louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00604370: Retrospective Study to Review Patients at Risk for VTE at Hospital Discharge
Official title: VTE Prophylaxis Across the Continuum of Care: High Risk Patients at Hospital Discharge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2008-01-30
Enrollment: 2500
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acutely ill medical and surgical patients who were hospitalized at BWH and who are at risk for DVT.

Brief summary: An investigator initiated study exploring VTE prophylaxis at the time of hospital discharge.

Detailed description: It appears likely that many patients will remain at risk for VTE at the time of hospital discharge. These risks will go unrecognized, and discharge prophylaxis orders will not be prescribed.

To test this hypothesis, we will perform a retrospective review of approximately 2,500 patients at Brigham and Women's Hospital at risk for VTE at the time of hospital discharge to determine what proportion received VTE prophylaxis. We will correlate the implementation of discharge VTE prophylaxis with the occurrence of symptomatic DVT and pulmonary embolism within 90 days of hospital discharge.

We will also conduct a substudy of this patient population to determine adherence to VTE prophylaxis among hospitalized patients.

Eligibility criteria: Inclusion Criteria:

* Acutely ill medical and surgical patients with a risk score of 4 or greater without prophylaxis or a risk score of 4 or greater with anticoagulation at hospital discharge.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Symptomatic PE/DVT within 90 days of hospital discharge.
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Samuel Z Goldhaber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02411370: Correlation Between Respiratory Impairment and Phonemes Alteration in Dystrophinopathy Patients With Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: During the Medical Appointment, the Speech Therapist Will Perform Phonetic Tests
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Dystrophinopathy patients with limitive respiratory failure.

Brief summary: Communication is essential for patients quality of life because it impact on patients care quality. Neuromuscular diseases, caracterised by motor damages, hinder non-verbal communication of the patient. Therefore, speech must to be functional.

However, correlation between respiratory failure and voice quality is not very well known. The aim of the study is to search a link between respiratory failure and speech impairment in patients with neuromuscular diseases.


Eligibility criteria: Inclusion Criteria:

* Respiratory autonomy at least 1 hour per day
* Stable patient during the study
* Patient with education at least up to secondary school

Exclusion Criteria:

* Refusal to participate
* Inability to cooperate
* Tracheostomized patients
* Mechanic ventilation - dependant patients
* Respiratory autonomy lower than 1 hour per day
* Patients with hemodynamic instabillity
* Patient insured under the French social security system

Primary outcomes:
measure: Intelligibility phonetic test
timeFrame: 5 minutes
measure: Number and nature of altered phonemes
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital Raymond-Poincaré
state: Hauts-de-Seine
Study officials:
References:
Clinical trial NCT00980070: The Effectiveness of a Pediatric Lumbar Puncture Restraint Device
Official title: The Effectiveness of a Pediatric Lumbar Puncture Restraint Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Indication for Lumbar Puncture
Keywords: lumbar puncture positioning device
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2009-09-18
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a pilot study to evaluate a restraint device for lumbar punctures. Designed to help improve the restraint techniques for lumbar puncture, the restraint device will be compared to the current standard of manual physical restraint in neonatal and pediatric patients (age 1 day to 90 days of life). The investigators will study 30 subjects, with 20 randomized for the experimental device and 10 randomized for the "control" group, which is current standard of care. The investigators' primary outcomes will include time of procedure, red blood cells in the cerebrospinal fluid as well as physician satisfaction. Subjects will be eligible if they are 1-90 days of life, and their treating physician believes lumbar puncture is indicated. There is no follow-up once the lumbar puncture has been completed and the data has been obtained.


Eligibility criteria: Inclusion Criteria:

* Age 1 to 90 days of life
* Indication for lumbar puncture procedure as determined by the treating physician
* Informed Consent from the subject's legal guardian indicating their acceptance of a lumbar puncture for the work-up of sepsis
* Informed consent to enrolled in said protocol

Exclusion Criteria:

* No indication for lumbar puncture procedure as determined by treating physician

Primary outcomes:
measure: To evaluate the safety of the lumbar puncture restraint board
timeFrame: one time use
Secondary outcomes:
measure: To evaluate the effect of the restraint board on the quality of the procedure (time of procedure, quality of specimen obtained, physician impression)
timeFrame: One time use
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Childrens Hospital & Medical Center
state: Nebraska
Study officials:
affiliation: UNMC
name: Edward Truemper, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02792270: Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT
Official title: Effects Of Caloric Restriction On Post-Operative Complications In Sarcoma Patients Treated With Pre-Operative Radiation Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tumor Surgery
Keywords: Surgery
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is being conducted to decrease the rate of surgical wound complications. The investigators are studying the effects that caloric restriction has on decreasing the rate of surgical wound complications.

Detailed description: The goal is to decrease the chance of having wound complications after surgery. Caloric Restriction has been found to be a natural modifier of surgical outcomes. Participants will be randomize into the arms Caloric Restriction Diet or Normal Diet.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Biopsy proven soft tissue sarcoma located in the lower extremities
* Patient to be treated with radiation therapy for a primary lower extremity soft tissue sarcoma or recurrent tumor after surgery, followed by surgical resection
* Karnofsky Score ≥ 60%
* Body Mass Index (BMI) ≥ 20 kg/m2
* Protein levels within normal limits within 45 days of enrollment
* Normal kidney and liver function within 45 days of enrollment
* Normal blood counts within 45 days of enrollment
* Normal chemistries within 45 days of enrollment

Exclusion Criteria:

* Current pregnancy and breast feeding
* Other cancers diagnosed within the last 5 years (in situ and/or invasive)
* Diabetes mellitus
* Current metformin therapy
* Other conditions may exclude participants from the study (e.g. intractable nausea/emesis, allergic reaction to shake, patient decides not to have surgery, any medical condition that prevents patient from having surgery)

Primary outcomes:
measure: Change In The Rate Of Physical Function By MSTS
timeFrame: Baseline, 6 weeks, 3 months and 6 months visits after surgery
measure: Change In The Rate Of Physical Function By TESS
timeFrame: Baseline, 6 weeks, 3 months and 6 months visits after surgery
Secondary outcomes:
measure: The Rate Of Wound Healing
timeFrame: 2 years
measure: The Rate Of Wound Complications In The Protein Caloric Restriction (PCR) Versus Control Group
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts general Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Santiago A Lozano-Calderón, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05700370: MyProstateScore Equivalency With and Without DRE
Official title: Equivalency of MyProstateScore (MPS) Results Between Urine Samples Collected With or Without a Preceding Digital Rectal Examination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: biomarker
tumor
prostate
prostatic neoplasm
prostate-specific antigen
early detection of cancer
Lead sponsor: LynxDx
Sponsor class: INDUSTRY
First posted: 2023-01-26
Enrollment: 800
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of the study is to quantify the concordance of MPS results between first-catch urine samples collected post-DRE and those collected without a DRE.

Detailed description: The process for obtaining a urine sample for MPS currently requires a DRE within one hour prior to urine collection. We aim to understand whether a DRE is a required step prior to urine collection for MPS, and to explore alternative methods that may eliminate the need for a DRE. In order to do so, we will perform a crossover study in which each subject provides a sample under both conditions.

Eligibility criteria: Inclusion Criteria:

* Patient is a candidate for prostate biopsy (Bx)
* If Bx naïve and ≤75yo then PSA 3-10 ng/mL
* If Bx naïve and \>75yo then PSA 4-10 ng/mL
* If prior negative Bx then PSA may exceed 10 ng/mL
* If DRE very suspicious, then PSA below the thresholds of 3 ng/mL (≤75yo) and 4 ng/mL (\>75yo) are acceptable

Exclusion Criteria:

- Prior diagnosis of prostate cancer

Primary outcomes:
measure: MPS equivalency with and without DRE
timeFrame: Study participation will span 8 days
measure: MPS validity rate with and without DRE
timeFrame: Study participation will span 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State Urological Institute
state: Arizona
Study officials:
affiliation: Arizona State Urological Institute
name: Pratik Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03186170: Comparison of in Vitro Fertilization Rates of Oocytes and Embryo Development Using Two Techniques of Semen Processing
Official title: Comparison of in Vitro Fertilization Rates of Oocytes and Embryo Development Using Two Techniques of Semen Processing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.
Primary purpose: TREATMENT

Brief summary: The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.

Detailed description: The project is a RCT follow the orientation of CONSORT. The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.

Eligibility criteria: Inclusion Criteria:

* infertile women who will partcipate in an IVF programme

Exclusion Criteria:

* male factor of infertility

Primary outcomes:
measure: In vitro fertilization: Rate of embryo fertilizated
timeFrame: two weeks
Secondary outcomes:
measure: Embryo development after IVF: Rate of embryo development
timeFrame: two weeks
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: University of Campinas
state: SP
Study officials:
References:
Clinical trial NCT01303770: Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis
Official title: Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Cognitive Impairment
Keywords: Multiple Sclerosis
Cognitive impairment
Self-management programs
Occupational Therapy
Rehabilitation
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Multiple sclerosis (MS) is a progressive neurological disease that affects over 2.5 million people worldwide. Up to 50% of persons with MS (PwMS) will experience some form of cognitive impairment as a result of the disease including disturbances in memory, attention, concentration, information processing, and executive functions such as problem solving, and self-monitoring. MS-related cognitive impairments negatively affect many aspects of functioning and independent participation in everyday life. Thus, PwMS who experience cognitive impairments face a wide array of recurring barriers that pose grave challenges to carrying out everyday activities while trying to maintain multiple life roles and as they age.

Management of cognitive symptoms can be addressed through rehabilitation which has the potential to reduce disability, prevent complications of the disease, and enhance participation, independence, and quality of life. Considering the high frequency of cognitive impairments in MS and their significant, complex impact on functioning and independence, it is critical that cognitive interventions be an essential component of MS rehabilitation.

The overarching goal of this study is to develop and test a self-management, group-based cognitive rehabilitation program designed specifically for PwMS.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of MS
* 18 years of age or older
* Self-report of cognitive difficulties

Exclusion Criteria:

* Exacerbation of symptoms in past 3 months
* History of TBI, CVA, epilepsy, Psychiatric condition, drug/alcohol abuse

Primary outcomes:
measure: Cognitive strategy use
timeFrame: pre intervention, post intervention, 3,6,12 month followup
Secondary outcomes:
measure: Cognitive self-efficacy
timeFrame: pre-intervention, post intervention, 3,6,12 month followup
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Multiple Sclerosis Clinic
Study officials:
affiliation: Tel Aviv University
name: Eynat Shevil, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02385370: Bleb Function and Morphology With Intratendon Injection of MMC Compared With Standard Method
Official title: Bleb Function and Morphology With Intratendon Injection of 0.1 mg MMC in Comparison With Conventional Subtenon Application of 0.02% MMC Soaked Sponges in Trabeculectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Glaucoma
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 126
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with advanced glaucoma that are candidates for trabeculectomy will be included.

Thorough ophthalmic examination including best corrected visual acuity, slit lamp examination, intraocular pressure (IOP) measurement, gonioscopy, funduscopy and specularly microscopy will be performed for all participants. Patients will be assigned randomly to 2 groups. In one group they will undergo fornix based trabeculectomy with conventional MMC 0.02% soaked sponges application. In the other group 0.1 cc of 0.01 MMC will be injected into the tenon at the beginning of the surgery. The rest of the operation is the same for both groups as standard trabeculectomy. Ophthalmic examination including IOP measurement will be performed at one, 3 and 6th month post surgery. Specular microscopy will be requested at final follow up visit. Bleb morphology will be scored according to Indian grading system at 3rd and 6th months post surgery.


Eligibility criteria: Inclusion Criteria:

* Advanced uncontrolled glaucoma patients.

Exclusion Criteria:

* History of any kind of intraocular surgery.
* Monocular patients.
* Unwillingness to participate in the study

Primary outcomes:
measure: IOP (intraocular pressure)
timeFrame: until 6 months
Secondary outcomes:
measure: Bleb morphology
timeFrame: until 6 months
Other outcomes:
Locations:
city: Tahran
country: Iran, Islamic Republic of
Study officials:
References:
citation: Pakravan M, Esfandiari H, Yazdani S, Douzandeh A, Amouhashemi N, Yaseri M, Pakravan P. Mitomycin C-augmented trabeculectomy: subtenon injection versus soaked sponges: a randomised clinical trial. Br J Ophthalmol. 2017 Sep;101(9):1275-1280. doi: 10.1136/bjophthalmol-2016-309671. Epub 2017 Jan 18.
Clinical trial NCT00734370: Virtual Reality Exposure Therapy in Agoraphobic Participants
Official title: Virtual Reality Exposure Therapy in Agoraphobic Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder
Agoraphobia
Keywords: Panic Disorder and Agoraphobia
Virtual Reality Exposure Therapy
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
First posted: 2008-08-14
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Virtual Reality Exposure Therapy (VRET) is an effective treatment for anxiety disorders, particularly for specific phobias as fear of heights and fear of flying (e.g. Powers \& Emmelkamp, 2008). Recent technological advances (e.g. more realistic avatars) make research into the efficacy of VRET for participants with elevated agoraphobic symptoms desirable. Therefore, the aim of the present research proposal is to investigate the comparative efficacy of:

1. enhanced VRET making use of the latest avatar technology with
2. exposure in vivo in agoraphobic participants
3. wait-list control.


Eligibility criteria: Inclusion Criteria:

* A full diagnosis of panic disorder with agoraphobia according to the DSM-IV
* Between the ages of 18-65 years
* Sufficient fluency in Dutch to complete treatment and research protocol

Exclusion Criteria:

* Presence of medical condition, assessed by self-report questionnaires at the intake (i.e., pregnancy, seizure disorder, pacemaker)
* Current use of Beta-blockers
* Current use of tranquilizers (Benzodiazepines)
* Unstable psychotropic medication
* Substance dependence
* Psychosis
* Depression with suicidal ideation
* Posttraumatic Stress Disorder
* Dementia or other severe cognitive impairment
* Bipolar Disorder
* Borderline Personality Disorder
* Anti-social Personality Disorder

Primary outcomes:
measure: Panic Disorder Severity Scale (PDSS); Mobility Inventory for Agoraphobia (MI); Behavioural Avoidance Test (BAT)
timeFrame: Assessed at pre- and post-treatment and 6-12 months follow-up
Secondary outcomes:
measure: Beck Anxiety Inventory (BAI); Anxiety Sensitivity Inventory (ASI); Beck Depression Inventory (BDI); Panic Disorder Severity Scale (PDSS); Agoraphobic Cognitions Questionnaire (ACQ); Bodily Sensations Questionnaire (BSQ); Panic Appraisal Inventory (PAI)
timeFrame: Process measures: are taken prior to treatment, after the fourth treatment session and at post-treatment. The PDSS and PAI will be administered every therapy session
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: University of Amsterdam
Study officials:
affiliation: University of Amsterdam
name: Paul MG Emmelkamp, Professor
role: PRINCIPAL_INVESTIGATOR
References: