louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06974643: Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy
Official title: Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy: A Randomized Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Epidural Anesthesia
Paravertebral Block
Awake Thoracotomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare paravertebral block and thoracic epidural in awake thoracotomy.

Detailed description: Pain can often persist after thoracotomy, and the incidence of chronic pain is high, with studies revealing that 30% to 50% of patients still experience pain up to five years after surgery.

Thoracic epidural blockade (TEB) blocks nerves that supply the chest with local anesthetic bilaterally, at the spinal cord level. It acts by reducing the onward transmission of painful nerve signals, but may not abolish them altogether. Paravertebral blockade (PVB) involves injecting local anesthetic into the paravertebral space, which contains spinal nerves (and sometimes even extension of the dura), white and grey rami communicantes, the sympathetic chain, and intercostal vessels, on the side of surgery.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 60 years.
* Both genders.
* American Society of Anesthesiologists (ASA) physical status classification II or III.
* Scheduled for thoracotomy.

Exclusion Criteria:

* Poor cardiac function (ejection fraction less than 50%).
* Patients with bad pulmonary function testing (PFTs). Absolute contraindication to thoracic epidural anesthesia includes patient refusal, allergy to local anesthetics, coagulopathy, active neurologic disorders, skin infection at the insertion site, uncooperative patients, uncontrolled cough, and unfavorable anatomy for thoracic epidural.
* Thoracic spine disorders require chest wall resection or emergency thoracic surgery.
* Had a previous thoracotomy (scarring due to prior surgery can limit the effectiveness of paravertebral block, and these patients may have existing chronic pain).

Primary outcomes:
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperatively
Secondary outcomes:
measure: Time to the 1st rescue analgesia
timeFrame: 48 hours postoperatively
measure: Mean arterial pressure
timeFrame: Till the end of surgery (Up to 2 hours)
measure: Heart rate
timeFrame: Till the end of surgery (Up to 2 hours)
measure: Total morphine consumption
timeFrame: 48 hours postoperatively
measure: Degree of pain
timeFrame: 48 hours postoperatively
measure: Degree of patient satisfaction
timeFrame: 48 hours postoperatively
measure: Incidence of adverse events
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT06402643: Comparison of Recurrence Between Mini-SLET and Limbal-Conjunctival Autograft Techniques in Primary Pterygium
Official title: Comparative Analysis of Recurrence Rate Between Mini-Slet (Simple Limbal Epithelial Transplantation) Versus Limbal-Conjunctival Autograft Techniques in Primary Pterygium Excision
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pterygium of Right Eye
Pterygium of Left Eye
Pterygium of Both Eyes
Pterygium
Keywords: Pterygium,
Mini-SLET
Conjunctival-Limbal autograft
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The allocation sequence will be generated by an investigator and will
Primary purpose: TREATMENT

Brief summary: The surgical treatment options for pterygium, an abnormal growth on the eye's frontal surface can be treated with several surgical techniques. The rates of pterygium coming back varies depending on the surgical technique employed and other factors related to the patient and surgery. The objective of this study is to assess the efficacy and safety of incorporating a single amniotic membrane with stem cells in the treatment of primary pterygium, aiming to enhance surgical outcomes and minimize recurrence rates.

Detailed description: The surgical treatment options for pterygium, an abnormal growth on the eye's surface, encompass various approaches. These include standard surgical excision, which involves removing the pterygium using traditional surgical methods and more recently Simple Limbal Epithelial Transplantation. Recurrence rate of pterygium varies depending on the surgical technique employed and other factors related to the patient and surgery.The objective of this study is to assess the efficacy and safety of incorporating a single amniotic membrane with stem cells in the treatment of primary pterygium, aiming to enhance surgical outcomes and minimize recurrence rates.

Eligibility criteria: Inclusion Criteria:

* Patients with primary nasal pterygium \> 2mm
* Patients who can present and continue follow-up for the duration of the study
* Acceptance to participate in the study by signing the informed consent.

Exclusion Criteria:

* Patients with rheumatoid arthritis
* Collagenopathy
* Pregnant
* Infection, conjunctival inflammation or ocular trauma
* Glaucoma
* Previous ocular surgery

Primary outcomes:
measure: Recurrence rate
timeFrame: 1 month, 3, months, 6 months and 12 months after surgery.
Secondary outcomes:
measure: Postoperative symptoms
timeFrame: 1 month, 3, months, 6 months and 12 months after surgery.
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto de oftalmología conde de Valenciana
Study officials:
References:
Clinical trial NCT01425138: Systematic Review And Meta-Analysis Of Psoriasis Treatments.
Official title: Biologic And Non-biologic Systemic Treatments For Moderate To Severe Plaque Psoriasis: A Systematic Review & Meta-Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: psoriasis
systematic review
meta-analyses
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: University of Connecticut School of Pharmacy and Hartford Hospital
First posted: 2011-08-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate-to-severe plaque psoriasis published trials.

Brief summary: This project involved a systematic literature review of published trials of treatments for moderate-to-severe plaque psoriasis. Data was extracted from the publications on various psoriasis endpoints including the Physician Global Assessment (PGA), Dermatology Life Quality Index (DLQI), and Short-Form 36 (SF-36). A traditional meta-analysis and a mixed treatment comparison was conducted on the extracted data.

Detailed description: This project involved a systematic literature review of published trials of treatments for moderate-to-severe plaque psoriasis. Data was extracted from the publications on various psoriasis endpoints including the Physician Global Assessment (PGA), Dermatology Life Quality Index (DLQI), and Short-Form 36 (SF-36). A traditional meta-analysis and a mixed treatment comparison was conducted on the extracted data. We included all published randomized controlled trials of treatments for moderate-to-severe psoriasis that met the study inclusion criteria.

Eligibility criteria: Inclusion Criteria:

* Randomized controlled clinical trials of treatments for moderate-to-severe plaque psoriasis.
* Trials had to evaluate at least one of the following: Physician's Global Assessment (PGA), Dermatology Life Quality Index (DLQI) and/or the Short-Form 36 (SF-36).

Exclusion Criteria:

Observational studies

* Trials that did not report the Physician's Global Assessment (PGA),
* Dermatology Life Quality Index (DLQI) or the Short-Form 36 (SF-36).

Primary outcomes:
measure: Physician Global Assessment (PGA)
measure: Dermatology Life Quality Index (DLQI)
measure: Short-Form 36 (SF-36)
Secondary outcomes:
measure: No secondary outcomes
timeFrame: No secondary outcomes
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06843538: Peri-operative Tamsulosin and Impact on Voiding Trial After Same-day Urogynecology Surgery
Official title: Peri-operative Tamsulosin and Impact on Voiding Trial Following Outpatient Urogynecology Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Postoperative Urinary Retention (POUR)
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to determine if taking tamsulosin preoperatively decreases your chances of being discharged after surgery with a Foley catheter (flexible tube that drains urine from the bladder into a collection bag).


Eligibility criteria: Inclusion Criteria:

- Patients undergoing any pelvic organ prolapse repair or incontinence surgery

Exclusion Criteria:

* Any surgery involving a non-urogynecologist
* Patients already on an alpha blocker
* Baseline hypotension
* History of syncope
* Postural orthostatic tachycardia syndrome (POTS)
* Non-English speaker or interpreter unavailable for Spanish-speaking patient
* Impaired cognition impeding proper consenting
* Any other medical contraindication for tamsulosin use
* History of urinary retention requiring continuous or intermittent catheterization
* Patients consented for the study but then due to intraoperative complication, routine voiding trial no longer indicated due to requiring indwelling catheter or intermittent catheterization on discharge will be excluded from primary outcome analysis
* Pregnancy

Primary outcomes:
measure: Voiding trial on postoperative day 0
timeFrame: Day of surgery
Secondary outcomes:
measure: Secondary postoperative urinary retention
timeFrame: 2 weeks following surgery
measure: Postoperative urinary tract infection
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: TriHealth
state: Ohio
Study officials:
References:
Clinical trial NCT01146938: A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers
Official title: A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Essential Hypertension
Hepatic Impairment
Keywords: fimasartan
hepatic impairment
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Kyungpook National University Hospital
name: Yonsei University
First posted: 2010-06-22
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in hepatic impairment patients and healthy volunteers


Eligibility criteria: Inclusion Criteria:

\<Hepatic impairment patient\>

* age: 20 - 64 years
* sex: male
* Child-Pugh score A or Child-Pugh score B
* body weight: greater than 55 kg
* written informed consent

\<Healthy volunteer\>

* age: 20 - 64 years
* sex: male
* body weight: greater than 55 kg
* written informed consent

Exclusion Criteria:

\<Hepatic impairment patient\>

* portosystemic shunt surgery
* Child-Pugh score C
* creatinine clearance \< 80mL/min
* ascites

\<Healthy volunteer\>

* AST(SGOT), ALT(SGPT) \> 1.5 times of Upper Normal Range
* Total bilirubin \> 1.5 times of Upper Normal Range
* positive drug or alcohol screening

Primary outcomes:
measure: Pharmacokinetic characteristics of fimasartan
timeFrame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 48h
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Yonsei University
name: Minsoo Park, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim CO, Lee HW, Oh ES, Seong SJ, Kim DY, Lee J, Ahn SH, Yoon YR, Cho CM, Park MS. Influence of hepatic dysfunction on the pharmacokinetics and safety of fimasartan. J Cardiovasc Pharmacol. 2013 Dec;62(6):524-9. doi: 10.1097/FJC.0000000000000010.
Clinical trial NCT06297538: Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation
Official title: Targeting the Motor Cortex in Parkinson's Disease by Gamma-transcranial Alternating Current Stimulation: Pathophysiological and Therapeutic Implications
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Motor cortex
Transcranial magnetic stimulation
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
Collaborators: name: Fondazione Policlinico Universitario Campus Bio-Medico
name: I.R.C.C.S. Fondazione Santa Lucia
First posted: 2024-03-07
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cortical-basal ganglia gamma oscillations are pathologically reduced in Parkinson's disease (PD) and the plasticity of the primary motor cortex (M1) is impaired. Enhancing gamma oscillations through transcranial alternating current stimulation (tACS), a non-invasive neurophysiological tool that modulates cortical rhythms, can restore this alteration. However, whether tACS-related normalization of M1 plasticity results in positive clinical effects is unknown. Motor learning is also impaired in PD and gamma oscillations play a relevant role in different forms of learning in humans. Nevertheless, whether motor learning abnormalities relate to reduced gamma oscillations in PD is another unclear issue. It can be hypothesized that gamma oscillations impairment in M1 contributes to altered motor control, plasticity and learning in PD. Accordingly, in this project, the authors intend to test whether gamma-tACS on M1 in PD patients ameliorates motor performance and learning, as objectively assessed with kinematic techniques.


Eligibility criteria: Inclusion Criteria:

* PD diagnosis

Exclusion Criteria:

* severe cognitive and psychiatric comorbidities
* H\&Y\>3
* levodopa-induced dyskinesia and tremor-dominant phenotype
* history of additional neuropsychiatric disorders
* intake of medications acting on brain excitability or plasticity
* contraindications to non-invasive brain stimulation

Primary outcomes:
measure: Changes in bradykinesia features as objectively assessed by kinematic techniques
timeFrame: post 5, 15 and 30 minutes
measure: Changes in motor learning performance as objectively assessed by kinematic techniques
timeFrame: post 5, 15 and 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS Neuromed
Study officials:
References:
Clinical trial NCT03428438: Initial Education for Rehabilitation and Motivation Program Following a Myocardial Infarction Via SMS or Hospital
Official title: Initial Education for Rehabilitation and Motivation Program Following a Myocardial Infarction. Rehabilitation Exercises at Home Via SMS or in the Hospital Physiotherapy Department
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects recruited will be randomized into two groups: one group of subjects (the study group) A physical reminder by a physiotherapist, and a daily reminder of physical exercise by SMS on weekdays A through E. The second group (the control group) will be given a routine training in the ward by a nurse and you will receive a weekly SMS message
Primary purpose: SUPPORTIVE_CARE

Brief summary: The innovation in this preliminary study is the use of message reminders in patients after myocardial infarction in stage I of rehabilitation (ie discharge from hospital) at home via SMS, compared with studies of patients undergoing cardiac rehabilitation (stage II)in the hospital physiotherapy department.

Detailed description: The first stage of rehabilitation begins during hospitalization. Motivation for the rehabilitation process for the patient. At this stage there will be preparation for release and guidance for the patient and their families regarding secondary prevention and return to domestic activity. This stage includes mobility, walking, controlled motility and gradual joint activation to maintain ranges and prevent complications from prolonged immobilization in bed.

Eligibility criteria: Inclusion Criteria:

Informed consent Criteria for inclusion Patients after acute myocardial infarction admitted to the intensive care unit Patients who speak the Hebrew language Patients with a cell phone to receive a reminder using a message

Exclusion criteria:

Orthopedic or neurological problem that would prevent physical activity. A score lower than 24 in the MoCA test. High-risk patients.

Complications: of myocardial infarction congestive heart failure, cardiogenic shock and / or ventricular arrhythmias.

Angina or shortness of breath at rest. Decrease \>1mm in the ST segment in the ECG.

Primary outcomes:
measure: Cardiac rehabilitation
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hillel yaffe MC
name: Avraham Shotan, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04941638: Comparison of Vascular Access in STEMI
Official title: Comparison of Distal Radial, Proximal Radial and Femoral Access in ST-Segment Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST Elevation Myocardial Infarction
Keywords: Distal radial access
Snuffbox approach
ST Elevation Myocardial Infarction
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 109
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: Patients who underwent primary PCI for STEMI without ECMO

Brief summary: Distal radial access (DRA) has recently introduced and previous studies have demonstrated that it is feasible option, showing several advantages including less bleeding and access-site complications over proximal radial access (PRA). Previous study reported the feasibility of DRA as an alternative option for primary percutaneous coronary intervention (PCI) in STEMI patients without major complication. However, comparison study of each vascular access for primary PCI have not been conducted until now. Here, The investigators aim to compare the DRA, PRA and femoral access (FA), in terms of feasibility and safety, in patients with STEMI.

This is a retrospective study with patients who underwent primary PCI for STEMI between March 2020 to May 2021. The primary outcome of this study is the access-site complication including major bleeding requiring transfusion or surgery, hematoma and arterial occlusion.

Detailed description: Recently, DRA has gained the interest of interventional cardiologists and previous studies have demonstrated several advantages including patient and operator comfort, shorter hemostasis duration, less bleeding, and access-site complications over PRA. More recently, randomized trial demonstrated that DRA prevents radial artery occlusion after the procedure compared with PRA. From this perspective, DRA could be considered an alternative access route for primary PCI in selected STEMI patients using potent P2Y12 inhibitors such as ticagrelor or prasugrel, or glycoprotein IIb/IIIa inhibitors.

Eligibility criteria: Inclusion Criteria:

* Between March 2020 to May 2021, patients who underwent primary PCI for STEMI at the Yongin Severance Hospital

Exclusion Criteria:

* Refractory cardiogenic shock requiring extracorporeal membrane oxygenation (ECMO)

Primary outcomes:
measure: access-site complication
timeFrame: 1 month
Secondary outcomes:
measure: The success rate of the puncture
timeFrame: Through procedure
measure: The success rate of the primary PCI
timeFrame: Through procedure
measure: The percentage of puncture time in Door-to-wiring time (%)
timeFrame: Through procedure
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Gyeonggi-do
Study officials:
affiliation: Yongin Severance Hopistal
name: Yongcheol Kim
role: PRINCIPAL_INVESTIGATOR
References: