louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01352078: Wound Etiology and Healing Study
Official title: The Wound Etiology and Healing Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds
Hidradenitis Suppurativa
Hidradenitis
Acne Inversa
Keywords: Non healing ulcer
Wound
Hidradenitis suppurativa
Acne Inversa
Hidradenitis
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
name: National Institute of Nursing Research (NINR)
First posted: 2011-05-11
Enrollment: 743
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non healing wounds or hidradenitis suppurativa

Brief summary: The purpose of the WE-HEAL Study is to help researchers use human tissue samples and health records to study the reasons why some patients heal quickly and some have problems healing wounds. All patients seen with an open wound or hidradenitis suppurativa are invited to participate. Information from this research may help to understand how to prevent and treat certain diseases.


Eligibility criteria: Inclusion Criteria:

1. Age \>18
2. Open wound or hidradenitis suppurativa
3. English speaking
4. Able to give informed consent

Exclusion Criteria:

1. Non-English speaking.
2. Unable to give informed consent

Primary outcomes:
measure: Time to wound healing
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Victoria K Shanmugam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01290978: Compare Effect of Surgical Antiseptic Preparations on Incise Drape Adhesion to Skin
Official title: Prospective, Randomized Comparison of Two Presurgical Skin Antiseptic Preparations and Resultant Surgical Incise Drape Adhesion to Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: Cyberderm Inc.
name: 3M
First posted: 2011-02-07
Enrollment: 22
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: OTHER

Brief summary: The purpose of this study is to find out if presurgical antiseptic preparations affect how well surgical drapes adhere to skin.

Detailed description: Adhesive incise drapes are often used to provide a physical sterile barrier between the surrounding skin and the open wound at the beginning of a surgery. This study sought to determine the effect of presurgical skin antiseptic preparation on the adhesion of various incise drapes to the skin.

Eligibility criteria: Inclusion Criteria:

* Subject is willing to sign the Research Consent form
* Healthy male or female subjects ages between 18 - 65
* Subject has agreed to be and appears to be compliant with requirements of the study
* Subject has a back (the product application site) of sufficient size, free of blemishes to comfortably fit 18 strips of 1/2" x 3" drape samples
* Subject is willing to have the back clipped or shaved if it has excessive hair

Exclusion Criteria:

* Sensitivity/allergy to adhesive products (e.g. medical tapes)
* Sensitivity to the antimicrobial agent iodine, povidone iodine (PVPI), isopropyl alcohol (IPA), or chlorhexidine gluconate (CHG)
* Allergy to seafood
* History of psoriasis dermatitis, or any skin condition that might be exacerbated by the action of removing adhesive materials
* Active dermatitis (rash), sunburn, blemishes, broken skin, cuts, and/or infection on the subject's back
* History of diabetes
* Subject is currently pregnant or thinks she may be pregnant or is nursing
* Subject is receiving steroid-based anti-inflammatory or immunosuppressant drug therapy
* Subject is taking antihistamine medication
* Subject has been using moisturizers or other skin contact materials on the test sites for 24 hours prior to the start of the study
* Subject has a back problem that prohibits him or her from lying face downward for approximately 2 hours

Primary outcomes:
measure: Drape Adhesion
timeFrame: 30 minutes
Secondary outcomes:
measure: Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Broomall
country: United States
facility: cyberDERM Clinical Studies
state: Pennsylvania
Study officials:
affiliation: Cyberderm Inc.
name: Gary L Grove, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00009178: Treatment of Bulimia Nervosa in a Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia Nervosa
Keywords: Primary Care
Fluoxetine
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2001-01-23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bulimia Nervosa is a frequent problem for young women. It is widely assumed that this disorder cannot be treated effectively in a primary care setting. This assumption has never been tested empirically, and is probably incorrect.

In the last 15 years, effective treatment interventions for Bulimia Nervosa have been developed and validated in specialized treatment centers. The broad aim of this proposal is to examine whether these treatments, suitably adapted, can be usefully transferred to general health care settings. Specifically, the proposed study will determine the relative and combined effectiveness of the two leading treatments for Bulimia Nervosa in a primary care setting. The two major interventions are treatment with an antidepressant medication, fluoxetine, and with a form of cognitive behavioral therapy, guided self-help, designed for use in primary care.


Eligibility criteria: Inclusion Criteria:

* DSM-IV criteria for bulimia nervosa with a modified frequency criterion of at least once a week

Exclusion Criteria:

* Physical disorder requiring hospitalization or ongoing treatment likely to affect eating and/or weight
* Significant suicidal ideation or behavior
* Subjects judged unable to tolerate four-month treatments available in the study because of comorbid psychiatric conditions
* Current drug or alcohol dependence
* Current anorexia nervosa
* Pregnancy or any physical condition or treatments known to influence eating and weight
* Current psychiatric treatment or medication known to affect eating or weight
* Previous course of fluoxetine at a dose of 60 mg. per day for at least four weeks
* Allergy to fluoxetine
* Previous course of cognitive behavioral therapy for Bulimia Nervosa at a qualified center

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia University
name: B. T. Walsh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waller D, Fairburn CG, McPherson A, Kay R, Lee A, Nowell T. Treating bulimia nervosa in primary care: a pilot study. Int J Eat Disord. 1996 Jan;19(1):99-103. doi: 10.1002/(SICI)1098-108X(199601)19:13.0.CO;2-L.
Clinical trial NCT04548778: BÜHLMANN FPELA in the Diagnosis of Exocrine Pancreatic Insufficiency
Official title: Clinical Evaluation of BÜHLMANN Fecal Pancreatic Elastase (fPELA) Tests in the Diagnosis of Exocrine Pancreatic Insufficiency (PEI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exocrine Pancreatic Insufficiency
Lead sponsor: Bühlmann Laboratories AG
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Included are subjects for which pancreatic elastase testing was indicated due to a suspected exocrine pancreatic insufficiency and which were at least 18 years of age. Following patient groups show an increased risk for developing an exocrine insufficiency: chronic pancreatitis, cystic fibrosis, diabetes, pancreatic resection. Eligible study subjects provide one stool sample which is forwarded to the study site within three days.

Brief summary: The study shall determine the clinical performance of the BÜHLMANN fecal pancreatic elastase (fPELA) assays in the diagnosis of exocrine pancreatic insufficiency (PEI).

This is a observational and cross-sectional performance study. Specimens and clinical data are collected by a single study site.

Included are subjects for which pancreatic elastase testing was indicated due to a suspected exocrine pancreatic insufficiency and which were at least 18 years of age. Subjects which suffered from diarrhea (stool water content ≥ 75%) at the time of sample collection are excluded from the study.


Eligibility criteria: Inclusion Criteria:

* suspected exocrine pancreatic insufficiency
* at least 18 years of age.

Exclusion Criteria:

* diarrhea (stool water content ≥ 75%) at the time of sample collection

Primary outcomes:
measure: Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI
timeFrame: December 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Halle (Saale)
country: Germany
facility: Universitätsklinikum Halle (Saale)
Study officials:
affiliation: Universitätsklinikum der Martin-Luther-Universität Halle-Wittenberg
name: Jonas Rosendahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05907278: Advanced Cooking Education Feasibility Study
Official title: The Advanced Cooking Education (ACE) 4-H After School Club: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Nutrition, Healthy
Keywords: Adolescents
Nutrition intervention
Culinary program
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2023-06-18
Enrollment: 81
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants receive the intervention
Primary purpose: PREVENTION

Brief summary: The aim of this study is to look at outcomes related to diet and nutrition, mindfulness, and cooking skills amongst middle school students who participated in a 12-week 4-H after school program called the Advanced Cooking Education Program.

Detailed description: Participants are all assigned to the Advanced Cooking Education Program. Data collection was done before and after the program. The investigators hypothesize that after the program, adolescents' diet quality, cooking-related skills, stress levels will be improved compared to prior of the program.

Eligibility criteria: Inclusion Criteria:

* 7th and 8th grade students attending Title I funded schools in New York City
* Caregivers of 7th and 8th grade students attending Title I funded schools in New York City

Exclusion Criteria:

* Do not speak/understand English

Primary outcomes:
measure: Change in diet quality, measured by the Healthy Eating Index Scores
timeFrame: Baseline, 12 weeks [endpoint]
Secondary outcomes:
measure: Change in body mass index
timeFrame: Baseline, 12 weeks [endpoint]
measure: Change in body fat percentage
timeFrame: Baseline, 12 weeks [endpoint]
measure: Change in waist circumference
timeFrame: Baseline, 12 weeks [endpoint]
measure: Change in dermal carotenoids level
timeFrame: Baseline, 12 weeks [endpoint]
measure: Change in household food security
timeFrame: Baseline, 12 weeks [endpoint]
measure: Change in child food security
timeFrame: Baseline, 12 weeks [endpoint]
measure: Change in culinary skills
timeFrame: Baseline, 12 weeks [endpoint]
measure: Change in culinary attitudes
timeFrame: Baseline, 12 weeks [endpoint]
measure: Change in culinary self-efficacy
timeFrame: Baseline, 12 weeks [endpoint]
measure: Change in perceived stress
timeFrame: Baseline, 12 weeks [endpoint]
measure: Change in food neophobia
timeFrame: Baseline, 12 weeks [endpoint]
measure: Change in sense of purpose
timeFrame: Baseline, 12 weeks [endpoint]
measure: Change in social and emotional competency
timeFrame: Baseline, 12 weeks [endpoint]
measure: Change in family mealtime beliefs
timeFrame: Baseline, 12 weeks [endpoint]
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Cornell University
state: New York
Study officials:
affiliation: Cornell University
name: Tashara M Leak, PhD RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04148378: A Pilot Study to Explore the Role of Gut Flora in Colorectal Cancer
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Colorectal Cancer
Colorectal Neoplasms
Colorectal Carcinoma
Colorectal Adenocarcinoma
Colorectal Cancer Metastatic
Colorectal Sarcoma
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with colorectal cancer

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding colorectal cancer.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding colorectal cancer.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with mothers).
3. Diagnosis of colorectal cancer

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: One year
Secondary outcomes:
measure: Validation of Sequencing Methods
timeFrame: One year
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01380678: Intralesional Bevacizumab Injection on Primary Pterygium
Official title: A Randomized Controlled Trial of Intralesional Bevacizumab Injection on Primary Pterygium: Preliminary Results
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pterygium
Inflammation
Keywords: bevacizumab
pterygium
treatment
elevation
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 206
Sex: ALL
Standard ages: CHILD
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 that intralesional injection of bevacizumab on primary pterygium can reduce the corneal pterygium area, inflammation, redness and other symptoms.

Detailed description: To evaluate the efficacy and safety of intralesional injection of bevacizumab on primary pterygium treatment

Eligibility criteria: Inclusion Criteria:

* primary pterygium

Exclusion Criteria:

* previous ocular surgery

Primary outcomes:
measure: percentage of corneal pterygium area
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mueng
country: Thailand
facility: Srinagarind Hospital
state: Khon Kaen
Study officials:
affiliation: Khon Kaen University
name: Olan Suwan-apichon, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00815178: Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness
Official title: Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness: A Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Complications
Inspiratory Muscle Weakness
Keywords: inspiratory muscle weakness
autonomic modulation
diabetes mellitus
heart rate variability
functional capacity
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2008-12-29
Enrollment: 25
Sex: ALL
Minimum age (years): 40
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 the study is to determine if inspiratory muscle training improves inspiratory muscle strength of type 2 diabetes mellitus patients with inspiratory muscle weakness.

Detailed description: In congestive heart failure patients, inspiratory muscle weakness can be reversed by developing diaphragmatic hypertrophy through inspiratory muscle training, improving functional capacity and quality of life. In type 2 diabetes mellitus patients the frequency of inspiratory muscle weakness is unknown, as well as the response to inspiratory muscle training. For this reason, the present study evaluated the inspiratory muscle strength in type 2 diabetes mellitus patients and the effect of inspiratory muscle training on inspiratory muscle strength, pulmonary function, functional capacity and autonomic modulation assessed through heart rate variability.

Eligibility criteria: Inclusion Criteria:

* diabetes melittus
* sedentary
* inspiratory muscle weakness with PImax \< 70% of the predicted

Exclusion Criteria:

* mass index \> 33 kg/m2
* exercise-induced asthma history
* infectious disease
* osteoarticular disease
* regular alcohol or tobacco consumption in the past 6 months
* cardiac disease
* pulmonary disease

Primary outcomes:
measure: Maximum inspiratory pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Peak exercise oxigen consumption
timeFrame: 8 weeks
measure: pulmonary function
timeFrame: 8 weeks
measure: autonomic modulation assessed by heart rate variability
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
References:
citation: Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71. doi: 10.1016/j.jacc.2007.12.045.
citation: Correa AP, Ribeiro JP, Balzan FM, Mundstock L, Ferlin EL, Moraes RS. Inspiratory muscle training in type 2 diabetes with inspiratory muscle weakness. Med Sci Sports Exerc. 2011 Jul;43(7):1135-41. doi: 10.1249/MSS.0b013e31820a7c12.
Clinical trial NCT05406778: SPARK Neuro REMIND Study
Official title: SPARK Neuro Quantitative Resting State EEG Protocol for Assessing Cognitive Impairment and AD Status 'REMIND' Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Cognitive Impairment
Keywords: EEG
Electroencephalography
Machine learning
Lead sponsor: Spark Neuro Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-06
Enrollment: 800
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study utilizes investigational software, the SPARK Test, with an FDA-cleared electroencephalography (EEG) amplifier and EEG cap to collect and then analyze patient EEG data.

Detailed description: The aim of this study is to develop an algorithm and then evaluate it to determine whether applying machine-learning techniques to resting-state electroencephalography (EEG) can characterize patient's cognitive status and detect the presence or absence of AD on the basis of the patient's EEG.

Eligibility criteria: Inclusion Criteria:

1. Age 55 to 85 at the time of consent
2. Informant available and willing (remotely or in-person) to provide information about sleep patterns and cognitive functioning who spends \>8 hours per week with primary subject
3. Subject or Legally Authorized Representative (LAR) has the ability to provide informed consent and comply with the protocol.

Exclusion Criteria:

1. Unable to remain still for up to 30 minutes during EEG data recording
2. Subjects currently on and unable to wash out concomitant medications, including: 1) opiates; 2) benzodiazepines and nonbenzodiazepine hypnotics; 3) sedative antihistamines; 4) tricyclic anti-depressants; 5) skeletal muscle relaxants; 6) antiepileptics; 7) antipsychotics; 8) antimanic agents; 9) THC; 10) anticholinergics
3. Previous history of stroke, severe head injury, craniotomy or any other potentially confounding neurologic illness causing known structural brain damage
4. Medical or psychiatric illness that would interfere with study participation
5. History of epilepsy or chronic seizure disorder
6. Presence of non-dental metal in head
7. Currently experiencing a skin disease on scalp that would affect electrode contacts
8. TICS score indicative of cognitive impairment at screening
9. Substance Use Disorder, including Alcohol

Primary outcomes:
measure: Software malfunction occurrences
timeFrame: 10 weeks
measure: Assessment of patients SPARK Test data
timeFrame: 10 weeks
Secondary outcomes:
measure: Mean absolute error for specific cognitive assessment
timeFrame: 10 weeks
Other outcomes:
measure: Alzheimer's Disease positive vs. negative indication for biomarker-confirmed AD
timeFrame: 10 weeks
Locations:
city: Tempe
country: United States
facility: Voyage Medical
state: Arizona
Study officials:
References: