers will be collected in the database.

Eligibility criteria: Inclusion Criteria:

* acute pulmonary embolism
* catheter-directed embolectomy

Exclusion Criteria:

* appropriate data not available

Primary outcomes:
measure: Survival
timeFrame: 30 days after the procedure
Secondary outcomes:
measure: Complications
timeFrame: During hospitalisation (estimated 10 days)
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Piotr Purszczyk, prof.
role: STUDY_CHAIR
References:
Clinical trial NCT06950723: Chest Physical Therapy on Arterial Blood Gases for Neonates Post Hypoxic Ischemic Encephalopathy
Official title: Efficacy of Chest Physical Therapy on Arterial Blood Gases for Neonates Post Hypoxic Ischemic Encephalopathy in Neonatal Intensive Care Unit: A Clinical Trial Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypoxic Ischemic Encephalopathy of Newborn
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypoxic-ischemic encephalopathy (HIE) is a dangerous illness that happens when a newborn's brain does not receive adequate oxygen and blood flow, which can result in serious effects such as cerebral palsy and epilepsy. Infant diagnosed with HIE required ventilator support and subsequently developed pneumonia. They experienced respiratory problems and feeding challenges. Chest Physical Therapy is the best modalities to clear chest and improve ventilation.

Detailed description: The purpose of this study to investigate the effect of chest physical therapy on Arterial Blood Gases for neonates post hypoxic ischemic encephalopathy (HIE) in Neonatal intensive care unit.

Methods: Fifty neonates from both sexes, age from birth to 10 days, post HIE with chest problems were selected from neonatal intensive care unit (NICU) at Minia University hospital, Egypt. They were divided into two equal groups, control group (CG) received traditional medical treatment according to American Academy of Pediatrics (AAP) recommendations and study group (SG) received traditional medical treatment plus Chest Physical Therapy (CPT) modalities in the form of postural drainage, percussion and vibration. The sessions will apply once daily for 6 days/week, each session is about 30 minutes, according to the neonate tolerance till complete clinical cure and discharge from NICU.

the outcome will measure by Timing of Arterial blood gases improvement, Duration required for clinical improvement, Duration of Mechanical ventilation, Duration of Hospitalization.

Eligibility criteria: Inclusion Criteria:

* Neonates with chest problems post Hypoxic-ischemic encephalopathy

Exclusion Criteria:

* Neonates with chest problems due to other Causes except post Hypoxic-ischemic encephalopathy.
* unstable medical status
* Neonates with Post-operative s' respiratory problems due to any reasons.

Primary outcomes:
measure: Timing of Arterial blood gases improvement
timeFrame: 3-14 days
measure: Timing required for clinical improvement
timeFrame: 3-14 days
measure: Timing needed for Mechanical Ventilation
timeFrame: 3-7 days
measure: Hospitalization time
timeFrame: 5-21 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03393923: Anterior Wedge in Patients With Osteoarthritis Hip
Official title: Effect of Anterior Wedge Use in Patients With Osteoarthritis Hip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait, Frontal
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ostearthritis is a great source of pain. In symptomatic hip the pain can lead the major disability and poor quality of life. Understand the musculoskeletal factores can lead to a better clinical management. The muscle strenghening of posterolateral complexo of hip is a important consideration. General Objective: Perform a Kinetic analysis 2D using na anterior wedge. Specific objective: Analyze the influence of posterolateral hip complex. Controlled clinical trial, composed by 30 individuals with and without osteoarthritis of hip e will be used a tools; Analogic Visual Scale, manual dynamometry to analyze force and kinetic analyze of gait through of Myovídeo analysis software.


Eligibility criteria: Inclusion Criteria:

* Sedentary individuals
* Both genders
* Age equal to or greather than 50 years
* Diagnosis of osteoarthritis level II and III

Exclusion Criteria:

* fractures
* Neuromuscular diseases
* Other diseases of hip

Primary outcomes:
measure: Inproved performance of the gluteus maximus
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Flávia Nakatake
Study officials:
References: