louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00862693: Calcitriol in the Treatment of Immunoglobulin A Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Glomerulonephritis
Autoimmune Diseases
Keywords: Immunoglobulin A
Antibodies
treatment
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2009-03-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Immunoglobulin A (IgA) nephropathy is the common primary glomerulonephritis in the world. Much literature suggests that vitamin D and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy of Calcitriol in the treatment of IgA nephropathy. Forty patients with biopsy-proven IgA nephropathy will be recruited. They will be randomized to Calcitriol for six months or no treatment. Proteinuria, renal function, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and anti-inflammatory effects of Calcitriol in the treatment of IgA nephropathy, which has no specific treatment at present.


Eligibility criteria: Inclusion Criteria:

* Aged 18-65 years
* Biopsy-confirmed IgA nephropathy
* Proteinuria \> 0.8 g/day in 3 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment for at least 3 months or estimated glomerular filtration rate \< 60 ml/min/1.73m2
* Corrected serum calcium level \< or = 2.45 mmol/l
* Willingness to give written consent and comply with the study protocol

Exclusion Criteria:

* Pregnancy, lactating or childbearing potential without effective method of birth control
* Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
* History of malignancy, including leukemia and lymphoma within the past 2 years
* Systemic infection requiring therapy at study entry
* Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
* History of drug or alcohol abuse within past 2 years
* Participation in any previous trial on paricalcitol
* Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 3 months
* Patients receiving treatment of corticosteroid
* On other investigational drugs within last 30 days
* History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
* History of non-compliance
* Known history of sensitivity or allergy to paricalcitol or other vitamin D analogs

Primary outcomes:
measure: decline of urine protein
timeFrame: 12 months treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Renal Division, Peking University First Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00558493: Switching Study From Lamivudine to Clevudine in the Chronic Hepatitis B Patients
Official title: Phase lV Study to Evaluate the Safety and Effectiveness of Switching Treatment From Lamivudine to Clevudine in the Chronic Hepatitis B Patients With Suboptimal Virologic Response During Lamivudine Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis B
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2007-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A multi-center and open study to compare the safety and effectiveness of switching treatment from lamivudine to clevudine for 24 weeks.


Eligibility criteria: Inclusion Criteria:

* HBV DNA \> 2,000 copies/mL at screening
* Patients who have compensated liver disease (Child-Pugh score =\<6)
* Patients without LMV resistant mutation by RFMP assay
* Patients who have NOT experienced viral breakthrough at consecutive two measurements (at least one month apart) during lamivudine monotherapy
* Patients who can submit the written consent and comply with the claims postulated of this clinical trial

Exclusion Criteria:

* Currently receiving antiviral except LMV or corticosteroid therapy
* Patients that previously received antiviral treatment for hepatitis B other than lamivudine in the proceeding 12 months
* Previous treatment with interferon or other immunomodulatory therapies must have ended at least 6 months preceding the study screening
* Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
* Patients who is co-infected with HCV, HDV or HIV
* Serious concurrent medical conditions
* Prior organ transplantation
* Patient has creatinine clearance less than 60mL/min as estimated by the following formula:

\[(140-age in years) (body weight \[kg\])\] / \[(72) (serum creatinine\] \[mg/dL\])\[Note: multiply estimates by 0.85 for women\]

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Youngnam University Medical Center
Study officials:
References:
Clinical trial NCT01879293: Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease
Official title: Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease:A Randomized, Double-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Left Ventriclar Mass
Keywords: Metformin
Left ventricular mass
Endothelial dysfunction
cardiac magnetic resonance
aortic pulse wave
Lead sponsor: Wuhan General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cardiovascular disease is the most common cause of death in the world. Most of the attention in treating ischemic heart disease (IHD) is understandably directed toward treating coronary artery disease. However there are other treatable culprits in these patients.

Left ventricular hypertrophy (LVH) is widespread in IHD patients, even in the absence of hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. In one study, the presence of LVH was a stronger predictor of mortality than either multivessel cor-onary disease or impaired LV function.

Metformin is an antihyperglycemic agent with a history of successful use in type 2 diabetes. In the UKPDS (United Kingdom Prospective Diabetes Study), metformin was associated with a 39% lower risk of myocardial infarction compared with conventional therapy. Metformin also offered dual benefits of improving vascular function and lessening ischemia in nondiabetic patients.

Hence, the main aim of this study was to assess whether metformin could regress LVM in patients with IHD. The secondary aim was to assess the effect of metformin on LV volumes and endothelial function in this patient group.


Eligibility criteria: Inclusion Criteria:

* They had to have normal glucose tolerance.
* They had to have either angiographically documented coronary artery disease or a previous history of myocardial infarction.
* They were required to have an office BP \< 130/80 mm Hg
* The presence of LVH on echocardiography (American Society of Echocardiography criteria LVM index \[LVMI\] \> 115 g/m2 for men and \> 95 g/m2 for women).

Exclusion Criteria:

* They were currently prescribed metformin.
* They had renal and liver dysfunction, heart failure, or malignancy, or were unable to give informed consent.
* Patients with contraindications to cardiac magnetic resonance (CMR) (pacemakers, claustrophobia) were also excluded, as were pregnant or lactating women.

Primary outcomes:
measure: Left ventricular mass.
timeFrame: one year
Secondary outcomes:
measure: Left ventricular volume and endothelial function.
timeFrame: one year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan General Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT06860893: Spinal Anesthesia for Robotic Assisted Laparoscopic Prostatectomy
Official title: Spinal Anesthesia as an Adjunct to General Anesthesia for Robotic Assisted Laparoscopic Prostatectomy - a Randomised Placebo- Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Prostate Cancer Surgery
Keywords: Spinal anesthesia
Robotic assisted prostatectomy
Postoperative pain
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: University of Tromso
First posted: 2025-03-06
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded placebo controlled study
Primary purpose: TREATMENT

Brief summary: We hypothesised that spinal anesthesia as an adjunct to general anesthesia would facilitate faster recovery and less pain in patients undergoing laparoscopic robotic prostatectomy. A double-blind placebo-controlled study was subsequently designed.

Detailed description: Patients were allocated to either intrathecal injection of bupivacaine/morphine or a sham spinal procedure. All patients were placed in a sitting position and the skin over the lumbar region of the back was disinfected with chlorhexidine and draped sterile. In the intervention group the skin was infiltrated with 5 mL of lidocaine 10 mg/mL and a sterile 27-gauge pencil-point needle (Pajunk, GA, USA) was subsequently entered into the intrathecal space at the L2-3 or L3-4 interspace. After obtaining return of cerebrospinal fluid, hyperbaric bupivacaine 5 mg/mL 1,5 mL (7,5 mg) and morphine 200 µg/mL, 0.5 mL (100 µg) was injected intrathecally. Patients in the placebo group received an identical treatment as the patients in the intervention group, except for the intrathecal injection. After the skin was infiltrated with 5 mL of lidocaine 10 mg/mL, the attending anesthesiologist pressed one finger at the skin and talked as if she was giving an intrathecal injection at the L3-4 interspace. All patients were treated by the same anesthesiologist (MA).

Eligibility criteria: Inclusion Criteria:

- Prostate cancer

Exclusion Criteria:

* Benign prostate disease

Primary outcomes:
measure: Numeric rating scale
timeFrame: 24 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Tromso
country: Norway
facility: University Hospital of North Norway
Study officials:
References:
Clinical trial NCT00889993: Satiety Response After Mixed Fiber Doses
Official title: Effect of Four Doses of Mixed Fiber on Satiety, Food Intake, Glucose, Insulin, and Gut Hormone Release
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satiety
Keywords: Food intake
Gut hormones
Fiber
Visual analog scales
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Société des Produits Nestlé (SPN)
First posted: 2009-04-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: People who eat more dietary fiber have a lower body weight than people who eat less fiber. Potential mechanisms include greater feelings of satiety, reductions in food intake, changes in blood glucose, insulin, or gut hormones.

The investigators hypothesize that increasing doses of mixed fiber will influence satiety response, food intake, glucose, insulin, ghrelin, GLP-1, and PYY 3-36, in a dose-dependent manner, when given to subjects in muffins for breakfast.


Eligibility criteria: Inclusion Criteria:

* English speaking
* healthy men and women
* 18 and 65 years of age
* non-smoking
* not taking medications
* non-dieting (weight stable over last 3 months)
* BMI between 18 and 27
* able to give blood through an IV

Exclusion Criteria:

* irregular or erratic breakfast eating patterns
* food allergies to ingredients commonly found in muffins or pizza
* distaste for muffins or pizza
* BMI less than 18 or greater than 27
* weight change \> 5 kg in last 3 months (intentional or unintentional)
* cardiovascular disease
* diabetes mellitus (fasting blood sugar \> 126 mg/dl)
* cancer in prior 5 years (except basal cell carcinoma of skin)
* renal or hepatic disease
* Crohns disease
* ulcerative colitis
* any other gastrointestinal conditions that may affect digestion or absorption
* recent bacterial infection (\< 3 months)
* chronic medication use
* history of drug or alcohol abuse in prior 6 months
* concurrent or recent intervention study participation
* vegetarians
* people who ate more than approximately 15 g of fiber per day
* pregnant or lactating women
* women with irregular menstrual cycles

Primary outcomes:
measure: Satiety and Food Intake
timeFrame: November 2007 thru May 2008
Secondary outcomes:
measure: Glucose, Insulin, Gut Hormone Response
timeFrame: November 2007 thru October 2008
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota: General Clinical Research Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joanne L Slavin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Willis HJ, Thomas W, Eldridge AL, Harkness L, Green H, Slavin JL. Glucose and insulin do not decrease in a dose-dependent manner after increasing doses of mixed fibers that are consumed in muffins for breakfast. Nutr Res. 2011 Jan;31(1):42-7. doi: 10.1016/j.nutres.2010.12.006.
Clinical trial NCT02218593: WREX Outcome Study
Official title: WREX Outcome Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscular Dystrophy
Arthrogryposis
Spinal Muscular Atrophy
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with Neuromuscular disease who use the Wilmington Robotic Exoskleton

Brief summary: This study is to evaluate how the Wilmington Robotic Exoskeleton (WREX) is working for children who are using the WREX, or have used it in the past. The survey consists of a set of questions a) performed online and b) performed over the phone.

Detailed description: The WREX (Wilmington Robotic EXoskeleton) is being used by many children with neuromuscular conditions such as arthrogryposis and muscular dystrophy. Nemours/A.I. duPont Hospital for Children alone has provided a WREX for about 80 children in the last 3 years. This is being done through the orthopedic and muscle clinics in the hospital. We would like to perform a retrospective study to see how well the children are doing with the WREX. We propose getting this feedback through a survey administered to families using the WREX. The survey will be performed in two parts. 1) A phone survey will use the Canadian Occupational Performance Measure (COPM). 2) an online survey with additional questions. The parents are asked to submit answers on behalf of the children if they are unable to.

Eligibility criteria: Inclusion Criteria:

* Neuromuscular disease
* Use the Wilmington Robotic Exoskeleton

Exclusion Criteria:

* people who do not use the Wilmington Robotic Exoskeleton

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Surveys were conducted at a single timepoint for each subject. The surveys were administered over a 4-month period for all the subjects.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01685593: Abdominal Binder Study to Decrease Postoperative Pain
Official title: A Controlled Randomized Trial Examining the Ability of the Mott Compression Bonder to Decrease Postoperative Pain in Gynecologic Abdominal Laparotomy Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: abdominal binder
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2012-09-14
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We conducted a controlled randomized trial examining the ability of the Mott abdominal Compression Binder to decrease postoperative pain in gynecologic abdominal laparotomy patients


Eligibility criteria: Inclusion Criteria:

* gynecologic abdominal laparotomy patients

Exclusion Criteria:

* non gynecologic abdominal laparotomy patients

Primary outcomes:
measure: postoperative pain
timeFrame: 24 hours
Secondary outcomes:
measure: ambulations in 24 hours postoperatively
timeFrame: 24 hours
Other outcomes:
measure: amount morphine used in 24 hours postoperatively
timeFrame: 24 hours
Locations:
city: Ft Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT07014293: Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors
Official title: Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lymphoma
Keywords: coping
psychosocial intervention
survivorship
resilience
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn if a mind body resilience group program can help increase lymphoma survivors' ability to cope with and manage the challenges that come with the transition into early post treatment survivorship.

Detailed description: This is a randomized controlled trial assessing the effects of the Stress Management and Resiliency Training: Relaxation Response Resiliency-Lymphoma (SMART3RP-Lymphoma) compared to Enhanced Usual Care on 254 early post treatment lymphoma survivors. The SMART-3RP is a comprehensive, evidence-based mind body group program designed to help individuals adapt to chronic stress (i.e., increase their resilience). It understands the adjustment to chronic stress as a dynamic process, blending CBT, positive psychology and mind body tools to target key coping processes.

This trial seeks to answer the following questions:

* Will survivors randomized to SMART3RP-Lymphoma demonstrate greater improvements in coping skills when compared to survivors randomized to enhanced usual care?
* Do factors, such as age, sex, race/ethnicity, rural/urban living, socioeconomic status, impact how survivors respond to the treatment?

Eligibility criteria: Inclusion Criteria:

* English speaking adult (18 years or older at enrollment)
* Within 5 years of completing active, curative treatment for lymphoma (includes surgery, chemo-/immuno-/radiation therapy, or other)

Exclusion Criteria:

* Active Psychiatric or cognitive comorbidity as determined by site PI or treating clinician
* Unwilling or unable to participate using telehealth platform

Primary outcomes:
measure: Change from Baseline in Coping Scores on the Measure of Current Status Scale (MOCS-A)
timeFrame: Baseline to 3 month follow up
Secondary outcomes:
measure: Change in Emotional Distress (anxiety and depression) based on the PROMIS-Anxiety 8a and PROMIS-Depression 8a
timeFrame: Enrollment to 3 month follow up
measure: Change in Physical Health (PROMIS Physical Function-8b)
timeFrame: Enrollment to 3 month follow up
measure: Change in Quality of Life scores (Functional Assessment of Cancer Therapy (FACT-G))
timeFrame: Enrollment to 3 month follow up
measure: Change in Resilience scores (Current Experiences Scale (CES-23))
timeFrame: Enrollment to 3 month follow up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mass General Brigham
state: Massachusetts
Study officials:
References:
Clinical trial NCT01238393: Treatment of Epiretinal Membranes With Ranibizumab
Official title: A Prospective Pilot Study of Lucentis for Epiretinal Membranes: the LERM Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epiretinal Membrane
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2010-11-10
Enrollment: 11
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 determine whether intraocular injection of ranibizumab decreases the retinal thickness in patients with epiretinal membranes and reduces associated symptoms.


Eligibility criteria: Inclusion Criteria:

* symptomatic idiopathic epiretinal membrane

Exclusion Criteria:

* vision worse than 6/18 and fit for surgery
* prior vitreoretinal surgery or injection
* diabetes
* any past or current form of retinal vein occlusion or neovascularization
* age-related macular degeneration
* other condition causing significant limitation of visual potential

Primary outcomes:
measure: Evidence of improvement measured by optical coherence tomography
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Distance visual acuity (ETDRS)
timeFrame: 3 and 6 months
measure: Near visual acuity (Snellen)
timeFrame: 3 and 6 months
measure: Subjective change in symptoms
timeFrame: 3 and 6 months
measure: Amsler grid improvement
timeFrame: 3 and 6 months
measure: Quality of life improvement
timeFrame: 6 months
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University, Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Jeffrey Gale, MD
role: PRINCIPAL_INVESTIGATOR
References: