louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04660487: Relationship Between "FODMAPs" and "GVHD"
Official title: Relationship Between the Utilization and Degradation Rate of "FODMAPs" by Intestinal Flora and "GVHD"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Graft Versus Host Disease
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Successful bone marrow colonization after bone marrow transplantation

Brief summary: With the stem cell transplanting increasing, patients which effected with "GVHD" were also increased. To evaluation the relationship between "FODMAPs" and "GVHD", Bone marrow transplant patients were recruited.

Detailed description: The feces were collected from the patients who had been successfully transplanted after bone marrow transplantation. After 24 hours of culture in the culture medium, the degradation rate of "FODMAPs" was detected, and the relationship between the degradation rate and the occurrence time and degree of "GVHD" was observed

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of "AML","ALL","MDS" or "MM" Disease;
2. Must be treated with bone marrow transplantation;
3. The transplanted bone marrow was successfully planted

Exclusion Criteria:

1. Gastrointestinal diseases；
2. Age\>60; or Age\<10；
3. Probiotics or prebiotics were taken before enrollment

Primary outcomes:
measure: Occurrence of GVHD
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: 中国
state: Jiangsu
Study officials:
affiliation: SOOCHOW UNIV
name: Depei Wu
role: STUDY_CHAIR
References:
Clinical trial NCT00704587: Prognostic Factors for All Types of Cancer Combined
Official title: Flow Cytometrical Analysis of the Human Immune System to Assess Tumor-related Material Piling up in Activated Macrophages in All Relevant Cancer Types.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: cancer occurence
cancer recurrence
neo-adjuvant treatment response measurement
Lead sponsor: Atrium Medical Center
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
First posted: 2008-06-25
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients diagnosed or suspected of cancerous conditions in the broadest sense of the word

Brief summary: The purpose of this study is to investigate every possible applicability of flow cytometrical analysis in the intracellular detection of tumor-related material in activated macrophages in the broadest range of cancer types.


Eligibility criteria: Inclusion Criteria:

* (Suspicion of) presence of cancer in the broadest sense of the word
* Must be able to understand and sign written informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: screening and followup
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Atrium Medical Centre Parkstad
state: Limburg
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Atrium Medical Centre Parkstad, Heerlen
name: Dennis Japink, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05346887: Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture
Official title: Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Perinatal Stroke
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess implementation and effectiveness of a caregiver-delivered rehabilitation intervention for infants and toddlers with cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* aged three to 24 months (corrected, if premature)
* clinician-identified hand asymmetry
* suspected/confirmed cerebral palsy (hemiplegia or triplegia)
* willing to withhold other formal upper-limb focussed treatment during the study intervention - willing to commit to completing 18 weeks of daily home-practice and attending weekly therapy sessions.

Exclusion Criteria:

* participation in formal constraint induced movement therapy (CIMT) within last six months
* upper limb botulinum toxin A injections within previous six months
* brachial plexus injury
* lower motor neuron dysfunction
* upper limb congenital limb difference.

Primary outcomes:
measure: Satisfaction of therapists
timeFrame: <7 days after the 18-week intervention
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: <7 days after the 18-week intervention
measure: Age-appropriate hand assessment (HAI/mini-AHA/AHA)
timeFrame: <7 days after the 18-week intervention
Secondary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 8 weeks +/-3days after the the 18-week intervention.
measure: Age-appropriate hand assessment (HAI/mini-AHA/AHA)
timeFrame: 8 weeks +/-3days after the the 18-week intervention.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References:
Clinical trial NCT05492487: A Pilot Study on Fertility Conservative Treatment of Atypical Endometrial Hyperplasia in Singapore
Official title: A Pilot Study on Fertility Conservative Treatment of Atypical Endometrial Hyperplasia in Singapore
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Endometrial Hyperplasia
Fertility Issues
Disease Regression
Treatment Side Effects
Keywords: Endometrial Hyperplasia
Fertility
Disease Regression
Randomised Clinical Trial
Mirena IUS
Megace
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2022-08-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised into either the megace group or the Mirena group. There will be sealed envelopes containing a paper with either Mirena or megace printed on each of them. Participants can chose an envelope at random. The patient and PI will not be blinded of the selection in the study.
Primary purpose: TREATMENT

Brief summary: The investigators' objective is to determine the regression rate, side effects and acceptability of Mirena compared to megace in the treatment of atypical endometrial hyperplasia among women desiring fertility.

Detailed description: Atypical endometrial hyperplasia is a growing clinical problem that increases the risk of carcinogenesis and negatively impacts fertility. Although oral medical treatment may lead to regression in up to 90% of patients, they are associated with adverse side effects such as weight gain, that negatively affects fertility. To-date, there has been no RCTs evaluating the performance of the Mirena Intrauterine System (IUS) with megestrol acetate (megace) (the most effective and commonly used progestogen) in treating women with atypical hyperplasia who still desire fertility.

Eligibility criteria: Inclusion Criteria:

* All women diagnosed with atypical hyperplasia aged 21 years to 40 years
* Keen for fertility-preserving treatment

Exclusion Criteria:

* Patients who are currently undergoing treatment for atypical hyperplasia
* Patients with a history of endometrial carcinoma

Primary outcomes:
measure: Rate of Regression
timeFrame: Review in 3 months, maximum up to 9 months of treatment.
measure: Time taken for regression of the disease
timeFrame: Review in 3 months, maximum up to 9 months of treatment.
Secondary outcomes:
measure: Patient Acceptability
timeFrame: Review in 3rd months.
measure: Patient Acceptability
timeFrame: Review in 6th months.
measure: Patient Acceptability
timeFrame: Review in 9th months.
measure: Side Effects
timeFrame: Through study completion, an average of 9 months.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
References:
Clinical trial NCT03368833: Caudal Blockade and Electrocardiographic Changes
Official title: Caudal Blockade and Electrocardiographic Changes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Regional Anesthesia Morbidity
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 5
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients having general surgery at Nationwide Children's Hospital.

Brief summary: Caudal epidural blockade is frequently used as an adjunct to general anesthesia in children for perioperative analgesia. Intravascular injection of local anesthetic is a known complication that can adversely affect the neurological and cardiovascular systems. This study will look at the delayed effects of a caudal epidural block on the electrical activity of the patient's myocardium by trying to characterize the incidence of ECG changes within 60 minutes after the caudal dose is given.


Eligibility criteria: Inclusion Criteria:

* ASA grade 1 or 2
* Receiving general anesthesia with a caudal block

Exclusion Criteria:

* Preexisting cardiac comorbidities

Primary outcomes:
measure: Change in T wave amplitude
timeFrame: Baseline to 60 mins. post caudal
measure: Change in T wave width
timeFrame: Baseline to 60 mins. post caudal
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Senthil Krishna, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00668733: Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year
Official title: Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year After Completion of Studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Actinic Keratoses
Keywords: Actinic keratoses
Dermatologic disease
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of subjects who have been treated with imiquimod or with placebo in one of the aformentioned studies and who demonstrated complete clearance of all clinically visible or palpable AK lesions in the selected treatment area at the end-of-study visit.

Brief summary: The objective of this study was to obtain long-term sustained clearance rates for subjects previously treated with imiquimod creams in studies GW01-0702, GW01-0703, GW01-0704 and GW01-0705.

Detailed description: This is a Phase 3 longitudinal and observational study. Subjects who previously enrolled in studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705 and were completely cleared of their AK lesions in the selected treatment area at the end-of-study visit will return for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.

The NCT numbers for the above mentioned studies are:

NCT00603798 - for Studies GW01-0703 and GW01-0705

NCT00605176 for Studies GW01-0702 and GW01-0704

Eligibility criteria: Inclusion Criteria:

* Are willing and able to give informed consent;
* Have successfully completed one of the following studies: GW01-0702, GW01- 0703, GW01-0704, or GW01-0705 and have been determined to be completely clear of AK lesions at the EOS visit in the designated treatment area from the previous study
* Are willing to participate in the study as an outpatient, make visits to the study center for follow-up evaluation, and agree to comply with all study requirements.

Exclusion Criteria:

* None. All subjects who meet the inclusion criteria above may participate.

Primary outcomes:
measure: Number of Participants With Recurrence of AK Lesions
timeFrame: Up to one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Graceway Pharmaceuticals, LLC
name: Sharon Levy, MD
role: STUDY_DIRECTOR
References:
citation: Hanke CW, Swanson N, Bruce S, Berman B, Kulp J, Levy S. Complete clearance is sustained for at least 12 months after treatment of actinic keratoses of the face or balding scalp via daily dosing with imiquimod 3.75% or 2.5% cream. J Drugs Dermatol. 2011 Feb;10(2):165-70.
Clinical trial NCT02522533: Intervention for Pre-Frailty and Frailty in Thoracic Surgery Patients
Official title: Intervention for Pre-Frailty and Frailty in Thoracic Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 7
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Frailty has been associated with poor acute and long-term outcomes after major surgery. We recently determined that nearly 70% of patients undergoing major thoracic surgery are pre-frail or frail. We are interested in assessing whether a strength training intervention for frail or pre-frail patients has an impact on surgical decision making and on surgical outcomes.


Eligibility criteria: Inclusion Criteria: • Age ≥60 years, • Qualified to consent for participation in a research study, •Thoracic disease that may require major surgery (major anatomic lung resection, esophagectomy, repair of giant paraesophageal hernia, chest wall resection, extended pleurectomy/decortication, thymectomy or major surgery for other mediastinal process),• No obvious contraindications to surgery (end-stage heart disease, end-stage lung disease, severe dementia, other specific comorbidity that would prevent surgery), • Ability to participate in physical therapy and an independent exercise program for frailty mitigation, •No need for induction chemotherapy or radiation therapy, • Recent evaluation including computed tomography of the chest or chest/abdomen.

Exclusion Criteria:• Age \<60 years, •Unable to provide informed consent, • No indication for major thoracic surgery, •Obvious contraindication to major thoracic surgery (end-stage heart disease, end-stage lung disease, severe dementia, other specific comorbidity that would preclude surgery),• Inability to participate in physical therapy and/or an independent home exercise for frailty mitigation, •Need for induction chemotherapy or radiation therapy

Primary outcomes:
measure: Reduction in the degree of frailty after strength training
timeFrame: 18 months
Secondary outcomes:
measure: Changes in surgeon risk assessment after strength training
timeFrame: 18 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Mark Ferguson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02304133: Transfer From a Point-of-care Ultrasound Course
Official title: Transfer From a Point-of-care Ultrasound Course to Diagnostic Performance on Patients - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasonography
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-12-01
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study explores the effect of a four-hour ultrasound course on physicians' point-of-care ultrasound performance on patients representing acute abdominal surgical conditions.

Detailed description: A randomized controlled trial with physicians was conducted. The intervention group participated in a four-hour abdominal POC US course before performing ultrasound on four patients with different abdominal surgical conditions. The control group did not participate in a course before performing ultrasound on the patients.

Eligibility criteria: Inclusion Criteria:

* Medical Doctor
* Signed up for a courses in abdominal point-of-care ultrasound

Exclusion Criteria:

* None

Primary outcomes:
measure: Ultrasound performance
timeFrame: 4 ultrasound cases conducted by the study participants were assessed immediately after the intervention/control circumstances
measure: Diagnostic accuracy
timeFrame: 4 ultrasound cases conducted by the study participants were assessed immediately after the intervention/control circumstances
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Todsen T, Jensen ML, Tolsgaard MG, Olsen BH, Henriksen BM, Hillingso JG, Konge L, Ringsted C. Transfer from point-of-care Ultrasonography training to diagnostic performance on patients--a randomized controlled trial. Am J Surg. 2016 Jan;211(1):40-5. doi: 10.1016/j.amjsurg.2015.05.025. Epub 2015 Jul 31.
Clinical trial NCT00896233: Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED)
Official title: Test-Retest Repeatability Study of Magnetic Resonance Elastography (MRE) for Liver Fibrosis Assessment in Healthy Volunteers and Hepatitis C Virus-Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Fibrosis
Hepatitis C Virus
Keywords: Staging of liver fibrosis prior to clinical trials for treatment of Hepatitis C Virus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-05-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will assess the repeatability of Magnetic Resonance Elastography (MRE) in both healthy volunteers and Hepatitis C Virus (HCV)-infected patients with fibrosis and lay the groundwork for the validation of MRE as an alternative to liver biopsy.


Eligibility criteria: Inclusion Criteria:

* Male or female and at least 18 years of age
* Generally good health
* Willing to fast for 8 hours prior to each study visit

Hepatitis C Virus (HCV) Inclusion Criteria:

* Positive serology for HCV and detectable HCV ribonucleic acid (RNA) in blood within 12 weeks of screening;

For Part I, known fibrosis stage of at least =F2 (METAVIR) or =F3 (Ishak) from biopsy performed within 3 months of screening; For Part 2, known fibrosis stage of F1-F4 (METAVIR) or F1-F6 (Ishak)

* Never been treated for HCV

Healthy Participant Inclusion Criteria:

* Documented absence of hepatitis B virus, HCV, acute hepatitis A virus, and human immunodeficiency virus (HIV) within 12 weeks of screening

Exclusion Criteria:

* History of stroke, seizures, or neurological disorders
* Consumption of excessive amounts of alcohol
* Use of products containing nicotine
* Unable to hold a breath for 20 seconds
* Claustrophobia
* Use of illicit drugs or history of drug or alcohol abuse

HCV-Positive Exclusion Criteria:

* Evidence or history of chronic hepatitis not caused by HCV
* HIV

Primary outcomes:
measure: Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements
timeFrame: 14 days
measure: Repeated Mean Liver Elastic Stiffness (kPa) Measurements
timeFrame: 14 days
measure: Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants
timeFrame: 14 days
measure: Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Shire NJ, Yin M, Chen J, Railkar RA, Fox-Bosetti S, Johnson SM, Beals CR, Dardzinski BJ, Sanderson SO, Talwalkar JA, Ehman RL. Test-retest repeatability of MR elastography for noninvasive liver fibrosis assessment in hepatitis C. J Magn Reson Imaging. 2011 Oct;34(4):947-55. doi: 10.1002/jmri.22716. Epub 2011 Jul 12.
Clinical trial NCT01252433: Children's Intake of Foods Reduced in Energy Density
Official title: Children's Intake of Foods Reduced in Energy Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vegetable Intake
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-12-03
Enrollment: 49
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to investigate children's responses to incorporating vegetables into selected entrees and snacks over several days. The hypothesis is that children will increase their vegetable intake by consuming foods that have been reduced in energy density through the addition of vegetables. Effects on energy intake will also be examined.


Eligibility criteria: Inclusion Criteria:

* enrolled in daycare centers at Penn State University

Exclusion Criteria:

* food allergies or intolerances

Primary outcomes:
measure: Food intake
timeFrame: 1 month
Secondary outcomes:
measure: Energy intake
timeFrame: 1 month
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
References:
citation: Spill MK, Birch LL, Roe LS, Rolls BJ. Hiding vegetables to reduce energy density: an effective strategy to increase children's vegetable intake and reduce energy intake. Am J Clin Nutr. 2011 Sep;94(3):735-41. doi: 10.3945/ajcn.111.015206. Epub 2011 Jul 20.