louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04153253: Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage
Official title: Intravitreal Aflibercept Injection With Panretinal Photocoagulation Versus Early Vitrectomy for Diabetic Vitreous Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Vitreous Hemorrhage
Keywords: Aflibercept
panretinal photocoagulation
vitrectomy
Lead sponsor: Al Hadi Hospital
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 34
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: Prospective study comparing efficacy and safety of intravitreal aflibercept injection and panretinal photocoagulation to early vitrectomy for patients with diabetic vitreous hemorrhage.

Detailed description: Selected patients were divided into two groups, Group I for whom intravitreal aflibercept injection followed by panretinal photocoagulation was done and group II for whom early vitrectomy was done.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years.
* Any sex.
* Type Ι or ΙΙ DM,
* recent diabetic VH which is causing vision impairment, precluding complete PRP and needing treatment.
* BCVA is less than 20/70 (log MAR BCVA 0.6) and better than 20/1000 (log MAR BCVA 1.7).

Exclusion Criteria:

* Tractional retinal detachment.
* Previous PRP.
* History of anti VEGF therapy within the past two months.
* Neovascular glaucoma
* Subhyaloid hemorrhage.
* Vitreomacular traction.
* Diabetic macular edema .
* Patients with systemic contraindications for anti VEGF or unstable medical conditions as uncontrolled hypertension (persistently above 180/110 mmhg) or recent thromboembolic event within the past six months.

Primary outcomes:
measure: Mean best corrected visual acuity(BCVA) change in both groups.
timeFrame: 9 months follow up.
Secondary outcomes:
measure: Rate of recurrent bleeding.
timeFrame: 9 months follow up.
measure: Number of additional treatment procedures .
timeFrame: 9 months follow up
Other outcomes:
Locations:
city: Ḩawallī
country: Kuwait
facility: Alhadi Hospital
state: Aljabyria
Study officials:
affiliation: Alhadi hospital
name: Ahmed H Abdelhamid, MD
role: STUDY_DIRECTOR
References:
citation: Abd Elhamid AH, Mohamed AAEA, Khattab AM. Intravitreal Aflibercept injection with Panretinal photocoagulation versus early Vitrectomy for diabetic vitreous hemorrhage: randomized clinical trial. BMC Ophthalmol. 2020 Apr 6;20(1):130. doi: 10.1186/s12886-020-01401-4.
Clinical trial NCT00757653: Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings
Official title: Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Femoral Neck Fractures
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Biomet U.K. Ltd.
First posted: 2008-09-23
Enrollment: 57
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: Retrieval study and histological examination of BiMetric Femoral Components with hydroxyapatite coatings.

Detailed description: A single type of femoral component with 3 different HA coatings will be evaluated in this study. Patients with fractured neck of femur requiring hemi-arthroplasty will be recruited. Safety and performance of the device will be determined by adverse events (device related or non-related), survival and histological exam.

Eligibility criteria: Inclusion Criteria:

* Fractured neck of femur requiring hemi-arthroplasty. Selection of subjects for this evaluation should include the following considerations:-.
* A likelihood of obtaining relief of pain and improved function.
* Full skeletal maturity.
* Ability to follow instructions.
* Good general health for age.
* Willing to return for follow-up evaluations .
* No bias to sex.

Exclusion criteria:

• None

Primary outcomes:
measure: Adverse Event
timeFrame: Anytime
Secondary outcomes:
measure: Histological Exam
timeFrame: Anytime
Other outcomes:
Locations:
city: Ashford
country: United Kingdom
facility: William Harvey Hospital
state: Kent
Study officials:
affiliation: William Harvey Hospital
name: Helmut Zahn, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00176553: A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity
Official title: A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neurotoxicity Syndromes
Keywords: methotrexate neurotoxicity
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to find out whether dextromethorphan can prevent the short or long-term neurologic side effects of methotrexate, and whether dextromethorphan can improve symptoms of short-term neurologic side effects if they do occur.

Detailed description: We believe that we are beginning to understand the biological cause of the neurotoxicity that happens after treatment with methotrexate. Dextromethorphan, an ingredient in common cough medicines, may be able to prevent and/or treat this neurotoxicity. We have given dextromethorphan to a small group of patients who developed severe neurologic side effects after methotrexate. All had a complete recovery within one day.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed acute lymphocytic leukemia (ALL), non-Hodgkin's lymphoma (NHL) or OS. Patients will be separately stratified and randomized by disease.
* Patients with history of seizures are eligible but will be stratified separately.

Exclusion Criteria:

* Patients taking monoamine oxidase inhibitors (MAOIs) will be excluded from the study, because of the risk of severe drug interactions.
* Pregnant or lactating women.

Primary outcomes:
measure: To determine whether dextromethorphan decreases the subacute toxicities associated with intravenous and intrathecal methotrexate
timeFrame: 5 years
Secondary outcomes:
measure: To determine whether dextromethorphan can alleviate acute or subacute neurotoxicity when it does occur after intravenous or intrathecal methotrexate
timeFrame: 5 years
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Peter Cole, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05496153: The Clinical Effect of Adaptive Posture-balance Cardiac Rehabilitation Exercise on Cardiovascular Diseases
Official title: The Clinical Effect of Adaptive Posture-balance Cardiac Rehabilitation Exercise on Cardiovascular Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Rehabilitation
Exercise Therapy
Balance Exercises
Cardiovascular Diseases
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2022-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The whole experiment included one-month APBCRE therapy and two assessments. The one-month APBCRE consisted of twelve exercise sessions, evenly three times per week. At baseline and after rehabilitation, participants underwent one assessment, including car-diopulmonary exercise testing (CPET), resting metabolic rate (RMR) detection, and quality of life questionnaire (QoL). The primary outcomes were exercise capacity measured by function parameters at anaerobic threshold (AT) and other CPET physiological indexes. The secondary endpoints were the RMR level and QoL score.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 90 years
* With cardiovascular diseases

Exclusion Criteria:

* abnormal blood pressure response
* unstable angina pectoris
* acute heart failure
* congenital heart disease
* severe musculoskeletal diseases

Primary outcomes:
measure: CPET
timeFrame: Baseline and immediately after the intervention, about one month
Secondary outcomes:
measure: Quality of life
timeFrame: Baseline and immediately after the intervention, about one month
measure: RMR
timeFrame: Baseline and immediately after the intervention, about one month
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT01722253: Postoperative Analgesia After Low Frequency Electroacupuncture
Official title: Postoperative Analgesia After Low Frequency Electroacupuncture as Adjunctive Therapy in Inguinal Hernia Surgery With Abdominal Wall Mesh Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Keywords: electroacupuncture
acupuncture
pain management
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2012-11-06
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in the Surgical Clinic with right or left inguinal hernia, residents of Thessaly, Greece.

Brief summary: The purpose of this study is to determine whether electroacupuncture is a effective tool to the postoperative analgesia

Detailed description: The electroacupuncture is a known therapeutic modality with particular application to pain. In this study the investigators investigate the effect of electroacupuncture in condition of surgery, which is a particularly painful situation. The investigators will verify the postoperative analgesia, as patients will receive either electroacupuncture or placebo electroacupuncture.

Eligibility criteria: inclusion criteria:

* healthy male volunteers
* 18-75 years old

Exclusion Criteria:

* bilateral or recurrent hernia
* significant cardiovascular, pulmonary, renal, hepatic, neurological disease
* psychiatric history
* use of opioids until the last month
* body mass index greater than 30
* treatment with beta-blockers
* aged over 75
* previous experience with acupuncture
* hypersensitivity to opioids
* pacemaker patient
* patients being treated with monoamine oxidase inhibitors and selective serotonin reuptake inhibitors.

Primary outcomes:
measure: Monitoring of pain with the Visual Analogue scale within the first 24 hours after surgery
timeFrame: within the first 24 hours after surgery
Secondary outcomes:
measure: Control of anxiety with the State-Trait Anxiety Inventory within 24 hours after surgery
timeFrame: within the first 24 hours after surgery
Other outcomes:
measure: Monitoring of pain with the use of an algometer within the first 24 hours after surgery
timeFrame: within the first 24 hours after surgery
Locations:
city: Thessaloniki
country: Greece
facility: Aristotle University
Study officials:
affiliation: Aristotle University
name: Dimitrios G Vasilakos, Professor
role: STUDY_CHAIR
affiliation: Aristotle University
name: Maria I Dalamagka, consultant
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dalamagka M, Mavrommatis C, Grosomanidis V, Karakoulas K, Vasilakos D. Postoperative analgesia after low-frequency electroacupuncture as adjunctive treatment in inguinal hernia surgery with abdominal wall mesh reconstruction. Acupunct Med. 2015 Oct;33(5):360-7. doi: 10.1136/acupmed-2014-010689. Epub 2015 Jun 3.
Clinical trial NCT05251753: Evaluation of a Novel Sutureless Drain Securement Device
Official title: Evaluation of a Novel Sutureless Drain Securement Device (K-Lock Device) and Comparison to Standard Suture-based Drain Securement Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Injury
Keywords: drain
suture
body contouring
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate an investigational sutureless drain securement device (K-Lock) and compare this device to standard drain securement.

Detailed description: This study will evaluate the feasibility, safety and efficacy of a novel sutureless drain securement device (K-Lock) via direct comparison to suture-based techniques. In this study the sutureless drain securement device will be compared to the use of sutures to secure drains. Patients will be randomized to either A) left side K-Lock with right side suture-based technique or B) right side K-Lock with left side suture-based technique.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Patient of the Department of Plastic and Reconstructive Surgery
* Able to sign English language Consent form
* Undergoing any of the following procedures requiring placement of 2 or more drains (preferably bilateral) including: Breast reconstruction, Bilateral Breast Reduction, Abdominoplasty, Body Contour surgery (e.g. panniculectomy, brachiplasty, thighplasty)

Exclusion Criteria:

* Patients with unilateral drain placement
* Unable to sign English language consent form
* Allergy to Tegaderm Dressing

Primary outcomes:
measure: Time it Takes to Secure and Dress Each Drain in Totality
timeFrame: Day of Surgery
Secondary outcomes:
measure: Ease of Use
timeFrame: Day of Surgery
measure: Skin Injury
timeFrame: On Average Day 10
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Lisa David, MD MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Adam J Katz, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03004053: Feasibility Testing of a Novel Endoscope for Reflectance Confocal Microscopy of Normal Oral Tissue In Vivo
Official title: Feasibility Testing of a Novel Endoscope for Reflectance Confocal Microscopy of Normal Oral Tissue In Vivo
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Tissue
Keywords: Reflectance Confocal Microscopy
Normal Oral Tissue
16-1652
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Head and Neck clinic

Brief summary: The purpose of this study is to obtain images (pictures) of normal oral tissue, which occur inside the mouth, using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. The technology is called "reflectance confocal microscopy."


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Ability to sign informed consent
* Age ≥ 18 years.

Exclusion Criteria:

* Inability to give informed consent.
* Previously known oral disease

Primary outcomes:
measure: number of images with acceptable quality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Snehal Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01808053: Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects
Official title: Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
name: Preventice
First posted: 2013-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy older adults living at an independent living center.

Brief summary: To adapt and refine the BodyGuardian remote health monitoring system to acquire ECG, Heart rate (HR), activity and breathing data, which will be integrated with weight, blood pressure and symptom data, in subjects in an independent living center, with wireless transmission of data to a central data analysis hub.

Detailed description: The elderly are facing an increasing prevalence of chronic disease and rapidly escalating healthcare costs threatening independent living. Congestive heart failure (CHF) is a growing health epidemic and is associated with significant morbidity, mortality and cost. Mayo Clinic and Preventice have developed a non-invasive, minimally obtrusive, interactive remote monitoring platform. It enables on-body monitoring and integration of ECG, heart rate, breathing, and activity, with measures of weight and blood pressure. It is designed as a platform for physician directed patient self-management. This technology may be useful in monitoring CHF patients. Our overall objective is to adapt, refine, test and validate this technology in subjects in an independent living center, with wireless transmission of data to a central data analysis hub.

Eligibility criteria: Inclusion Criteria:

* Resident at independent living facility
* Adequate phone service
* Healthy with life anticipated survival \>than one year

Exclusion Criteria:

* Skin reaction/allergies to adhesives
* Have implantable pacemaker and/or defibrillator or have a bed partner with an implantable pacemaker

Primary outcomes:
measure: Number of subjects with successful data transfer at the end of 30 day monitoring period.
timeFrame: approximately at the end of 30 day monitoring period
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Charles J Bruce, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01208753: Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 in Healthy Subjects
Official title: Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Doses of GLPG0555 in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2010-09-24
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.


Eligibility criteria: Inclusion Criteria:

* healthy male, age 18-50 years
* BMI between 18-30 kg/m², inclusive.

Exclusion Criteria:

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse

Primary outcomes:
measure: Safety and tolerability of multiple dosing
timeFrame: Daily during treatment, up to 10 days postdose
Secondary outcomes:
measure: Pharmacokinetics of repeated doses
timeFrame: 24 hours postdose
measure: Pharmacodynamics (PD) of GLPG0555 after repeated oral administration
timeFrame: up to 10 days postdose
measure: The relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions administered for three days
timeFrame: up to 24 hours postdose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS Stuivenberg
Study officials:
affiliation: Galapagos NV
name: Gerben van 't Klooster, PhD
role: STUDY_DIRECTOR
affiliation: SGS Stuivenberg
name: Wouter Haazen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00725751: Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)
Official title: Evaluation of Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Patients With/Without Substitution Therapy in Austria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients receiving treatment for hepatitis C with/without substitution therapy at sites in Austria.

Brief summary: Although injection drug users represent the majority of new and existing cases of infection with hepatitis C virus (HCV), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection. On the basis of a small but growing body of evidence showing that injection drug users can undergo treatment for HCV infection successfully, the 2002 NIH Consensus Statement on Hepatitis C has recommended that substance users be treated for HCV infection on a case-by-case basis. In this study, all patients will receive pegylated interferon alfa-2b (PegIFN-2b) and ribavirin according to European labeling; one cohort of participants will also be receiving substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine).


Eligibility criteria: Inclusion Criteria:

* Adult patients with hepatitis C

Exclusion Criteria:

* According to the products' European labeling

Primary outcomes:
measure: Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin
timeFrame: 24 to 48 weeks
Secondary outcomes:
measure: Number of Participants Who Achieved Sustained Virologic Response (SVR)
timeFrame: 24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype)
measure: Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References: