louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04476810: Long Term Outcome of Combined Phacoemulsification and Excisional Goniotomy With the Kahook Dual Blade
Official title: Long Term Outcome of Combined Phacoemulsification and Excisional Goniotomy With the Kahook Dual Blade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Glaucoma, Open-Angle
Cataract
Angle Closure Glaucoma
Surgery
Keywords: glaucoma
goniotomy
Kahook Dual Blade
combined phacoemulsification
MIGS
Schlemm's Canal
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.
Primary purpose: TREATMENT

Brief summary: Purpose: Characterize changes in intraocular pressure (IOP), IOP-lowering medications, and visual acuity (VA) through 3 years in patients undergoing combined phacoemulsification and excisional goniotomy with the Kahook Dual Blade (phaco-KDB), with simultaneous goniosynechialysis in cases of angle-closure glaucoma, by a single surgeon (A.H.) in King Fahd Hospital of the University, Dammam, Saudi Arabia.

Methods: Prospective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.


Eligibility criteria: inclusion criteria:

* adults 18 years or older
* medically-managed glaucoma
* visually significant cataract

Exclusion Criteria:

* Patients undergoing any other combined procedures
* active uveitis
* coexisting retinopathy that limits visual acuity potential
* active neovascularization
* angle dysgenesis
* those with less than 6 months of follow-up, were excluded.

Primary outcomes:
measure: Intraocular pressure
timeFrame: 36 months
measure: Intraocular pressure lowering medications
timeFrame: 36 months
Secondary outcomes:
measure: Visual acuity
timeFrame: 36 months
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Imam Abdulrahman Bin Faisal University Hospital
Study officials:
affiliation: assistant professor
name: Ahmed Al habash, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04872010: Construction of a Database for the Life-cycle Sepsis-specific Disease Cohort
Official title: Construction of a Database for the Life-cycle Sepsis-specific Disease Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 4000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1-100 years

Brief summary: Establish a structured clinical database for sepsis screening, and establish a special data set standard for sepsis throughout the life cycle.


Eligibility criteria: Inclusion Criteria:

1. Patients with sepsis who meet the Sepsis 3.0 standard proposed by the 2016 International Sepsis Expert Consensus, that is, for patients with infection or suspected infection, when sepsis-related sequential organ failure (Sequential (Sepsis-related) Organ Failure) Assessment (SOFA) score increased by ≥ 2 points from the baseline can be diagnosed as sepsis;
2. It is estimated that the patient's ICU stay ≥24 hours;
3. Obtain informed consent and sign an informed consent form.

Exclusion Criteria:

1. The patient's ICU hospital stay is less than 24 hours;
2. Participated in other clinical research;
3. Failed to sign the informed consent form.

Primary outcomes:
measure: Sepsis organ function status and survival analysis.
timeFrame: 2022.09.30
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05873010: Manual Compression and Stretching for The Myofascial Trigger Points in Upper Trapezius and Levator Scapulae
Official title: Effectiveness Of Manual Compression and Stretching for The Myofascial Trigger Points in Upper Trapezius and Levator Scapulae
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myofascial Trigger Point Pain
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 30
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To compare the effectiveness of manual compression and stretching for myofascial trigger points in upper trapezius and levator scapulae in male office workers


Eligibility criteria: Inclusion Criteria:

* male office workers with age of 25-45 working from Monday to Friday for 6-8 hours in a day.

Exclusion Criteria:

* male office workers having any past trauma, chronic illness, any recent surgery and systemic diseases.

Primary outcomes:
measure: VAS (visual analogue scale) for pain
timeFrame: 6 Months
measure: mechanical algometer Scale for pain
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudary Muhammad Akram Teaching Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT03097510: Meditation and Emotional Intelligence
Official title: Meditation and Emotional Intelligence: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Job Stress
Perceived Stress
Keywords: Perceived stress
Leadership
Transcendental Meditation
Lead sponsor: Maharishi International University
Sponsor class: OTHER
Collaborators: name: Center for Wellness and Achievement in Education
First posted: 2017-03-31
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial evaluated the impact of the Transcendental Meditation program on emotional intelligence and perceived stress in supervisors and administrative staff in a public school system

Detailed description: The objective of this study was to determine whether a mind-body technique, known as the practice of Transcendental Meditation® (TM), could significantly increase emotional intelligence and decrease perceived stress in supervisors and administrative staff in a public school system. For this purpose, 96 participants from the administrative offices of the San Francisco Unified School District were randomly assigned to either immediate start of the TM program or to a delayed start wait-list control group. Subjects learning TM were instructed to meditate for 20 minutes twice a day for the four month duration of the project. All subjects were administered the BarOn Emotional Quotient Inventory (EQ-i) and Perceived Stress Scale (PSS) at baseline and posttest. If successful, these findings would suggest that TM could be used as a professional development program in organizations to increase emotional intelligence and decrease perceived stress, in turn enhancing leadership capacity and organizational effectiveness.

Eligibility criteria: Inclusion Criteria:

* 18 years or older,
* an employee of the San Francisco Unified School District (SFUSD),
* attendance at an informational meeting on the TM program,
* willingness to be randomly assigned to either active treatment or the control group.

Exclusion Criteria:

* having already learned the TM program,
* not being available to attend treatment or testing sessions.

Primary outcomes:
measure: Emotional Quotient Inventory (EQ-i)
timeFrame: Change from baseline EQ-i at four months
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: Change from baseline PSS at four months
Other outcomes:
Locations:
Study officials:
affiliation: Center for Wellness and Achievement in Education
name: Laurent D Valosek
role: STUDY_DIRECTOR
References:
Clinical trial NCT01020110: Study in an Ex-vivo Thrombosis Model With Human Umbilical Vein Endothelial Cells (HUVEC)-Perfusion
Official title: Human Umbilical Vein Endothelial Cells (HUVEC)-Perfusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombosis
Thrombus Formation
Thrombus Stability
Keywords: perfusion chamber
thrombus D-Dimer
HUVEC
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 healthy subjects

Brief summary: Evaluation of fibrin and platelet deposition on a human umbilical endothelial cell surface in perfusion chamber experiments using human whole blood.

Open-label, non interventional study Perfusion chamber experiment will be performed in 30 healthy patients. The Impact of different pH-solutions on thrombus lysis will be evaluated in an in-vitro second step

Outcome:

D-Dimer content of the thrombus reflecting the size of the thrombus.

Detailed description: All Subjects will have two perfusion chamber experiment as follow with an estimated maximum of blood loss of 165ml:

Before blood perfusion, perfuse the system including the chambers with human umbilical vein endothelial cell coated glass slides (HUVEC), with sodium chloride (NaCl) (0.9%), to ensure no leaks and to remove all air bubbles.

Blood is drawn from a vein in the arm with a Surflo® Winged Infusion Set, 19G (Terumo Europe, Leuven, Belgium) with a pump (Masterflex® L/S™, Cole-Parmer Instrument Company, Vernon Hills, Illinois, USA). Five mL of blood is discarded before each perfusion.

Three in serial placed flow chambers (with HUVEC) heated to 37°C are used. They are made of a Plexiglas block through which a cylindrical hole of 0.2 cm in diameter is machined. The aorta pieces are perfused at 10 mL/min for 5 minutes, followed by a 30 seconds perfusion with NaCl (0.9%).

The plasmin degraded thrombus D-Dimer content will be further evaluated under different conditions (different pH solutions).

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Written informed consent

Exclusion Criteria:

* Use of any medication
* Current diseases
* Anemia

Primary outcomes:
measure: D-Dimer content of the plasmin degraded thrombus
timeFrame: Assessment will follow after all perfusion chamber experiments (1 week)
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna- Dept. of Clinical Pharmacology
Study officials:
affiliation: Medical University Vienna
name: Michael Wolzt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05076110: Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures
Official title: Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hip Arthroscopy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 188
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to evaluate the effectiveness of post-operative pain control without using narcotic pain medications.


Eligibility criteria: Inclusion Criteria:

• Scheduled for a primary Hip Arthroscopy at Mayo Clinic (Rochester, MN)

Exclusion Criteria:

* medical history of known allergies or intolerance to allergies or intolerance to Motrin, Gabapentin, Tylenol, dexamethasone, tramadol, or Robaxin.
* Substantial alcohol or drug abuse.
* History of narcotics within 6 months of surgery.
* Pregnancy.
* Renal impairment.
* Peptic ulcer disease.
* GI bleeding.

Primary outcomes:
measure: Change in pain score
timeFrame: Baseline, 14 days post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kelechi Okoroha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03102710: Neuromodulation of Lidocaine and Capsaicin Cream Effects on Pain Experience
Official title: Neuromodulation of Placebo and Nocebo Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 103
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to use a brain stimulation tool called transcranial direct current stimulation (tDCS) to investigate the analgesic (reducing sensitivity to pain) effects of lidocaine cream and the hyperalgesic (increasing sensitivity to pain) effects of capsaicin cream using a neutral cream as a control. tDCS stimulation has been shown to temporarily influence the way the stimulated part of the brain functions. With this method, the involvement of specific parts of the brain can be investigated in the working of the brain as a whole.


Eligibility criteria: Inclusion Criteria:

* Right handed healthy male and female adults aged 21-50
* No contraindications to fMRI scanning
* At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

Exclusion Criteria:

* Current or past history of major medical, neurological, or psychiatric illness
* Claustrophobia
* History of head trauma
* Instability of responses to experimental pain
* Non-fluent speaker of English
* Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy
* History of alcohol/substance abuse

Primary outcomes:
measure: Comparison of Functional Connectivity Changes of the DLPFC Before and After tDCS Stimulation
timeFrame: up to 2 weeks
measure: fMRI Resting States Functional Connectivity Changes During Pain Stimulation
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Gracely Sensory Scale Pain Rating Changes in Response to Lidocaine and Capsaicin Creams and tDCS
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Jian Kong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06627010: Herpes Simplex Meningo Encephalitis Recurrence
Official title: Herpes Simplex Meningo Encephalitis Recurrence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Herpes Simplex Meningo Encephalitis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Herpes Simplex Meningo Encephalitis Recurrence

Brief summary: study of risk factors and prognosis of herpes simplex encephalitis recurrence.


Eligibility criteria: Inclusion Criteria:

* documented herpes simplex recurrence

Exclusion Criteria:

* other cause

Primary outcomes:
measure: survival rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: vandoeuvre les Nancy
country: France
facility: Chru Nancy
Study officials:
affiliation: CHRU NANCY
name: Valentin HESS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06832410: An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant
Official title: A Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of VX-880 in Subjects With Type 1 Diabetes With a Kidney Transplant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Type 1 Diabetes
Kidney Transplant
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2025-02-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy, safety, and tolerability of VX-880 in participants with Type 1 Diabetes (TID) with a kidney transplant.


Eligibility criteria: Key Inclusion Criteria:

* Clinical history of T1D with greater than or equal to (≥)5 years of insulin dependence
* Taking a stable immunosuppression regimen of tacrolimus and mycophenolate mofetil, mycophenolate sodium, or sirolimus for at least 4 weeks
* Consistent use of continuous glucose monitor (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study

Key Exclusion Criteria:

* Prior islet cell transplant, organ transplant (other than kidney transplant) or cell therapy
* Participants had greater than (\>)1 kidney transplant procedure

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Proportion of Participants who are Insulin Independent
timeFrame: At 1 year After VX-880 infusion
Secondary outcomes:
measure: Proportion of participants who achieve insulin independence and are insulin independent 12 months later
timeFrame: 1 year after achieving insulin independence
measure: Change from Baseline in glycosylated hemoglobin (HbA1c)
timeFrame: Baseline, At 1 year After VX-880 infusion
measure: Proportion of Participants who Maintain Insulin Independence for at least 1 year
timeFrame: From VX-880 infusion to End of Study (up to 2 years)
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Signing of informed consent to End of Study (up to 2 years)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Montefiore
state: Pennsylvania
city: Toronto
country: Canada
facility: Toronto General Hospital (TGH)
city: Vancouver
country: Canada
facility: Vancouver General Hospital
Study officials:
References:
Clinical trial NCT02961712: Immunotherapy of Natural Killer(NK) Cells in Human T Lymphotropic Virus Type 1(HTLV-1) Associated Myelopathy(HAM)
Official title: Immunotherapy of Natural Killer in HTLV-1 Associated Myelopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: HAM
Lead sponsor: The Second Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
Collaborators: name: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
First posted: 2016-11-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: HTLV-1 Associated Myelopathy is a chronic disease of the spinal cord, caused by a virus called human T lymphotropic virus type 1（HTLV-1）. Natural Killer cells provide rapid responses to viral-infected cells, acting at around 3 days after infection, and respond to tumor formation. In this trial, the investigators aim to study the therapeutic safety and the effect on HTLV-1 virus. This in turn will improve the knowledge and understanding of the disease and should lead to better therapy.

Detailed description: HAM is a chronic disease of the spinal cord, caused by a virus called HTLV-I. Natural Killer cells provide rapid responses to viral-infected cells, acting at around 3 days after infection, and respond to tumor formation. In this trial, the investigators aim to study the therapeutic safety and the effect on HTLV-1 virus. This in turn will improve the knowledge and understanding of the disease and should lead to better therapy.

In a single-center, one year open-label trial, 5 HAM patients will be treated with single intravenous injection of NK cells (0.9\~1\*10\^9). Then, the the clinical effect was evaluated by dynamic analysis of Osame's Motor Disability Score and other related physiological indices, such as HTLV-1 antibody titer in blood and cerebrospinal fluid.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of HTLV-1 associated myelopathy

Exclusion Criteria:

* HIV infection
* Hepatitis B \& C viral infections
* Pregnant

Primary outcomes:
measure: change of Osame's Motor Disability Score
timeFrame: 1 year
Secondary outcomes:
measure: HTLV-1 antibody titer in serum
timeFrame: 1 year
measure: HTLV-1 antibody titer in cerebrospinal fluid
timeFrame: 1 year
measure: HTLV-1 proviral load in blood
timeFrame: 1 year
Other outcomes:
Locations:
city: Quanzhou
country: China
facility: The Second Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: The Second Affiliated Hospital of Fujian Medical University
name: Hongzhi Gao, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04014712: O2 Transport and Utilization in Health and Lung Disease
Official title: Role of Nitric Oxide Coupling in Muscle Dysfunction With COPD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: COPD
Tetrahydrobiopterin Deficiency
Oxidative Stress
Keywords: BH4
Exercise
Mitochondria
Vascular function
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Skeletal muscle dysfunction is a frequent and clinically relevant systemic manifestation of Chronic Pulmonary Obstructive Disease (COPD), which is still poorly understood. Therefore, the focus of this study is on the role of a deficit in tetrahydrobiopterin and nitric oxide synthase uncoupling induced by chronic oxidative stress on metabolic and vascular abnormalities in skeletal muscle of patients suffering from COPD.

Detailed description: The purpose of this study is to assess the efficacy of supplementation with tetrahydrobiopterin (BH4) for improving vascular and muscle function in patients with COPD and healthy controls.

Eligibility criteria: Inclusion Criteria:

* All subjects must be between the age of 18 and 85 years;
* For the COPD cohort, patients with a diagnosis of stable COPD (i.e., those not experiencing an acute exacerbation of symptoms) and spirometric evidence of airway obstruction (FEV1 \<80% predicted, FEV/FVC\<0.70);
* Ability to perform motor tests;
* Ability to provide informed consent

Exclusion Criteria:

* uncontrolled hypertension;
* hyperlipidemia;
* recent exacerbation;
* Major cardiovascular event procedure (\<3 months);
* Pregnancy
* known significant hepatic, renal disease, active substance abuse
* contraindication to MRI, claustrophobia

Primary outcomes:
measure: Mitochondrial function
timeFrame: 4 hours
measure: intracellular PO2
timeFrame: 4 hours
Secondary outcomes:
measure: systemic blood markers of oxidative stress
timeFrame: 4 hours
measure: Peripheral Blood flow
timeFrame: 4 hours
Other outcomes:
Locations:
city: Amherst
country: United States
facility: Institute of Applied Life Sciences
state: Massachusetts
Study officials:
References: