louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03069586: Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain
Official title: The Effect of Low Pressure Pneumoperitoneum and Pulmonary Recruitment Manoeuvre on Postoperative Pain After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumoperitoneum
Recruitment
Postoperative Pain
Lead sponsor: General Hospital Groeninge
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators want to test the hypothesis that the addition of a recruitment manoeuvre to a low pressure pneumoperitoneum will lead to an additional reduction in postoperative pain. Therefore the investigators will conduct a prospective randomized controlled, single blind trial.

Detailed description: Two groups:

1. A cholecystectomy at a low pressure pneumoperitoneum (8-10 mmHg)
2. A cholecystectomy at a lowpressure pneumoperitoneum (8-10mmhg) and at the end a pulmonary recruitment manoeuvre (5 sec at max 40 cmH2O).

Eligibility criteria: Inclusion Criteria:

* ASA I and II

Exclusion Criteria:

* refusal to give consent
* cholecystitis
* BMI above 35
* intolerance to one of the pain medication
* pregnancy

Primary outcomes:
measure: pain relief during the first 24 hours
timeFrame: 24hours
Secondary outcomes:
measure: Total analgesic use during the first 24 hours
timeFrame: 24hours
measure: Length of hospital stay
timeFrame: 2 days
measure: Recovery after 48 hours
timeFrame: 48 hours
Other outcomes:
Locations:
city: Kortrijk
country: Belgium
facility: AZ groeninge
Study officials:
References:
Clinical trial NCT06029686: Vibrotactile Coordinated Reset for Parkinson's Patients of a More Variable Population
Official title: Vibrotactile Coordinated Reset for Parkinson's Patients of a More Variable Population
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on Parkinson's symptoms of a more variable population. vCR will be administered with a device called the Stanford Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as Levodopa and or deep brain stimulation. Patients will be followed for two years.


Eligibility criteria: Inclusion Criteria:

1. Age at the time of enrollment: 35 - 92 years
2. Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to
3. Fluent in English
4. Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
5. Feels comfortable going off PD related medication during in person study visits
6. Lives in the United States

Exclusion Criteria:

1. Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies
2. Any current drug or alcohol abuse.
3. Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
4. Pregnancy, breast-feeding or wanting to become pregnant
5. Craniotomy
6. Brain surgery
7. Patient is unable to communicate properly with staff (i.e., severe speech problems)
8. Excessive drooling
9. Patient is taking a medication that may cause significant withdrawal effects

Primary outcomes:
measure: Change in Parkinsonian symptoms as defined by the change in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Peter A Tass, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01820286: Positive Psychology for Mood Disorders
Official title: Trial of a Positive Psychology Intervention to Reduce Suicide Risk in Patients With Mood Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Depression
Keywords: Bipolar disorder
Depression
Positive psychology
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are doing this study to see if "positive psychology" can help adults with depression or bipolar disorder.

Positive psychology involves exercises-short tasks-that try to increase good feelings and emotions, like optimism, happiness, personal strengths, and well-being. Positive psychology exercises might include imagining a bright future, being grateful for good events, forgiving others, and doing kind acts for others.

The investigators want to see if practicing positive psychology exercises after leaving the hospital can increase feelings of hope, optimism, and positive thinking. The investigators are asking you to take part in this research study because you are in the hospital for depression or bipolar disorder.

This research study will compare "positive psychology exercises" to "control condition exercises." During the study, you may take part in control condition exercises instead of positive psychology exercises.


Eligibility criteria: Inclusion Criteria:

* Patient admitted to Massachusetts General Hospital Inpatient Psychiatric Unit
* Age 18 and older
* Able to read and write in English
* Admission diagnosis of major depressive disorder or bipolar affective disorder (current depressive episode), confirmed using the Mini International Neuropsychiatric Interview and inpatient chart review

Exclusion Criteria:

* Psychotic symptoms, as assessed using the Mini International Neuropsychiatric Interview and inpatient chart review
* Cognitive disorder, assessed using a six-item cognitive screen developed for research
* Primary admission diagnosis of substance use disorder

Primary outcomes:
measure: Feasibility of positive psychology exercises
timeFrame: 8 weeks
Secondary outcomes:
measure: Impact of positive psychology exercises on positive affect
timeFrame: 8 weeks
measure: Impact of positive psychology exercises on negative affect
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jeff C Huffman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06783686: Evaluation of NV701 (Pilocarpine 1.25%) Compared with Vuity (Pilocarpine 1.25%) on Pupil Size in Subjects with Presbyopia
Official title: Effect on Pupil Size After One-time Administration of NV701 (Pilocarpine 1.25%) Vs. Vuity (Pilocarpine 1.25%)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Pupil Constriction
Lead sponsor: Novus Vision LLC
Sponsor class: INDUSTRY
First posted: 2025-01-20
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Randomized contralateral eye study to evaluate the effect of one-time dosing of NV701 versus commercially available 1.25% pilocarpine solution on pupil size.


Eligibility criteria: Inclusion Criteria:

* Age 40-55 years with presbyopia
* Able to understand and willing to sign the informed consent for the study
* Resting mesopic pupil diameter of \>4 mm in both eyes
* Change in mesopic pupil diameter of \>1 mm after 1 hour in response to pilocarpine 1.25% in both eyes
* Willing to abstain from contact lens use for 7 days before the study visit
* Women of childbearing age must have a negative urine pregnancy test at the screening visit and be willing to use a reliable method of birth control during the study

Exclusion Criteria:

* Anisocoria \>1 mm in photopic or mesopic conditions
* High myopia (-6.00 diopters or greater)
* Any iris abnormality making it difficult to judge pupil diameter as determined by the principal investigator
* Known allergy to any of the study products or medications
* Concurrent use of any topical prescription ophthalmic products
* History of uveitis or intraocular inflammation
* Inability to complete any of the study procedures
* History of ocular surgery other than LASIK or PRK
* History of retinal tear or retinal detachment
* Presence of retinal lattice degeneration, operculated hole, or other retinal pathology on screening exam.
* History of punctal plugs or punctal cautery in one or both eyes
* History of nasolacrimal duct surgery in one or both eyes
* History of blepharoplasty or ptosis surgery in one or both eyes
* History of glaucoma, glaucoma suspect or ocular hypertension diagnosis
* History of acute angle closure or laser peripheral iridotomy
* History of moderate or severe dry eye disease
* Females who are pregnant, nursing, or planning a pregnancy during the study
* Females of childbearing potential and males with partners of childbearing potential who do not agree to use reliable contraception during the study
* Uncontrolled systemic disease

Primary outcomes:
measure: Change in pupil size over 8 hours
timeFrame: 8 hours
Secondary outcomes:
measure: Mesopic pupil diameter difference
timeFrame: 8 hours
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Glendale
country: United States
facility: Global Research Management, Inc
state: California
Study officials:
References:
Clinical trial NCT00651586: Safety and Efficacy Study of Gatifloxacin Compared With Ciprofloxacin in Patients With Acute Bacterial Corneal Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Bacterial Corneal Ulcers
Bacterial Keratitis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 129
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety and efficacy of gatifloxacin 0.3% ophthalmic solution compared with ciprofloxacin 0.3% ophthalmic solution in patients with acute bacterial corneal ulcers


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis in one eye only of an acute bacterial corneal ulcer (\>1mm)

Exclusion Criteria:

* Corneal ulcer that in the opinion of the investigator had to be treated with fortified antibiotics, or multiple antibiotics, or anti-infectives other than study medication

Primary outcomes:
measure: Complete re-epithelialization of the corneal ulcer
timeFrame: Day 21
Secondary outcomes:
measure: Investigator's evaluation of clinical efficacy
timeFrame: Day 21
measure: Patient reported outcomes
timeFrame: Day 21
measure: Microbiological Cure
timeFrame: Day 21
Other outcomes:
Locations:
city: Galveston
country: United States
state: Texas
city: Madurai
country: India
state: Tamilnadu
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Prajna V, Vajpayee R, Trocme S, Davitt WF, III, Jensen H, Liu R, Safyan E. Safety and Efficacy of Gatifloxacin 0.3% as Compared With Ciprofloxacin 0.3% for the Treatment of Acute Bacterial Corneal Ulcers. Investigative Ophthalmology & Visual Science. 5-1-2006; 47(5):1916
Clinical trial NCT01908686: Pivotal Response Treatment for Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Keywords: ASD
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2013-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the application of an evidence-based, manualized treatment for children with Autism Spectrum Disorder (ASD) (Pivotal Response Treatment, PRT) to children ages four through six years of age with ASD. Specifically, children will be randomly assigned to receive either (1) 10 hours per week of intervention services, including two hours per week of parent education, and eight hours per week of direct clinician-delivered services, or (2) a treatment as usual control. Intervention will focus on enhancing the following developmental skills: expressive and receptive language, play, and social interaction. Outcome measures will address changes in the aforementioned domains during structured observation and standardized assessment.


Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:

Participants will:

1. Fit the age requirement: age 4-35
2. Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team.
3. Be in good medical health
4. Be cooperative with testing
5. English is a language spoken in the family
6. Successfully complete an fMRI and EEG scan
7. Full-scale IQ\>50

Exclusion Criteria:

* Exclusion Criteria:

Participants may not have:

1. Any metal or electromagnetic implants, including:

   1. Cardiac pacemaker
   2. Defibrillator
   3. Artificial heart valve
   4. Aneurysm clip
   5. Cochlear implants
   6. Shrapnel
   7. Neurostimulators
   8. History of metal fragments in eyes or skin
2. Significant hearing loss or other severe sensory impairment
3. A fragile health status.
4. Current use of prescription medications that may affect cognitive processes under study.
5. A history of significant head trauma or serious brain or psychiatric illness

Primary outcomes:
measure: Social Responsiveness Scale (SRS) Total Score
timeFrame: 16 weeks
Secondary outcomes:
measure: Clinical Global Impressions Scale (CGI-I)
timeFrame: 16 weeks
measure: Autism Diagnostic Observation Schedule (ADOS) Comparison Score
timeFrame: 16 weeks
measure: Aberrant Behavior Checklist (ABC)
timeFrame: 16 weeks
measure: Vineland Domain Scores
timeFrame: 16 weeks
measure: Change in Eye Tracking (ET) patterns
timeFrame: 16 weeks
measure: Change in neural response to social stimuli using fMRI
timeFrame: 16 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center - Autism Program
state: Connecticut
Study officials:
References:
Clinical trial NCT05352386: Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia
Official title: Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Familial Hypercholesterolemia
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Dutch Heart Foundation
First posted: 2022-04-28
Enrollment: 135
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates plaque burden and characteristics in early-treated FH patients compared to late-treated FH patients and healthy individuals.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with heterozygous familial hypercholesterolemia or non FH-control
* Adult patients between 25 and 55 years old.

Exclusion Criteria:

* Renal insufficiency, defined as eGFR \< 30 ml/min
* Atrial fibrillation
* Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.

Primary outcomes:
measure: Total coronary plaque volume (mm3)
timeFrame: Day 0
measure: Total coronary plaque burden (%)
timeFrame: Day 0
Secondary outcomes:
measure: Presence of >50% obstructive stenosis per vessel
timeFrame: Day 0
measure: Presence of <50% nonobstructive stenosis per vessel
timeFrame: Day 0
measure: Calcified coronary plaque volume (mm^3)
timeFrame: Day 0
measure: Calcified coronary plaque burden (%)
timeFrame: Day 0
measure: Non-calcified plaque volume (mm^3)
timeFrame: Day 0
measure: Non-calcified plaque burden (%)
timeFrame: Day 0
measure: Low attenuation plaque volume (mm^3)
timeFrame: Day 0
measure: Low attenuation plaque burden (%)
timeFrame: Day 0
measure: Number of high risk plaque features (positive remodeling, low attenuation plaque, spotty calcification and napkin ring sign)
timeFrame: Day 0
measure: Pericoronary adipose tissue attenuation (Hounsfield units)
timeFrame: Day 0
measure: Plasma LDL cholesterol (mmol/l)
timeFrame: Day 0
measure: Plasma apolipoprotein B (g/l)
timeFrame: Day 0
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
Study officials:
References:
Clinical trial NCT03362086: The Osteosarcoma Biobank in Peking University People's Hospital
Official title: Establishment of Osteosarcoma Biobank
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteosarcoma
Keywords: bone tumor osteosarcoma
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients diagnosed with osteosarcoma without pulmonary metastasis

Brief summary: Osteosarcoma is very rare bone tumor. The investigator set up the biobank to ensure the patients has the chance to participate in future research

Detailed description: Samples of blood and other stored material such as slides,frozen tissues and so on .

Questionnaire information, including health history, growth and development, physical activity and family medical history information.

Eligibility criteria: Inclusion Criteria:

Proband Inclusion criteria: A diagnosis or suspected diagnosis of osteosarcoma

Exclusion Criteria:

non-asian pulmonary metastasis

Primary outcomes:
measure: Examine VEGFR-2 and PD-L1 gene expression osteosarcoma
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Tingting Ren, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03177486: Frank Score and Coronary Artery Disease
Official title: Frank Score and Its Guidance Significance of Making Treatment Strategy in Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Syntax score
Frank sign
Coronary angiography
Lead sponsor: Shaanxi Provincial People's Hospital
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients receiving coronary angiography

Brief summary: Patients with coronary artery disease (CAD) were enrolled. CAD was diagnosed by coronary angiography which also resulted Syntax score. Images of left and right ears were captured by a digital camera. Frank score of each patients was calculated based on characteristics and numbers of wrinkles of the earlobes. Statistic analysis were carried out to analyze the correlation between Frank Score and Syntax Score.


Eligibility criteria: Inclusion Criteria:

* Diagnosis coronary artery disease by coronary angiography

Exclusion Criteria:

* Diagnosis of malignant tumor
* Positive heart transplant history
* Positive CABG history
* Positive PCI history
* Pregnant and lactating women
* Diagnosis of chronic kidney disease
* Any external ear trauma or disease history

Primary outcomes:
measure: Syntax score completed
timeFrame: Up to 30 minutes after completion of coronary angiography
Secondary outcomes:
measure: Follow-up MACE
timeFrame: When MACE is reported or up to 1 year after diagnosis of coronary artery disease
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT06617286: CD30 CAR T-cells Post AutoHSCT for Poor-risk Hodgkin Lymphoma
Official title: MAC-CAR: a Phase 1B/II Trial of Myeloablative Conditioning and Autologous Stem Cell Transplantation Followed by Autologous CD30+ CAR T Cells in Children, Adolescents and Young Adults with Poor-Risk Classical Hodgkin Lymphoma (cHL)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Classical Hodgkin Lymphoma
Keywords: classical Hodgkin lymphoma
CAR T-cells
Lead sponsor: New York Medical College
Sponsor class: OTHER
Collaborators: name: University of North Carolina
First posted: 2024-09-27
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with poor risk classical Hodgkin Lymphoma (cHL) will undergo myeloablative chemotherapy (MAC) with autologous stem cell transplantation (AutoHSCT) and subsequently receive autologous CD30+ CAR T-cells.

Detailed description: Eligible patients will be screened for study entry and proceed to cell procurement at local sites with collection of peripheral blood mononuclear cells (PBMC) for CD30+ CAR T-cell manufacturing at UNC. Patients will then have autologous stem cells collected (PBSC) and stored for future AutoHSCT.

After another screening for MAC+AutoHSCT, patients who meet criteria will receive BEAM conditioning followed by AutoHSCT. About 21-42 day after the autologous stem cell infusion, patients will receive their autologous CD30+ CAR T-cell infusion, if they meet subsequent pre CD30+ CAR T-cell eligibility criteria.

Eligibility criteria: Inclusion Criteria:

* Age between ≥ 6 and ≤ 29.99 years at the time of consent.
* Lansky OR Karnofsky score of ≥ 60% (see Appendix VI)
* Disease Status: Confirmed diagnosis of CD30+ classical Hodgkin Lymphoma and meets eligibility to undergo ASCT. Must meet one of the following:

Induction failure Progressive disease Disease relapse (1st, 2nd or 3rd)

* Confirmatory re-biopsy of relapse/refractory/persistent CD30+ cHL prior to study entry.
* Risk Factors: Patient must meet 2 or more of the established risk factors:

Performance score (Karnofsky/Lansky) \<;90% Time from diagnosis to first relapse of \<1 year Extra nodal involvement at the time of relapse/progression High baseline metabolic tumor volume (MTV, \>60mL) by 18F-fluorodeoxyglucose positron emission tomography (PET)/computed tomography (CT) Chemo resistant disease (Deauville 4-5) after the first re-induction

Exclusion Criteria:

* not meeting the inclusion criteria

Primary outcomes:
measure: Safety of administering CAR T-cells
timeFrame: 2 years
measure: Feasibility of Central Manufacturing of CAR T-cells
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: New York Medical College
state: New York
Study officials:
References: