louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06153108: Monitoring Biomarker for Detecting Change in Physical Activity and Limb Function in Inclusion Body Myositis Over Time
Official title: Monitoring Biomarker for Detecting Change in Physical Activity and Limb Function in Inclusion Body Myositis Over Time
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inclusion Body Myositis
Keywords: Biomarker
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: BioSensics
First posted: 2023-12-01
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with diagnosed inclusion body myositis

Brief summary: Inclusion-Body Myositis (IBM) results in weakness and the deterioration of distal arm muscles, the symptoms of which are currently assessed through expert examination at clinical visits. Such in-clinic assessments are time-consuming, subjective, of limited sensitivity, and only provide a snapshot of a patient's disease. In this project, the investigators will conduct clinical validation of monitoring digital biomarkers of upper limb function during activities of daily living using a wearable sensor platform that enables frequent, at-home monitoring of upper limb function health in IBM and could be incorporated into IBM trials.


Eligibility criteria: Inclusion Criteria:

1. Meet any of the European Neuromuscular Centre Inclusion Body Myositis research diagnostic criteria 2011 categories for IBM.
2. Able to provide informed consent.

Exclusion Criteria:

1. Unwillingness to follow study procedures.
2. Participation in an investigational drug research study within the past 30 days.

Primary outcomes:
measure: Investigate validity of PAMSys wrist sensor and pendant sensor as monitoring biomarker of upper and lower limb function and physical activity, including leg function, change in IBM patients.
timeFrame: Baseline, Month 6, Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Mazen Dimachkie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02419508: SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)
Official title: Additive Effect of Twice Daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-04-17
Enrollment: 290
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 additive intraocular pressure (IOP) lowering effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a prostaglandin analogue (PGA) in subjects with open-angle glaucoma or ocular hypertension.

Detailed description: This study consisted of 2 sequential phases: Screening/Eligibility Phase, followed by a Masked Treatment Phase (Phase II). Subjects were assigned into one of 3 PGA therapy groups for the duration of the study, based upon commercial availability.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of either open-angle glaucoma or ocular hypertension;
* Must sign an informed consent form;
* Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye\[s\]) ≥ 19 and \< 32 mmHg at 09:00.
* Willing and able to attend all study visits;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study;
* Any form of glaucoma other than open-angle glaucoma or ocular hypertension;
* Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol;
* Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Mean Diurnal IOP at Week 6
timeFrame: Week 6
measure: Mean Percentage Change From Baseline in Diurnal IOP at Week 6
timeFrame: Baseline, Week 6
measure: Mean Change From Baseline in IOP at 11:00 at Week 6
timeFrame: Baseline, Week 6
measure: Mean Percentage Change From Baseline in IOP at 11:00 at Week 6
timeFrame: Baseline, Week 6
measure: Mean Change From Baseline in IOP at 09:00 at Week 6
timeFrame: Baseline, Week 6
measure: Mean Percentage Change From Baseline at 09:00 at Week 6
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon, a Novartis Company
name: Clinical Manager, Ophtha, GCRA
role: STUDY_DIRECTOR
References:
Clinical trial NCT04951908: Correlation Between Types of Lateral Pterygoid Muscle Attachment and Internal Derangement of the Temporomandibular Joint
Official title: Correlation Between Types of Lateral Pterygoid Muscle Attachment, Type of Disk Displacement and Osteoarthritic Changes of the Temporomandibular Joint
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: TMJ Disorder
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 900
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The retrospective study included patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University. The sample originally included patients who provided consent to participate in this study and who ultimately underwent treatment for TMJD between 2008 and 2019.

Brief summary: the study aimed to evaluate the clinical and MRI finding of TMJ AND LPM with predication of the risk factors. Study design: this retrospective study included 1365 joints in 800 patients diagnosed as TMJ internal derangement and all the patients examined by MRI from 2008 to 2019. Cases with loss of continuity of articular disk or the posterior attachment of the disk were considered as positive cases.

Detailed description: the study aimed to evaluate the clinical and MRI finding of TMJ with LPM with predication of the risk factors. Study design: this retrospective study included patients diagnosed as TMJ internal derangement and all the patients examined by MRI from 2008 to 2019. Cases with loss of continuity of articular disk or the posterior attachment of the disk were considered as positive cases.

Eligibility criteria: Inclusion Criteria:

- study included patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University.

Exclusion Criteria:

* Exclusion Inclusion criteria: Patients were included if they were older than 18 years and diagnosed with TMJD. criteria for this study included systemic diseases (the presence of polyarthritis or other rheumatic diseases), contraindications for MRI (e.g., implanted metal or medical devices, claustrophobia), the presence of neurologic disorders, head and neck cancer, oral submucous ﬁbrosis, a history of TMJ surgery, a history of previous nonsurgical treatment such as occlusal splints, and a history of joint injection with HA/PRP. Trauma patients with subcondylar fracture and patients with congenital and developmental disorders of the TMJ were also excluded from the study.

Primary outcomes:
measure: VAS
timeFrame: baseline (pre treatment)
measure: mouth opening
timeFrame: baseline (pre treatment)
Secondary outcomes:
measure: joint sound
timeFrame: baseline (pre treatment)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine Alazhar University
state: Nasr City
Study officials:
References:
Clinical trial NCT01735708: Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings
Official title: Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Interference
Depression
Antiretroviral Adherence
Keywords: pain
depression
HIV
adherence
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
name: National Institute of Nursing Research (NINR)
First posted: 2012-11-28
Enrollment: 187
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 purpose of this study is to determine whether participation in the study intervention, which involves collaboration between the study interventionist and the participant's primary care physician, will reduce symptoms of pain and depression in HIV+ patients.


Eligibility criteria: Inclusion Criteria:

* Chronic Pain (pain duration for at least six months with a mean score of 5 or higher on the BPI Pain Interference Scale)
* Pain severity of 40 or higher on a Visual Analog Scale (0-100) indicating "worst pain in the last week"
* At least one trial of PCP-recommended medication (i.e. acetominophen, NSAIDS, skeletal muscle relaxants) judged through interviews with patients and PCPs
* QIDS score of ≥ 9 (depression severity)
* Stable dose of an antidepressant, if using, for the previous 2 months
* Age 18 or older
* HIV+

Exclusion Criteria:

* Lifetime DSM-IV diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition
* Current DSM-IV diagnosis of substance dependence for alcohol, sedative/ hypnotic drugs, stimulants, or cocaine
* Suicidal ideation or behavior requiring immediate attention
* In psychotherapy or in a multidisciplinary pain management program
* Expected surgery in the next 6 months
* Pain thought to be due to cancer, infection, or inflammatory arthritis
* Pregnancy

Primary outcomes:
measure: Brief Pain Inventory Interference Scale at 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Brief Pain Inventory Interference Scale at 12 Months
timeFrame: 12 months
measure: Quick Inventory of Depression Symptoms at 3 Months
timeFrame: 3 months
measure: Quick Inventory of Depression Symptoms at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Michael Stein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uebelacker LA, Weisberg RB, Herman DS, Bailey GL, Pinkston-Camp MM, Garnaat SL, Stein MD. Pilot Randomized Trial of Collaborative Behavioral Treatment for Chronic Pain and Depression in Persons Living with HIV/AIDS. AIDS Behav. 2016 Aug;20(8):1675-81. doi: 10.1007/s10461-016-1397-7.
Clinical trial NCT02595008: Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Atopic Dermatitis
Official title: An Open Label, Safety Study to Assess the Potential for Adrenal Suppression and Pharmacokinetics Following Maximal Use Treatment With DSXS in Patients With Atopic Dermatitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Atopic
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2015-11-03
Enrollment: 24
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe atopic dermatitis.

Detailed description: The objective of this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe atopic dermatitis.

The secondary objectives are to evaluate to evaluate adverse event (AE) profiles of DSXS administered to patients with moderate to severe atopic dermatitis.

Eligibility criteria: Inclusion Criteria:

* Patients with a definite clinical diagnosis of stable atopic dermatitis

Exclusion Criteria:

* Patient is under the age of 2

Primary outcomes:
measure: Number of Participants With HPA Axis Suppression
timeFrame: 28 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Hawthorne
country: United States
facility: Taro Pharmaceuticals USA Inc.
state: New York
Study officials:
affiliation: http://www.novumprs.com/contact
name: Novum Pharmaceutical Research Services
role: STUDY_CHAIR
References:
Clinical trial NCT03943823: Postmenopausal Pessary Users: Estrogen Versus Trimosan
Official title: Postmenopausal Pessary Users: Estrogen Versus Trimosan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Vaginosis
Vaginosis, Bacterial
Vaginal Discharge
Keywords: Pessary
Vaginal pH
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 4
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare vaginally applied estrogen with the vaginal gel trimosan for their effects on vaginal pH and vaginal symptoms in postmenopausal pessary users.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal female pessary user (ring with support pessaries only). Postmenopausal will be defined as: amenorrhea for a year or 3 months after surgical bilateral salpingo-oophorectomy
* Is a new pessary user, or has not had a pessary for a year

Exclusion Criteria:

* Pregnancy
* Persistent Bacterial Vaginosis infection in the first two clinic encounters
* Currently on hormone replacement therapy
* Previously on hormone replacement therapy in the past 6 months
* Currently on antibiotics
* Patients with existing vaginal erosions/ulcerations

Primary outcomes:
measure: Vaginal pH as Measured by pH Strips
timeFrame: baseline
measure: Vaginal pH as Measured by pH Strips
timeFrame: 3 months
Secondary outcomes:
measure: Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire
timeFrame: baseline
measure: Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire
timeFrame: 3 months
Other outcomes:
measure: Number of Participants With Vaginitis Infection
timeFrame: baseline
measure: Number of Participants With Vaginitis Infection
timeFrame: 3 months
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Gazala Siddiqui, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02122523: Sentinel Lymph Node (SLN) in Colorectal Carcinoma (CRC) With a Near-infrared (NIR)-Dye
Official title: In Vivo Study to Determine the Efficacy of Sentinel Node Mapping in Patients With Colon Carcinoma Using Near-infrared Laparoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sentinel Lymph Node
Colorectal Cancer
Metastasis
Keywords: Image guided surgery
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The sentinel lymph node (SLN) procedure is a standard staging technique in several types of cancer. One of the major problems of SLN mapping in colorectal cancer is the lack of an optimal dye and technique for identification of the nodes. In this study the investigators used the Near-Infrared (NIR) dye Indocyanin Green (ICG) to identify nodes with a newly developed NIR laparoscope. The investigators compared two different injection techniques; subserosal and submucosal injection.

Patients planned for a laparoscopic resection of a colorectal carcinoma without distant metastases were included. Dye was injected in the subserosa or submucosa of the bowel. Ten minutes after injection the investigators searched for fluorescent nodes with the NIR laparoscope. Fluorescent nodes were harvested and analyzed by the pathologist using H\&E and additional immunohistochemistry.


Eligibility criteria: Inclusion Criteria:

* Oral and written Informed Consent (IC)
* Age 18 years and older
* Patients histological or radiological suspicion of colon cancer
* Surgical resection of the tumor
* Regular Pre-operative work-up

Exclusion Criteria:

* Gross lymph node involvement
* Distant metastases
* Advanced disease with invasion of adjacent structures
* Prior colorectal surgery
* Metastatic or T4 disease discovered during intraoperative staging
* Contraindications to laparoscopy
* Rectal cancer
* Allergy to iodine
* Patients at higher risk for anaphylactic reactions

Primary outcomes:
measure: Number of fluorescent lymph nodes
timeFrame: 4 hours
Secondary outcomes:
measure: Number of Lymph nodes with metastasis
timeFrame: 4 hours
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
state: Noord-Holland
Study officials:
References:
Clinical trial NCT06380023: An Investigation Into the Dispersion Pattern During Coughing and Open Nasopharyngeal Suction Using Various Barrier Devices
Official title: An Investigation Into the Dispersion Pattern During Coughing and Open Nasopharyngeal Suction Using Various Barrier Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Aspiration
Lead sponsor: North District Hospital
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
First posted: 2024-04-23
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Registered physiotherapist

Brief summary: The aim of the study is to examine the air dispersion pattern and the environmental influence of open airway suction in general ward setting. Secondly, the study is aimed at identifying a simple \& practical enclosure device in general ward. Suction will be performed in manikin in supine lying.

Nasopharyngeal suction will be performed by physiotherapist with working experience more than 1 years. Besides, surgical mask \& enclosure tent will be adopted as the enclosure barrier device in this study.

Research Question

1. To assess the extent of the environmental contamination during coughing and simulated airway suction
2. To measure the air particle count during coughing and simulated open airway suction.
3. To evaluate how effective the enclosure barrier in reducing the air particle dispersion during open airway suction.


Eligibility criteria: Inclusion Criteria:

* physiotherapists with working experience more than one year

Exclusion Criteria:

* physiotherapists with working experience less than one year

Primary outcomes:
measure: Air particle count
timeFrame: one minute
Secondary outcomes:
measure: A fluorescent Dye
timeFrame: one minute
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: North District Hospital
Study officials:
affiliation: NDH
name: Connie TO, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00735423: Infant Diet Effects on Brain Function and Language Processing (fMRI)
Official title: Effects of Neonatal Diet on Language, Neurocognitive Functions at Eight Years Old: fMRI, ERP and Standardized Behavioral Measures
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy
Keywords: Healthy children
Brain Function
Diet
Nutrition
Language
fMRI
ERP
Behavior
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2008-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 90
Maximum age (years): 101
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy 8-year-old children

Brief summary: The purpose of this study is to identify neurocognitive functions and language processing of 8-year-old children who were fed either breast milk, milk-based formula or soy-based formula during the first year of life.


Eligibility criteria: Inclusion Criteria:

* Healthy 8-year-old children
* Full term
* Birth weight between the 5th - 95th weight-for-age
* Use of Breast milk, milk-based formula or soy-based formula throughout first year of life
* English as primary language
* Right handed first visit
* BMI between 5th - 95th percentile-for-age

Exclusion Criteria:

* Children with sleep disorders
* Children who use certain medications that may interfere with study assessments
* Illnesses or diseases or conditions that may interfere with study assessments

Primary outcomes:
measure: Brain function test
timeFrame: 8 year old
measure: Language processing tests
timeFrame: 8 year old
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Nutrition Center
name: Xiawei Ou, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ou X, Andres A, Cleves MA, Pivik RT, Snow JH, Ding Z, Badger TM. Sex-specific association between infant diet and white matter integrity in 8-y-old children. Pediatr Res. 2014 Dec;76(6):535-43. doi: 10.1038/pr.2014.129. Epub 2014 Aug 28.