louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01825759: Danshen Dropping Pill for Coronary Heart Disease Heart and Artery Structure and Function
Official title: The Impact of Compound Danshen Dropping Pill for Coronary Heart Disease With Hypertension Patient Heart and Artery Structure and Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Heart Disease
Essential Hypertension
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Impact of Compound danshen dropping pill for coronary heart disease (CHD) heart and artery structure and function in patients with hypertension

Detailed description: Compound danshen dropping pill for coronary heart disease (CHD) heart and artery structure and function in patients with hypertension.We can accorand the pwv ,IMT and MDA to assess the impact of heart and artery structure and function.

Eligibility criteria: Inclusion Criteria:coronary heart disease，primary hypertension， -

Exclusion Criteria:secondary hypertension，diabetes mellitus，chronic renal disease，cardiac insufficiency

-

Primary outcomes:
measure: Pulse wave velocity
timeFrame: one year
Secondary outcomes:
measure: ankle-brachial index
timeFrame: one year
Other outcomes:
measure: intima-media thickness,methyl-di-aide-hyde
timeFrame: one year
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: organizer
name: chen xi ping, master
role: STUDY_DIRECTOR
References:
Clinical trial NCT01594359: Nutrition Study of Effect of High Iron Beans on Iron Status
Official title: Efficacy of Iron Biofortified Beans in Improving the Iron Status of Rwandan Adolescent Girls: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Keywords: Ferritin
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: HarvestPlus
First posted: 2012-05-09
Enrollment: 300
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether beans bred to have a high iron content are effective in improving the iron status of young women.

Detailed description: The goal of the study is to determine the efficacy of biofortified beans in improving the iron status of young women in Rwanda.

Eligibility criteria: Inclusion Criteria:

* Non-pregnant adolescent subjects of reproductive age with low iron stores with or without mild anemia, who are otherwise healthy, will be enrolled in the study

Exclusion Criteria:

* Pregnant, lactating, severe anemia, low BMI would be excluded

Primary outcomes:
measure: Improved iron status
timeFrame: 1 year
Secondary outcomes:
measure: Improved physical and cognitive performance
timeFrame: 1 year
Other outcomes:
Locations:
city: Butare
country: Rwanda
facility: National University of Rwanda
state: Kigali
city: Kigali
country: Rwanda
Study officials:
affiliation: ETH Zurich
name: Richard F. Hurrell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luna SV, Pompano LM, Lung'aho M, Gahutu JB, Haas JD. Increased Iron Status during a Feeding Trial of Iron-Biofortified Beans Increases Physical Work Efficiency in Rwandan Women. J Nutr. 2020 May 1;150(5):1093-1099. doi: 10.1093/jn/nxaa016.
citation: Wenger MJ, Rhoten SE, Murray-Kolb LE, Scott SP, Boy E, Gahutu JB, Haas JD. Changes in Iron Status Are Related to Changes in Brain Activity and Behavior in Rwandan Female University Students: Results from a Randomized Controlled Efficacy Trial Involving Iron-Biofortified Beans. J Nutr. 2019 Apr 1;149(4):687-697. doi: 10.1093/jn/nxy265.
citation: Murray-Kolb LE, Wenger MJ, Scott SP, Rhoten SE, Lung'aho MG, Haas JD. Consumption of Iron-Biofortified Beans Positively Affects Cognitive Performance in 18- to 27-Year-Old Rwandan Female College Students in an 18-Week Randomized Controlled Efficacy Trial. J Nutr. 2017 Nov;147(11):2109-2117. doi: 10.3945/jn.117.255356. Epub 2017 Sep 27.
citation: Haas JD, Luna SV, Lung'aho MG, Wenger MJ, Murray-Kolb LE, Beebe S, Gahutu JB, Egli IM. Consuming Iron Biofortified Beans Increases Iron Status in Rwandan Women after 128 Days in a Randomized Controlled Feeding Trial. J Nutr. 2016 Aug;146(8):1586-92. doi: 10.3945/jn.115.224741. Epub 2016 Jun 29.
Clinical trial NCT03028259: Glucose Variability
Official title: Does Plasma Glucose Variability in Obese Diabetic Pregnancies Influence Maternal or Neonatal Outcomes?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glucose Variability
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 161
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with diabetes in pregnancy of any age, any ethnic background

Brief summary: A retrospective data review of 243 pregnant women (≤32 wks gestational age), dtat collected prior to 5/18/2014, with GDM, or T2DM, and their infants (until discharge from the hospital, typically up to 1 week after deliver) will be conducted. These women are of any age and all ethnic backgrounds delivering at St. Mary's Health Center.

Detailed description: Maternal glucose control is considered to be a major determinant of neonatal outcome in pregnancies complicated by diabetes. Studies have examined the link between neonatal mortality and morbidity using specific mean preprandial or postprandial plasma glucose levels, however, have not taken into account the daily wide excursions that occur in maternal glucose levels. Limited data are available on glucose variability (GV) in pregnancy and affect on maternal or neonatal outcomes. A recent study amongst diabetics showed that glucose variability between two data points, a morning fasting blood glucose and an afternoon blood glucose, increased the rate of adverse neonatal outcomes1. Glycosylated hemoglobin (A1c), which has been considered the "gold standard" for diabetes control since the Diabetes Control and Complication Trial (DCCT)2, lacks the specificity to predict pregnancy outcomes. Through review of data, we propose to examine other methods of evaluating daily maternal glucose variations to determine the correlation to maternal and neonatal outcomes.

The objective of this study is to determine the effect of glucose variability and/ or other elements on maternal and neonatal outcomes in the obese diabetic patient. We hypothesize that glucose variability will be a stronger indicator of neonatal outcome than A1c or any single given blood glucose value. Glucose variability, including the magnitude of hyperglycemia or the incidence of acute maternal hypo- or hyperglycemic events, will be explored. We hypothesise that obese pregnant women with higher magnitude of glucose fluctuations have more maternal and fetal co morbidities.

Eligibility criteria: Inclusion Criteria:

* Women with diabetes in pregnancy of any age, any ethnic background who deliver at St. Mary's Health Center, 1/1/2000 to 5/18/2014.

Exclusion Criteria:

* Data collected ager 5/18/2014

Primary outcomes:
measure: glucose levels
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St. Louis University
name: Laura Vricella, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00212459: The Effect of Patient Counseling on Adolescent Hemophilia Patient Compliance With Bleeding Logs
Official title: A Prospective Randomized Pilot Study on the Effect of Patient Counseling on Adolescent Hemophilia Patient Compliance With Bleeding Logs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia A
Hemophilia B
Keywords: Bleeding logs
Factor Infusions
Lead sponsor: New York Presbyterian Hospital
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 14
Sex: MALE
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study will see if counselling adolescents with severe or moderate Hemophilia A or B results in increased compliance in the maintenance of bleeding logs.

Detailed description: The study will see if counselling adolescents with severe or moderate Hemophilia A or B results in increased compliance in the maintenance of bleeding logs.To do this subjects will be randomized into a control group and a group who will receive consistent counselling by a pharmacist about their bleeding logs.

The aims of the study are:

* To provide a new method of bleeding and treatment documentation in the home setting (logs) to adolescent subjects with Hemophilia A or B
* To counsel these subjects about adherence to their treatment regimen prescribed by physician and the importance of keeping accurate documentation of each bleeding episode and its treatment.
* To improve maintenance of logs, to allow for 1) assessment of bleeding frequency and treatment efficacy and 2) early detection of target joint bleeding and the potential need for prophylactic factor replacement.

Eligibility criteria: Inclusion Criteria:

* Ages 12 through 20
* Severe or moderate Hemophilia A or B
* Self-infusing or transitioning to self infusion in the home setting
* Already assigned responsibility of monitoring bleeding logs

Exclusion Criteria:

* Not meeting inclusion criteria

Primary outcomes:
measure: Study and control groups will be compared with respect to the % of bleeds reported to the HTC and % of recommended therapy recorded in bleeding logs after a 6 month period
timeFrame: 6 months
Secondary outcomes:
measure: Study and control groups will be compared with respect to time between initiation of target joint bleeding and the identification and treatment of such by HTC personnel
timeFrame: 6 months
measure: Clotting factor consumption and the cost of therapy in each group will be compared
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NY Presbyterian Hospital
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Donna M DiMichele, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02813759: Sucralose in Subjects With Diabetes Mellitus Insulin Requesting
Official title: Effect of a Sucralose Preload on Postprandial Metabolic Parameters and Satiety in Subjects With Type 2 Diabetes Mellitus Under Intensive Insulin Therapy - Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: GLYCEMIA
SATIETY
C PEPTIDE
PRELOAD
INSULIN
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 10
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the acute effect of a preload of sucralose in presence of carbohydrate (HC) available on the glycemic response, postprandial C peptide and satiety in patients with type 2 diabetes mellitus (DM2) in intensive insulin therapy (IIT).


Eligibility criteria: Inclusion Criteria:

* Minimum period of six month intensive insulin therapy
* Prescription rapid insulin in the breakfast
* Aged 35 to 70 years
* BMI 25 to 39.9 kg / m2
* HbA1c lower than or equal to 10% (86 mmol / mol)
* Menopausal women under hormone replacement therapy

Exclusion Criteria:

* History of intolerance artificial sweetener sucralose
* Pregnant women
* Puerperal women
* Subjects with neurological disease, endocrine disorder no treatment, kidney disease stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, HIV
* Subjects with history of stroke , acute myocardial infarction and gastrointestinal resection

Primary outcomes:
measure: Glycemia
timeFrame: up to 120 minutes
measure: C peptide
timeFrame: up to 60 minutes
measure: Satiety
timeFrame: up to 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.
Clinical trial NCT04648059: Epigenetics in Lupus Nephritis
Official title: Unmethylated CpG-rich DNA Fragments in TLR-mediated Renal Fibrogenesis of Lupus Nephritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Lupus Erythematosus
Lupus Nephritis
Keywords: Epigenetics
Methylation
Toll-like receptors
Fibrosis
Lead sponsor: University of Göttingen
Sponsor class: OTHER
Collaborators: name: King's College London
name: Università degli Studi di Brescia
First posted: 2020-12-01
Enrollment: 60
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 consists of a sample of patients with systemic lupus nephritis (SLE). There will be analyses for the presence of epigenetic markers (methylated CpG-rich DNA fragments) between two groups: 1) patients with SLE with Lupus nephritis (LN) and 2) patients with SLE without LN. In the first phase of the study, a cross-sectional sample of patients will be analyzed. In the second phase of the study, patient samples will be prospectively analyzed for the presence of these markers.

Brief summary: This is a translational study for the identification of epigenetic changes detectable in sera of patients suffering from Systemic Lupus erythematosus. The aim of the study is to analyze whether circulating DNA fragments are 1) different in patients with or without Lupus nephritis and 2) present and detectable in the circulation before the development of Lupus nephritis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of systemic lupus erythematosus according to the current classification criteria
* a subgroup requires the presence of Lupus nephritis (no restriction to specific LN histologic subtypes)

Exclusion Criteria:

* patients not able or unwilling to provide written informed consent

Primary outcomes:
measure: Methylated CpG-rich DNA fragments
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Göttingen
state: Lower Saxony
Study officials:
References:
Clinical trial NCT03758859: CLARITY Imaging Study
Official title: CLARITY Imaging Study: The Effect Of Cross-linked Sodium Hyaluronate On The Quality Of Optical Coherence Tomography Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: OCT image quality is necessary to provide accurate diagnostic information to ophthalmologists. The increasing resolution of imaging techniques will require ever more high standards of optical transmission through the cornea and tear film. Given that lubricant drops can improve optical transmission through the cornea, this study will attempt to quantify this. The primary objective is to assess the effect of cross-linked sodium hyaluronate on OCT image quality compared to the effect of blinking alone.


Eligibility criteria: Inclusion Criteria:

* Patients subjectively deemed to have poor image quality by the photographer

Exclusion Criteria:

* Patients with a known adverse reaction to any of the constituents of the XLHA
* Patients wearing contact lenses
* Patients who have used eyedrops in the past 2 hours

Primary outcomes:
measure: Clarity of retinal images obtained by Optical Coherence Tomography.
timeFrame: immediately after the administration of drops.
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Western Eye Hospital
Study officials:
affiliation: Imperial College NHS Trust
name: Timothy Yap
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06167759: Preventing Opioid Misuse Through Safe Opioid Use Agreements Between Patients and Surgical Providers
Official title: Preventing Opioid Misuse Through Safe Opioid Use Agreements Between Patients and Surgical Providers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid Use
Inguinal Hernia
Ventral Hernia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2023-12-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The effect of pain agreements to reduce opioid misuse is an accepted practice in many settings, but it has never been applied to the acute care setting. Pain agreements are considered the standard of care for chronic pain management reliant on opioid prescribing, and they are a mandated component of care in many states. Therefore, the adjunct of safe opioid use agreements into acute pain management offers a logical extension of current practices from chronic pain management.

This study will test the use of agreements to improve safe opioid use to prevent misuse and opioid-related harm.


Eligibility criteria: Inclusion Criteria:

Adult patients (at least 18 years of age), of any gender, who speak English or Spanish, undergoing general surgery procedures with a high likelihood of receiving an opioid prescription (bariatric, inguinal hernia, or ventral hernia), who have their preoperative appointment at UT Physicians Health Center at Memorial Hermann Sugar Land Medical Plaza, Lyndon Baines Johnson, and Bellaire

Exclusion Criteria:

Patients with a known allergy or contra-indication to opioids, pregnancy, signification cognitive impairment, history of opioid misuse/abuse, chronic opioid use, readmission before the follow up appointment

Primary outcomes:
measure: Patient self-reported disposal of prescription opioids
timeFrame: 25-40 days after surgery
Secondary outcomes:
measure: Opioid pills used
timeFrame: 25-40 days after surgery
measure: Opioid pills leftover
timeFrame: 25-40 days after surgery
measure: Storage method
timeFrame: 25-40 days after surgery
measure: Disposal method
timeFrame: 25-40 days after surgery
measure: Other pain management strategies
timeFrame: 25-40 days after surgery
Other outcomes:
Locations:
city: Bellaire
country: United States
facility: UT Physicians-MIST Bellaire Clinic
state: Texas
city: Houston
country: United States
facility: Lyndon B. Johnson General Hospital
state: Texas
city: Sugar Land
country: United States
facility: UT Physicians-MIST Sugar Land Clinic
state: Texas
Study officials:
affiliation: UTHealth
name: Jonah J Stulberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00413959: VELCADE,Rituximab,Cyclophosphamide and Decadron
Official title: Phase II Study Investigating the Efficacy of VELCADE®, Rituximab, Cyclophosphamide and Decadron (VRCD Regimen) in Front-line Therapy of Patients With Low-grade Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Keywords: NHL
Lead sponsor: Oncology Specialists, S.C.
Sponsor class: OTHER
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2006-12-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Overall response rate and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma.

Detailed description: This is a phase II open label study that is looking at the VRCD combination regimen in patients with previously untreated low-grade Non-Hodgkin's Lymphoma. Treatment will start by combining oral dexamethasone and cyclophosphamide with intravenous VELCADE, rituximab. Chemotherapy cycles will be given as outlined below every 35-days and will continue until two cycles beyond complete remission (CR), toxicity, patient's withdrawal, disease progression, or a maximum of 8 cycles.

Eligibility criteria: Inclusion Criteria:

* Small Lymphocytic Lymphoma
* Follicular Cell Lymphoma (grades I and II)
* Mantle Cell Lymphoma patients that are not considered eligible for high-dose therapy and stem cell transplant
* Lymphoplasmacytic lymphoma including Waldenstrom's Macroglobulinemia
* Marginal Zone Lymphoma
* MALT Lymphoma that has ONLY failed antibiotic therapy or involved field radiation.
* Adequate bone marrow function, renal function, and hepatic function as outlined in details below.
* ECOG performance status of 0, 1, or 2
* Able to read, understand, and sign an IRB approved informed consent

Exclusion Criteria:

* Known HIV positive status
* Known CNS involvement
* Prior therapy for lymphoma EXCLUDING antibiotic treatment for MALT-Type NHL.

Primary outcomes:
measure: Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.
timeFrame: 4 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 4 years
Other outcomes:
Locations:
city: Niles
country: United States
facility: Onocology Specialists, S.C
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists, S.C
state: Illinois
Study officials:
affiliation: Oncology Specialists, SC
name: Chadi Nabhan, MD
role: PRINCIPAL_INVESTIGATOR
References: