louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03394326: Eat Healthy for Families
Official title: Implementing a Dietary Energy Density Intervention in Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Energy Density
Diet Quality
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 41
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study investigates the effect of a low energy-density dietary prescription as compared to MyPlate recommendations in preschool children at risk for obesity.


Eligibility criteria: Inclusion Criteria:

* the parent is ≥18 years-old with a BMI ≥30 kg/m2 (indicating the child to be at risk for obesity);
* the child is 2-5 years-old with a BMI-for-age and sex \<95th percentile;
* the parent and child live together ≥50% of the time;
* the parent and child are able to read, speak and understand English;
* the family has transportation to the University of Delaware; and
* the family is committed to the 6-month program.

Exclusion Criteria:

* the child is participating in a weight management program or seeing a Registered Dietitian for weight loss;
* the child is taking weight loss medication or medication that impacts appetite; or
* the child has a medical condition that impacts growth or has a medical condition that requires a specific eating plan.

Primary outcomes:
measure: Dietary Energy Density
timeFrame: 6 months
measure: Energy Intake
timeFrame: 6 months
measure: Dietary Quality
timeFrame: 6 months
Secondary outcomes:
measure: zBMI
timeFrame: 6 months
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
References:
Clinical trial NCT03169426: Effect of Beta-blocker on Cardioprotective Effect of Remote Ischemic Conditioning
Official title: Effect of Beta-blocker on Cardioprotective Effect of Remote Ischemic Conditioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Keywords: remote ischemic conditioning
beta-blocker
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 11
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Remote ischemic conditioning has been shown to protect myocardium from ischemia-reperfusion injury during cardiac intervention or cardiac surgery. However, effect of beta-blocker, commonly used cardiovascular medication in patients with cardiac diseases such as hypertension or angina pectoris, on cardioprotective role of remote ischemic conditioning has not been well documented. The purpose of the study is to investigate the effect of beta-blocker on remote ischemic conditioning in healthy volunteers.

Detailed description: This study is prospective cross-over study investigating effect of beta-blocker on cardioprotective role of remote ischemic conditioning. Eleven male healthy volunteers are going to take oral beta-blocker (carvedilol, 12.5 mg once) or not before undergoing remote ischemic conditioning (consisting of 4 cycles of 5-min ischemia and subsequent 5-min reperfusion of upper arm), separated by 6-day wash-out period. To evaluate cardioprotective effect of remote ischemic conditioning, blood samples will be obtained before and after remote ischemic conditioning. Form the samples, human dialysate will be obtained and be perfused to rat heart through Langendorff apparatus before ischemia-reperfusion injury to the rat heart. Changes of infarct size of the rat heart will be compared between the beta-blocker and control groups.

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteer
* Not taking any medication

Exclusion Criteria:

* BMI \< 18 kg/m2 or \> 30 kg/m2
* Allergic history of any medication
* Baseline SBP \> 150 mmHg or \< 100 mmHg
* Baseline DBP \> 100 mmHg or \< 50 mmHg
* Strenuous exercise, excessive caffeine or alcohol, smoking 24 h prior to experiment
* Cannot undergoing remote ischemic conditioning for any reason
* Refuse to enroll

Primary outcomes:
measure: Changes in infarct size of rat heart perfused with human dialysate after taking beta-blocker or not to evaluate the effect of beta blocker on remote ischemic conditioning performed to healthy volunteers
timeFrame: 24 hour after remote ischemic conditioning to healthy volunteers
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yunseok Jeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01004926: Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial Amputees
Official title: Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Unilateral Trans Tibial Amputation
Keywords: Unilateral trans-tibial amputees
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-10-30
Enrollment: 10
Sex: MALE
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 aim of this work was to test the Echelon foot efficiency to offer enhanced safety, comfort and function over a wide range of walking surfaces, inclines and stairs, thereby improving the quality of life for amputees.

Ten individuals with a unilateral trans- tibial amputation will participate in two test sessions- one while using their own prosthetic foot, the other while using the Echelon foot.


Eligibility criteria: Inclusion Criteria:

* Ten individuals with a unilateral trans tibial amputation due to trauma.
* Walking at list one year from the end of their gait training. Mobility status is 3 or 4.

Exclusion Criteria:

* Bilateral amputation.
* Injury of the sound limb that compromises the gait of the amputee.

Primary outcomes:
measure: While using the Echelon foot the amputees will present lower internal mechanical strain in the soft tissue of the stump while standing on a 10 degrees platform.
timeFrame: Beginning of the trial and one month after
Secondary outcomes:
measure: Using the Echelon foot the Kinematic of level ground walking and climbing up and down stairs will be closer to normal curves.
timeFrame: At the beginning of the trial and one month later
Other outcomes:
Locations:
city: Ramat- Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Itzhak Siev- Ner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02770326: Safety of Stool Transplant for Patients With Difficult to Treat C. Difficile Infection
Official title: Safety of Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: C. Difficile Infection
Cancer
Keywords: Safety of Stool Transplant
Fecal Microbiota Transplantation (FMT)
15-337
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
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 the safety of FMT in patients with C. difficile and cancer. In previous other studies, FMT has been shown to cure C. difficile when antibiotics have failed, but most of these studies have not included patients with cancer. The investigators want to prove that FMT is safe in this group of people so that doctors will feel more comfortable prescribing it for their patients with cancer.


Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* Patients with solid organ malignancy who have received chemotherapy within the past six months.
* Clinical and microbiologic relapse of C. difficile associated diarrhea after at least one course of adequate antibiotic therapy or refractory disease that does not respond to treatment.

  * At least 10 days of vancomycin at least 125mg QID, or metronidazole 500mg TID
  * C. difficile associated diarrhea is defined as: ≥3 loose or watery stools per day for at least 2 consecutive days or ≥8 loose stools in 48 hours and Positive Clostridium difficile PCR
* Life expectancy of \>3 months.

Exclusion Criteria:

* Expected prolonged compromised immunity

  * HIV infection with CD4 count \<240
  * History of hematopoietic stem cell transplant (HSCT)
  * Hematologic malignancy
  * ANC \<1000/mm3
* Contraindications to anesthesia for procedure

  * Serious cardiopulmonary comorbidities
  * Inability to tolerate anesthesia
  * HGB \<8 g/dL
* Risk of bleeding during procedure

  * PLT \<50,000 K/mcL
  * INR \>1.5 INR
* Pregnancy

  o Pregnant patients will be excluded from this study.
* Gastrointestinal (GI) contraindications

  * Inflammatory bowel disease
  * Active fistula
  * Small bowel obstruction
  * Ileus
  * Gastroparesis
  * Nausea and vomiting
  * Gastrointestinal surgery within the previous 3 months

Primary outcomes:
measure: Number of Participants Evaluated for Infection During Treatment Intervention
timeFrame: 2 weeks after the FMT
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: Robin B. Mendelsohn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01071226: Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device
Official title: CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With The CliniMACS Device for T and B Cell Depletion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Diseases (ie, Leukemia, MDS, Lymphoma)
Non-malignant Diseases (ie, Bone Marrow Failure Syndromes)
Keywords: Malignant and non-malignant diseases
Hematopoietic stem cell transplant
Peripheral blood progenitor cell transplant
CliniMACS device
T cell depletion
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2010-02-19
Enrollment: 60
Sex: ALL
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: T cell depletion utilizing the CliniMACS device will allow more precise, specific and controlled graft engineering of peripheral blood stem cells from unrelated and partially matched related donors without an increase in relapse or graft rejection and grade III or IV acute graft versus host disease (GVHD).


Eligibility criteria: Inclusion Criteria:

* All races are eligible
* Malignant diseases: Leukemias and Lymphomas
* Non-malignant diseases: Severe Aplastic Anemia, immunodeficiencies

Exclusion Criteria:

* Lansky or Karnofsky \> 70
* Echo \> 27% shortening fraction
* renal function:serum creatinine \< 1.5 x for normal age
* no active untreated infection
* DLCO \> 50% of predicted value
* Hepatic: AST and ALT \< 3x upper limit of normal; bilirubin \< 2.0.

Primary outcomes:
measure: To measure the incidence and quality of engraftment
timeFrame: Weekly for first 100 days, 6 months and 1 year
Secondary outcomes:
measure: Evaluate the incidence of acute Graft versus Health Disease and treatment related mortality.
timeFrame: weekly for the first 100 days and then 6 and 12 months post transplant date
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Julie A Talano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05635526: Assessment of Corneal Biomechanics With the Corvis ST in Different Age of Myopia With Orthokeratology
Official title: Assessment of Corneal Biomechanics With the Corvis ST in Different Age of Myopia With Orthokeratology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Orthokeratology
Keywords: Myopia prevention and control
Orthokeratology
Dynamic corneal response
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 134
Sex: ALL
Minimum age (years): 8
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Myopia with orthokeratology lens and complete follow-up.

Brief summary: The present research focused on the effect of the age for the corneal biomechanics of low and moderate myopia patients after wearing orthokeratology (OK lens). According to age, the included cases were divided into 3 groups. Through the analysis of corneal biomechanical parameters, further learn the influence of OK lens on the patient cornea. It would help ophthalmologist and optometrist find out the potential issue and reach a better control result.

Detailed description: The present research focused on the effect of the age for the corneal biomechanics of low and moderate myopia patients after wearing orthokeratology (OK lens). According to age, the included cases were divided into 3 groups: Ⅰ (8-12 years old), Ⅱ (13-16 years old), Ⅲ (over 16 years old). The OK lenses used in the present study are of the same design (Euclid Systems Orthokeratology; Euclid System, Herndon, VA, USA). The base line (Day 0) and different follow-up time point (Day 1, Week 1, Week 2, Month 1, Month 3, and Month 6) of dynamic corneal response (DCR) (including 19 items) of the patients derived by Corvis ST were collected. The difference between before and after wearing OK Lens and the changes of parameters among the three groups were both analyzed. And the correlation between axis length (AL) and the 19 parameters also was analyzed. Through the analysis of corneal biomechanical parameters, further learn the influence of OK lens on the patient cornea. It would help ophthalmologist and optometrist find out the potential issue and reach a better control result.

Eligibility criteria: Inclusion Criteria:

* age from 8 to 40 years old
* spherical equivalent(SE) was range from -1.00D to -5.00D
* conform to the standard of wearing orthokeratology lens

Exclusion Criteria:

* ocular diseases and systemic diseases
* visual acuity was less than 20/20
* unable to follow visitors on time

Primary outcomes:
measure: The change of dynamic corneal response (DCR)
timeFrame: The change of baseline and 1 day, 1 week, 2 weeks, 1 month, 3 months, and 6 months
Secondary outcomes:
measure: The change of axial length
timeFrame: The change of baseline and 6 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tiajin Eye Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT06020326: A Retrospective Cohort Study of HFRS
Official title: A Retrospective Cohort Study of Hemorrhagic Fever With Renal Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HFRS
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatients with HFRS diagnosed

Brief summary: The goal of this retrospective cohort study is to learn about the clinial characteristics of HFRS patients, explore the risk factors of the occurrence and death of HFRS, and build a risk prediction model for HFRS.

Detailed description: HFRS remains an important public health issue in China, which not only poses a threat to people's physical health and safety, but also has a serious impact on social and economic development. At present, there is no unified standard for clinical prediction of the occurrence and death of HFRS. In order to better prevent and treat HFRS, this multicenter retrospective clinical study is designed to include HFRS inpatients, and collect their demographics, epidemiological history, hospitalization information, clinical manifestation, laboratory results, imaging results, treatment plan and outcome.

Eligibility criteria: Inclusion Criteria:

The patients must meet all of the following criteria:

* Inpatient with clinical diagnosis of Haemorrhagic Fever with Renal Syndrome

Exclusion Criteria:

Exclude patients who meet any of the following criteria:

* Patients with previous chronic kidney disease
* Pregnant or perinatal patients
* Patients unsuitable for inclusion by investigators' evaluation

Primary outcomes:
measure: short-term mortality
timeFrame: 90 days post diagnosed HFRS
Secondary outcomes:
Other outcomes:
Locations:
city: Guangshui
country: China
facility: No.1 Peoples Hospital of Guangshui
state: Hu Bei Province
city: Huanggang
country: China
facility: Huanggang Central Hospital
state: Hu Bei Province
city: Huanggang
country: China
facility: People's Hospital of Luotian County
state: Hu Bei Province
city: Macheng
country: China
facility: People's Hospital of Macheng City, Affiliated Hospital of Hubei University of Science and Technology
state: Hu Bei Province
city: Qianjiang
country: China
facility: Qianjiang Central Hospital
state: Hu Bei Province
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
state: Hu Bei Province
city: Xianning
country: China
facility: Xianning Central Hospital
state: Hu Bei Province
city: Yichang
country: China
facility: The Third Peoples Hospital of Yichang
state: Hu Bei Province
Study officials:
affiliation: Tongji Hospital
name: Qin Ning, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00217126: The Study of Long-term Deterioration of Kidney Transplants.
Official title: Long-term Kidney Function (2 Arms-Prospective and Retrospective)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Hennepin County Medical Center, Minneapolis
name: University of Alabama at Birmingham
name: University of Alberta
name: University of Iowa
First posted: 2005-09-22
Enrollment: 870
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney Transplant Recipients

Brief summary: This study is being done to create a kidney transplant database with information from many transplant centers for the purpose of studying ways to help improve transplant outcomes and the care of transplant recipients. This is also being done to learn why kidney transplant recipients have worsening of their kidney function, and whether there are specific findings that could result in future treatments.

Detailed description: Data will be collected from the participant's medical records, local health care providers and participant's to clarify or add any information. Participants will have samples of blood, and urine obtained during their routine visits, that will be saved for testing in this study. In addition, participant's receiving a kidney biopsy performed as a part of their clinical care, will have a piece of the biopsy used for the study. This study will be followed for five years.

Eligibility criteria: In the prospective group, all participants who will be receiving a kidney transplant are eligible. In the retrospective group, kidney transplant recipients who are undergoing a kidney biopsy to determine the cause of change in their serum creatine level.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Fernando G. Cosio, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04093726: Lollipop on Gastric Volume
Official title: Effect of Chewing Lollipop on Gastric Residual Volume
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Volume
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To observe the effect of chewing lollipop on residual gastric volume in healthy volunteers with fasting.


Eligibility criteria: Inclusion Criteria:

* volunteer aged 18 years-45 years old
* volunteer with a body mass index between 18 and 28 kg/m2

Exclusion Criteria:

* those with history of diabetes mellitus
* those with gastric diseases
* those with history of gastro-intestinal surgery
* those with history of smoking
* those with use of gastric mobility medicines
* those with pregnancy or breeding

Primary outcomes:
measure: residual gastric volume at 30 minutes after chewing lollipop
timeFrame: from starting chewing lollipop to 30 minutes after chewing, on an average of 30 minutes
Secondary outcomes:
measure: residual gastric volume at 2 hours after chewing lollipop
timeFrame: from starting chewing lollipop to 2 hours after chewing, on an average of 2 hours
measure: residual gastric volume at 1 hour after chewing lollipop
timeFrame: residual gastric volume at 1 hour after chewing lollipop
measure: time to peak gastric volume
timeFrame: from starting chewing lollipop to gastric volume reaching peak , on an average of 1 hour
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References:
citation: Schoenfelder RC, Ponnamma CM, Freyle D, Wang SM, Kain ZN. Residual gastric fluid volume and chewing gum before surgery. Anesth Analg. 2006 Feb;102(2):415-7. doi: 10.1213/01.ane.0000189218.07293.6e.