louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04571723: Health Mindset as a Driver of Efficacy of a Diabetes Prevention Program in the Blackfeet Community
Official title: Health Mindset as a Driver of Efficacy of a Diabetes Prevention Program in the Blackfeet Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Montana State University
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will receive the original diabetes prevention program curriculum, and other group will receive modified health mindset curriculum.
Primary purpose: PREVENTION

Brief summary: The overall goal of this project is to understand whether the established Diabetes prevention program works to reduce diabetes risk by shifting mindsets about health.

Detailed description: The Diabetes Prevention Program (DPP), a lifestyle intervention which aims to modify health behaviors, has reduced diabetes risk across several American Indian Communities. However, there were significant attrition rates, and non-completers were at the highest risk at baseline. One's mindset about health (i.e. whether it is fixed or malleable) may affect their likelihood of completing the intervention and its efficacy in reducing risk. With an existing CAB, I will develop a culturally congruent adaptation of the DPP, the Mindset-DPP (M-DPP). The M-DPP will include a discussion of mindset in each session and will present material focused on the plasticity of health, including evidence that one's mindset can affect outcomes that relate to risk for diabetes. The investigators will implement the DPP and the MDPP in a sample of 40 Blackfeet community members at risk for diabetes and test whether the M-DPP associates with greater shifts towards a growth health mindsets (i.e. health can be changed by effort) compared to the DPP, and whether the M-DPP associates with greater increases in physical activity levels and greater reductions in waist circumference, and greater retention compared to the standard DPP.

Eligibility criteria: Inclusion Criteria:

* self identified as American Indian
* identified as high risk for diabetes based on the American Diabetes Association paper and pencil test
* must reside on the Blackfeet reservation

Exclusion Criteria:

-chronic disease diagnosis

Primary outcomes:
measure: Change in Health Mindset
timeFrame: baseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline)
Secondary outcomes:
measure: physical activity levels
timeFrame: during the intervention, up to 11 weeks.
measure: waist circumference
timeFrame: baseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline)
Other outcomes:
Locations:
city: Browning
country: United States
facility: Blackfeet Community College
state: Montana
Study officials:
References:
Clinical trial NCT00205023: Disseminated Endometrial Cancer Cells During Sonohysterography
Official title: The Incidence of Disseminated Endometrial Cancer Cells During Sonohysterography and Their Functional Viability: a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of study is to: 1) determine critical volume necessary to overcome tubal pressure and result in fluid dissemination and 2) evaluate functional viability of any disseminated tumor cells collected during SHG


Eligibility criteria: Inclusion Criteria:

* Stage I endometrial Cancer Disease
* State IIA endometrial Cancer Disease

Exclusion Criteria:

* Prior tubal ligation
* Prior bilateral salpingectomy

Primary outcomes:
measure: determine the critical volume necessary to overcome tubal pressure and result in fluid dissemination during SHG
timeFrame: during surgery
Secondary outcomes:
measure: evaluate the functional viability of any disseminated tumor cells collected during SHG
timeFrame: during surgery
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: David M Kushner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02352623: Quality of Life and Surgical Late Effects of Melanoma Treatment
Official title: Quality of Life and Surgical Late Effects of Melanoma Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Quality of Life
Lymphedema
Depression
Anxiety
Pain
Cicatrix
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2015-02-02
Enrollment: 435
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated for cutaneous melanoma (AJCC stage IB-III) with wide local excision (WLE) and sentinel lymph node biopsy (SNB) and/ or complete lymph node dissection in the axilla and/or groin will be included in the study.

Brief summary: Health-related Quality of life in Danish stage IB-III cutaneous melanoma patients.

Detailed description: The aim of the PhD-study is to evaluate, in a large cohort of Danish melanoma patients:

1. Health-related quality of life assessing psychological, physical and social well-being
2. Physical long term side effects (lymphoedema, scarring and neuropathic pain)
3. Lymphoedema assessed by clinical examination and DXA scans

Eligibility criteria: Inclusion Criteria:

* AJCC stage IB-III cutaneous melanoma patients
* At least one year follow-up after melanoma surgery

Exclusion Criteria:

* Pregnancy
* Bilateral axilla or groin melanoma surgery

Primary outcomes:
measure: Global Health Score
timeFrame: 12 months
Secondary outcomes:
measure: Anxiety
timeFrame: 12 months
measure: Depression
timeFrame: 12 months
measure: Lymphoedema
timeFrame: 12 months
measure: Neuropathic pain
timeFrame: 12 months
measure: Volume and tissue composition assessed with DXA scan
timeFrame: 12 months
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Plastic Surgery, Herlev Hospital
Study officials:
affiliation: Department of Plastic Surgery
name: Caroline Asirvatham Gjørup, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gjorup CA, Groenvold M, Hendel HW, Dahlstroem K, Drzewiecki KT, Klausen TW, Holmich LR. Health-related quality of life in melanoma patients: Impact of melanoma-related limb lymphoedema. Eur J Cancer. 2017 Nov;85:122-132. doi: 10.1016/j.ejca.2017.07.052. Epub 2017 Sep 15.
Clinical trial NCT04963023: Biomarkers of Chronic Obstructive Pulmonary Disease
Official title: Specific Biomarker Identification of Different Subgroups of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Asthma-COPD Overlap Syndrome
Asthma
Keywords: COPD
Asthma-COPD Overlap Syndrome
Asthma
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic obstructive pulmonary disease (COPD) patients, followed in Amiens-University Hospital

Brief summary: There are few studies about immunological explorations in COPD. Because of the complications of lung biopsies, analyses are generally made on blood samples instead of lung tissue. No study tried to classify COPD vs Asthma vs ACOS. The investigators wondered if there were differences in biomarkers between these groups. The investigators decided to open a pilot-study among COPD patients followed in Amiens-University Hospital. Each patient will be examined and a blood-test will be performed.


Eligibility criteria: Inclusion Criteria:

* BPCO patients
* ACOS patients
* asthmatic patient without BPCO

Exclusion Criteria:

* infection
* exacerbation
* immunosuppressive treatment
* immunosuppressive disease

Primary outcomes:
measure: identification specific blood immunologic marker for COPD
timeFrame: one hour
Secondary outcomes:
measure: Complete blood count (CBC) Variation between COPD and asthmatic patients
timeFrame: one hour
measure: c-reactive protein concentration variation between COPD and asthmatic patients
timeFrame: one hour
measure: Plasma protein electrophoresis profile Variation between COPD and asthmatic patients
timeFrame: one hour
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT04206423: Grip Strength or Pinch Strength in Lateral Epicondylitis
Official title: Grip Strength or Pinch Strength: Which is Preferred to Evaluate Lateral Epicondylitis?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lateral Epicondylitis
Keywords: Disability evaluation
Hand Strength
Quality of life
Pain
Pinch Strength
Tennis elbow
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2019-12-20
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants suffering from lateral epicondylitis will be included in the patient group and healthy control will be included in control group.

Brief summary: Grip strength can be decreased in lateral epicondylitis. Pinch strength is also affected in people suffering from lateral epicondylitis. In this study, participants will be evaluated using a hydraulic dynamometer, a pinch meter and we will evaluate pain, disability and quality of life.

Detailed description: Newly diagnosed patients with lateral epicondylitis and healthy controls will be included in the study with an allocation ratio of 2:1. Using a hydraulic dynamometer grip strength will be evaluated three times, one minute between each measurement. Then palmar pinch, key pinch and tip pinch measurements will be evaluated for three times each. For each measurement, the participants will rest one minute between repetitive measurements, and five minutes between each parameters. The order of measurements will be randomized for each participants to avoid bias. Then the participants will be evaluated using different scales for pain, disability and quality of life.

Eligibility criteria: Inclusion Criteria:

* Pain in elbow for at least two weeks

Exclusion Criteria:

* Nonsteroidal antiinflammatory drug usage during last week.
* Rheumatic diseases (Rheumatoid arthritis, systemic lupus erythematosus, reactive arthritis, etc.)
* Malignancy
* Extracorporeal shock wave therapy in last six months
* Lateral epicondylitis injection in last six months or any treatment.
* Lateral epicondylitis brace usage

Primary outcomes:
measure: Hand (grip) Strength
timeFrame: 0.day
measure: Pinch Strength (key pinch, palmar pinch and tip pinch)
timeFrame: 0.day
Secondary outcomes:
measure: Visual Analog Scale (VAS)-During day
timeFrame: 0.day
measure: VAS-Night
timeFrame: 0.day
measure: Patient Rated Tennis Elbow Evaluation Scale
timeFrame: 0.day
measure: Disability
timeFrame: 0.day
measure: World Health Organization-Quality of Life- Bref (WHOQOL-BREF) scale
timeFrame: 0.day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Taksim Research and Education Hospital
Study officials:
affiliation: Gaziosmanpasa Training and Research Hospital
name: Ebru Y Yalcınkaya, Ass. Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT00444223: Fluorine F 18 FEQA in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer and in Healthy Participants
Official title: The Biodistribution of N-{4-[3'-[F-18] Fluoroethylphenyl)Amino]-6-quinazolinyl}-Acrylamide ([F-F18]FEQA) in Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC) and in Healthy Subjects: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Keywords: stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2007-03-07
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: Fluorine F 18 FEQA may be an effective radioactive drug to use with positron emission tomography (PET) scans.

PURPOSE: This clinical trial is studying the use of fluorine F 18 FEQA in patients with stage III or stage IV non-small cell lung cancer and in healthy participants.

Detailed description: OBJECTIVES:

* Determine the biodistribution of fluorine F 18 FEQA in patients with stage III or IV non-small cell lung cancer (NSCLC) and in healthy participants.
* Determine whether fluorine F 18 FEQA can be used as an imaging agent with positron emission tomography in patients with stage III or IV NSCLC.

OUTLINE: This is a pilot study.

Patients and healthy participants receive fluorine F 18 FEQA IV and then undergo whole-body dynamic scans comprising positron emission tomography.

Blood is collected during and after imaging to measure radioactivity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility criteria: Inclusion Criteria:

* Must meet 1 of the following criteria:
* Diagnosis of non-small cell lung cancer by CT scan, bone scan, or biopsy

  * Stage III or IV disease
  * Clinically assessed with
* Healthy participant

Exclusion Criteria:

Primary outcomes:
measure: Biodistribution of fluorine F 18 FEQA
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Johannes Czernin, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00240123: Effect of Benadryl Sedation During ERCP or EUS
Official title: Effect of Diphenhydramine Sedation During Endoscopic Retrograde Cholangio-pancreatography (ERCP) or Endoscopic Ultrasound (EUS)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Gallbladder Disease
Gallstones
Pancreatitis
Abdominal Pain
Jaundice
Keywords: ERCP
EUS
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2005-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to determine if adding Benadryl improves sedation for patients scheduled to undergo ERCP or EUS procedures.

Detailed description: The usual sedatives used for endoscopy are meperidine (Demerol) and midazolam (Versed). Benadryl (Diphenhydramine) is often used in addition to these medications in an effort to improve sedation. There is little published information regarding the use of diphenhydramine in conscious sedation. It is recognized that certain patients have features that predict difficult sedation such as prescription sedative use or heavy alcohol use. In addition, prolonged procedures like ERCP and EUS require higher doses of sedatives. Diphenhydramine may improve the quality of sedation in patients undergoing endoscopic retrograde cholangio-pancreatography (ERCP) or endoscopic ultrasound (EUS) procedures. You are being asked to participate because you are already scheduled to undergo one of these procedures.

Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 65 years of age who present for outpatient ERCP or EUS at Strong Memorial Hospital Endoscopy Center will be included

Exclusion Criteria:

* Allergy to diphenhydramine, narrow angle glaucoma, or inability to consent

Primary outcomes:
measure: Recovery score
Secondary outcomes:
measure: Quality of sedation
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester Medical Center, Digestive and Liver Disease Unit
name: Benedict Maliakkal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04769323: Use of Virtual Reality Devices for Vestibular Rehabilitation
Official title: Use of Virtual Reality Devices for Vestibular Rehabilitation in Patients with Vestibular Hypofunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the superiority of virtual reality-supported vestibular rehabilitation exercises over conventional vestibular rehabilitation exercises in patients with complaints such as vertigo, loss of balance, falling, and gait imbalance.


Eligibility criteria: Inclusion Criteria:

* Complaining dizziness and/or instability for more than 3 months
* Patients aged 18 and over and under 65

Exclusion Criteria:

* Ear disease, head injury
* Ototoxic drug use
* Neurological and psychiatric illness that causes cooperation disorder
* Patients with orthopedic and systemic disorders that prevent exercising
* Patients with active malignancies
* Diseases that affect the use of glasses (epilepsy, vision loss, etc.)

Primary outcomes:
measure: Posturography
timeFrame: 1 year
measure: Subjective Visual Vertical
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Fazıl N Ardıç, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06372223: A Food Effect Study of SPH5030 Tablets.
Official title: A Single-center, Randomized, Open, Single-dose, Two-cycle, Two-sequence Crossover Food Effect Study of SPH5030 Tablets in Healthy Chinese Adult Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-04-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects.


Eligibility criteria: Inclusion Criteria:

1. Fully informed subjects who voluntarily sign the ICF；
2. Females who are not pregnant, non-lactating. Subjects who complied with the contraceptive requirements of the protocol.

Exclusion Criteria:

1. Subjects with any medical history assessed by the investigator that unsuitable for participation in a clinical study;
2. Subjects with abnormal test results during the screening period；
3. Subjects who have difficulty in venous blood collection;
4. Subjects who cannot accept uniform diet or have difficulty swallowing;
5. Other situations that meet the exclusion criteria.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: Approximately 2 months
measure: Peak time（Tmax）
timeFrame: Approximately 2 months
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Approximately 2 months
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Approximately 2 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Second Hospital ,Sichuan University
Study officials:
References:
Clinical trial NCT03963323: Glucosamine and Chondroitin in Gut in Preventing People From Inflammation
Official title: GLANCE2.1 - Glucosamine and Chondroitin (G&C) Effects Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subject
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This trial studies glucosamine and chondroitin in preventing inflammation. Glucosamine and chondroitin often used as a dietary supplement to promote joint health may have a preventive role in inflammation and cancer. This trial may help identify the bacteria that help process them in the gut.


Eligibility criteria: Inclusion Criteria:

- From the Greater Seattle area

Exclusion Criteria:

* Chronic medical illness, history of gastrointestinal, hepatic, or renal disorders, or inflammatory conditions (including autoimmune and inflammatory diseases)
* Pregnancy or lactation
* Currently on a weight-loss diet
* Alcohol intake of greater than 2 drinks/day (2 drinks being equivalent to 720 ml beer, 240 ml wine or 90 ml spirits)
* Current use of prescription or over-the-counter medications other than oral contraceptives and hormone secreting intrauterine device (IUD)s, multivitamin pills or infrequent use of aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs), or use of aspirin or NSAIDs more than 2 days per week
* Abnormal renal, liver or metabolic test
* Inability to swallow pills
* Known allergy to shellfish
* Not willing to take pills made from shellfish or animal sources
* Intention to relocate out of study area within next 2 months
* Any antibiotic use in the past 6 months

Primary outcomes:
measure: Number of participants that experienced a shift in bacterial community assessed by operational taxonomic units
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Joanna Lampe
role: PRINCIPAL_INVESTIGATOR
References: