louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02317224: The Safety and Efficacy of "3-Hole" Subxiphorid Approach in the Treatment of Anterior Mediastinal Tumor
Official title: Comparison of Safety and Efficacy Among "3-Hole" Subxiphorid Approach, Trans Sternal Approach and VATS in Surgical Treatment of Anterior Mediastinal Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Thymectomy
Myasthenia Gravis
Keywords: 3-Hole approach
extended thymectomy
myasthenia gravis
safety
effectiveness
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2014-12-15
Enrollment: 240
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: Surgery plays an important role in the treatment of anterior mediastinum disease. The major surgical approaches include: cervical approach, mid-sternal approach, cervical combined mid-sternal approach and video-assisted thoracoscopic approach. The cervical approach is rarely adopted because of its restricted visual field. The cervical combined mid-sternal approach have a broader field of vision, given this advantage, the surgeon can remove the thymus and its surrounding fat tissue more thoroughly. But the trauma of this approach is much larger, and the postoperative complication is also a serious problem. The video-assisted thoracoscope is often adopted by left or right approach, this minimally invasive procedure can not remove anterior mediastinum fat thoroughly. In clinical practice, the investigators designed a new method named "3-Hole" subxiphoid approach. This study is designed to compare the safety and validity between this new method and others.


Eligibility criteria: Inclusion Criteria:

* MG with thymic hyperplasia, thymoma or other anterior mediastinum disease
* Masaoka stagingⅠ-Ⅱ
* Thymoma without MG
* Mass diameter \<10cm
* Inform Consent Form is signed

Exclusion Criteria:

* Unable to tolerate surgery
* myasthenic crisis
* Masaoka staging Ⅲ-Ⅳ
* Patients who have undergone previous surgery or radiotherapy
* pregnancy , breastfeeding or younger than 18 years old

Primary outcomes:
measure: Amount of bleeding
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Rate of conversions to thoracotomy
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Duration of operation
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Mortality rate
timeFrame: up to 10 years
measure: Overall survival
timeFrame: up to 10 years
measure: Quality of life
timeFrame: up to 10 years after operation
measure: Number of Participants with Adverse Events
timeFrame: up to 8weekss afte operation
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT01100424: Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining
Official title: Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Staining
Keywords: Contact lenses
Contact lens solution
Corneal staining
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to investigate the association of inflammatory mediators found in the tear film during the development and following the induction of contact lens solution-induced corneal staining.


Eligibility criteria: Inclusion Criteria:

For non-lens wearers:

* Normal eyes.
* Currently not wearing contact lenses and has not worn contact lenses for the previous 6 months.
* Free of dry eye using the Ocular Surface Disease Index (Schiffman et al).
* Other protocol-defined inclusion criteria may apply.

For contact lens wearers:

* Currently wearing soft contact lenses.
* Free of dry eye during lens wear using the Contact Lens Dry Eye Questionnaire Short-Form (Nichols et al, Cornea, 2002).
* Reports a contact lens wearing time of at least 12 hours per day, 7 days per week, daily wear basis (not overnight wear).
* Reports only occasional use of contact lens rewetting drops or artificial tears.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

For non-lens wearers and contact lens wearers:

* Pregnant.
* Participating in another research study.
* Exhibiting staining with fluorescein in more than 5% of the total cornea (graded by "extent" of staining across 5 regions).
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Tear Protein Expression
timeFrame: 1 day
Secondary outcomes:
measure: Corneal Staining
timeFrame: 1 day
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon, Ltd.
name: Jami Kern
role: STUDY_DIRECTOR
References:
Clinical trial NCT02106624: A Trial to Assess the Effect of High Nitrogen Intake in Critically Ill Patients
Official title: The Efficacy and Safety of High Nitrogen Intake in Critically Ill Patients: a Randomized and Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill
Keywords: mechanical ventilation
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 89
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: The patients with sepsis are in high risk of malnutrition, which could contribute to infection, difficulty in weaning from ventilators. The investigators speculate whether nutrition therapy with high nitrogen could attenuate the malnutrition status and improve the outcome in these sepsis patients. In this prospective Randomized Controlled Trial, the investigators aim to compare high nitrogen intake with conventional nitrogen supply which were recommended in guidelines.


Eligibility criteria: Inclusion Criteria:

* need mechanical ventilation for more than 2 days
* mean blood pressure more than 60mmHg
* predicted ICU stay more than 7 days
* tolerance of parenteral or enteral nutrition

Exclusion Criteria:

* irreversible status of primary disease
* any history of malnutrition before enrollment
* history of steroid cortisol administration
* severe liver dysfunction (Child-Pugh Score C)
* pregnancy
* refuse to enrollment
* re-admission to ICU and has been enrolled during former admission to ICU

Primary outcomes:
measure: all cause mortality
timeFrame: 28 days
measure: all cause mortality
timeFrame: 90 days
Secondary outcomes:
measure: duration on ventilators
timeFrame: patients enrolled will be followed for the duration of mechanical ventilation, an expcected average of 4 weeks
measure: ICU stay
timeFrame: patients enrolled will be followed for length of ICU stay, an expected average of 6 weeks
measure: infection incidence rate
timeFrame: 28 days
measure: Liver function and renal function
timeFrame: on 1st. day, 3rd. day, 7th. day, 14th. day, 21st. day, 28th. day after enrollment
measure: diameter of midpoint of musculus rectus femoris
timeFrame: on 28th. day or endpoint of the trial
measure: serum concentration of albumin, pre albumin, retinaldehyde binding protein, transferrin
timeFrame: on 7th. day , 14th. day, 21st. day, 28th. day after enrollment
measure: change of body composition
timeFrame: on 7th.day, 14th.day, 21st.dat, 28th.day after enrollment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Division of Critical Care Medicine: Zhongshan Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00163124: A Randomized Controlled Trial of Best Approach to Care Compared to Diversified Chiropractic Adjustive Technique
Official title: A Randomized Controlled Trial of Best Approach to Care Compared to Diversified Adjustive Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Headache
Shoulder Pain
Keywords: chiropractic
spinal manipulation
low back pain
Lead sponsor: Parker College of Chiropractic
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: There are a variety of treatment approaches used by the chiropractic profession. Some of these require forceful joint manipulation and some do not. This study is designed to compare outcomes of two such techniques that are common to chiropractic practice. The hypothesis is that there is no difference between forceful and non-forceful approaches to treatment.

Detailed description: The comparison will permit a one month treatment period for both techniques and a three week follow-up. Patients will be assessed at baseline (intake), and at specified intervals and at three weeks following the termination of care.

Eligibility criteria: Inclusion Criteria:

chronic musculoskeletal pain ability to communicate in English

Exclusion Criteria:

pregnancy contraindications to manipulation pending litigation chiropractic care within the last month

Primary outcomes:
measure: Pain Disability Index (PDI)
Secondary outcomes:
measure: Beck Depression Inventory
measure: Patient Expectation
measure: Evaluation of Clinic Services
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parker College of Chiropractic
state: Texas
Study officials:
affiliation: Parker College of Chiropractic
name: Cheryl Hawk, PhD DC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01894724: Targeted Hypothermia During Cardiac Surgery
Official title: Targeted Cerebral Hypothermia During Cardiac Surgery: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiac Surgery
Lead sponsor: NeuroSave Inc.
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 5
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 study designed to evaluate the safety and feasibility of the NeuroSave device to rapidly reduce brain temperature while maintaining the brain at a lower temperature than the body core during cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Undergoing coronary revascularization or valvular cardiac surgery
* The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Human Research Ethics Committee (HREC) of the respective clinical site
* The study patient agrees to comply with all study -related procedures

Exclusion Criteria:

* Women known or suspected to be pregnant (as confirmed by a pregnancy test for all women of child-bearing age)
* Past history of cerebrovascular accident (stroke or TIA)
* History of clinically diagnosed active psychiatric conditions
* Emergency or salvage cardiac valve operations
* Body weight \< 50 kg
* Leukopaenia (WBC \< 3000 cell/mL), anaemia (Hgb \< 11g/dL), Thrombocytopaenia (Plt \< 50,000 cell/mL)
* Active upper GI bleeding within 3 months (90 days) prior to procedure
* Renal insufficiency (creatinine \> 265 micromol/L) and/or renal replacement therapy at the time of screening
* Estimated life expectancy \< 12 months (365 days)
* Structural abnormality or disease of nose, mouth, pharynx and oesophagus (excluding gastric reflux oesophagus disease),
* Currently participating in an investigational drug or another device study that would potentially impact the results of this study as determined by the PI. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials

Primary outcomes:
measure: Freedom from major adverse events related to the use of the NeuroSave device
timeFrame: Surgery through discharge (up to 5 days post-surgery)
Secondary outcomes:
measure: Brain-core temperature differential during cardiac surgery
timeFrame: Continuously assessed over course of cardiac surgery
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: Silvanna Marasco
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05390424: Screening for Hepatitis B, Hepatitis C and AIDS Viruses Using Dried Blood Spot
Official title: Screening for Hepatitis B, Hepatitis C and AIDS Viruses Using Dried Blood Spot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis B
Hepatitis C
AIDS
Keywords: Dried Blood Spot
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to screen for hepatitis B, hepatitis C and AIDS viruses using a Dried Blood Spot in drug users


Eligibility criteria: Inclusion Criteria:

* Former or active intravenous and/or nasal drug user
* Person on opiate substitution therapy

Exclusion Criteria:

* Person with known active viral infection(s)

Primary outcomes:
measure: Number of person with an active hepatitis C infection
timeFrame: Day 1
measure: Number of person with an active hepatitis B infection
timeFrame: Day 1
measure: Number of person with an active AIDS infection
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: CSAPA la Boussole
Study officials:
affiliation: University Hospital, Rouen
name: Ghassan RIACHI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04828824: Premature Discontinuation of Contraceptive Implants
Official title: Reduction of Premature Discontinuation of Contraceptive Implants by Advance Provision of an OCP-based Participant Intervention: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Contraception Behavior
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 600
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator).

Detailed description: Objective:

To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator).

Secondary Objectives:

To determine if participants initiating the contraceptive implant who are also provided COCR are more likely than participants receiving standard counseling to:

1. report higher levels of satisfaction with their contraceptive implant at one year following initiation
2. require less clinical follow-up and clinical resources in the year following initiation.

Eligibility criteria: Inclusion Criteria:

1. You are between ages of 14 to 22.9 years.
2. Started etonogestrel implant for the first time and have never used the implant before.

Exclusion Criteria:

1. There is any contraindication to estrogen containing birth control.
2. Desire of pregnancy in next 12 months.
3. Plans to move from the area in next 12 months and is not able to come to the clinic.

Primary outcomes:
measure: Implant Continuation
timeFrame: 12 months post-insertion
Secondary outcomes:
measure: Satisfaction with contraceptive implant
timeFrame: 3, 6, and 12 months post-insertion
Other outcomes:
measure: Implant-related health care interactions
timeFrame: within 12 months of insertion
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
References:
Clinical trial NCT01606696: Higher Intensity Interval Training in Cardiac Rehabilitation
Official title: Practical Use of Higher Intensity Interval Exercise in Cardiac Rehabilitation to Improve Aerobic Fitness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CAD
Keywords: CAD
cardiac rehabilitation
fitness
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2012-05-28
Enrollment: 49
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: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare the effect higher intensity interval exercise (HIIT) with standard intensity non-interval exercise on fitness in cardiac rehabilitation patients with CAD. Also to assess practical implementation of HIIT in cardiac rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* Male or female
* Angiographic documentation of CAD

Exclusion Criteria:

* Unstable angina pectoris
* MI / PCI \< 3 weeks
* CABG \< 4weeks
* Exercise induced ischemia \> 1mm ST depression
* LVEF \< 40%
* complex ventricular arrhythmias or atrial fibrillation
* orthopedic limitations to treadmill exercise

Primary outcomes:
measure: Cardiovascular fitness
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Steven J Keteyian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07022496: Assessment of Oral Caffeine Intake in Changing the Severity of Acute Migraine Attack Using VAS Score Among Patients Attending Headache and Neurology Outpatients Clinic of Ainshams University Hospitals
Official title: Assessment of Oral Caffeine Intake in Reducing the Severity of Acute Migraine Attack Among Patients Attending Headache and Neurology Outpatients Clinic of Ainshams University Hospitals: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Migraine
Migraine Disease
Migraine Headache
Migraine Headache, With or Without Aura
Migraine, Acute
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Caffeine extracted from green tea to abort acute attack of Migraine

Detailed description: Caffeine tablets extracted from green tea can be used as caffeinated drinks to decrease intensity of migraine attacks

Eligibility criteria: Inclusion Criteria:

Patients suffering from migraine with aura, migraine without aura, episodic, and chronic migraine according to ICHD-3 diagnosis will be legible for the study.

Exclusion Criteria:

Patients who have history of any cardiac dysrhythmia, hypertension, ischemic heart disease, active peptic ulcer disease, inflammatory bowel disease, obsessive compulsive disorder, pregnancy, breast-feeding, renal failure, hepatic failure, sleep disorder, mental retardation, and history of substance abuse that prevent them from cooperating with us during the study Patients who had headache due to: Cluster headache, trigeminal neuralgia, glossopharyngeal neuralgia, headache secondary to trauma, cranial disorder, vascular disorder, infection, or mass lesion, will also be excluded

Primary outcomes:
measure: To reduce the severity of migraine attack
timeFrame: Three years
Secondary outcomes:
measure: To evaluate the effect of oral caffeine in reducing pain associated with acute migraine attacks among patients attending Headache Clinic, Ain Shams University hospital via Visual analogue scale
timeFrame: Three year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams university
Study officials:
References:
Clinical trial NCT02399696: Primary Care-Based Mindfulness Intervention for Veterans With PTSD
Official title: Primary Care-Based Mindfulness Intervention for Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Lead sponsor: Syracuse VA Medical Center
Sponsor class: FED
Collaborators: name: Syracuse University
First posted: 2015-03-26
Enrollment: 62
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: Primary care patients typically do not receive adequate PTSD treatment because of their reluctance to engage in empirically-supported treatments offered in specialty care settings. Effective treatments for PTSD are also typically not provided in primary care. Brief skill-based treatments offered in primary care may alleviate symptoms and prepare patients to engage in additional treatment. VA primary care patients with PTSD (N=62) were recruited for a randomized clinical trial comparing a Primary Care-Brief Mindfulness Program (PC-bMP) to primary care-treatment as usual (PC-TAU). PC-bMP is a 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum. Veterans in the PC-bMP condition demonstrated significantly greater decreases in PTSD and depressive symptoms from pre-treatment to post-treatment compared to PC-TAU. These gains were maintained at 8 and 12 week follow-up. PC-bMP participants experienced clinically significant decreases in PTSD, averaging a 15-point drop on the Clinician-Administered PTSD Scale. Exploratory analyses revealed that the describing, non-judging, and acting with awareness facets of mindfulness may account for decreases in PTSD. Our data support preliminary efficacy of a brief mindfulness-based intervention for Veterans with PTSD in primary care. Further research is needed to investigate how PC-bMP may facilitate engagement into full length empirically-supported treatment for PTSD.


Eligibility criteria: Inclusion Criteria:

1) sub-threshold or diagnostic level PTSD related to military service as determined by the Clinician Administered PTSD Scale

Exclusion Criteria:

1) gross cognitive impairment, 2) moderate to severe traumatic brain injury, 3) suicide attempt or intent to commit suicide in the last two months, and 4) receipt of mental healthcare (psychotherapy or medication) outside VA primary in the last two months.

Primary outcomes:
measure: PTSD symptoms as measured by the PTSD Checklist
timeFrame: 8 weeks
Secondary outcomes:
measure: Depression symptoms as measured by the Patient Health Questionaire-9
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Syracuse VAMC
name: Kyle Possemato, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: