louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00288145: Statewide (Rhode Island and Neighboring States) Partnerships for Worksite Weight Management
Official title: Statewide Partnerships for Worksite Weight Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight
Obesity
Keywords: worksite
weight gain prevention (among adults)
obesity (among adults)
physical activity
nutrition
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2006-02-07
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The project is designed to test the effectiveness of a multilevel worksite wellness program, based in Rhode Island and nearby neighboring states to impact employee weight, dietary intake and physical activity, compared to an attention placebo condition.

Detailed description: Accomplishment of the specific aim will be determined by a two group randomized effectiveness study (Treatment vs. Comparison) utilizing 24 RI worksites with randomization by site. The specific impact and outcome evaluation measures (BMI, DHQ-FFQ, and 7-day PAR) will be collected at Baseline, 12, and 24 months on a longitudinal cohort selected at random from the employee lists of each participating worksite. Extensive process evaluation and a mediating variable framework are also included to identify the mechanisms in successful change at both the worksite and individual level, which will maximize the potential for dissemination and generalization of the intervention as well as advance theory and improve intervention practice and policy.

Primary outcome measure will be weight (BMI).

Eligibility criteria: Inclusion Criteria:

Worksite

* worksite located in Rhode Island or neighboring state
* has food service on site
* approximately 200 - 500 employees
* low rate of employee turnover

Exclusion Criteria:

* worksites outside New England

Cohort participants:

* permanent employee, who works 20 or more hours on site
* speaks/reads some English at level to complete survey eval items
* able to walk at a brisk pace

Primary outcomes:
measure: Weight (BMI)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University, Institute for Community Health Promotion
name: Kim M Gans, PhD MPH LDN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Proper KI, Koning M, van der Beek AJ, Hildebrandt VH, Bosscher RJ, van Mechelen W. The effectiveness of worksite physical activity programs on physical activity, physical fitness, and health. Clin J Sport Med. 2003 Mar;13(2):106-17. doi: 10.1097/00042752-200303000-00008.
citation: Hallam JS, Petosa R. The long-term impact of a four-session work-site intervention on selected social cognitive theory variables linked to adult exercise adherence. Health Educ Behav. 2004 Feb;31(1):88-100. doi: 10.1177/1090198103259164.
Clinical trial NCT02650245: Breath and Blood Ammonia Response to an Oral Protein Challenge
Official title: Breath and Blood Ammonia Response to an Oral Protein Challenge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Keywords: breath
gastroenterology
ammonia
blood
protein
cirrhosis
encephalopathy
Lead sponsor: St. Luke's Hospital and Health Network, Pennsylvania
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators specific aim is to evaluate the changes in breath ammonia in comparison to blood ammonia and other physiologic markers after a moderate oral protein challenge in healthy subjects and subjects with liver cirrhosis.

Detailed description: Ammonia is an important molecule relevant to numerous diseases, especially to the millions of patients with cirrhosis worldwide. Venous blood ammonia via limb phlebotomy, can at best roughly estimate whole body ammonia, but says little or nothing about intestinal production, and cannot "source" ammonia to any particular organ or body compartment. Unfortunately, there are no presently available better tests. Therefore, despite these acknowledged limitations, venous ammonia the "bronze standard" benchmark by which new metrics are assessed.

The present protocol attempts to address both concerns and build upon the investigators prior high protein experience. By using a standard moderate protein challenge, the investigators can evaluate the breath ammonia responsiveness in healthy subjects and those with cirrhosis. This protocol leverages the power of breath research to evaluate responses to oral challenges. This remains a key asset of breath research.

Since the protocol proposes a moderate protein challenge, the investigators can evaluate disease states with minimal or no risk. As with past high protein studies, lactulose (10gm) will still be added to provoke a hydrogen response.

Eligibility criteria: Inclusion Criteria:

* \<18 and \<75 yrs of age

Exclusion Criteria:

* Diabetic, smoker, substance abuse

Primary outcomes:
measure: Levels of Ammonia (parts per billion) in response to an oral protein challenge using the Bedfont breath monitor
timeFrame: 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: St. Luke's University Hospital and Health Network
state: Pennsylvania
Study officials:
affiliation: St. Luke's University Hospital and Health Network
name: Steve Solga, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04632745: A Study Evaluating Splinting and Casting for Distal Radius Fractures in the Elderly
Official title: A Prospective Randomized Evaluation of Splinting and Casting for Distal Radius Fractures in the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Distal radial fractures are the most common fracture of the upper extremity in adults, with a higher incidence in those 65 years of age or older. In 2009, Karl et al demonstrated that there are 25.42 distal radial fractures in this age group per 10,000 person-years in the US. Despite the frequency of distal radius fractures, there is still debate over the best method of treatment. In contrast to younger patients, patients who are 65 years or older appear to have acceptable functional outcomes and treatment satisfaction regardless of the presence of malalignment on radiographic imaging.Therefore, nonsurgical management has been shown to be a viable treatment option.

The purpose of this study is to compare non-operative treatment with a removable splint versus a short arm cast for distal radial fractures in patients who are 65 years of age or older who are indicated for non-operative fracture treatment.


Eligibility criteria: Inclusion Criteria:

* Patients greater than 65 years old with isolated distal radius fracture amenable to non-operative treatment

Exclusion Criteria:

* Patients younger than 65 years old
* Open fractures (Gustilo Grade 2 or 3)
* Pathologic fractures
* Multiple fractures in the upper or lower extremities
* Fracture indicated for surgical repair of the distal radius for any reason
* Lack of health insurance
* Inability to provide consent to the study

Primary outcomes:
measure: Fracture treatment outcome
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02557945: Gabapentin in Patients at Clinical Risk for Psychosis
Official title: Gabapentin in Patients at Clinical Risk for Psychosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Clinical High Risk for Psychosis
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to test the effects of the drug gabapentin on brain function thought to be important in the development of schizophrenia. Researchers think that treating a brain region with gabapentin (the hippocampus) may reduce the risk for developing schizophrenia.

Detailed description: Six week, single site, proof-of concept, randomized double-blind placebo-controlled pilot study to examine the effects of moderate dose gabapentin (3600mg) in n= 100 putatively prodromal patients on hippocampal activity.

Eligibility criteria: Inclusion Criteria:

1. COPE patient between age of 18-30
2. Capacity to give informed consent
3. Currently using a reliable method of birth control (female) (condom plus spermicide, diaphragm plus spermicide, IUD, birth control pills, norplant, vasectomy in partner)

Exclusion Criteria:

1. Metal implants in body or a history of metal working, or more than one past MRI scan with gadolinium
2. Lifetime diagnosis of asthmatic symptoms within the past 3 years or known sensitivity to contrast agents
3. Lifetime diagnosis of renal failure/disease
4. Acute neurological, neuroendocrine,or medical disorder including renal insufficiency
5. Lifetime diagnosis of hypertension or diabetes
6. Intelligence Quotient (IQ) \< 70
7. Acute risk for suicide and/or violence
8. Pregnant, lactating
9. Current abuse of substances (alcohol, cocaine, stimulants, cannabis, opiates, sedative hypnotics)
10. Current use or anticipated need for antipsychotics or mood stabilizers (all antipsychotics, also Depakote, lithium, lamotrigine, pregabalin or any med with a mechanism of action like gabapentin)
11. The Clinical Global Impressions Scale (CGI)-improvement score during study equal to or greater than 6

Primary outcomes:
measure: Change in Left CA1 Cerebral Blood Volume (CBV) (MRI Measure)
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Positive, Negative, Disorganization, and General Symptoms Over Time as Measured by the Structured Interview for Psychosis-Risk Syndromes (SIPS)/the Scale of Psychosis-Risk Symptoms (SOPS)
timeFrame: 6 weeks
measure: Change in Cognitive Function (Hippocampal-dependent Verbal Memory) as Measured by the California Verbal Learning Test-Second Edition (CLVT-II)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: NYSPI/Columbia
name: Ragy Girgis, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01218945: Development of Bone Grafts Using Adipose Derived Stem Cells and Different Scaffolds
Official title: Development of Bone Grafts Using Adipose Derived Stem Cells and Different Scaffolds: Impact of Pre-engineered Capillaries in Critical Size Grafts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted for reconstructive surgery

Brief summary: The repair of large osseous defects remains still unsolved. Aim of this study is to isolate and cultivate fat-derived progenitor cells and differentiation into osteoblasts. Therefore, our research idea is to pre-engineer large synthetic bone grafts and study the vascularization process in vivo.


Eligibility criteria: Inclusion criteria:

* German-speaking patients aged 18-70 admitted to the Clinic of Reconstructive surgery for reconstructive surgery and fat-excision.

Exclusion criteria:

* Drug-abuse, neoplasia and metabolic disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Clinic of Reconstructive Surgery
state: ZH
Study officials:
affiliation: University Hospital Zurich, Clinic of Reconstructive Surgery
name: Maurizio Calcagni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01937845: Evaluating the Health Outcomes of the Joslin Why WAIT? Program
Official title: Evaluating the Health Outcomes of the Joslin Why WAIT? Program (Weight Achievement & Intensive Treatment Program)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetes
Obesity
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Type 2 diabetes enrolled in the Why WAIT? Program

Brief summary: Evaluating the health outcomes of patients that were enrolled in Joslin's Why WAIT Program. These outcomes include BMI, A1C, lipid profile.

Detailed description: This study is aimed to evaluate the health outcomes of patients enrolled in Joslin's Why WAIT Program. This program aims to control diabetes and help patients lose weight.

Eligibility criteria: Inclusion Criteria:

* Patients with Type 2 diabetes with BMI over 35

Exclusion Criteria:

* Patients with type 1 diabetes

Primary outcomes:
measure: Weight loss of 7% body weight
timeFrame: 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hamdy O, Mottalib A, Morsi A, El-Sayed N, Goebel-Fabbri A, Arathuzik G, Shahar J, Kirpitch A, Zrebiec J. Long-term effect of intensive lifestyle intervention on cardiovascular risk factors in patients with diabetes in real-world clinical practice: a 5-year longitudinal study. BMJ Open Diabetes Res Care. 2017 Jan 4;5(1):e000259. doi: 10.1136/bmjdrc-2016-000259. eCollection 2017.
Clinical trial NCT05770245: Novel Electrolyzed Water Spray Treatment Mild Dermatophytosis
Official title: A Novel Electrolyzed Water Spray Reduces the Discomfort or Itching Scores, and Promotes Healing of the Damaged Skin of Patients With Mild Dermatophytosis: A Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatophytoses
Keywords: Electrolyzed water device
Hydroxyl radical
Tap water
Spray
Dermatophytosis
Itching
Lead sponsor: Dove Medical Press Ltd
Sponsor class: NETWORK
First posted: 2023-03-15
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether spraying the skin of patients of patients by use of the novel electrolyzed water spray will produce improvement in the condition of mild dermatophytosis.

Detailed description: In this study, water inculding tap water,pure water and salt water, and an apparatus for producing electrolyzed water (https://www.deposon.com.cn; https://www.deposon.com）were used to generate an electrolyzed water mist spray or spray. This instantly generated electrolyzed water mist spray or spray has oxidation-reduction potential (ORP) ≥1200mv,and contains non-specific total oxidation capacity which equals to 0.28±0.10ppm,0.06±0.04ppm and 3.92±0.39ppm of desolved ozone. This instantly generated electrolyzed water mist spray or spray does not release detectable ≥0.1mg/m3 of gaseous ozone. This instantly generated electrolyzed water mist spray or spray has pH 8.4±0.4 and releases negative air ion.The apparatus for producing electrolyzed water has a positive electrode which is covered by a conductive diamond material (Patent# CN215308550U).This is an open-label, single-arm, and before and after treatment comparison study. This study uses this novel electrolyzed water device and the water spray to treat mild dermatophytosis.

Eligibility criteria: Inclusion Criteria:

* mild dermatophytosis accompanied by significant itching symptom
* Patient \> 18 years old.

Exclusion Criteria:

* severe dermatophytosis.
* 80 years or older.
* Pregnant or breastfeeding women.

Primary outcomes:
measure: An itching scale made by modifying the Numeric Pain Rating Scale (NPRS)
timeFrame: 7 days
Secondary outcomes:
measure: A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS).
timeFrame: 7 days
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Huinuode Biotechnology Co., Ltd.
Study officials:
References:
Clinical trial NCT03718845: A Mind-Body Medicine Curriculum for Peer Counselors
Official title: Evaluation of a Mind-Body Medicine Curriculum for High School Peer Counselors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Keywords: Empathy
Hope
Lead sponsor: The Center for Mind-Body Medicine
Sponsor class: OTHER
Collaborators: name: Silicon Valley Community Foundation
First posted: 2018-10-25
Enrollment: 124
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: High school students who are participating in the Peer Counseling Program at Marjory Stoneman Douglas High School

Brief summary: This study will evaluate a Mind-Body Medicine curriculum for high school peer counselors in order to answer the following research questions:

1. Will peer counselor participation in the Mind-Body Medicine curriculum increase their sense of self-regulation, responsibility, social competence, and empathy; decrease anxiety; and increase hope?
2. What are the experiences of peer support counselors participating in the Mind-Body Medicine curriculum?

Detailed description: The study will be done at the Marjory Stoneman Douglas High School. The research will use a mixed-methods design by collecting both quantitative and qualitative data. The quantitative data will be in the form of standardized research instruments and the qualitative data will be gathered through focus group interviews with the peer-counselors.

Eligibility criteria: Inclusion Criteria:

• All high school students who are participating in the Peer Counseling Program at Marjory Stoneman Douglas High School

Exclusion Criteria:

• None (as long as the students meet the inclusion criteria)

Primary outcomes:
measure: Change in State-Trait Anxiety Inventory (STAI) scores
timeFrame: baseline, approximately 2 months, approximately 8 months
Secondary outcomes:
measure: Change in the Social Emotional Assets and Resilience Scales for Adolescents (SEARS-A)
timeFrame: baseline, approximately 2 months, approximately 8 months
measure: Change in the Adult Hope Scale
timeFrame: baseline, approximately 2 months, approximately 8 months
Other outcomes:
measure: Focus Group Interviews
timeFrame: baseline, approximately 2 months, approximately 6 months, and approximately 8 months
Locations:
city: Parkland
country: United States
facility: Marjory Stoneman Douglas High School
state: Florida
Study officials:
affiliation: The Center for Mind-Body Medicine
name: James S Gordon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06405945: Cervical Cancer Susceptible Population Classification
Official title: Evalutaion of the SNPs Test in Average Cervical Cancer Screening Episode
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer Susceptible Population Classification
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-09
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HPV positive person at average risk of cervical cancer

Brief summary: Cervical cancer is the third most common lethal tumor globally, causing around a quarter million deaths annually, despite the availability of HPV vaccines. Recent Genome-wide association studies (GWAS) have identified numerous genetic markers linked to cervical cancer, including rs10175462, rs10007915, rs35721900, and rs61646675, which have been verified as being related to susceptibility to cervical cancer. However, many reports lack clarity, consistency, and validation. In this comprehensive study, we will analyze the genomic risk factors associated with cervical cancer, classify individuals into different risk categories, and explore potential biomarkers and therapeutics.


Eligibility criteria: Inclusion Criteria:

1. Subjects aged \>=18 years at time of consent
2. Intended to undergo screening colposcopy
3. Considered by a physician or healthcare provider as being of "average risk" for cervical cancer
4. Willing to consent to blood draw cervical disease treatments
5. Willing to sonsent to follow-up for five years as per protocol

Exclusion Criteria:

1. History of cervical cancer
2. History of any malignancy (patients who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study)
3. Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs.
4. Any major physical trauma (e.g. disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent
5. Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study

Primary outcomes:
measure: Evalutaiton of the SNPs test in an average cervical cancer patients screening episode
timeFrame: two years
Secondary outcomes:
measure: Classified susceptied person into different ladders
timeFrame: two years
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of USTC
name: Yingying Wang, Doctor
role: STUDY_CHAIR
References: