louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05211427: Bitter Taste Receptors in Oropharynx Cancer
Official title: Expression of Bitter Taste Receptors in Oropharynx Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oropharynx Cancer
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this work is to investigate the expression of the bitter taste receptors in p16-positive and negative oropharyngeal carcinomas (in comparison to healthy, local tissue).

Detailed description: Goal setting The aim of this work is to investigate the expression of the bitter taste receptors in p16-positive and negative oropharyngeal carcinomas (in comparison to healthy, local tissue).

The hypothesis is that oropharyngeal carcinomas express TAS2Rs and that their stimulation can induce apoptosis. The lower expression of certain TAS2Rs in the tumor cells could represent protection from apoptosis by stimulation with the bitter ligands. Alternatively, it could polymorphisms of the bitter taste receptors, which can influence their function independently of the expression. In order to address the question of general bitter sensitivity in more detail, the investigators are planning to carry out a bitter taste test on the test subjects.

methodology As this is a pilot study, the investigators limit the number of subjects to 10 patients with p-16 positive and negative oropharyngeal squamous cell carcinoma and 10 patients with acute recurrent tonsillitis or other benign pathology in pharynx. The expression analysis is carried out using qPCR and possibly immunohistochemical methods. Taste strips are used for the taste tests.

Cognitive interest The results of this study will provide important insight into the pathophysiology of oropharyngeal cancers and possibly all TAS2R-expressing cancers. In addition, this and further studies can create a theoretical basis for new therapeutic methods for this group of diseases.

Eligibility criteria: Inclusion Criteria:

* Oropharynx SCC for the patient group
* signed informed consent for all

Exclusion Criteria:

-

Primary outcomes:
measure: Expression of TAS2-Receptors
timeFrame: The day of surgery and the day before
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Smell and Taste Center, University Klinik Dresden
state: Saxony
Study officials:
References:
Clinical trial NCT04343027: Patient Satisfaction in the Orthopedic Surgery Clinic
Official title: Patient Satisfaction in the Orthopedic Surgery Clinic
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: All
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Patients in the orthopedic surgery clinic routinely fill out a patient- reported outcome measurement survey prior to their visit. These scores are stored in Epic, but are not routinely reviewed with patients during their office visit. Study subjects will be randomly assigned into one of two groups: those who have their patient- reported outcome measurements reviewed with them by their physician, and those who will not have their patient-reported outcome measurements reviewed during the visit. Following the visit, patients will complete a patient satisfaction survey.

Detailed description: This patient satisfaction survey is a modified version of the Press-Ganey Outpatient Medical Practice 10-question survey. The patient satisfaction survey scores will then be compared between the two groups to quantify the effect of reviewing of patient-reported outcome measurements with patients on their satisfaction with the office visit

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Ages 18 and 100 years
* Men and women will be included in this study
* Willing and able to provide consent
* Able to communicate in English
* All patients of the Principal Investigator(s) that have an clinic appointment during the study date range will be considered for inclusion in the study

Exclusion Criteria:

* Patients whose visit is related to workman's compensation, a disability claim, or a "no-fault" case (i.e. a law suit related to personal injury)
* Patients that do not complete the patient satisfaction survey following their visit
* Patient with mental disabilities or other handicap that would interfere with their capability of completing the surveys

Primary outcomes:
measure: Change in participants' satisfaction
timeFrame: 1 day (Visit 1)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Andrew Rokito, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02269527: Effects of Live Music on the Perception of Noise in the SICU: A Patient, Caregiver, and Medical Staff Environmental Study
Official title: Effects of an Integrative Music Therapy Program on the Perception of Noise in the SICU: A Patient, Caregiver, and Physician/Nursing Environmental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Stress
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The use of live music in SICU might affect the perception of noise, which may reduce staff's stress level and further decrease the possibility of clinical errors, reduce patient's anxiety and perception of pain as well as increase compliance from patient and family. Live music might also enhance the quality of stay and promote a holistic healing process for the patient.

Detailed description: In this study, the research team is looking at the effect of the live music provided by a trained music therapist, created through incorporating the noises in the SICU - such as the beeping of the machines as part of the elements in the music, to organize the sound environment as well as introducing familiar songs, chosen according to the cultures and ages of the patients, caregivers and staff, to increase a sense of familiarity and comfort. Through the intervention, the research team hope to ameliorate the effects of a noxious sound environment, which may reduce the stress level of the staff and increase their acuity level while decrease patients and caregivers' anxiety level and improve their mood state and the quality of hospitalization

Eligibility criteria: Inclusion Criteria:

* SICU patients, caregivers, and physicians/nursing staff

Exclusion Criteria:

* Non-medical Staff

Primary outcomes:
measure: Self-report stress level from SICU staff
timeFrame: 6 months
measure: Pre and Post-intervention score on the perception of SICU noises from SICU and Hospital Anxiety and Depression Scale for SICU patients
timeFrame: 1 week
measure: Pre and Post-intervention score on the perception of SICU noises from SICU patients, caregivers
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
Study officials:
affiliation: Mount Sinai Union Square
name: Joanne Loewy, DA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01466127: The Effect of Oxytocin on Fear Memory Consolidation Novel Intervention to Prevent Posttraumatic Stress Disorder (PTSD)
Official title: The Effect of Oxytocin on Fear Memory Consolidation: A Novel Intervention to Prevent PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Effect of oxytocin on learning
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2011-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to learn how differences in learning under mildly-stressful circumstances may be changed by taking oxytocin. Oxytocin is a hormone made naturally in the body. The investigators will also examine the impact of any anxiety, depression, and stress related symptoms on learning processes.


Eligibility criteria: Inclusion Criteria:

* Men or women 18 to 65 years of age
* Score in study range on the Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI)
* No current Axis I Diagnostic and Statistical Manual-IV (DSM) excluded diagnoses as determined by the Structured Clinical Interview DSM (SCID) completed within the past 4 months.
* Must be able and willing to understand study procedures and return to the clinic on two separate consecutive days for the fear-conditioning procedures.
* Subjects must be able to give informed consent and be willing and able to comply with study procedures.

Exclusion Criteria:

* Presence of a current DSM-IV Axis I diagnosis as measured by the SCID.
* A serious medical condition or other condition deemed likely to result in surgery or hospitalization, or which would make participation in the study difficult.
* Patients with a history of trauma resulting in head injury related seizures or with epilepsy (except a prior history of febrile seizures of infancy which are not exclusionary).
* Use of supplemental hormones (birth control, estrogen, testosterone, prednisone, etc) or narcotics.
* Pregnant or lactating women.
* Women of childbearing potential not using medically accepted forms of contraception.
* Current use of the excluded psychiatric medications.
* Known hypersensitivity to oxytocin
* Known hyponatremia.

Primary outcomes:
measure: Differential Skin Conductance Response (SCR) During the First Two Extinction Trials
timeFrame: Day 2 of Conditioning (1 day post Day 1 of Conditioning)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center for Anxiety and Traumatic Disorders, MGH
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elizabeth A Hoge, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03772327: HIV Adherence Bottle Intervention Trial
Official title: HIV Adherence Bottle Intervention Trial (HABIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-1-infection
Adherence, Medication
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: AdhereTech
First posted: 2018-12-11
Enrollment: 63
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: This is a randomized study for participants treated with tenofovir-based antiretroviral drug regimens with a history of suboptimal adherence (detectable HIV RNA twice over the last year). Eligible participants are enrolled, receive routine adherence counseling and are randomized to receive an AdhereTech "smart pill bottle" or not (open label). The "smart pill bottle" quantitates the number of tenofovir-containing pills taken and sends this to a centralized server; if a dose is missed, the participant is contacted by either phone or text. Participants are assessed at baseline and weeks 4, 8, and 12 for tenofovir diphosphate (TFV-DP) levels (by plasma and dried red blood cell spots), HIV RNA level, and adherence using a standardized questionnaire. Primary outcome is change in TFV-DP levels from baseline in the 2 groups.


Eligibility criteria: Inclusion Criteria:

* HIV-infected
* Taking a tenofovir-containing antiretroviral regimen for HIV treatment
* Documented suboptimal adherence (2 HIV RNA levels documented above the level of detection, i.e. not suppressed, on 2 occasions over the prior 52 weeks

Exclusion Criteria:

* Plans to change the current HIV drug regimen

Primary outcomes:
measure: Change in Tenofovir Diphosphate (TFV-DP) Drug Levels
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Number of Participants Completing the 12 Week AdhereTech Bottle Intervention Compared to the Routine Counseling Only Group.
timeFrame: Week 12
measure: Change in Quantitative HIV Viral Load
timeFrame: Baseline and Week 12
measure: Number of Participants With HIV RNA ≥ 20 Copies/mL at Baseline That Had a Decrease in HIV RNA to < 20 Copies/mL at Week 12 in the AdhereTech Bottle Arm Versus the Routine Counseling Only Arm.
timeFrame: Baseline and Week 12
measure: TFV-DP Plasma Levels
timeFrame: Baseline and Week 12
measure: Number of Participants Reporting 100% Adherence to Antiretroviral Medications in During to the Prior 4 Days at Week 12.
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Weill Medical College of Cornell University
name: Roy M Gulick, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellsworth GB, Burke LA, Wells MT, Mishra S, Caffrey M, Liddle D, Madhava M, O'Neal C, Anderson PL, Bushman L, Ellison L, Stein J, Gulick RM. Randomized Pilot Study of an Advanced Smart-Pill Bottle as an Adherence Intervention in Patients With HIV on Antiretroviral Treatment. J Acquir Immune Defic Syndr. 2021 Jan 1;86(1):73-80. doi: 10.1097/QAI.0000000000002519.
Clinical trial NCT03124927: Accuracy of Methemoglobin Measurement for Rainbow DCI Sensors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of a noninvasive HbMet measurement by a DCI pulse oximeter sensor will be assessed by comparison to blood measurements from a laboratory analyzer.


Eligibility criteria: Inclusion Criteria:

1. Subjects must understand and consent to be in the study
2. American Society of Anesthesiology Class I (Healthy subjects without any systemic disease at all).

Exclusion Criteria:

1. Subjects who have any systemic disease at all.
2. Subjects who do not understand the study and the risks involved.
3. Current smokers.
4. Subjects who are pregnant.

Primary outcomes:
measure: Accuracy of Sensor by Arms Calculation
timeFrame: 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
References:
Clinical trial NCT03819127: Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment
Official title: Effects of Vildagliptin, a DPP-4 Inhibitor, in Elderly Diabetic Patients With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mild Cognitive Impairment
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the effect of vildagliptin, an inhibitor of the enzyme DPP-4, on the cognitive functioning of elderly diabetic patients with mild cognitive impairment (MCI) documented at mini mental state examination (MMSE).

In this prospective study, 60 diabetic elderly people were enrolled and divided according to their glycated hemoglobin (HbA1c) values in 2 groups: Group A, (HbA1c \<7.5%, n=30) treated with metformin, and Group B (HbA1c \>7.5%, n=30) treated with metformin plus vildagliptin. We evaluated MMSE, fasting plasma glucose (FPG) and HbA1c at baseline and after 24 weeks treatment.


Eligibility criteria: Inclusion Criteria:

* age \>65 years
* MMSE score ≥18 and ≤23
* diagnosis of diabetes mellitus

Exclusion Criteria:

* heart failure
* coronary heart disease
* stroke
* chronic kidney disease (G3 grade KDOQI)
* liver cirrhosis
* chronic respiratory failure
* depression evaluated by Geriatric Depression (GDS, GDS \>15)
* diagnosis of dementia based on DSM 5 criteria
* anticholinesterase or memantine therapy

Primary outcomes:
measure: Evaluation of cognitive decline
timeFrame: 24 weeks
Secondary outcomes:
measure: Rate of Glycated hemoglobin (%)
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06486727: Efficacy and Safety of 675-nm Laser for Dorsal Hand Rejuvenation
Official title: Efficacy and Safety of 675-nm Laser for Dorsal Hand Rejuvenation in Thai Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Wrinkle
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate efficacy and safety of 675-nm laser for dorsal hand rejuvenation in Thai patients. Twenty-six subjects aged 50 to 65 years diagnosed with wrinkle and solar lentigines on both dorsums of hands were included and treated with RedTouch for 3 times every 4 weeks. Then, they were follow up at 3 and 6 months after the final treatment. The measurement of 5-point Global Aesthetic Improvement Scale scores by physicians and subjects were conducted. Moreover, pigmentation level, wrinkle and texture were also recored using Antera. Elasticity was measured using Cutometer.

Detailed description: RedTouch parameter included Moveo, power 5 W, Energy/DOT 500 mJ/DOT, then Standard, power 4 W, spacing 2000 μm, 1 pass per side.

Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with wrinkles and solar lentigines on both dorsum of hands

Exclusion Criteria:

* Pregnant or lactation
* Sugjects with a history of allergy to near-infrared wavelength or photosensitizing agents
* Subjects who have been treated with any kind of energy-based device on both dorsum of hands 6 months prior to the inclusion
* Subjects who have been injected with filler, or platelet-rich plasma on both dorsum of hands on their faces 6 months prior to the inclusion
* Active skin infections
* History of hypertrophic scars or keloids

Primary outcomes:
measure: The change in pigmentation level, wrinkle and texture
timeFrame: Baseline, 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment
Secondary outcomes:
measure: The change in elasticity
timeFrame: Baseline, 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment
measure: Overall improvement by physicians and patients
timeFrame: 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment
measure: Adverse events
timeFrame: 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment
measure: Pain score
timeFrame: Baseline, 4, 8, 12 weeks after the first treatment
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol University
name: Woraphong Manuskiatti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01297127: Observational Study on Predictors of Response to Invirase (Saquinavir) Treatment in Treatment-naïve Patients With HIV Infection
Official title: Prospective Multicentre Noninterventional Observational Study on Predictors of Treatment Response in a Cohort of Treatment naïve HIV-infected Patients Treated With Saquinavir (PROSPECTOR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-02-16
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Treatment-naïve HIV-infected patients initiated on treatment with Invirase

Brief summary: This prospective observational study will evaluate predictors of response to Invirase (saquinavir) treatment in treatment-naïve patients with HIV infection. Data will be collected during 48 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* HIV infection
* Treatment-naïve
* Initiation of treatment with Invirase

Exclusion Criteria:

* Contraindications according to Invirase Summary of Product Characteristics

Primary outcomes:
measure: Predictive value of baseline CD4 count and HIV RNA on virological and immunological response at 12, 24 and 48 weeks of treatment
timeFrame: 48 weeks
Secondary outcomes:
measure: Host- and virus-related factors influencing virological and immunological response at 12, 24 and 48 weeks of treatment
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Chorzow
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Zielona góra
country: Poland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00809627: Caffeine Versus Placebo for Spinal Headaches
Official title: A Prospective Trial of IV Caffeine vs Placebo for Post-Dural-Puncture Headache in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Dural Puncture Headache
Keywords: headache
caffeine
pain
Lead sponsor: United States Naval Medical Center, Portsmouth
Sponsor class: FED
First posted: 2008-12-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Caffeine will be studied against placebo in patients with positional headache after a lumbar puncture (aka "spinal headache").

Detailed description: Pain will be assessed at set intervals using a Visual Analog Scale. Blood patch therapy will be offered to all those still in pain at the end of one hour after drug administration.

Eligibility criteria: Inclusion Criteria:

* diagnosed with post dural puncture headache

Exclusion Criteria:

* age \< 18
* pregnant
* allergic to caffeine
* cardiac or peripheral vascular disease
* uncontrolled hypertension

Primary outcomes:
measure: Pain as measured by Visual Analog Scale
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Portsmouth
country: United States
facility: Emergency Department, Naval Medical Center Portsmouth
state: Virginia
Study officials:
affiliation: United States Naval Medical Center, Portsmouth
name: Mark A Kostic, MD
role: STUDY_CHAIR
affiliation: United States Naval Medical Center, Portsmouth
name: Marcelo Darabos, MD
role: PRINCIPAL_INVESTIGATOR
References: