louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05070910: NDT Effectiveness Study
Official title: Determining the Efficacy of the Neurodevelopmental Treatment Contemporary Practice Model for the Treatment of Children With Cerebral Palsy or Other Neuromuscular Conditions to Improve Functional Outcomes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Neuromuscular Diseases
Neurodevelopment Treatment
Lead sponsor: MultiCare Health System Research Institute
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 14
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether there is a functional change in children with Cerebral Palsy (CP) and other neuromuscular disorders participating in Neurodevelopmental Treatment (NDT) intervention using the contemporary practice model (CPM).


Eligibility criteria: Inclusion Criteria:

* The children will be aged 2 to 15 years with a diagnosis of CP, hypotonia, global developmental delay and/ or neuromuscular disorders not otherwise specified.
* Children must also be willing to receive physical guidance for movement and clearly attempt to respond to simple instructions on request.
* Children and their families are available and willing to attend the practicum portion of the course for both blocks.

Exclusion Criteria:

* Parent/Guardian unable to complete the 4 required interview sessions.
* Unable to commit to attending 75% of practicum sessions.

Primary outcomes:
measure: Significant increase in functional outcomes in COPM scores
timeFrame: Significant change after an 8 week NDT-CPM treatment occurring from November 2, 2021 to completion on March 12, 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Puyallup
country: United States
facility: Good Samaritan Hospital
state: Washington
Study officials:
References:
Clinical trial NCT02396810: Utilization of iMRI for Transsphenoidal Resection of Pituitary Macroadenomas
Official title: A Single-center, Prospective, Randomized Controlled Trial Investigating the Utility if Intraoperative MRI in Transphenoidal Pituitary Surgery Off Macroadenomas.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pituitary Macroadenoma
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators are studying the utility of intra-operative magnetic resonance imaging (iMRI) during transsphenoidal pituitary surgery for large macroadenomas by randomizing patients to either an intra-operative MRI after resection, or no intra-operative MRI. The investigators will then count the number of gross total resection in each group of patients and also the complications related to surgery.


Eligibility criteria: Inclusion Criteria:

* Adults 18-90
* Capable of giving informed consent
* Elect for transsphenoidal surgery
* Has pre-operative MRI demonstrating pituitary tumor that is:

  1. deemed resectable using a transsphenoidal approach and
  2. has a maximal diameter equal to or greater than 15 mm.
* No contraindications for MRI.

Exclusion Criteria:

* Children (age \< 18)
* Not able to give consent
* No pituitary tumor visible on MRI or an adenoma measuring less than 15mm in maximal dimension.
* Unable to tolerate MRI

Primary outcomes:
measure: Rate of gross total or maximal resection
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Operative time
timeFrame: intraoperative
measure: Frequency of post-operative CSF leak
timeFrame: 30 days post surgery
measure: Rate of Readmission
timeFrame: 30 days post surgery
measure: Length of anesthesia time
timeFrame: intraoperative
measure: Rate of post-operative endocrinopathies
timeFrame: 30 days post surgery
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
Clinical trial NCT01952210: Effectiveness of a Nutritional Consultation and Exercise Program in Esophageal Cancer Patient
Official title: The Effectiveness of a Nutritional Consultation and Exercise Program in Esophageal Cancer Patient Receiving Neoadjuvant Chemoradiation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-09-27
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this randomized pilot study, a nutritional consultation combining exercise program is planned for 25 locally advanced esophageal cancer patients undergoing neoadjuvant chemoradiation. The purpose of this study is to determine the effects of nutritional and exercise intervention in locally advanced esophageal cancer patients undergoing neoadjuvant chemoradiation.

Detailed description: Patients with esophageal cancer are often malnourished at presentation due to the primary symptom of dysphagia. Treatments for esophageal cancer are commonly multimodal, incorporating polychemotherapy, radiotherapy and surgery. These treatments frequently cause or exacerbate poor nutritional status. Recent literature has proved that malnutrition is associated with longer hospital stays, reduced responses to and increased complications from therapies, increased costs, worse quality of life and lower survival rate. The aim of this study was to investigate the effectiveness of an intensive nutritional consultation and exercise program on nutritional status and outcomes in patients undergoing chemoradiation for esophageal cancer.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of locally advanced esophageal cancer, neoadjuvant chemoradiation is indicated
* Informed consent signed

Exclusion Criteria:

* stage IV, underwent palliative chemotherapy or radiotherapy patient
* clinically significant cardiac or pulmonary disease
* Unable to walk or exercise

Primary outcomes:
measure: General nutritional status
timeFrame: 10 weeks
Secondary outcomes:
measure: Treatment tolerance
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Nursing, National Taiwan University Hospital
name: Cheryl Chia-Hui Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04262310: Standardizing Method and Development of Normal Values to Measure Human Small Intestinal and Colonic Permeability
Official title: Standardizing Method and Development of Normal Values to Measure Human Small Intestinal and Colonic Permeability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers

Brief summary: To develop a test to measure small bowel and colonic permeability.

Detailed description: The study consists of a physical examination, standardized meals and 3 oral sugar tests with 24 hour urine collections. It requires the participants to visit the Clinical Research Trials Unit in the Charlton Building and Domitilla Building. Remuneration will be offered.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Non-Obese
* Non-pregnant
* Caucasian
* BMI \<30kg/m2

Exclusion Criteria:

* Diabetes
* Hypertension
* BMI ≥30kg/m2
* Chronic NSAID use (\>3 days/week)

Primary outcomes:
measure: Standard Method to Measure Intestinal Permeability
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Camilleri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00215410: Study in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Formoterol
Fumarate
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 36
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the most safe and effective dose of the investigational drug in comparison with a control drug and placebo.


Eligibility criteria: Inclusion Criteria:

* Children with a history of asthma
* Written guardian approval

Exclusion Criteria:

* Current or recent asthma exacerbation, requiring hospitalization
* History of smoking
* Debilitating or systemic and/or life-threatening diseases.

Primary outcomes:
measure: Measure of lung function
Secondary outcomes:
measure: Change in lung function, as well as vital signs
measure: Physical Exam results, AE reporting, etc
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Long Beach
country: United States
facility: Research Site
state: California
city: Mission Viejo
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: Vista
country: United States
facility: Research Site
state: California
city: Englewood
country: United States
facility: Research Site
state: Colorado
city: Oklahoma
country: United States
facility: Research Site
state: Oklahoma
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Fort Worth
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
Study officials:
References:
Clinical trial NCT00479310: Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice
Official title: A Multi-Center, Randomized, Vehicle Controlled, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the Treatment of Head Lice.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head Lice
Lead sponsor: Summers Laboratories
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multi-center, Randomized, Vehicle Controlled, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the treatment of Head Lice.


Eligibility criteria: Inclusion Criteria:

1. Males and females 6 months of age or older.
2. Have an active infestation with Pediculus capitis, the human head louse, with at least three live lice at baseline.
3. Agree not to use any other pediculicides or medicated hair-grooming products during the duration of the study.
4. Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period.
5. Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form.
6. Subject or guardian has read, understood, and signed appropriate informed consent in English. If English is not the primary language, the information about the study must be explained in their language and a copy of the informed consent must be in that language.
7. Subject is willing to participate in the study, and abide by the protocol requirements.

Exclusion Criteria:

1. Participation in any clinical study within the past 30 days.
2. Known hypersensitivity to any ingredient in the product formulation.

Primary outcomes:
measure: Treatment success is defined as the absence of live lice.
Secondary outcomes:
measure: The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit.
Other outcomes:
Locations:
Study officials:
References:
citation: Meinking TL, Villar ME, Vicaria M, Eyerdam DH, Paquet D, Mertz-Rivera K, Rivera HF, Hiriart J, Reyna S. The clinical trials supporting benzyl alcohol lotion 5% (Ulesfia): a safe and effective topical treatment for head lice (pediculosis humanus capitis). Pediatr Dermatol. 2010 Jan-Feb;27(1):19-24. doi: 10.1111/j.1525-1470.2009.01059.x.
Clinical trial NCT05190510: Assessment of Vulnerability to Carotid Stenosis by MultiModal Imaging and Cellular and Molecular Biology Analysis
Official title: Assessment of Vulnerability to Carotid Stenosis by MultiModal Imaging and Cellular and Molecular Biology Analysis Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Internal Carotid Artery
Atheromatous Stenosis
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Scheduled surgery

Brief summary: Cerebrovascular accidents (CVA) are the second leading cause of death in France, and the most frequent cause of acquired physical and mental disability. Up to 90% of strokes are ischemic, among which about 15% are due to the presence of stenosis of the carotid sinus, at the base of the extracranial internal carotid artery.

For many years, only the degree of stenosis was used to assess the risk of stroke, based on the results of original studies from the 1990s. However, the significant improvement in medical treatments since then has significantly reduced the risk of stroke, and the benefits of carotid intervention are becoming increasingly debatable.

Since the publication of the latest recommendations, the degree of stenosis alone is no longer sufficient to propose an intervention, since most of them will never lead to a neurological event. In addition to stenosis greater than 60%, for the first time, other criteria must be sought to decide on treatment. For example, so-called carotid plaque "vulnerability" criteria, defining patients "at high risk of stroke," should be sought.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic or asymptomatic atheromatous stenosis of the internal carotid artery, of a degree ≥ 50%, for which an operative indication is retained
* Scheduled surgery

Exclusion Criteria:

Samples collected from patients :

* who did not have a preoperative CT angiogram of the supra-aortic trunks
* with contraindication to MRI
* with contraindication to PET scan
* with a history of cervical radiotherapy
* with uncontrolled diabetes
* with a previous homolateral carotid endarterectomy
* who has already undergone angioplasty-stenting of the homolateral carotid artery
* with a neoplasia considered active / not cured
* Surgical procedure performed in emergency

Primary outcomes:
measure: rate of 18FDG tracer uptake in carotid stenosis
timeFrame: At baseline
measure: Degree of instability of the plate
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT02811510: Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I
Official title: Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cannabis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Detailed description: To characterize the acute effects of oral Dronabinol (10 mg capsule) in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Eligibility criteria: Inclusion Criteria:

* At least one lifetime exposure to cannabis
* Good physical and mental health

Exclusion Criteria:

* Cannabis naive individuals
* Major current or recent stressors
* Taking estrogen supplements or oral contraceptive pills (for women)
* Sesame oil allergy

Primary outcomes:
measure: Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS)
timeFrame: changes in "high" assessed over the following timepoints: baseline, +60, +80, +120, +180, +300 minutes after start of oral Dronabinol administration.
measure: Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: baseline and +80 minutes after start of oral Dronabinol administration.
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
state: Connecticut
Study officials:
References:
Clinical trial NCT01186510: Lung Perfusion With Oxygenated Blood During Aortic Clamping
Official title: Lung Perfusion With Oxygenated Blood During Aortic Clamping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pulmonary Dysfunction
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2010-08-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pulmonary dysfunction presumably linked to an inflammatory response is frequent after cardiac operations using cardiopulmonary bypass (CPB) and pulmonary hypoperfusion.

Aim of the study: To evaluate the protective effect of continuous pulmonary perfusion with oxygenated blood during aortic crossclamping on the inflammatory response.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 ys
* Cardiopulmonary bypass procedure
* FEV1 \<80%
* COPD \>II

Exclusion Criteria:

* Emergency cases

Primary outcomes:
measure: Inflammatory marker
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Goethe University
Study officials:
References:
citation: Kiessling AH, Guo FW, Gokdemir Y, Thudt M, Reyher C, Scherer M, Beiras-Fernandez A, Moritz A. The influence of selective pulmonary perfusion on the inflammatory response and clinical outcome of patients with chronic obstructive pulmonary disease undergoing cardiopulmonary bypass. Interact Cardiovasc Thorac Surg. 2014 Jun;18(6):732-9. doi: 10.1093/icvts/ivu062. Epub 2014 Mar 14.
Clinical trial NCT03587610: Evaluation of a Tdap-IPV (Tetanus, Diphteria, Pertussis and Inactivated Polio) Vaccination Remedial Strategy on Vaccination Coverage in Patients 65 Years of Age or Older
Official title: Evaluation of a Tdap-IPV Vaccination Remedial Strategy on Vaccination Coverage in Patients 65 Years of Age or Older in the French County of Sarthe
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaccination
Keywords: vaccination coverage
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 402
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, prospective, cluster randomized trial.
Primary purpose: TREATMENT

Brief summary: In France, vaccination coverage is insufficient (in 2002, 71.2% coverage for tetanus, 41.9% for poliomyelitis and 33.7% for diphteria). These numbers decrease significantly with age: coverage for people aged over 65 was 60.5%, 13.3% and 10.5% for tetanus, poliomyelitis and diphteria coverage respectively.

The primary objective of this study is to evaluate the impact of a hospital based vaccination remedial strategy for Tdap-IPV (tetanus, diphteria, pertussis and polio vaccine) in patients 65 years of age or older.

Secondary objectives are to measure the vaccination coverage of patients aged 65 years or older hospitalised in a medical ward in our hospital, to evaluate their knowledge of their vaccination coverage, and to evaluate the socio-demographic factors associated with vaccination coverage.


Eligibility criteria: Inclusion Criteria:

* Patients aged 65 years or older
* Patients capable of understanding and giving informed consent to participate in the study
* Valid social security coverage

Exclusion Criteria:

* Patients under judicial safeguard measures
* Refusal to participate in the study
* Vaccination contra-indication
* Patient already included in the study

Primary outcomes:
measure: Change in immunization rate after a hospital centered remedial strategy for Tdap-IPV vaccination in patients 65 years or older
timeFrame: two months
Secondary outcomes:
measure: Immunisation rate among patients 65 years of age or older in the Sarthe department of France
timeFrame: two months
measure: Immunisation rate according to sex among patients 65 years or older
timeFrame: two months
measure: Immunisation rate according to primary care coverage among patients 65 years of age or older
timeFrame: two months
measure: Immunisation rate according to socio professional category
timeFrame: two months
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
Study officials:
affiliation: Centre Hospitalier du Mans
name: Sophie Blanchi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: