louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01387464: Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery
Official title: A Double-Masked Clinical Study To Determine The Aqueous Humor Concentration Of Bromfenac Sodium In Subjects Administered Multiple Topical Ocular Doses Of ISV-303 Or Bromday™ Once Daily (QD) Prior To Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cataract
Keywords: bromfenac concentrations
ISV-303
Bromday
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2011-07-04
Enrollment: 60
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 purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to routine cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects age 18 or older scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation
* If a female is of childbearing potential, the subject must agree to and submit a urine sample for pregnancy testing at Visit 1 prior to enrollment and at the end of the study, and the subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months.
* Signature of the subject on the Informed Consent Form
* Willing and able to follow all instructions and attend all study visits
* Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)

Exclusion Criteria:

* Use of any drug containing bromfenac within 2 weeks prior to surgery
* Contact lens wear during the dosing period
* Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the investigational medicinal product (IMP) or any of the procedural medications
* Any serious complications with or macroscopic damage to the corneal epithelium
* Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test
* Currently suffer from alcohol and/or drug abuse
* Prior participation in this study protocol
* Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
* A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation

Primary outcomes:
measure: Mean Aqueous Humor Bromfenac Concentration
timeFrame: Approximately 3 hours post last dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00129064: Improving the Outpatient Referral Process With Electronic Communications
Official title: Improving the Outpatient Referral Process With Electronic Communications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Interprofessional Relations
Keywords: Referrals
Quality of care
Ambulatory care
Electronic medical record
Referral communication
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: The Commonwealth Fund
First posted: 2005-08-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: An electronic referral application will be developed and integrated into the existing outpatient information system. The primary goal of this software is to improve the quality and coordination of patient care by increasing physician-to-physician communication. The investigators anticipate that improved communications will also enhance physician and patient satisfaction and provide cost savings. These outcomes will be formally evaluated following implementation of the application.

Detailed description: A trial will be performed to test and quantify the benefits of electronic referrals. Primary care physicians (PCPs) from 2 community-based clinics will be recruited for enrollment. The control group will initiate referrals using the pre-existing paper forms; physician-to-physician communication can occur by e-mail, phone, or mail at the discretion of the referring physician as is currently the standard. Physicians randomized to the intervention arm will be asked to use the electronic application for every referral during the study period. For 6 months, every new referral initiated within the study groups will be assessed for the completeness of patient information and timing of feedback to the referring physician via physician surveys. In addition, a subgroup of patients in the control and intervention arms will be surveyed to assess the impact of the intervention on patient satisfaction with the referral process.

Eligibility criteria: Inclusion Criteria:

* Any referral initiated by a PCP at the study sites for a patient to go to a specialist for the first time

Exclusion Criteria:

* Referrals for repeat specialist visits or referrals not initiated by a PCP

Primary outcomes:
measure: Percentage of referral requests with complete information
measure: Percentage of referrals with timely information exchanged
Secondary outcomes:
measure: Physician satisfaction
measure: Patient satisfaction
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Tejal K Gandhi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04554264: Complicated Grief in ICU in the Aftermath of COVID-19
Official title: Complicated Grief in ICU in the Aftermath of COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Complicated Grief
Intensive Care
Covid19
Keywords: Complicated grief
Intensive Care
Covid19
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
name: University Hospital, Rouen
First posted: 2020-09-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: An increased proportion of deaths occur in the intensive care unit (ICU). Some amenable factors such as end-of-life practices may contribute to complicated grief.

Because of the COVID-19 pandemic, visitor restrictions in health care facilities have been implemented. Families were also unable to implement usual funerals. The investigators hypothesize that these policies and practices may impact grief during covid-19 pandemic. The aim of this study is to evaluate the prevalence of complicated grief after death of a relative in the ICU during the COVID-19 pandemic.


Eligibility criteria: Inclusion Criteria:

* adult relative (\>18 years)
* adult relative from patients who died in ICU after SARS-COV-2 infection

Exclusion Criteria:

* adult relative (\<18 years)

Primary outcomes:
measure: Proportion of complicated grief 4 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score.
timeFrame: 4 months after relative death
measure: Proportion of complicated grief 6 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score.
timeFrame: 6 months after relative covid-19 death
measure: Proportion of complicated grief 12 month after death in relative from patients who died in ICU after covid-19 infection evaluate with ICG score.
timeFrame: 12 months after relative covid-19 death
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT00859664: Use of Pharmacogenetics in the Treatment of Children With Autistic Spectrum Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism
Neuroleptic Treatment
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-03-11
Enrollment: 500
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children over the age of 3, diagnosed with autism, treated with neuroleptics

Brief summary: Children with autism are often treated with psychiatric drugs. These medications have been shown to improve their language and social function, and are important in improving their quality of life. In many cases it is difficult to determine the best drug dose, and a favorable response occurs in only 30%-70% of individuals, with many children suffering significant adverse drug reactions.

Pharmacogenetics is the study of the role of different genes on drug behavior. The cytochrome P450 is the most important enzyme, involved in the metabolism of a vast number of drugs, including psychiatric medications. The multiple variations in this gene can result in the different response observed in different patients, even when treated with similar doses of the drug.

Hypothesis(es):

Mapping the different types of cytochrome P450 gene, in children with autistic disorders will improve the rate of success of medical treatment, and prevent adverse drug reactions.

Potential Impact:

If successful, our study can help thousands of children and their families by developing a system of "tailored medicine" that is based on the specific activity of the various enzymes present in that particular patient. Better medical treatment will facilitate better daily interactions with the children and enhance their quality of life. Furthermore, recognizing children that are resistant to medication will prevent unnecessary use of drugs.

It should be noted this is the first study focusing on children receiving psychiatric medications using pharmacogenetics. Found to be effective, this method can also be applied to other groups of medications and to other patients.


Eligibility criteria: Inclusion Criteria:

* Age\> 3 years
* Diagnosed with autism
* Treated with neuroleptics

Exclusion Criteria:

* Patients with known allergy to second generation neuroleptics.
* Patients with moderate to severe renal insufficiency
* Patients with liver disease
* Patients with active cardiac disease
* Patients with hypertension not responsive to anti-hypertensive therapy
* Patients with substance abuse
* Suicidal patients

Primary outcomes:
measure: Genotyping of the polymorphic cytochrome P450 (CYP) 2D6 gene, in children with autistic spectrum disorder treated with neuroleptics, will improve treatment efficacy and prevent undesired adverse drug reactions.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical center
Study officials:
References:
Clinical trial NCT01414790: The Use of Human Acellular Dermal Matrix to Improve Infraauricular Depressed Deformities and Frey's Syndrome
Official title: The Use of Human Acellular Dermal Matrix in the Prevention of Infraauricular Depressed Deformities and Frey's Syndrome Following Total Parotidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parotid Tumor
Keywords: human acellular dermal matrix
parotid tumor
total parotidectomy
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 70
Sex: ALL
Minimum age (years): 10
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study was to explore whether human acellular dermal matrix (ADM) implantation could prevent infraauricular depressed deformities and Frey's syndrome following total parotidectomy.

Detailed description: Seventy patients who underwent total parotidectomy were selected for inclusion in the study. We analyzed 41 cases of total parotidectomy (control group) and 29 cases of simultaneous ADM implantation following total parotidectomy (ADM group) for infraauricular depressed deformities and the presence of gustatory flushing or sweating. The follow-up periods ranged from 6 months to 7 years.

The Results showed facial contours and bilateral symmetry improved after surgery in the ADM group. In the control group, an infraauricular depressed deformity was evident in all 41 cases. Frey's syndrome was recorded in one patient (3.4%) from the ADM group and 14 patients (34.1%) from the control group. No cases of immune rejection, infection, hematoma, or salivary fistula were observed in either group.

Eligibility criteria: Inclusion Criteria:

* (1) a clinical and imaging diagnosis of either a malignant parotid tumor or deep parotid tumor
* (2) no previous surgical treatment

Exclusion Criteria:

* recurrent parotid tumors or patients who had previously undergone unsuccessful surgery

Primary outcomes:
measure: infraauricular depressed deformities and the presence of gustatory flushing or sweating
timeFrame: from 6 months to 7 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Stomatology
state: Sichuan
Study officials:
affiliation: West China Hospital of Stomatology
name: Wen Luo, DMD
role: STUDY_CHAIR
References:
citation: Sinha UK, Saadat D, Doherty CM, Rice DH. Use of AlloDerm implant to prevent frey syndrome after parotidectomy. Arch Facial Plast Surg. 2003 Jan-Feb;5(1):109-12. doi: 10.1001/archfaci.5.1.109.
Clinical trial NCT05908890: A Study to Determine the Efficacy of a Denture Adhesive to Seal Out Food Particles From Under the Mandibular Partial Denture
Official title: A Study to Determine the Efficacy of a Denture Adhesive Formulation to Seal Out Food Particles From Under the Mandibular Partial Denture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Denture
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the effectiveness of two denture adhesives at keeping food particles (seeds) from becoming trapped underneath partial denture(s).


Eligibility criteria: Inclusion Criteria:

* give written informed consent prior to their participation;
* be 18 years of age or older;
* have a Kennedy Class I or class II partial mandibular denture with a minimum of three consecutive teeth on the prosthesis;
* have a history of food particles getting under their partial, mandibular denture;
* agree not to use any denture adhesive on the day of their study visits, prior to the visit;
* agree to not participate in any other oral/dental product studies during the study;
* be willing to use or not use denture adhesive as instructed during the treatment periods;
* be willing to eat a poppy seed muffin;
* be in good general health as determined by the Investigator/designee based on a review of the medical history/update; and
* have a minimum of 4 total poppy seeds on their mandibular denture base and gingiva after eating the muffin.

Exclusion Criteria:

* present with any disease or conditions that could be expected to interfere with examination procedures or the subject's safe completion of the study;
* self-report that they are allergic to denture adhesives or to the test food (gluten intolerance to muffin or intolerance to poppy seeds); or
* have appliances with intracorneal attachments, crowns with precision attachments or implant overdentures:
* have any condition or medication which, in the opinion of the investigator, is currently causing xerostomia.

Primary outcomes:
measure: Poppy Seed Count Before Treatment Application
timeFrame: Immediately following consumption of the muffin before treatment application
measure: Poppy Seed Count After Treatment Application
timeFrame: Immediately following consumption of the muffin after treatment application
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research, Inc
state: Indiana
Study officials:
References:
Clinical trial NCT04935190: Comparison of Resting Heart and Respiratory Rate Measurements Acquired by Contactless Radar Sensors, Electrocardiography, and Capnography
Official title: Comparison of Resting Heart and Respiratory Rate Measurements Acquired by Contactless Radar Sensors, Electrocardiography, and Capnography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vital Signs
Lead sponsor: DawnLight
Sponsor class: INDUSTRY
First posted: 2021-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects that have a diagnosis of a cardiac, pulmonary, or cardio-pulmonary condition (e.g., Congestive Heart Failure, COPD, Asthma) will be assigned to Group 1.

Subjects who are not known to have a cardiac, pulmonary, or cardio-pulmonary condition will be assigned to Group 2.

Brief summary: 1. Determine agreement (accuracy) of resting heart rate measured by Vitalpercept when compared to an FDA-cleared electrocardiograph (ECG) device, LifeSignals Wireless Biosensor.
2. Determine agreement (accuracy) of resting respiratory rate measured by Vitalpercept when compared to an FDA-cleared capnographer, Capnostream 20.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects ≥ 21 years of age at the time of signing the informed consent.
2. Subjects willing to sign the informed consent and capable of committing to the duration of the study.
3. Subjects with the ability to lie flat, lie on left side, lie on right side, and sit in a chair.
4. Subjects who are able to breathe through their nose for the capnography assessment.
5. Subjects that have a diagnosis of a cardiac, pulmonary, or cardio-pulmonary condition (e.g., Congestive Heart Failure, COPD, Asthma) will be assigned to Group 1.
6. Subjects who are not known to have a cardiac, pulmonary, or cardio-pulmonary condition will be assigned to Group 2.

Exclusion Criteria:

1. Subjects who are prone to excessive coughing and excessive movement
2. Subjects who have a condition that involves uncontrollable movement of the body such as Parkinson's Disease or Essential Tremor.
3. Subjects with a history of allergy to adhesive, latex or Nuprep.

Primary outcomes:
measure: Incidence of Adverse events
timeFrame: During Data collection-Expected time=45-60 minutes
measure: Measurement of Heart Rate
timeFrame: During Data collection-Expected time=45-60 minutes
measure: Measurement of Respiratory Rate
timeFrame: During Data collection-Expected time=45-60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
Study officials:
References:
Clinical trial NCT02575664: Effects of Low Dose Buprenorphine on Recovery After Hip or Knee Arthroplasty
Official title: Effects of Low Dose Buprenorphine on Recovery After Hip or Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Osteoarthritis
Keywords: Pain
Arthroplasty
Buprenorphine
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2015-10-15
Enrollment: 160
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: Buprenorphine is a highly lipophilic thebaine derivative that appears to have high affinity for mu-, kappa-, and delta-opioid receptors and low affinity for opioid receptors like 1 -receptors. It acts as a partial agonist at the mu-opioid and as a partial agonist/antagonist at the kappa-opioid, and as an antagonist at the delta opioid receptors. Buprenorphine has up to two-fold duration of action and it is approximately 30-fold more potent when compared to morphine.

Pain is a common problem in patients coming to joint arthroplastic surgery. Buprenorphine low dose patches are recommended for treatment of moderate pain for example osteoarthritis pain. It is known that well treated pain even preoperatively may prevent prolonged postsurgical pain.

In the present study the effects of low dose buprenorphine on postoperative pain and recovery were assessed.


Eligibility criteria: Inclusion Criteria:

* no pregnancy/lactation, reliable contraception before menopause
* elective knee or hip arthroplasty surgery
* BMI (=body mass index) 18-35 kg/m2
* obtained informed consent

Exclusion Criteria:

* buprenorphine medication
* allergy to study drugs• ikä \< 18 tai \>75 years

  * BMI \<18 tai\>35 kg/m2
  * weight below 50 kg
  * Other contraindication for the study drug

Primary outcomes:
measure: Pain relief
timeFrame: time from drug patch administration up to five weeks
measure: Prolonged pain after arthroplastic surgery
timeFrame: from time from drug patch administration up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Northern Savo
Study officials:
affiliation: Kuopio University Hospital
name: Merja Kokki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: