louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01338103: Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex
Official title: Treatment of Moderate to Severe Patients With Pemphigus With the Monoclonal Anti CD20 Antibody Rituximab at a Protocol of 1000mgX2 and Assessment of Their Immune Status Via the Cylex Test
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pemphigus
Keywords: Pemphigus
Rituximab
Cylex
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Leumit Health Services
First posted: 2011-04-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Rituximab, in the same doses as used in rheumatoid arthritis patients, will benefit pemphigus patients. It also tests immune function via the Cylex assay in pemphigus patients before and after treatment with RItuximab.


Eligibility criteria: Inclusion Criteria:

1. Pemphigus patients with moderate-severe disease

Exclusion Criteria:

1. Pregnancy or lactation
2. Woman of reproductive age not using birth control measures.
3. Prior severe allergy or anaphylaxis with a human monoclonal antibody
4. Heart failure
5. Unstable angina or ischemic heart disease
6. Uncontrolled arrhythmia
7. HIV positive
8. Active hepatitis B infection or positive for hepatitis C virus (HCV) antibodies.
9. Severe dementia or a psychiatric illness
10. Active acute infection

Primary outcomes:
measure: Complete or partial remission off treatment (based on the consensus statement for pemphigus)
timeFrame: 6 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tiqva
country: Israel
facility: Bullous diseases clinic, Department of dermatology, Rabin Medical Center
Study officials:
References:
Clinical trial NCT00382603: Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Soft Contact Lenses in Symptomatic Patients
Official title: Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to a Marketed Multi-Purpose Solution for Care of Soft Contact Lenses in Symptomatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Care
Keywords: Contact Lens Care
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-09-29
Enrollment: 362
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: The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses in patients who experience discomfort with their contact lenses.


Eligibility criteria: Inclusion Criteria:

* Symptomatic for contact lens related discomfort at the end of the lens wearing day.
* Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks.
* Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).
* Successful lens wear for at least 4 hours per day.
* Vision correctable to 20/30.
* Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
* No corneal surgery within the past 12 months.
* No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
* No over-the-counter or prescription ocular medication.
* No enrollment in another clinical study within 30 days prior to enrollment.

Primary outcomes:
measure: Efficacy:
measure: Ocular Comfort and Symptom Scales
measure: Subject Questions/Subject Likert Questionnaire
measure: Safety:
measure: Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications
measure: Adverse Events
Secondary outcomes:
measure: Corneal Fluorescein Staining (Type and Area)
measure: Lens Surface Evaluation (Lens Deposit and Lens Wettability)
measure: Lens Replacement Incidence and Causality
measure: Corrected Visual Acuity with Study Lenses (Snellen)
measure: Rewetting Drop Frequency
measure: Lens Removal Frequency
measure: Average Lens Wearing Time
measure: Average Uncomfortable Lens Wearing Time
Other outcomes:
Locations:
city: Highlands Ranch
country: United States
facility: Highlands Ranch
state: Colorado
Study officials:
affiliation: Alcon Research
name: Leslie Napier
role: STUDY_DIRECTOR
References:
Clinical trial NCT06371703: Enhancing Radiation Safety for Nuclear Medicine Radiographers: the Impact of Introducing the Automat-ed Radiopharmaceutical Preparation and Administration System
Official title: Enhancing Radiation Safety for Nuclear Medicine Radiographers: the Impact of Introducing the Automated Radiopharmaceutical Preparation and Administration System
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Radiation Exposure
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthcare professionals working in nuclear medicine departments

Brief summary: This project aims to evaluate the impact of the introduction of an automated system for radiopharmaceutical preparation and administration on the radiation safety of the radiographers working in nuclear medicine. This study will help to fill the existing gap in the scientific literature and provide useful guidance for the selection of the safest and most effective automated infusion system.


Eligibility criteria: Inclusion Criteria:

* 1)Nuclear medicine radiographers with experience in manual prepa-ration of radiopharmaceuticals.

  2) Nuclear medicine healthcare professionals with experience in radiopharmaceutical administration.

  3) Ability to provide written informed consent.

Exclusion Criteria:

* 1) Nuclear medicine radiographers without experience in manual preparation of radiopharmaceuticals.

  2) Nuclear medicine healthcare professionals without experience in radiopharmaceutical administration.

  3) Inability to provide written informed consent.

Primary outcomes:
measure: Change in absorbed dose by radiographers during PET/CT procedures, measured in millisieverts (mSv).
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Irccs San Raffaele
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Arturo Chiti
role: STUDY_DIRECTOR
References:
Clinical trial NCT06296303: Effect of Pulsed Magnetic Therapy Versus Phonophoresis in Discogenic Lumbar Radiculopathy Patients
Official title: Effect of Pulsed Magnetic Therapy Versus Phonophoresis on Sciatic Nerve Cross Section Measured by Ultrasonography in Discogenic Lumbar Radiculopathy Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lumbar Radiculopathy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purposes of the study

To investigate the effect of pulsed magnetic therapy versus phonophoresis in discogenic lumbar radiculopathy patients

Detailed description: Patients will be randomized into either pulsed magnetic therapy group or phonophoresis group. Patients will receive the intervention for six weeks. Outcomes will be assessed at baseline and post-intervention.

Eligibility criteria: Inclusion Criteria:

* Patient age ranges from 20 -45
* Unilateral chronic lumbosacral radiculopathy
* Intervertebral disc herniation confirmed by MRI
* one of the following :

  1. H- reflex amplitude side to side difference 0.67 in absence of latency difference.
  2. H- reflex amplitude side to side difference smaller than 0.5 in p of latency difference.

  3 - Side to side H- reflex latency difference more than 1 msec. 4- Prolonged H-reflex latency more than 30 msec.

Exclusion Criteria:

* Systematic disease
* Lumbar canal stenosis
* Pervious surgeries
* Scoliosis
* Kyphosis
* Spinal fracture
* Bilateral symptoms
* Steroid injection

Primary outcomes:
measure: Pain
timeFrame: Change from Baseline pain and function at 6 weeks
measure: Disability
timeFrame: Change from Baseline pain and function at 6 weeks
measure: Sciatic nerve cross sectional area
timeFrame: Change from Baseline pain and function at 6 weeks
Secondary outcomes:
measure: H-reflex amplitude
timeFrame: Change from Baseline pain and function at 6 weeks
measure: H-reflex side-to-side amplitude (H/H) ratio
timeFrame: Change from Baseline pain and function at 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05171803: Investigating Immune Escape by SARS-CoV-2 Variants
Official title: Investigating Immune Escape by SARS-CoV-2 Variants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19; Immunity
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Advarra
First posted: 2021-12-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults living in Los Angeles County

Brief summary: The purpose of this protocol is to investigate the ability of pre-existing immunity by natural infection or vaccination to prevent infections by emerging SARS-CoV-2 variants.

Detailed description: Several variants of the SARS-CoV-2 virus were identified in 2020 including the United Kingdom variant (known as 20I/501Y.V1, VOC 202012/01, or B.1.1.7), South Africa variant (known as 20H/501Y.V2 or B.1.35), and Brazil variant (known as P.1), with more variants still being discovered. There is concern that these variants, due to mutations in spike protein and receptor-binding domain of the spike protein, can be more infectious, lethal, and potentially escape the immune responses from vaccination or prior infection. Research is needed to understand the risks associated with currently known variants of SARS-CoV-2 as well as investigate if there is potential for new mutations to form that would allow SARS-CoV-2 variants to partially or entirely escape the immune mechanisms developed from vaccination and/or prior infection from the wild-type strain of SARS-CoV-2.

Eligibility criteria: Inclusion Criteria:

* People who have been fully vaccinated for COVID-19 2-12 weeks prior to enrollment or individuals \<3 months post-COVID-19 infection.
* Collection of samples for blood samples will be done only from healthy, nonpregnant adults who weigh at least 110 pounds.
* Participants must be able to provide informed consent.

Exclusion Criteria:

-Subjects considered vulnerable including children, pregnant women, nursing home residents, or other institutionalized persons, fetuses, prisoners, and persons without decisional capacity.

Primary outcomes:
measure: Assessing immunity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: San Dimas
country: United States
facility: Curative
state: California
Study officials:
References:
Clinical trial NCT05957003: Fluid Responsiveness in Post-cardiac Surgery
Official title: The Validity of Combined End-expiratory and End-inspiratory Occlusion Test and Tidal Volume Challenge Test for Prediction of Fluid Responsiveness in Immediate Post-cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fluid Overload
Cardiac Surgery
Postoperative Complications
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the study aims to examine the validity of combined end-expiratory and end-inspiratory occlusion test and tidal volume challenge test for prediction of fluid responsiveness in immediate post-cardiac surgery patients

Detailed description: multiple studies prove that dynamic variables based on heart-lung interactions accurately can predict fluid responsiveness in mechanically ventilated patients, including pulse pressure variation (PPV) and stroke volume (SV) variation.

Furthermore, passive leg raising (PLR), end-expiratory occlusion test, and tidal volume challenge test, "Mini"-fluid challenge are currently available to assess fluid responsiveness.

Eligibility criteria: Inclusion Criteria:

* Patients on mechanical ventilation
* Patients ≥18 years of age
* patients undergoing cardiac surgery (coronary artery bypass graft, valve repair/ replacement, combined cardiac surgery)
* patients with normal systolic function of the left and right ventricle
* patient is mechanically ventilated with a protective lung strategy

Exclusion Criteria:

* Patients with Spontaneously breathing activity
* Patients undergoing emergent cardiac surgery.
* Patient with severe peripheral arterial occlusive disease
* Pregnant women
* Contraindication of passive leg raising test
* unstable post-operative course
* Post-operative complications such as uncontrolled bleeding, severe neurologic impairment, or accidental mechanical complications;
* presence of residual severe tricuspid or any valvular regurgitations
* low cardiac output, low ejection fractions (EF ≤45%)
* open chest,Pao2/Fio2 ≤ 200

Primary outcomes:
measure: The number of volume responder participants could be detected using each fluid responsiveness test
timeFrame: immediate postoperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of medicine, Tanta university
state: El Gharbyia
Study officials:
References:
Clinical trial NCT01791803: Smoking Cessation After Hospitalization for a Cardiopulmonary Illness
Official title: Smoking Cessation Treatment of CardioPulmonary Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking cessation
Tobacco abstinence
hypnotherapy
Nicotine replacement therapy
Lead sponsor: North Shore Medical Center
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Smoking-related cardiopulmonary diseases account for a large number of hospital admissions. We investigated the efficacy of hypnotherapy as an aid to a counseling-based smoking cessation program in improving quit rates of hospitalized smoking patients at 12 and 26 weeks after hospital discharge. We compared outcomes with hospitalized patients who received more conventional therapy, namely nicotine replacement therapy, or patients who decided to quit on their own. We also compared smoking cessation rates at 12 and 26 weeks after hospitalization among patients admitted with a cardiac or a pulmonary diagnosis.

Detailed description: Hospitalized patients with a cardiopulmonary diagnosis who were contemplating quitting were recruited into 4 groups: Hypnotherapy, Nicotine replacement therapy (NRT), both hypnotherapy and NRT, and self-quit group. All patients received self-help brochures and in-hospital counseling. Intervention groups received more extensive counseling, free NRT supply for a month and/or a 90 minute hypnotherapy session within 2 weeks of discharge. They also had follow up telephone counseling at 1,2,4,8 and 12 weeks after discharge. 7 day prevalence of tobacco abstinence rates at 26 weeks after hospitalization were verified by self report and urinary Cotinine levels.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with a Cardiopulmonary admission.

Exclusion Criteria:

* Terminal illness, history of Serious Psychiatric illness or substance abuse, Pregnancy, Cognitive or language barriers.

Primary outcomes:
measure: Abstinence From Smoking
timeFrame: at 26 weeks after hospitalization
Secondary outcomes:
measure: Smoking Cessation
timeFrame: at 12 weeks after hospitalization
measure: Smoking Abstinence Rate at 12 and 26 Weeks
timeFrame: 12 weeks and 26 weeks after hospital discharge
Other outcomes:
Locations:
city: Salem
country: United States
facility: North Shore Medical Center
state: Massachusetts
Study officials:
affiliation: North Shore Medical Center
name: Faysal Hasan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04463303: The Role of Lung Ultrasound in The Diagnosis of Weaning -Induced Pulmonary Edema
Official title: The Role of Lung Ultrasound in The Diagnosis of Weaning -Induced Pulmonary Edema
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Detecting the Number of B-lines in Lung Ultrasound and Its Accuracy in Diagnosis of Weaning Induced Pulmonary Oedema
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 50
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include patients on mechanical ventilation who will be suitable for spontaneous breathing trial (SBT).

Brief summary: The aim of the work is to

1. Assess the incidence of weaning induced pulmonary adema(WIPO).
2. Assess the risk factors of WIPO.
3. Evaluate the role of lung ultrasound in detecting WIPO during spontenous breathing trial(SBT).
4. Detect the threshold of B-line increase (Delta-B-lines) that provided the best diagnostic accuracy of WIPO.


Eligibility criteria: Inclusion Criteria:

* The study will include patients on mechanical ventilation who will be suitable for spontaneous breathing trial (SBT).

Exclusion Criteria:

* Patients with poor lung ultrasound window, history of cardiomyopathy, significant valvular disease (aortic or mitral insufficiency of grade ≥ 2, mild or severe aortic and mitral stenosis) will be excluded from the study.

Primary outcomes:
measure: the number of B-lines in lung ultrasound and its accuracy in diagnosis of weaning induced pulmonary oedema
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01345903: Robotic-Assisted Surgery in Treating Patients With Spine Tumors
Official title: A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Adult Spinal Cord Neoplasm
Spinal Bone Metastases
Spinal Cord Metastases
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-05-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot clinical trial studies robotic-assisted surgery in treating patients with spine tumors. Robotic-assisted surgery is a less invasive type of surgery for spine tumors and may have fewer side effects and improve recovery

Detailed description: PRIMARY OBJECTIVES:

I. To perform a small pilot study that will demonstrate the feasibility of neurosurgical spinal procedures using the da Vinci surgical robot.

SECONDARY OBJECTIVES:

I. To compare complication rates, operative time and estimated blood loss with historical controls.

II. To observe wound healing, cerebrospinal fluid (CSF) leaks, neurological injury and hardware failure.

II. Routine imaging of the spinal segment.

OUTLINE:

Patients undergo robotic-assisted surgery using the da Vinci robot.

After completion of study treatment, patients are followed up for 100 days.

Eligibility criteria: Inclusion Criteria:

* Patient has primary or secondary spine tumor based on computed tomography (CT) or magnetic resonance imaging (MRI)
* Karnofsky performance status (PS) of \>= 80 or Eastern Cooperative Oncology Group (ECOG) PS 0-1
* Expected survival greater than 3 months
* Patient must be able to understand and sign a study-specific informed consent form

Exclusion Criteria:

* Previous surgery at that specific segment
* Radiation at that specific spinal segment within the last 2 months
* Karnofsky PS \< 80 or ECOG PS \> 1
* Pregnancy (due to risk of anesthesia)
* The presence of medical conditions which contraindicate general anesthesia
* Unexplained fever or untreated, active infection
* Inability to obtain exposure to allow performance of the planned spine surgical procedure
* History of psychiatric condition or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance

Primary outcomes:
measure: Complication rates with 95% confidence bounds of +/- 31% or smaller
timeFrame: For 100 days post-surgery
measure: Estimated blood loss
timeFrame: For 100 days post-surgery
measure: Operation duration
timeFrame: At the completion of surgery
measure: Complication rate
timeFrame: For 100 days post-surgery
measure: Demographic and clinical data such as stage, grade and histology
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: City of Hope Medical Center
name: Mike Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02210403: The Influence of tDCS on the Arm and Hand Function in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transcranial Direct Current Stimulation
Cerebrovascular Accident (CVA)
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether tDCS in combination with motor training can improve hand and arm function in stroke patients.


Eligibility criteria: Inclusion Criteria:

* Stroke patients onset \> 6 months
* First ever stroke
* Decreased hand and arm function
* Mini Mental State Examination (\>24)

Exclusion Criteria:

* Depression
* Pregnancy
* Alcohol abuse
* Aneurysm clips
* Pacemaker
* Neurostimulator
* Implemented defibrillator
* Magnetically activated implant or device
* implemented pump
* Spinal cord simulator
* Implemented hearing aid
* Artificial or prosthetic limb
* Metal parts in the body
* Any external or internal metal
* Artificial heart valve
* Other implants
* History of brain surgery
* Migraine
* Family history of Epilepsy

Primary outcomes:
measure: Change of Fugl-Meyer assessment (FMA) score
timeFrame: Change from baseline in FMA score on the 3rd intervention day; change from baseline in FMA score at 1 week post intervention
Secondary outcomes:
measure: Change of Modified Ashworth scale (MAS)
timeFrame: Change from baseline in MAS scale on the 3rd intervention day; change from baseline in MAS scale at 1 week post intervention
Other outcomes:
measure: Change of motor task performance
timeFrame: Change from baseline motor task performance on the 3rd intervention day, and change from baseline in motor task performance at 1 week post intervention
Locations:
city: Leuven
country: Belgium
facility: K U Leuven
Study officials:
References:
citation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.