louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00954655: Study of Tumor Samples in Patients Undergoing Treatment for Gastrointestinal Stromal Tumors on Clinical Trial ACOSOG-Z9001
Official title: Genetic Risk Factors for Gastrointestinal Stromal Tumors (GIST)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Stromal Tumor
Keywords: gastrointestinal stromal tumor
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-08-07
Enrollment: 1
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: Tumor samples from patients with gastrointestinal stromal tumors enrolled on clinical trial ACOSOG-Z9001

Brief summary: RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor samples in patients undergoing treatment for gastrointestinal stromal tumors on clinical trial ACOSOG-Z9001.

Detailed description: OBJECTIVES:

Primary

* To examine polymorphisms in selected genes involved in the detoxifying/metabolizing and DNA repair pathways in relation to specific mutations and types of mutation in the c-kit gene in tumor tissue from patients with gastrointestinal tumors (GIST) undergoing treatment on clinical trial ACOSOG-Z9001.

Secondary

* To examine approximately 758 polymorphisms among candidate genes involved in detoxification/metabolism, cell cycle control, and DNA damage/repair in relation to specific mutations and types of mutation in the c-kit gene in tumor tissue from GIST patients for hypothesis generation. (exploratory)
* To conduct an exploratory analysis of the polymorphism distribution in these patients. (exploratory)
* To examine the association between the above polymorphisms and major toxicity (Grade 3/4) of adjuvant imatinib mesylate. (exploratory)

OUTLINE: Tumor samples are used for polymorphism and mutation analysis.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Tumor samples from patients with gastrointestinal stromal tumors enrolled on clinical trial ACOSOG-Z9001

Primary outcomes:
measure: response
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Lawrence Engel, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05261555: Mixed Methods Feasibility Study of an App for Childhood Obesity Prevention and Management
Official title: Acceptability and Usability of a Mobile Health App for Family Obesity Prevention and Management: A Mixed-methods Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Obesity
Keywords: child obesity
digital health
mobile applications
behavior change
Lead sponsor: University of Plymouth
Sponsor class: OTHER
Collaborators: name: Health Education England, Wessex
First posted: 2022-03-02
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This evaluation evaluated Health Education England's NoObesity digital health app's usability and acceptability to undertake activities improving families' diet, physical activity and weight. The purpose of the study is to evaluate the app's influence on self-efficacy and goal setting and to determine what can be learned to improve its design for future studies, should there be evidence of adoption and sustainability.


Eligibility criteria: Inclusion Criteria:

* adult users (over 18 years)
* fluent in English
* willing to use the app
* parents or legal guardians of a child or children OR health care professionals linked to the parent or guardian
* owner of a smartphone to access the app, with 4G data access

Exclusion Criteria:

* individuals who are known to the researchers or staff at Health Education England
* deaf or hearing impairment
* prior use of the app before study commencement
* refusal to give informed consent
* children, vulnerable young people, or vulnerable adults.

Primary outcomes:
measure: User experiences and acceptability of the NoObesity app
timeFrame: 6 months
Secondary outcomes:
measure: Usability of the NoObesity app
timeFrame: 6 months
measure: Qualitative user perspectives of usability
timeFrame: 6 months
measure: Perceived impact of app on motivation
timeFrame: 6 months
measure: Perceived impact of specific app features on motivation
timeFrame: 6 months
measure: Perceived impact of app on health behaviours
timeFrame: 6 months
measure: Self-reported impact of the app on health behaviours
timeFrame: 6 months
measure: Perceived impact of app on self-efficacy
timeFrame: 6 months
measure: Engagement with the app
timeFrame: 6 months
measure: Factors relating to adoption, implementation, and sustainability
timeFrame: 6 months
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: University of Plymouth
state: Devon
Study officials:
affiliation: University of Plymouth
name: Edward Meinert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meinert E, Rahman E, Potter A, Lawrence W, Van Velthoven M. Acceptability and Usability of the Mobile Digital Health App NoObesity for Families and Health Care Professionals: Protocol for a Feasibility Study. JMIR Res Protoc. 2020 Jul 22;9(7):e18068. doi: 10.2196/18068.
Clinical trial NCT02307955: Firefly ANKLE Sprain Study
Official title: Firefly ANKLE Sprain Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Grade I/II Ankle Sprain
Lead sponsor: Firstkind Ltd
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 24
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: The device to be tested (fireflyTM) stimulates the common peroneal nerve and causes the foot to twitch, and has been shown to increase blood flow. The device is also indicated for the treatment of oedema. In this study the investigators intend to assess the use of the device as an adjunctive therapy for people recovering from grade 1 and 2 ankle sprains.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 years and over
2. Referred to physiotherapy for treatment of ankle sprain
3. Clinical diagnosed ankle sprain with evidence of swelling
4. Able to understand the Subject Information Sheet and willing to sign the written Informed Consent Form.
5. Able and willing to follow the protocol requirements

Exclusion Criteria:

1. Has an ankle sprain grade 3
2. Evidence of fracture
3. Has a pacemaker
4. Chronic Obesity (BMI Index \>40kg/m2).
5. Pregnancy.
6. History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
7. Varicosities, ulceration or erosion around the area of the leg where the study device would be fitted
8. Not able to fit firefly device

Primary outcomes:
measure: Oedema lower leg
timeFrame: 1 week
measure: FAAM ankle function measure
timeFrame: 1 week
Secondary outcomes:
measure: Ankle proprioception - as assessed by the time that the participant can stand on one leg for with their eyes closed, this will be recorded and repeated three times, the average will be taken
timeFrame: 1 week
measure: VAS Pain score
timeFrame: 1 week
measure: Adverse event rate
timeFrame: 1 week
Other outcomes:
Locations:
city: Poole
country: United Kingdom
facility: Poole NHS Trust Hospital
state: Dorset
Study officials:
References:
Clinical trial NCT01694355: The Impact of Severe Vitamin D Deficiency and Its Correction on Bone Mineral Density (BMD) in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 32
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is well known that postmenopausal women are at risk for osteoporosis. The study hypothesis is that vitamin D deficiency (≤17.5nmol/L) is frequently associated with osteomalacia and will cause low BMD estimation in DXA scan due to insufficient bone mineralization.

We assume that among these postmenopausal women, Vitamin D treatment will improve bone mineralization and will cause a rapid increase in BMD. According to the results, bisphosphonates therapy may be an unnecessary treatment.

The objective of this study is to evaluate the impact of severe vitamin D deficiency and its correction on Bone Mineral Density (BMD) in postmenopausal women.


Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent.
2. Female age 55-70
3. At least 2 years past menopause
4. 25(OH)D≤ 17.5nmol/L (≤7 ng/ml)

Exclusion Criteria:

1. Vitamin D levels \> 30nmol/L in the past 2 years 2. Creatinine \> 1.2%mg 3. Calcium ≥ 10.2mg/dl 4. Current or previous vitamin D treatment over 2 weeks 5. Previous vitamin D treatment over 2 months in the past 2 years 6. BMI\>35 or BMI\<20 7. Menopause before age 45 8. Type 1 diabetes 9. Concomitant disease:

1. Mal-absorptive diseases (Cystic Fibrosis, Crohn's, gastric bypass surgery, celiac disease)
2. Rheumatoid arthritis
3. Nephrotic syndrome
4. Chronic renal failure
5. Primary hyperparathyroidism
6. Hyperthyroidism
7. Malignancies excluding skin cancers (within the last 5 years)
8. Kidney stones or history of renal colic 10. Medications:
9. Steroids use (past or present)
10. Anti rejection drugs in the last 5 years
11. Anticonvulsant (carbamezapine, hydantoin, Phenobarbital etc) in the last 5 years
12. Any anti osteoporotic medication: Prolia, Bisphosphonates, Teriperatide, Evista, Protelos, (past or present)
13. Post menopausal HRT (in the last 10 years)
14. Aromatase inhibitors: Femara, Arimadex (past or present)
15. Current use of PPIs (lanton, controloc, zoton, omepradex etc)
16. Current or past use of anti depressant SSRI (favoxil,cipralex etc)

Primary outcomes:
measure: Change in BMD (Z score) following 10 months of vitamin D supplementation
timeFrame: 10-14 months
Secondary outcomes:
measure: To examine the effect of increasing vitamin D levels on other objective parameters such as PTH, calcium, phosphorus and other subjective parameters such as muscle weakness, according to comparison between baseline visit and end of study visit.
timeFrame: 10-14 months
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
References:
Clinical trial NCT00942955: Point-Of-Care Chemistry Test (POCT) Effect on the Emergency Department (ED)
Official title: A Randomized Controlled Multi-center Trial of a Point-Of-Care Chemistry Test for Reduction of Turnaround and Clinical Decision Time in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency Department
Length of Stay
Turnaround-time
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-07-21
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study was performed in five EDs. Three were urban EDs with 30,000 to 45,000 annual visits, and two were suburban EDs with 15,000 to 25,000 annual visits. Each hospital has its own central laboratory which can test the same emergency chemistry tests, including liver panel (alkaline phosphatase, protein, albumin, total bilirubin, direct bilirubin, GOT, and GPT), renal panel (BUN, creatinine, calcium, and phosphorus), pancreas enzymes (amylase, lipase), electrolytes (sodium, potassium, chloride, total CO2), lipid panel (total cholesterol, triglyceride, LDL-cholesterol, HDL-cholesterol), and blood gases (pH, pO2, pCO2, and bicarbonate).

Brief summary: The hypothesis of this study is that POCT will shorten ED turn-around-time (TAT) such as blood drawing TAT, lab TAT, and decision TAT.


Eligibility criteria: Inclusion Criteria:

* Patients older than 15 years
* clinically required to have chemistry lab tests
* agreement

Exclusion Criteria:

* no agreement
* ESI level 1

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00334555: Control of Trichomoniasis
Official title: Control of Trichomoniasis - A Paradigm for STD Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trichomoniasis
Keywords: trichomoniasis
partner notification
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2006-06-08
Enrollment: 599
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is designed to try to find the best method of partner notification and treatment for partners of women with trichomonas

Detailed description: To carry out a randomized trial to compare the effectiveness of three methods of partner notification and treatment for sexual partners of women with vaginal trichomoniasis - patient self-referral of partners (the current practice standard), delivery of curative therapy to partners by patients themselves, or public health style Disease Intervention carried out by a specially trained Disease Intervention Specialists (DIS) locating the partners and delivering the medication in the field. Reinfection rates with trichomonas at three months of follow-up among the index women will be the measure of effectiveness.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria {for Women}:

Age {\> 15 years} Culture or wet prep proven T. vaginalis infection Willingness to provide informed consent and take part in study procedures

-

Exclusion Criteria:

* Exclusion criteria:

Infection with other STD pathogens requiring Health Dept DIS intervention (syphilis or HIV) Pregnancy or currently breast feeding Recent (8 hours) ingestion of alcoholic beverages or intent to do so in the 24 hours following treatment Allergy to metronidazole The presence of a sexual partner in the clinic at the time of enrollment A history of referral by a partner already treated for trichomoniasis Report of more than four sexual partners in the preceding 30 days

Primary outcomes:
measure: recurrence of trichomonas in the index patient
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Jefferson County Department of Health STD Clinic
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jane Schwebke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02857855: Postoperative Supplemental Oxygen in Liver Transplantation
Official title: The Impact of Postoperative Oxygen Therapy on the Results of Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infection
Keywords: liver transplantation
postoperative infection
biliary complications
patient survival
graft survival
supplemental oxygen
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this prospective randomized controlled trial is to evaluate the impact of high concentration supplemental postoperative oxygen therapy on short-term and long-term results of liver transplantation, particularly with respect to infections and biliary complications.

Detailed description: The aim of this prospective randomized controlled trial is to evaluate the impact of high concentration supplemental postoperative oxygen therapy on short-term and long-term results of liver transplantation, particularly with respect to infections and biliary complications. A total of 296 patients immediately after liver transplantation will be randomly assigned to receive either 80% (high concentration) or 28% (controls) fraction of inspired oxygen for 6 hours after surgery with a 1:1 allocation ratio. Patients will be blinded to the type of received intervention. Randomization will be stratified by the Child-Turcotte-Pugh classification. Both groups will be compared to short- and long-term outcome measures.

Eligibility criteria: Inclusion Criteria:

* active liver transplant waitlist status

Exclusion Criteria:

* active infection at the time of transplantation
* malignancy
* cardiac arrest during transplantation
* chronic obstructive pulmonary disease
* acute myocardial infarction

Primary outcomes:
measure: Number of patients with postoperative infections
timeFrame: 30 days
Secondary outcomes:
measure: Biliary complications
timeFrame: 5 years
measure: Postoperative mortality
timeFrame: 90 days
measure: Severe postoperative complications
timeFrame: 90 days
measure: Patient survival
timeFrame: 5 years
measure: Graft survival
timeFrame: 5 years
measure: Postoperative hospital stay
timeFrame: 1 year
measure: Postoperative intensive care unit stay
timeFrame: 1 year
measure: Serum aspartate aminotransferase activity
timeFrame: 5 days
measure: Serum alanine aminotransferase activity
timeFrame: 5 days
measure: Serum bilirubin concentration
timeFrame: 5 days
measure: International normalized ratio
timeFrame: 5 days
measure: Early allograft dysfunction
timeFrame: 7 days
measure: Pulmonary complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of General, Transplant and Liver Surgery, Medical University of Warsaw
state: Mazowieckie
Study officials:
affiliation: Department of General, Transplant and Liver Surgery, Medical University of Warsaw
name: Michał Grąt, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02213055: Pediatric Head Lice Study Product Comparison
Official title: Safety and Efficacy of a 100% Dimethicone Pediculocide in School-Age Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head Lice
Keywords: Lice
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2014-08-11
Enrollment: 97
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * To evaluate the efficacy of LiceMD for the treatment of head lice in a pediatric population.
* To evaluate the safety of LiceMD in a pediatric population.

Detailed description: Head lice, or Pediculus humanus capitis, cause an estimated 6 to 12 million infestations per year in the U.S., most commonly affecting children 3 to 11 years of age. Despite common perceptions, head lice crawl, and cannot hop or fly. For this reason, transmission occurs most often by human head-to-head contact, and much less commonly by the sharing of personal items such as hats, coats, combs, or towels. Because head lice feed on human blood, they cannot live on pets and are only viable 1-2 days on surfaces other than the human head.

Eligibility criteria: Inclusion Criteria:

* Subject Inclusion Criteria
* Current lice infestation, confirmed by school nurse. Must have live lice - not just eggs. A minimum of one live louse and 10 viable eggs must be seen or three live lice.
* Male or female child; age 3 - 12
* Willing to participate in study, and parent/guardian sign informed consent
* Parent/guardian must be able to read and follow directions and complete all questionnaires
* For children/parents who agree to the experimental arm of the study, agree not to use any other head lice product or home remedy lice treatment during the study.

Exclusion Criteria:

* No live lice, only eggs.
* Less than three live lice observed with less than ten viable eggs
* No hair on the head
* Buzz cut or crew cut
* Use of other lice treatment or home remedy lice treatment within the past 4 weeks
* Chronic scalp disorder (such as psoriasis) that would limit the school nurse's ability to detect lice and/or identify adverse events
* Currently taking an antibiotic
* Does not follow instructions.

Primary outcomes:
measure: Number of Participants Free of Live Head Lice and Free of Viable Eggs
timeFrame: Day after first treatment and Day 14 of study
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Lawrence Rosen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hackensack Meridian Health
name: Jeffrey Boscamp, MD
role: STUDY_DIRECTOR
References:
citation: Ihde ES, Boscamp JR, Loh JM, Rosen L. Safety and efficacy of a 100% dimethicone pediculocide in school-age children. BMC Pediatr. 2015 Jun 20;15:70. doi: 10.1186/s12887-015-0381-0.
Clinical trial NCT06386055: Air Pollution and Physical Activity: A Randomized Controlled Trial
Official title: Air Pollution and Physical Activity: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Physical Inactivity
Pollution; Exposure
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a small pilot intervention trial in which we will collect preliminary data to demonstrate the feasibility of an intervention study.

Detailed description: This is a pilot randomized, control, clinical trial.

We will recruit 24 adults in Buffalo and randomize them to the physical intervention groups. The intervention group will be provided with physical activity courses.

We will follow up all participants until the end of the study.

We will collect their baseline information via questionnaire, and at the end of the follow-up we will collect the exit questionnaire and biospecimen.

The study aims to demonstrate our ability to recruit eligible participants and provide data of the compliance of participants to the intervention.

Eligibility criteria: Inclusion Criteria:

* 1) age 35-55 years old; 2) plan to stay in Buffalo most of the time in the next three months; 3) no adverse conditions

Exclusion Criteria:

* those with unstable or life-threatening medical conditions. The pilot study will also demonstrate our ability to recruit the modified study population.

Primary outcomes:
measure: blood pressure
timeFrame: 3 months
Secondary outcomes:
measure: Self-report questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Lina Mu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: