louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02949076: Skeletal Muscle Atrophy and Dysfunction in Human Cancer
Official title: Skeletal Muscle Atrophy and Dysfunction in Human Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonsmall Cell Lung Cancer
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: University of South Carolina
First posted: 2016-10-31
Enrollment: 11
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Cancer and its treatment can have profound effects on skeletal muscle, the most well-recognized being atrophy, weakness and diminished oxidative capacity. These adaptations negatively impact quality of life, treatment decisions and survival. Despite these consequences, the factors promoting these adaptations remain poorly defined and understudied in human patients. To address this gap in knowledge, our goal in this study is to examine the role of muscle disuse as a regulator of muscle size and function in human cancer patients


Eligibility criteria: Inclusion Criteria:

* 50-75 yrs of age
* histologically-documented, stage III or IV non-small cell lung carcinoma (NSCLC)
* estimated life expectancy \>6 mos
* Karnofsky's performance score of ≥70

Exclusion Criteria:

* history, signs or symptoms of inflammatory or autoimmune disease
* uncontrolled hypertension
* heart or renal failure
* exercise limitations from peripheral vascular disease or stroke
* neuromuscular disease
* knee/hip replacement
* additional, actively-treated malignancy or history of malignancy, except non-melanoma skin cancer
* taking medication that can have anti-coagulant effects that cannot be stopped prior to the muscle biopsy

Primary outcomes:
measure: Cross-sectional area of skeletal muscle fibers
timeFrame: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
measure: Single muscle fiber contractile function
timeFrame: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
measure: Mitochondrial content
timeFrame: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
measure: Mitochondrial function
timeFrame: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Secondary outcomes:
measure: Whole muscle size
timeFrame: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
measure: Whole muscle isometric function
timeFrame: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
measure: Whole muscle isokinetic function
timeFrame: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont College of Medicine
state: Vermont
Study officials:
affiliation: University of Vermont
name: Michael J. Toth, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04644276: Mask Adhesive Institutional Study
Official title: Feasibility Study of a Mask Adhesive in Patients Treated With NIV in an Institutional Setting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Failure
Covid19
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2020-11-25
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To reduce interface leak and aerosol spread, Philips has developed an accessory to non-invasive ventilation(NIV) masks to be used with the Philips AF531 and the PerformaTrak mask on respiratory failure patients. For the purposes of capturing initial mask leak and safety data, this trial will enroll patients treated with NIV in an institutional setting (i.e., sleep lab).

Detailed description: The Mask Adhesive will serve as an accessory to the AF531/PerformaTrak masks with the intention to reduce patient leak while a patient is receiving therapy. This accessory is a double-sided adhesive; with one side applied directly to the patient's skin and the other side connected to the mask cushion. Each adhesive is only to be applied to a patient once. The AF531/Performatrak mask can be removed from the adhesive and then re-applied, as necessary. For example, if the patient needs to remove the mask to eat or take medicine, the mask is removed from the patient and the adhesive will stay on the patient's face

Eligibility criteria: Inclusion Criteria:

* Adults patients age 18 to 85 (inclusive)
* Adult patients treated with NIV
* Able to read, write, and speak English
* Able to provide written informed consent
* Willing to have facial hair removed for adhesive placement (if required)

Exclusion Criteria:

* Pre-existing allergy to tape or adhesive;
* Blisters, open skin or pre-existing skin condition that may impact the ability to support removal of the mask adhesive without tearing the skin
* pregnant (for females of childbearing age);
* Individuals sentenced to such an institution under a criminal or civil statute,
* Individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing

Primary outcomes:
measure: Medical Adhesive-Related Skin Injury (MARSI)
timeFrame: Up to 5 business days
measure: Clinician Ease of Use
timeFrame: Initial Impressions at Baseline and Overall Impressions at Study Completion (After at least two mask applications)
Secondary outcomes:
measure: Leak Change
timeFrame: Up to 5 business days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorder Center of Alabama
state: Alabama
Study officials:
References:
Clinical trial NCT04631276: Clinical Study on Histamine H3 Receptor Occupancy of TS-091 by PET Examination in Healthy Adult Subjects
Official title: Clinical Study on Histamine H3 Receptor Occupancy of TS-091 by PET Examination in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the following items by PET examination in Japanese heathy adult male subjects who received single oral administration of TS-091 in an unblinded manner.

1. Relationship between plasma concentration and H3 receptor-occupancy of TS-091
2. Time course changes in H3 receptor-occupancy of TS-091


Eligibility criteria: Inclusion Criteria:

Subjects who met all of the following criteria.

* Age: between ≥20 years and \<40 years at the time of providing written consent for participation in the study.
* Body mass index (BMI): ≥18.5 and \<25.0 on the day of screening test.
* Subject who received a prior explanation on the study and was able to understand its content and capable of providing voluntary written consent for participation in the study.
* Other protocol defined inclusion criteria could apply-

Exclusion Criteria:

Subjects who came under any of the following exclusion criteria.

* Subjects who were considered to have some disease and not healthy by the investigator or subinvestigator according to his medical judgment based on the results of screening test
* Subjects with a drug or food allergy or a history thereof.
* Subjects with a significant allergic disposition (e.g. asthma requiring treatment) or a history thereof.
* Subjects with a history of heparin-induced thrombocytopenia.
* Other protocol defined exclusion criteria could apply

Primary outcomes:
measure: H3 receptor occupancy
timeFrame: 2 hours after administration of TS-091
measure: Changes in the H3 receptor occupancy
timeFrame: 2, 6, and 26 hours after administration of TS-091
measure: Plasma concentration of unchanged TS-091
timeFrame: 2, 6, and 26 hours after administration of TS-091
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Taisho Director
role: STUDY_DIRECTOR
References:
citation: Kimura Y, Takahata K, Shimazaki T, Kitamura S, Seki C, Ikoma Y, Ichise M, Kawamura K, Yamada M, Zhang MR, Higuchi M, Nishino I, Suhara T. Pharmacokinetic and pharmacodynamic assessment of histamine H3 receptor occupancy by enerisant: a human PET study with a novel H3 binding ligand, [11C]TASP457. Eur J Nucl Med Mol Imaging. 2022 Mar;49(4):1127-1135. doi: 10.1007/s00259-021-05571-1. Epub 2021 Oct 15.
Clinical trial NCT01415076: The Optimal Timing of Carbon Dioxide Insufflation During Colonoscopy in Unsedated Patients
Official title: The Optimal Timing of Carbon Dioxide Insufflation During Colonoscopy in Unsedated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Outpatients
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Insufflation of carbon dioxide (CO2) instead of air can reduce pain resulting from colon distension after colonoscopy because CO2 is rapidly absorbed from the colon and excreted through the lungs. This reduces the effects of colonic distension and minimizes intracolonic gas at the end of the examination. The aims of the study were to evaluate the timing of administering CO2 insufflation and to identify predictors of discomfort for colonoscopy.


Eligibility criteria: Inclusion Criteria:

* patients with an appropriate indication for colonoscopy were considered eligible.

Exclusion Criteria:

* Exclusion criteria included severe hematochezia, acute colonic pseudo-obstruction, known obstructive lesions, age \<18 years, prior colon resection, fulminant colitis, chronic obstructive pulmonary disease requiring oxygen, and a medical history of CO2 retention. Patients that required only a partial colonoscopy or were unable to read or understand Chinese were also excluded.

Primary outcomes:
measure: abdominal pain during and after colonoscopy
timeFrame: One day
Secondary outcomes:
measure: delayed bleeding
timeFrame: One day
measure: colonoscopic cecal intubation time
timeFrame: One day
measure: completeness of intubation
timeFrame: One day
measure: loop formation
timeFrame: One day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Division of Gastroenterology, Tri-Service General Hospital
Study officials:
affiliation: Division of Gastroenterology, Tri-Service General Hospital
name: Tsai-Yuan Hsieh, MD.PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01643876: The Effect of Palatal Brushing on Denture Stomatitis
Official title: Phase-I Clinical Trial on the Effect of Palatal Brushing on Denture Stomatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Denture Stomatitis
Keywords: Denture stomatitis
Denture Plaque
Oral Candidiasis
Oral Hygiene
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2012-07-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Palatal brushing has several advantages including removal of debris and stimulation of blood flow and saliva, which may help to prevent or treat oral diseases, such as denture-related stomatitis in complete denture wearers.

However, there is no previous clinical trial testing this effect. Therefore, the investigators goal is to evaluate whether palatal brushing may change the severity of denture stomatitis and counts of microbes on denture and palatal mucosa.

After an initial exam and data collection, participants will receive instructions about palatal brushing and they will be assessed after 1 and 3 months. Collection of data will include patient-reported information, intraoral photographs and swabbing (for counting microbes).

Tested Hypotheses:

* There is no difference in the extent of palatal inflammation in edentulous patients with denture stomatitis before and after 3 months of palatal brushing.
* There is no difference in the number of colony forming unit (CFU) of Candida isolated from palate and denture of patients affected by denture stomatitis before and after 3 months of palatal brushing.


Eligibility criteria: Inclusion Criteria:

* Good general health.
* Completely edentulous maxilla.
* Currently wearing complete upper dentures.
* A clinical diagnosis of denture stomatitis.

Exclusion Criteria:

* Conditions known to promote Candida carriage such as diabetes, anemia, xerostomia, immunosuppression, chemotherapy and radiotherapy.
* Use of antibiotics, antifungal agents or corticosteroids at least 4 weeks before the study.
* Previous palatal brushing habit.
* Changing of the existing prosthesis during the trial.

Primary outcomes:
measure: Palatal Inflammation
timeFrame: 3 months
Secondary outcomes:
measure: Candida Species Count
timeFrame: 3 months
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of Sao Paulo - Ribeirão Preto Dental School
state: São Paulo
city: Montréal
country: Canada
facility: Faculté de Médecine Dentaire, Université de Montréal
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Elham Emami, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Raphael F de Souza, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00807976: Orthostatic Hypotension and Diabetes Mellitus
Official title: The Orthostatic Hypotension in the Diabetic Elderly Patients Trial (ODET)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthostatic Hypotension
Diabetes Mellitus Type 2
Keywords: Diabetes mellitus
Elderly
Orthostatic hypotension
Lead sponsor: Medical Research Foundation, The Netherlands
Sponsor class: OTHER
First posted: 2008-12-15
Enrollment: 500
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetic patients aged 70 years and older

Brief summary: Rationale: Orthostatic hypotension increases with age and is associated with increased vascular and all-cause mortality. The prevalence of orthostatic hypotension is also increased in diabetic subjects. In order to prevent related adverse events and vascular mortality it is of great interest to examine the prevalence of orthostatic hypotension in elderly diabetic subjects.

Objective: To examine the prevalence of orthostatic hypotension and associated adverse events in type 2 diabetic elderly subjects.

Study design: Cross-sectional observational study.

Study population: Elderly type 2 diabetic subjects (70 years and older).


Eligibility criteria: Inclusion Criteria:

* diabetes mellitus
* age (70 years and older)

Exclusion Criteria:

* Known autonomic dysfunction
* Neurodegenerative diseases
* Current malignancy
* Living in a nursing-home
* Irregular pulse

Primary outcomes:
measure: Prevalence of orthostatic hypotension
timeFrame: 1-12 months (orthostatic blood pressure is assessed only once during the running time of the study)
Secondary outcomes:
measure: Adverse events, Score risk profile questionnaire, Heart rate, Gender, Body mass index, Medication, Smoking, History of cardiovascular disease, Family history of cardiovascular disease, Duration of diabetes mellitus, Glycosylated haemoglobin, Insulin use
timeFrame: 1-12 months (the outcome measures are assessed only once during the running time of the study)
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Diabetes centre, Isala Clinics
Study officials:
affiliation: Diabetes centre, Isala Clinics
name: Kornelis JJ van Hateren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01621776: Effect of Apidra Compared to Humalog in Decreasing Post-Prandial Hyperglycemia
Official title: Comparison of Effectiveness of Glulisine and Lispro in Decreasing Post-Prandial Hyperglycemia in a Real-World Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: post-prandial hyperglycemia
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2012-06-18
Enrollment: 107
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to compare the post-meal blood glucose values of two drugs in a "real-world" setting.

Detailed description: This is a randomized, open-label trial that aims to compare the glycemic excursion following food intake following post-meal injection of Glulisine (Apidra) insulin and Lispro (Humalog) insulin in a real-world setting. Children participating in the Florida Camp for Children and Youth with Diabetes will be randomized to receive either Glulisine or Apidra to cover carbohydrates after meals. The difference in blood glucose values will be analyzed before and 2 hours after meals to see if there is a difference in post-prandial hyperglycemia between groups.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 1 Diabetes
* Children and Youth attending Florida Diabetes Camp in DeLand, FL

Exclusion Criteria:

* only campers participating in sessions I and II are eligible to participate

Primary outcomes:
measure: The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch.
timeFrame: averaged over 5 days
Secondary outcomes:
measure: Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner
timeFrame: averaged over 5 days
measure: Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast
timeFrame: averaged over 5 days
Other outcomes:
Locations:
city: DeLeon Springs
country: United States
facility: Camp Winona
state: Florida
Study officials:
affiliation: University of Florida
name: Janet Silverstein, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03562676: VESTIBULAR EVOKED MYOGENIC POTENTIALS IN ALTERED GRAVITY
Official title: VESTIBULAR EVOKED MYOGENIC POTENTIALS IN ALTERED GRAVITY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Recently, new clinical testing of saccular and utricular function have been developed and validated, the so-called vestibular-evoked myogenic potentials - VEMP (Brantberg et al. 2009, Cornell et al. 2009, Curthoys 2010, Manzari et al. 2012). Among them, the cervical VEMP (cVEMP) are short-latency electromyographic (EMG) modulations of the contracted sternocleidomastoid muscles in responses to vibration applied on the forehead. The clinical literature suggests that cVEMP are almost entirely saccular in origin (Halmagyi et al 1995).

The aim of our research is to evaluate changes in the otolith function in microgravity and hypergravity using this clinical test. Cervical vestibular-evoked myogenic potentials (cVEMP) will be recorded by surface EMG electrodes in response to bone conducted vibration to specifically assess saccular function (Halmagyi et al 1995). The primary measures will include muscle activity response amplitudes and the stimulus intensity threshold at which the cVEMP is detected.

Given that there is an off-loading of the saccules in microgravity and an increased loading in hypergravity, we hypothesize that there will be a reduction in cVEMP amplitude in microgravity and an increase in cVEMP amplitude in hypregravity compared to normal gravity. These changes in amplitude will be accompanied by changes in the threshold of the stimulus level required to elicit a cVEMP.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 18 to 67
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who have given their written stated consent
* With normal cVEMP
* Who have passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Exclusion Criteria:

* Persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Pregnant women (urine pregnancy test for women of childbearing potential)

Primary outcomes:
measure: vestibular-evoked myogenic potentials (P13-N23)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References: