louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01141881: Evaluation of the Role of Intravitreal Tissue Plasminogen Activator in Treatment of Refractory Diabetic Macular Edema
Official title: Evaluation of the Role of Intravitreal Injection of TPA in Treatment of Refractory Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Macular Edema
Keywords: Tissue Plasminogen activator,
Clinically significant macular edema,
Refractory Diabetic macular edema ,
posterior vitreous detachment
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-06-11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Purpose: to evaluate the effect of intravitreal injection of tissue plasminogen activator(tPA) in treatment of refractory diabetic macular edema(DME).


Eligibility criteria: Inclusion Criteria:

1. type 2 diabetes
2. Non proliferative diabetic retinopathy(NPDR) stage of diabetic retinopathy
3. patients with refractory DME CSME (patients with the last MPC at least 3 months before and no improvement was observed in BCVA, macular thickness inOCT, clinical examination and fundus photographs of patients )
4. Absence of PVD in the B-scan
5. Absence of PVD in OCT of macular area and optic disk
6. Absence of PVD in slit lamp biomicroscopy(SLE)
7. the last PRP session was at least 3 months ago.
8. Absence of traction on macula in clinical examination and OCT

Exclusion Criteria:

1. One eye patients
2. Patients who are candidates for intraocular surgery.
3. Patients with the history of glaucoma or ocular hypertension
4. Patients with a history of vitrectomy in the study eye
5. Not being able to refer for the next visits
6. Eyes with cataract that makes the assessment of the macula impossible.
7. Intraretinal hemorrhage at fovea that will interfere with OCT.
8. BCVA ≤ 0.1

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Khatam Hospital
state: Khorasan Razavi
Study officials:
affiliation: mashhad university of medical science
name: naser shoeibi, MD
role: STUDY_DIRECTOR
References:
citation: Murakami T, Takagi H, Ohashi H, Kita M, Nishiwaki H, Miyamoto K, Watanabe D, Sakamoto A, Yamaike N, Yoshimura N. Role of posterior vitreous detachment induced by intravitreal tissue plasminogen activator in macular edema with central retinal vein occlusion. Retina. 2007 Oct;27(8):1031-7. doi: 10.1097/IAE.0b013e318074bc39.
Clinical trial NCT04540081: Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer
Official title: Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Lung Cancer
Tobacco Use Cessation
Obesity
Pneumonia, Bacterial
Shingles
Hepatitis C
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: University of California, Irvine
First posted: 2020-09-07
Enrollment: 20000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of CLOVER is to utilize Epic Healthy Planet to increase adherence to United States Preventive Services Task Force (USPSTF) and Centers for Disease Control and Prevention (CDC) recommendations in adults age 50 and older.


Eligibility criteria: Inclusion Criteria:

- Any patient who has a UC Davis or UC Irvine primary care provider (PCP) and is deficient in any of the following: colon cancer screening, lung cancer screening, tobacco cessation counseling, obesity counseling, pneumonia vaccination, shingles vaccine, and hepatitis C screening.

Exclusion Criteria:

- Patients outside of the age limits or have an established PCP.

Primary outcomes:
measure: Overall Adherence to CLOVER Metrics
timeFrame: 6 months
Secondary outcomes:
measure: Colon cancer screening
timeFrame: 6 months
measure: Lung cancer screening
timeFrame: 6 months
measure: Tobacco cessation counseling
timeFrame: 6 months
measure: Obesity counseling
timeFrame: 6 months
measure: Pneumonia vaccination
timeFrame: 6 months
measure: Shingles vaccination
timeFrame: 6 months
measure: Hepatitis C screening
timeFrame: 6 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
References:
Clinical trial NCT06415981: Proof-of-Concept Study to Determine the Flow Changes When Stimulating Two Neural Targets for the Treatment of Obstructive Sleep Apnea
Official title: Single Center Proof-of-Concept Study to Determine the Flow Changes When Stimulating Two Neural Targets for the Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep Apnea
Sleep Apnea, Obstructive
Sleep Disorder
Sleep Apnea Syndromes
Keywords: Sleep Apnea
Lead sponsor: Invicta Medical Inc.
Sponsor class: INDUSTRY
Collaborators: name: University College London Hospitals
First posted: 2024-05-16
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This proof-of-concept study will evaluate the impact of surgically placing and stimulating the hypoglossal nerve and/or a second neural target Ansa Cervicalis, with a set of off-the-shelf electrode arrays.


Eligibility criteria: Inclusion Criteria:

* Age above 18 years not under guardianship, under curatorship or under judicial protection.
* Body Mass Index (BMI) \< 35 kg/m2.
* Subject suffers from OSA (15 \< AHI \< 80) documented by a sleep study performed during the past 36 months.
* Subject must be eligible for a diagnostic or surgical procedure.
* Written informed consent obtained from the patient prior to performing any study specific procedure.
* Willing and capable to comply with all study requirements, including specific lifestyle considerations, evaluation procedures and questionnaires for the whole duration of the trial.

Exclusion Criteria:

* Major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned
* Significant comorbidities that contraindicate surgery or general anesthesia
* Significant tongue weakness
* Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator.
* Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems:
* Airway cancer surgery or radiation,
* Mandible or maxilla surgery in the previous 3 years (not counting dental treatments),
* Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery),
* Prior hypoglossal nerve stimulation device implantation.
* Currently pregnant, or breastfeeding during the study period

Primary outcomes:
measure: Incidence of participants with changes in cross-sectional area airway opening during target stimulation
timeFrame: Day 0
measure: Assessment of changes in airflow outcomes
timeFrame: Day 0
Secondary outcomes:
measure: Number of participant adverse events observed during the study
timeFrame: Day 30
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
References:
Clinical trial NCT02272881: A Randomized, Prospective Clinical Trial of Immediate Flap Closure Versus Wound Care for Management of Late-stage Pressure Ulcers
Official title: The Santa Barbara Pressure Ulcer Study Comparison of Immediate Flap Closure Versus Wound Care for Management of Late-stage Pressure Ulcers: a Randomized, Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pressure Ulcer
Lead sponsor: Santa Barbara Cottage Hospital
Sponsor class: OTHER
First posted: 2014-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the number of and degree of pressure ulcers healed, as measured by intact skin at the original ulcer site at 6 months of follow-up in patients randomized to immediate operative closure versus those who are maintained in a wound care program in patients with Stage 3 and 4 sacral and peri-sacral decubitus ulcers.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old;
* Stage III or IV pressure ulcers on or near trochanter, ischium, sacrum or buttocks;
* Receiving treatment at the Center for Wound Management - Goleta Valley Cottage Hospital; Santa Barbara Cottage Hospital or Santa Ynez Cottage Hospital, all part of Cottage Health System;
* Underlying etiology for immobility secondary to spinal cord injury (SCI) or other neuromuscular condition not expected to become progressive in next 12 months;
* No contraindications to undergo surgical intervention, including medical ability to tolerate surgical procedure with general anesthesia.

Exclusion Criteria:

* Unable or unwilling to provide informed consent;
* Underlying cause of immobility secondary to chronic medical disease outside of nonprogressive SCI or neuromuscular disease as described above;
* Patients requiring immediate surgical closure determined by physician judgment;
* Those deemed inappropriate to consider for surgery outside of study; potential reasons normally include medical comorbidities, inability to comply with post-operative care, and lack of funding source for elective procedure, peri-operative, and / or wound care.
* Patients who have already been receiving active, professionally supervised wound care for \> 2 week period prior to presentation
* Patient is pregnant or breastfeeding.

Primary outcomes:
measure: Wound Closure
timeFrame: 6 months after randomization
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04855981: Whole-body Vibration Versus Aerobic Exercise on the Inflammatory Status and Hormonal Parameters Premenstrual Syndrome
Official title: Effect of Whole-body Vibration Versus Aerobic Exercise on the Inflammatory Status and Hormonal Parameters in Females With Premenstrual Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: whole body vibration
aerobic exercises
premenstrual syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: whole-body vibration and aerobic exercise
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate and compare the effect of whole-body vibration to aerobic exercise on inflammatory status in females with premenstrual syndrome.

Detailed description: Premenstrual syndrome (PMS) is a complex disorder characterized by moderate to severe symptoms taking place during the luteal phase of the menstrual cycle. It has a negative impact on females' lives, which can affect their relationships, educational efficiency, social activities, and quality of life. Despite previous studies reported that physical exercise improves the symptoms of PMS, the effects of physical exercise on inflammatory status in females with PMS are not clear yet. sixty females allocated to three groups randomly to group (A) that will receive whole-body vibration+supplementation, group (B) that will receive aerobic exercises+supplementation, and group c that will receive supplementation only

Eligibility criteria: Inclusion Criteria:

1. Females suffering from PMS (as determined by PMS scale).
2. Their ages will range from 18 to 25 years.
3. Having regular menstrual cycle.

Exclusion Criteria:

1. Smoking.
2. Taking any medications.
3. History of chronic disease.
4. Having any psychiatric or gynecological problems

Primary outcomes:
measure: premenstrual symptoms
timeFrame: up to twelve weeks
Secondary outcomes:
measure: CRP level assessment
timeFrame: up to twelve weeks
measure: cortisol level
timeFrame: up to twelve weeks
measure: hormonal analysis
timeFrame: up to twelve weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Al Shaymaa Shaaban Abd El Azeim
Study officials:
References:
Clinical trial NCT01677481: Randomized Evaluation of Vascular Entry Site and Radiation Exposure: REVERE Trial
Official title: Randomized Evaluation of Vascular Entry Site and Radiation Exposure: REVERE Trial.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exposure to Ionizing Radiation
Lead sponsor: Total Cardiovascular Solutions
Sponsor class: OTHER
First posted: 2012-09-03
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred for diagnostic coronary angiography

Brief summary: The study compares radiation exposure parameters between coronary angiography procedures performed by left wrist, right wrist or groin (femoral) procedure access site

Detailed description: Patients referred for coronary angiography will be randomized to either left radial, right radial or femoral arterial access sites, and the coronary angiogram will be performed in a standard fashion, including left ventriculography. Radiation exposure parameters including Air Kerma, Dose-area product, Fluoroscopy time and Operator radiation exposure will be recorded. Operator experience as well as demographic data will be recorded.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing diagnostic coronary angiography

Exclusion Criteria:

* non-availability of one or more of the three access sites History of coronary artery bypass graft surgery Need for percutaneous coronary intervention.

Primary outcomes:
measure: Air Kerma
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
measure: Operator radiation exposure
timeFrame: 1 day
Locations:
city: Ahmedabad
country: India
facility: V.S. General Hospital
state: Gujarat
Study officials:
affiliation: Chief
name: Tejas M Patel, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pancholy SB, Joshi P, Shah S, Rao SV, Bertrand OF, Patel TM. Effect of Vascular Access Site Choice on Radiation Exposure During Coronary Angiography: The REVERE Trial (Randomized Evaluation of Vascular Entry Site and Radiation Exposure). JACC Cardiovasc Interv. 2015 Aug 17;8(9):1189-1196. doi: 10.1016/j.jcin.2015.03.026. Epub 2015 Jul 22.
Clinical trial NCT02537795: Psychiatric Neurosurgery (PNS) for Obsessive Compulsive Disorder (OCD): A Qualitative Analysis of Patient and Family Member Experiences
Official title: Psychiatric Neurosurgery (PNS) for Obsessive Compulsive Disorder (OCD): A Qualitative Analysis of Patient and Family Member Experiences
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obsessive-Compulsive Disorder
Keywords: Deep Brain Stimulation
Anterior Capsulotomy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the University Hospital of Leuven, more than thirty patients suffering from severe OCD have been treated with DBS. The investigators will ask patients who are currently being treated with DBS whether they are willing to participate in this study. The investigators will also ask whether one of their family members might participate, preferentially their partner or another close family member. The aim is to include at least ten patients and their family members. OCD patients, who have been treated with anterior capsulotomy, and their family members will also be asked for participation in this study. The aim is to also include ten patients and family members in this group.

Brief summary: In this study the investigators will use semi-structured interviews to qualitatively analyse patient and family member experiences with either deep brain stimulation or other forms of psychiatric neurosurgery.


Eligibility criteria: Inclusion Criteria:

* (family member of) patient who has previously been treated with deep brain stimulation or anterior capsulotomy

Exclusion Criteria:

* none

Primary outcomes:
measure: Semi-structured Interview
timeFrame: up to 180 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UPC KU Leuven
name: Chris Bervoets, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03754595: Application of 2D and 3D Laparoscopy in Laparoscopic Pancreaticoduodenectomy: a Prospective Randomized Clinical Trial
Official title: Application of 2D and 3D Laparoscopy in Laparoscopic Pancreaticoduodenectomy: a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatoduodenectomy
Keywords: 2D and 3D Laparoscopic pancreatoduodenectomy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two parallel groups: 2DLaparoscopic pancreatoduodenectomy and 3DLaparoscopic pancreatoduodenectomy
Primary purpose: TREATMENT

Brief summary: Pancreatic cancer is extremely malignant, with a low sensibility to chemotherapy and radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic cancer. Laparoscopic pancreatoduodenectomy is a standard radical procedure we are going to compare and discuss the advantages of 2D and 3D Laparoscopic pancreatoduodenectomy in our RCT study.

Detailed description: This study is to compare the efficiency and safety between 2D laparoscopic pancreatoduodenectomy and 2D laparoscopic pancreaticoduodenectomy for pancreatic cancer. We design a prospective randomized study. Patients with malignant pancreatic tumor who underwent pancreatoduodenectomy are recruited to the study. After obtaining informed consent, eligible patients are randomly allocated to 2D laparoscopic or 3D laparoscopic group before the operation day . The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate.

Eligibility criteria: Inclusion Criteria:

Age: \>18yr, \<75yr Patients with pancreatic cancer or non-pancreatic cancers (biliary duct cancer or ampullary cancer) who underwent pancreatoduodenectomy Preoperative imaging assessment is resectable or borderline resectable -

Exclusion Criteria:

- Benign tumors of the head of pancreas Enhanced CT diagnosis revealed that the excess of SMV was more than 180 degrees, or distant metastasis.

conversion to laparotomy because of intraoperative difficulty

Primary outcomes:
measure: Overall survival
timeFrame: 60 month
Secondary outcomes:
measure: Overall complications
timeFrame: Up to postoperative 30 days
Other outcomes:
measure: Operative time
timeFrame: 12 hours
measure: Pancreatic fistula
timeFrame: Up to postoperative 30 days
Locations:
Study officials:
affiliation: Peking Union Medical Coll3ge hospital
name: Menghua Dai, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01920295: Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation as First-line Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Yuksek Ihtisas Hospital
Sponsor class: OTHER
First posted: 2013-08-09
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: Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy compared to second choice after failed medical therapy


Eligibility criteria: Inclusion Criteria:

* paroxysmal atrial fibrillation, symptomatic

Exclusion Criteria:

* atrial fibrillation other than PAF, asymptomatic, previous AF ablation

Primary outcomes:
measure: Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)
timeFrame: 12 months from the procedure
measure: Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)
timeFrame: 3 months from the procedure
measure: Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)
timeFrame: 6 months from the procedure
measure: Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)
timeFrame: 9 months from the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Yuksek Ihtisas Heart-Education and Research Hospital
Study officials:
References:
Clinical trial NCT06372795: Resistance Swallowing Training in Patients With Tracheotomy
Official title: Effect of Early Progressive Resistance Swallowing Training on Swallowing Related Muscle Strength in Patients With Tracheotomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Swallowing Training on Muscle Strength
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn investigate the effect of instrument-assisted early progressive resistance swallowing training on swallowing related muscle strength in critically ill patients. It will also learn about the safety of swallowing training. The main questions it aims to answer are:

* Does instrument-assisted early progressive resistance swallowing training increase the swallowing related muscle strength in critically ill patients?
* What medical problems do participants have when taking swallowing training?

Researchers will compare instrument-assisted early progressive resistance swallowing training to pure effortful swallowing to see if instrument-assisted early progressive resistance swallowing training works to increase muscle strength.

Participants will:

-Take instrument-assisted early progressive resistance swallowing training or pure effortful swallowing every day for 2 weeks and take muscle strength test every week.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old
* Tracheotomy after intubation and ventilator ventilation
* Receiving treatment in ICU, and expected hospital stay \> 2 weeks after pneumonectomy
* Be able to cooperate to complete the maximum anterior tongue pressure test

Exclusion Criteria:

* Inability to cooperate with tongue pressure testing and swallowing training, including disturbance of consciousness, oropharyngeal neuromuscular or motor impairment
* Patients refuse to participate in this study
* Significant malocclusion and facial asymmetry

Primary outcomes:
measure: Forced swallowing tongue pressure
timeFrame: Day 14 after training
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: