louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02331420: Effect of BAriatric Surgery Versus Optimal Medical Therapy on Cardiovascular Health and Atherosclerosis in Obese, Type II Diabetic Patients
Official title: Prospective Randomized Controlled Trial on the Effect of BAriatric Surgery Versus Optimal Medical Therapy on Cardiovascular Health and Progression of Atherosclerosis in Obese, Type II Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Diabetes Mellitus, Type 2
Atherosclerosis
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 58
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: DIAGNOSTIC

Brief summary: To assess the impact of weight loss due to bariatric surgery, as compared to the effect of optimal medical therapy alone on endothelial function, subclinical atherosclerosis, cardiovascular autonomic function in obese patient affected by type 2 diabetes.The study consists in a 2-arm randomized trial, in which patients will be randomly assigned to bariatric surgery or optimal medical therapy. Each patient will be studied at baseline (T0) and 12 months thereafter (T1).


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes: the American Diabetes Association (ADA) recommends the following criteria for diagnosis of diabetes: HbA1c ≥6.5% OR fasting plasma glucose‡ ≥126 mg/dL (7.0 mmol/L) OR 2-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test; 75-g glucose load should be used OR random plasma glucose concentration ≥200 mg/dL (11.1 mmol/L) in persons with symptoms of hyperglycemia or hyperglycemic crisis;
* indication to bariatric surgery: BMI ≥35 kg/m2 and one or more obesity related co-morbidities, including Type 2 Diabetes Mellitus.

Exclusion Criteria:

* overt cardiovascular disease (as assessed by clinical evaluation, physical examination, 12-lead ECG, 2D-echocardiogram);
* smoking habit;
* associated medical conditions, as chronic kidney disease (defined as creatinine clearance \<60 mL/min/L.73m2), liver cirrhosis, malignancies, chronic congestive heart failure, acute or chronic inflammatory disease;
* specific contraindication to bariatric surgery;
* pregnancy;
* medical conditions requiring acute hospitalization;
* psychological conditions which may hamper patient's cooperation;
* geographic inaccessibility.

Primary outcomes:
measure: Subclinical Atherosclerosis (ecographic assessment of carotid artery intima-media thickness)
timeFrame: 12 months
measure: Endothelial Function (ecographic assessment of flow-mediated dilation and nitrate mediated dilation)
timeFrame: 12 months
measure: Cardiac autonomic function (heart rate variability measurements on 24-hour Holter ECG recordings)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05847920: Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy
Official title: A Phase II Seamless Design, Randomized, Double-blind, Placebo-controlled, Dose-exploration Study Evaluate the Efficacy and Safety of SHR-2010 Injection in Patients With Primary IgA Nephropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Primary IgA Nephropathy
Lead sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-05-08
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy, and safety of SHR - 2010 injection in patients with primary IgA nephropathy.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Renal biopsy confirmed primary IgA nephropathy
3. 24 hours urinary protein quantity ≥1g, or UPCR≥0.8 g/g
4. eGFR≥30 mL/min/ 1.73m2
5. 40kg≤ Weight ≤100kg
6. Has been treated with optimized supportive treatment. (ACEI or ARB to maximum recommended dose or maximum tolerated dose).

Exclusion Criteria:

1. systemic disease which may cause secondary IgA deposition in the mesangial region
2. Specific type of IgA nephropathy
3. History of severe opportunistic infection
4. A history of chronic or recurrent infection within 1 year prior to screening
5. History of active digestive system within one year
6. Have a malignant tumor or a history of malignant tumor
7. Subjects who have received organ transplants
8. Associated with other serious or poorly controlled systemic diseases
9. Hepatitis, syphilis, human immunodeficiency virus (HIV) infection
10. Received systemic immunosuppressive drugs other than glucocorticoids 8 weeks before screening or during run-in period.
11. Received any systemic glucocorticoid 8 weeks before screening or during run-in period

Primary outcomes:
measure: Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks.
timeFrame: 12 weeks
measure: Part 2: change from baseline in UPCR at 24weeks.
timeFrame: 24 weeks
Secondary outcomes:
measure: change from baseline in 24 hours urinary protein at 12 weeks (part 1)
timeFrame: 12 weeks
measure: change from baseline in 24 hours urinary protein at 24 weeks (part 2)
timeFrame: 24 weeks
measure: change from baseline in urinary albumin creatinine ratio (UACR) at 12weeks（Part 1）
timeFrame: 12 weeks
measure: change from baseline in urinary albumin creatinine ratio (UACR) at 24weeks（Part 2）.
timeFrame: 24 weeks
measure: change from baseline in glomerular filtration rate (eGFR) at 12weeks and 24weeks （Part 1）.
timeFrame: 12, 24 weeks
measure: change from baseline in glomerular filtration rate (eGFR) at 24weeks and 36weeks （Part 2）.
timeFrame: 24, 36 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: General Hospital of Eastern Theater Command
state: Jiangsu
Study officials:
References:
Clinical trial NCT01346020: Genomic Analysis of Patients With Chronic Lymphocytic Leukemia
Official title: Genomic Analysis of Patients With Chronic Lymphocytic Leukemia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-05-02
Enrollment: 53
Sex: ALL
Minimum age (years): 0
Maximum age (years): 130
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic lymphocytic leukemia

Brief summary: This study aims to characterize clonal evolution in chronic lymphocytic leukemia (CLL) using different approaches and to identify a possible association with disease progression, i.e. therapy initiation.

1. Samples This monocentric study is carried out using representative bioarchived leukemic samples with a diagnosis of CLL, either at diagnosis or at evolution. These bioarchived samples were collected locally at our center during years of diagnostic activity, and were accurately pathologically, cytogenetically and molecularly characterized.
2. Clinical data The clinical data were retrospectively collected through collaboration with the referring physicians.
3. Methods Samples will be investigated by means of (1) conventional cytogenetics, (2) fluorescence in situ hybridization (FISH) and (3) SNP-arrays. After analysis of the array data sets, significant results will be validated and in addition, results will be correlated with clinical data.


Eligibility criteria: Inclusion Criteria:

* diagnosis of CLL,
* at least two available stored samples

Exclusion Criteria:

* at least one inclusion criterium not fulfilled

Primary outcomes:
measure: Time to therapy
timeFrame: baseline to day 1 of therapy
Secondary outcomes:
measure: Genetic abnormalities detected by karyotyping, FISH or array-analysis
timeFrame: 13-102 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of human genetics, University Hospital Leuven
Study officials:
References:
Clinical trial NCT06245720: Serum and Urine Metabolome Studies in Patients With Acute Kidney Injury After Cardiac Surgery
Official title: Serum and Urine Metabolome Studies in Patients With Acute Kidney Injury After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiac Surgery Associated Acute Kidney Injury
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cardiac surgery who have undergone cardiopulmonary bypass. Acute kidney injury is defined according to the KIDIGO guidelines.

Brief summary: The goal of this observational study is to learn about serum and urine metabolome in patients after cardiac surgery.

Detailed description: The main objective of this study is to collect blood and urine samples from patients after cardiac surgery, and to perform metabolomic analysis to find the differential metabolites and their enrichment pathways in AKI patients and non-AKI patients.The secondary objective is to intervene in its enrichment pathway to find ways to improve CSA-AKI.

Eligibility criteria: Inclusion Criteria:

1. Age\> 18 years old;
2. after cardiopulmonary bypass;

Exclusion Criteria:

1. Under the age of 18;
2. Previous chronic kidney disease or receiving renal replacement therapy;
3. Have a history of kidney transplantation or nephrectomy.

Primary outcomes:
measure: serum and urine metabolome studies
timeFrame: January 2025 - December 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Chen Wenxiu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01386320: Ultrasound Guided Ankle Block Versus Medial Forefoot Block for Forefoot Surgery
Official title: A Randomised, Blinded Comparison of an Ultrasound Guided Ankle Block Compared to a Nerve Stimulator Guided Ankle Block for Pain Relief After Forefoot Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Relief After Forefoot Surgery
Keywords: anaesthetic techniques, regional; surgery orthopaedic
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2011-07-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and is very painful. Local anaesthetic nerve blocks have been used for many years to help alleviate pain following this surgery. The present study aims to compare a new ultrasound guided nerve block to a well established nerve stimulator guided technique. Comparisons will include time taken to carry out the block, speed of onset of numbness and duration and quality of pain relief after surgery.


Eligibility criteria: Inclusion Criteria:

* Fit adult patients requiring forefoot surgery with bone cutting.

Exclusion Criteria:

* Morbid obesity (BMI \>40), known contraindications to regional anaesthesia

Primary outcomes:
measure: Time taken to carry out each local anaesthetic block
timeFrame: Over forty five minutes from the start of the study.
Secondary outcomes:
measure: Onset of local anaesthesia
timeFrame: Over thirty minutes from completion of the local anaesthetic block.
measure: Duration of pain relief following local anaesthetic block.
timeFrame: Over 24 hours following surgery.
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Castle Hill Hospital, Castle Road, Cottingham
state: East Yorkshire
Study officials:
affiliation: Hull University Teaching Hospitals NHS Trust
name: Andrew J Coe, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00486720: Phase IIa Vorinostat (MK0683, Suberoylanilide Hydroxamic Acid (SAHA)) Study in Lower Risk Myelodysplastic Syndromes (0683-064)
Official title: A Randomized Phase IIa Study of Vorinostat in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Myelodysplastic Syndromes
Blood Disease
Bone Marrow Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-06-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the efficacy, safety and tolerability of vorinostat in patients with lower risk Myelodysplastic Syndrome (MDS).


Eligibility criteria: Inclusion Criteria:

Patient is a male or female, at least 18 years of age with low or intermediate-1 risk Myelodysplastic Syndrome (MDS) defined by the International Prognostic Scoring System

* Patient has previously untreated disease, or has received up to one prior treatment regimen for lower-risk Myelodysplastic Syndrome
* Patient has a performance status of equal to or less than 2 on the Eastern Cooperative Oncology Group Performance Scale
* Patient must have adequate organ function

Exclusion Criteria:

* Patient has clinical evidence of Central Nervous System (CNS) leukemia
* Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
* Patient had prior treatment with a histone deacetylase inhibitor

Primary outcomes:
measure: Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria
timeFrame: 2 Years
measure: Safety and Tolerability as Assessed by the Number of Participants With Adverse Events.
timeFrame: Every 21 days while on therapy and at 30 days after the last dose of study therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06429020: Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy
Official title: Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reactive Axillary Lymphadenopathy for SARS-CoV-2 Vaccines in the Asian Taiwanese Population
Keywords: Breast Neoplasms
covid-19 vaccine
lymphadenopathy
Lead sponsor: Chimei Medical Center
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 1089
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent breast sonography in the radiology department of Chi Mei Medical Center between July 2021 and March 2022.

Brief summary: This study aimed to provide vast clinical information to facilitate breast sonographic examination for participants who underwent recent SARS-CoV-2 vaccination.

Among different SARS-CoV-2 vaccines in the Asian Taiwanese population, reactive axillary lymphadenopathy was investigated through breast sonographic findings and clinical data analysis. The sample included participants with recent vaccinations by different brands approved in Taiwan.

Detailed description: Study Design and Sample The retrospective study included female patients who underwent breast sonography in the radiology department of Chi Mei Medical Center between July 2021 and March 2022. The patients' breast cancer history and COVID-19 vaccination history were collected and analyzed.

Analysis of Breast Sonography Lymphadenopathy is defined as an enlarged lymph node with cortical thickening \>3 mm, either concentric or eccentric, with or without effacement of fatty hilum, or in-creased non-hilar vascularity on color or power Doppler. The positive axillary lymph node findings were correlated by confirming a link to SARS-CoV-2 vaccination history within 90 days in the ipsilateral arm.

Statistical Analysis All statistical analyses were performed using the R Stats package. Descriptive summaries were reported as mean ± standard deviation for continuous variables and percentages for categorical variables. For non-parametric variables, median with interquartile range and Mann-Whitney U test were used. Statistical significance was set at a p-value \<0.05.

Eligibility criteria: Inclusion Criteria:

* female patients receiving breast sonography

Exclusion Criteria:

* receive Covid 19 vaccine other than AZ, BNT, Moderna
* Ongoing primary breast malignancy
* History of malignancy other than primary breast malignancy

Primary outcomes:
measure: Presentation of axillary lymphadenopathy in sonographic examination
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: ChiMei Medical Center
Study officials:
affiliation: ChiMei Medical Center, Taiwan, R.O.C.
name: Pin Chi Huang
role: STUDY_CHAIR
References:
Clinical trial NCT03474120: Prospective Genetic Study in Patients With Ovarian Insufficiency
Official title: Prospective Genetic Study in Patients With Ovarian Insufficiency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Ovarian Failure
Primary Ovarian Insufficiency
Ovarian Dysgenesis
Diminished Ovarian Reserve
Keywords: Genetic causes
etiology
POI
DOR
Lead sponsor: The First Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
Collaborators: name: National Research Institute for Family Planning, China
First posted: 2018-03-22
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who come to the First Affiliated Hospital of Anhui Medical University Reproductive Center and diagnosed as "premature ovarian insufficiency", "diminished ovarian reserve", "primary amenorrhea", " ovarian dysgenesis", " repeated implantation failure"，Understand the content of the project and sign an informed consent form

Brief summary: genetic screening and etiological analysis was conducted on patients with ovarian insufficiency and decline in ovarian reserve. All patients were enrolled in the IVF-treated and non-IVF-treated groups, followed up for long-term treatment outcomes and genomic screening.

Detailed description: The cause of ovarian insufficiency and decline in ovarian reserve are not clear, but most researchers think the probable causes are mainly three aspects: chromosomal abnormalities, genetic factors and autoimmune diseases，But the majority of patients with normal chromosome karyotype analysis. The screening of pathogenic genes in patients with normal karyotype is the focus of current premature ovarian insufficiency(POI) and decline in ovarian reserve(DOR) etiology, to further explain the pathogenesis of patients, improve the diagnosis of those diseases and Clinical treatment.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as "premature ovarian insufficiency", "diminished ovarian reserve", "primary amenorrhea", " ovarian dysgenesis", " repeated implantation failure"

Exclusion Criteria:

* To rule out polycystic ovary syndrome（PCOS）, iatrogenic factors (such as surgery, radiotherapy and chemotherapy, etc.) lead to premature ovarian insufficiency in patients

Primary outcomes:
measure: Genotype
timeFrame: 1/4/2018-24/12/2020
Secondary outcomes:
measure: Dimensions of uterus
timeFrame: 1/4/2018-24/12/2020
measure: Antral follicle count
timeFrame: 1/4/2018-24/12/2020
measure: Endometrial thickness
timeFrame: 1/4/2018-24/12/2020
measure: Live birth rate
timeFrame: 1/4/2018-24/12/2020
measure: Neonatal weight
timeFrame: 1/4/2018-24/12/2020
Other outcomes:
Locations:
city: Hefei
country: China
facility: Reproductive Medicine Center, the First Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: Reproductive Medicine Center, the First Affiliated Hospital of AMU
name: Yunxia Cao, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04997174: Comparison of Postoperative Pain Management in Patients Undergoing Laparoscopic Colorectal Surgery Under Enhanced Recovery After Surgery (ERAS) Program, Laparoscopic Colorectal Surgery Without ERAS and Open Colorectal Surgery
Official title: Comparison of Postoperative Pain Management in Patients Undergoing Laparoscopic Colorectal Surgery Under Enhanced Recovery After Surgery (ERAS) Program, Laparoscopic Colorectal Surgery Without ERAS and Open Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pain
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 162
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group of interest: Laparoscopic colorectal surgery with Enhanced Recovery after Surgery (ERAS) program defined as patients undergoing laparoscopic colorectal surgery \[laparoscopic right / left hemicolectomy, laparoscopic low anterior resection, laparoscopic abdominoperineal resection (APR) and others\] under ERAS protocol.

Control 1: Laparoscopic colorectal surgery without Enhanced Recovery after Surgery (ERAS) program defined as patients undergoing laparoscopic colorectal surgery \[laparoscopic right / left hemicolectomy, laparoscopic low anterior resection, laparoscopic abdominoperineal resection (APR) and others\] under conventional protocol.

Control 2: Open colorectal surgery defined as patients undergoing open laparotomy for colorectal surgery \[open right / left hemicolectomy, open low anterior resection, open abdominoperineal resection (APR) and others\].

Brief summary: This is a retrospective study to compare postoperative pain intensity in patients going laparoscopic colorectal surgery with Enhanced Recovery after Surgery (ERAS), without ERAS and open colorectal surgery.

Detailed description: This study is a matched case-control study. Control patients will be matched to ERAS cases in a 1:1:1 ratio (laparoscopic surgery with ERAS protocol : laparoscopic surgery without ERAS protocol : open surgery).

Eligibility criteria: Inclusion Criteria:

* Patients undergoing colorectal surgery under ERAS program and those with the same sort of laparoscopic surgery without ERAS program as well as those with open colorectal surgery with complete required recorded data.

Exclusion Criteria:

* 1. Patients with incomplete required data on record.
* 2. Those with any major intraoperative or postoperative complications.

Primary outcomes:
measure: Pain intensity
timeFrame: Until discharge (5-7 days)
Secondary outcomes:
measure: Opioid
timeFrame: Until discharge (5-7 days)
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Sasikaan Nimmaanrat
state: Songkhla
Study officials:
References:
citation: Tan SJ, Zhou F, Yui WK, Chen QY, Lin ZL, Hu RY, Gao T, Li N. Fast track programmes vs. traditional care in laparoscopic colorectal surgery: a meta-analysis of randomized controlled trials. Hepatogastroenterology. 2014 Jan-Feb;61(129):79-84.