louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04845724: Dietary Phosphorus Load and Postprandial Serum Phosphate in HD Patients
Official title: The Effect of Dietary Phosphorus Load and Food Matrix on Postprandial Serum Phosphate in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Keywords: Dietary phosphorus
Hyperphosphatemia
Hyperkalaemia
Phytate
Hemodialysis
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to investigate the acute postprandial effect of a modified versus standard low phosphorus diet on serum phosphate, potassium and intact parathyroid levels in prevalent hemodialysis (HD) patients

Detailed description: Background: Potential dietary strategies for controlling hyperphosphataemia include the use of protein sources with lower phosphorus bioavailability such as pulses and nuts, focus on phosphorus to protein ratios and the avoidance of all phosphate additives.

Method: Controlled crossover feeding study in 8 HD patients. On one day, participants were directly observed eating a standard low phosphorous diet and on the other day, a modified low phosphorus diet. The modified diet included beef and less dairy, with a lower phosphorus to protein ratio, as well as plant-based protein, whole grains, pulses and nuts containing phytates which reduces phosphorus bioavailability. Both diets were tailored for each participant to provide 1.1g protein/kg ideal body weight. Participants provided fasting bloods before breakfast, a pre-prandial sample before lunch and samples at one hour intervals for the four hours after the meal, for analysis of phosphate, potassium and intact parathyroid hormone (iPTH).

Eligibility criteria: Inclusion Criteria:

* \> 18 years of age;
* on dialysis for \> 3 months;
* pre-dialysis serum phosphate \< 2.5 mmol/L and
* serum potassium \< 6.3 mmol/L on most recent routine monthly blood test;
* urinary outputs of \< 200 ml/day by self-report;
* being in their usual state of health

Exclusion Criteria:

* history of diabetes mellitus
* history of parathyroidectomy
* history of calciphylaxis

Primary outcomes:
measure: Serum Phosphate
timeFrame: Post -prandial period (4 hours)
Secondary outcomes:
measure: Serum Potassium
timeFrame: Post -prandial period (4 hours)
Other outcomes:
measure: Serum intact Parathyroid Hormone
timeFrame: Post -prandial period (4 hours)
Locations:
Study officials:
affiliation: University College Cork
name: Joseph Eustace, MB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Byrne F, Gillman B, Palmer B, Kiely M, Eustace J, Kearney P, Davidson F, Shiely F. The effect of dietary phosphorus load and food matrix on postprandial serum phosphate in hemodialysis patients: a pilot study. HRB Open Res. 2021 Nov 10;4:119. doi: 10.12688/hrbopenres.13382.1. eCollection 2021.
Clinical trial NCT03484624: Effect of Wearable Hip-Assist Robot on Reduction of Cardiopulmonary Metabolic Efficiency in Healthy Adults
Official title: Effect of Wearable Hip-Assist Robot on Reduction of Muscle Fatigue and Cardiopulmonary Metabolic Efficiency in Elderly Adults: A Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait
Keywords: Muscle; Fatigue
Wearable hip assist robot
Metabolic energy expenditure
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study was to investigate the changes in muscle fatigue and respiratory metabolic energy expenditure during walking with wearable hip-assist robot (V3).

Detailed description: The purpose of this study was to investigate the changes in muscle fatigue and respiratory metabolic energy expenditure during walking with wearable hip-assist robot (V3).

Metabolic energy expenditure and muscle fatigue are measured simultaneously.

Eligibility criteria: Inclusion Criteria:

* Elderly adults over age 65
* Those without a history of central nervous system disease

Exclusion Criteria:

* Those who have problems with walking due to problems such as visual field defects or fractures
* A person whose height is less than 140 cm or not more than 185 cm
* Body mass index BMI (body mass index) based on 35 or more obese
* Those with a cognitive problem that are difficult to understand and participate fully in this study
* Those who are at risk of falling when walking with serious dizziness

Primary outcomes:
measure: Change on metabolic energy expenditure
timeFrame: 1 hour
Secondary outcomes:
measure: Change on muscle fatigue
timeFrame: 1 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03316924: Analysis of in Vitro Biological Reaction of Diaphragmatic Prothesis When Congenital Diaphragmatic Hernia (CDH) Repair
Official title: Mecanical Properties of Biomaterials and Biological Integration of Diaphragmatic Prothesis in Infancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Diaphragmatic Repair
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 1
Sex: ALL
Minimum age (years): 0
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children that benefits of a foreskin resection, inguinal hernia repair or orchidopexy

Brief summary: In case of CDH, the incomplete development of a part of the diaphragm allows abdominal viscera to herniate into thorax cavity during fetal development and impaired lung and heart development.

After birth, CDH patients who survived thanks to an active reanimation management undergo diaphragmatic repair. In case of large defect, a patch is needed to complete diaphragmatic closure. Thanks to primary cell culture from foreskin, peritoneal epithelium or cremaster dedicated to incineration investigators want to analyse biological integration of actually used prothesis and others innovations.


Eligibility criteria: Inclusion Criteria:

* Minor aged 0 (day of birth) to 14 years
* Patient for whom an indication of posthectomy and / or cure of inguinal hernia and / or testicular ectopy is retained
* Patient whose legal representatives have agreed to the use of operational waste from mesenchymal tissues (foreskin, cremaster and peritoneum) destined for incineration.
* Patient affiliated to a social security scheme

Exclusion Criteria:

- parents don't agree to the use of its operating waste for research purposes

Primary outcomes:
measure: cell colonization
timeFrame: samples are processed immediately after sampling
measure: quality of the extracellular matrix
timeFrame: samples are processed immediately after sampling
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Isabelle TALON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03353324: Comparison of Therapeutic Effects Between Intravitreal Injection of Bevacizumab With Intravitreal Injection of Bevacizumab and Targeted Laser Photocoagulation of Non Perfused Areas of Retina in Patients With Acute Retinal Vein Occlusion
Official title: Comparison of Therapeutic Effects Between Intravitreal Injection of Bevacizumab With Intravitreal Injection of Bevacizumab and Targeted Laser Photocoagulation of Non Perfused Areas of Retina in Patients With Acute Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Retinal Vein Occlusion With Macular Edema
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with new onset retinal vein occlusion in less than 3 month whom has visual acuity less than 20/40 and central macular thickness more than 250micrometer and non perfused areas of retina more than 10 DD are included in over study and devided into 2 groups randomizely, Group A under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness, if in month four or more the CMT is more than 250 micrometer and the visual acuity is less than 8/10 the injection is repeated and follow up in this manner is continued until 9 months.

Group B is as the same of group A but patients in this group undergone laser photocoagulation of retinal non perfused areas based on FAG wide field imaging .

After 9 month follow up the outcomes such as Vusal acuity, Central macular thickness, intraocular pressure, neovascular formation are compared,


Eligibility criteria: Inclusion Criteria:

* Center-involved macular edema secondary to RVO on clinical exam
* Symptoms less than 3 months
* BCVA= 20/40 or worse
* Mean center point thickness \>250 μm
* Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs

One eye per participant is enrolled in the trial

Exclusion Criteria:

* Macular edema due to a cause other than CRVO
* An ocular condition such that visual acuity would not improve from resolution of the edema (eg, foveal atrophy)
* Substantial cataract estimated to have reduced visual acuity by \>3 lines
* Prior treatment with intravitreal or peribulbar steroid injection
* History of macular photocoagulation or PRP
* Prior pars plana vitrectomy
* Hx of Intraocular surgery (including cataract extraction)
* uveitis, NVG, exudative AMD, diabetic retinopathy, any malignancy, optic neuropathy, amblyopia
* vitreomacular traction or epiretinal membrane \*uncontrolled glaucoma ( \> 30mmHg with anti-glaucoma medications)

Primary outcomes:
measure: Visual acuity
timeFrame: Every month
Secondary outcomes:
measure: macular thickness
timeFrame: every month
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT05130424: A Real-world Study of Herombopag in the Treatment of Thrombocytopenia Related Diseases in Henan Province
Official title: A Real-world Study of Herombopag in the Treatment of Thrombocytopenia Related Diseases in Henan Province
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma;Blood
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2021-11-23
Enrollment: 498
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with thrombocytopenia-related diseases

Brief summary: To observe and evaluate the safety and effectiveness of herombopag in the treatment of thrombocytopenia-related diseases in Henan Province

Detailed description: This study is designed as a real-world study on the treatment of thrombocytopenia-related diseases with Herombopag, to observe and analyze the safety and efficacy of Herombopag for thrombocytopenia-related diseases in the real world.

Eligibility criteria: Inclusion Criteria:

1. Thrombocytopenia related diseases;
2. Volunteer to join this study and sign an informed consent form;
3. Clinical evaluation can benefit from Herombopag.

Exclusion Criteria:

1. Those who have been confirmed to be allergic to Herombopag and/or its excipients;
2. Pregnant or breastfeeding women;
3. Except for patients with contraindications to Herombopag;
4. Doctors evaluate patients who are not suitable for inclusion.

Primary outcomes:
measure: Incidence of adverse events after the treatment of Herombopag
timeFrame: From the treatment of Herombopag to 28 days after the end of the medication
Secondary outcomes:
measure: Changes of the platelet counts after the treatment of Herombopag
timeFrame: From the treatment of Herombopag to 28 days after the end of the medication
measure: Proportion of patients with platelet transfusion
timeFrame: From the treatment of Herombopag to 28 days after the end of the medication
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
References:
Clinical trial NCT00646724: Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients
Official title: Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Type 1 Diabetes Mellitus
Keywords: Islets of Langerhans Transplantation
Mesenchymal Stem Cells
Type 1 Diabetes Mellitus
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2008-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study evaluates the safety and efficacy of Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients. The researchers hypothesize that additional Mesenchymal Stem Cell infusion can benefit the promising clinical islet transplantation through the following mechanisms: protection of islet from inflammatory damage, immunological modulation, engraftment promotion, thus decrease or eliminate the need of exogenous insulin and improve β-cell function.


Eligibility criteria: Inclusion Criteria:

* Male and female patients age 18 to 60 years of age
* Ability to provide written informed consent
* Manifest signs and symptoms that are severe enough to be incapacitating
* Patients with poor diabetes control (HbA1c \> 7% but \< 12%)
* Progressive diabetic complications

Exclusion Criteria:

* age \< 18 years or \> 60 years
* diabetic history \< 5 years
* BMI \> 27
* body weight \> 80 kg
* exogenous insulin requirement \> 1 unit/kg/day
* severe anemia (male \< 8 g/dl, female \< 7 g/dl)
* low white blood cell count (\< 3000/dl)
* liver dysfunction
* Active infection including hepatitis B, hepatitis C, HIV, or TB
* panel reactive antibody \> 20%
* Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial

Primary outcomes:
measure: Exogenous insulin requirement
timeFrame: 5
measure: Hemoglobin A1c
timeFrame: 5
measure: Glucose and C-peptide levels
timeFrame: 5
Secondary outcomes:
measure: liver function
timeFrame: 5
measure: kidney function
timeFrame: 5
measure: Portal vein Ultrasound
timeFrame: 1
measure: autoantibodies
timeFrame: 5
measure: Complete Blood Count
timeFrame: 5
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fuzhou General Hospital
state: Fujian
Study officials:
affiliation: Fuzhou General Hospital
name: Jianming Tan, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00897624: Bone Marrow and Blood Samples From Patients With Metastatic Choroid Melanoma
Official title: Evaluation of the Detection of Tumor Cells in Bone Marrow and Blood in Patients With Choroid Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Melanoma
Keywords: metastatic intraocular melanoma
ciliary body and choroid melanoma, medium/large size
ciliary body and choroid melanoma, small size
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-05-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Studying samples of bone marrow and blood from patients with cancer may help doctors find out the extent of disease.

PURPOSE: This research study is collecting bone marrow and blood samples from patients with metastatic choroid melanoma.

Detailed description: OBJECTIVES:

Primary

* Develop and validate a method of detecting tumor cells in the bone marrow and blood in patients with metastatic choroid melanoma.

OUTLINE: While patients are under general anesthesia for standard treatment of their disease, samples of bone marrow from the iliac crest and blood are collected. Samples are analyzed for the expression of tyrosinase and Melan-a via RT-PCR.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Choroid melanoma

  * Metastatic disease
* Planning to undergo general anesthesia

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* No contraindications to the collection of a bone marrow sample
* No patient deprived of liberty or under trusteeship (including guardianship)
* No social or psychological situations that preclude the ability to give consent

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Detection of micro-metastatic cells in 20 x 10^6 nucleated cells
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institut Curie
name: Pierre T. Dorval, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03448224: Behavioral Intervention in Reducing Indoor Tanning
Official title: The Development and Evaluation of a Behavioral Intervention to Reduce Indoor Tanning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subject
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-02-28
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized clinical trial tests the efficacy of a behavioral intervention works in reducing indoor tanning. Artificial ultraviolet indoor tanning increases the chance of developing skin cancers. Behavioral interventions use techniques to help participants change the way they react to environmental triggers that may cause a negative reaction.

Detailed description: PRIMARY OBJECTIVE:

To develop and evaluate an online tailored indoor tanning (IT) intervention based on findings from phase 1.

OUTLINE:

INTERVENTION: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive intervention, weekly text messages about IT reduction, and personalized booster intervention. Participants then receive text messages twice weekly for 4 weeks.

GROUP II: Participants are placed on wait-list and may receive full intervention after follow-up.

After completion of study, patients are followed up at 3 months.

Eligibility criteria: Inclusion Criteria:

* Use of IT at least 25 times in the past year
* Women

Primary outcomes:
measure: Number of Prior 2-Month Indoor Tanning Sessions Reported by Participants on a Follow-up Survey
timeFrame: Up to 3 months
Secondary outcomes:
measure: Perceived Difficulty (Self-efficacy) in Quitting Tanning
timeFrame: At 3 months post-intervention
measure: Sunburns
timeFrame: Up to 3 months
measure: Intentions to Use Indoor Tanning
timeFrame: Up to 3 months
measure: Number of Participants Expressing Positive Interest in Changing Tanning
timeFrame: 3 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jerod Stapleton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stapleton JL, Ray AE, Glenn SD, McLouth LE, Parmar V, Manne SL. A randomized controlled trial of a web-based personalized feedback intervention targeting frequent indoor tanning bed users: Engagement, acceptability, and preliminary behavioral outcomes. J Health Psychol. 2022 Mar;27(4):923-935. doi: 10.1177/1359105320982038. Epub 2020 Dec 22.
Clinical trial NCT01615224: Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage
Official title: Repeated Doses of Misoprostol for Treatment of Missed Abortion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Missed Abortion
Keywords: missed abortion
miscarriage
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Missed abortion is a condition where the fetus has perished but the miscarriage is not expelled. Women often present at a routine ultrasound or with a slight brownish discharge. Traditionally this condition has been treated with curettage or vacuum aspiration. Lately, medical treatment has become more common due to less risk of infection and other complications. The routine medical treatment is 800mcg of misoprostol administered vaginally. We wish to examine of repeated doses of 400mcg misoprostol after the initial 800mcg vaginal misoprostol increases efficacy of the treatment.


Eligibility criteria: Inclusion Criteria:

* over 18 years of age healthy no contraindication to medical treatment visible fetal structures such as yolk sac or fetus

Exclusion Criteria:

* empty gestational sac more than sparse bleeding or dilated cervix mental instability after diagnosis contraindication to medical treatment

Primary outcomes:
measure: Efficacy
timeFrame: 1 day
Secondary outcomes:
measure: Acceptability
timeFrame: 1 day, 1 week, 2 weeks, 3 weeks, 5 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dept of Obstetrics and Gynecology, Danderyd Hospital
Study officials:
affiliation: Karolinska Institutet
name: Kristina Gemzell Danielsson, professor
role: PRINCIPAL_INVESTIGATOR
References: