louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01968044: A Phase IIIb Study to Evaluate the Safety and Efficacy of Gemigliptin in Type 2 Diabetes Mellitus Patients With Moderate or Severe Renal Impairment(GUARD Study)
Official title: A Multicenter,Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase IIIb Study to Evaluate the Safety and Efficacy After 12 Weeks Administration of Gemigliptin and Placebo in Type 2 Diabetes Mellitus Patients With Moderate or Severe Renal Impairment With an Additional 40 Weeks, Double-blind,Active-controlled, Double-dummy,Long-term Extension Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 DM Patients With Moderate or Severe Renal Impairment
Keywords: renal impairment
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2013-10-23
Enrollment: 132
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor gemigliptin in patients with type 2 DM and moderate or severe renal impairment for long-term peirod (52 weeks).


Eligibility criteria: Inclusion Criteria:

* Patients with Type 2 Diabetes Mellitus
* Patients with moderate or severe renal insufficiency
* All patients give written informed consent

Exclusion Criteria:

* Has type 1 diabetes mellitus or a history of ketoacidosis
* Is on dialysis or is likely to need dialysis during the study
* Has active liver disease

Primary outcomes:
measure: HbA1c change
timeFrame: HbA1c change from baseline to week 12
Secondary outcomes:
measure: HbA1c Change
timeFrame: HbA1c change from baselint to week 6, 52
measure: FPG
timeFrame: FPG change from baseline to week 6,12,52
measure: Glycated albumin
timeFrame: Glycated albumin change from baseline to week 6,12,52
measure: Fructosamin
timeFrame: Fructosamin change from baseline to week 6,12,52
measure: Waist
timeFrame: Waist change from baseline to week 12,52
measure: HbA1c responser (HbA1c<7.0%)
timeFrame: HbA1c responser rate at week 12,52
measure: Fasting serum C-peptide
timeFrame: Fasting serum C-peptide change from baseline to week 12,52
measure: Fasting Lipid parameters
timeFrame: Fasting Lipid parameters change from baseline to week 12,52
measure: Albuminuria
timeFrame: Albuminuria change from baseline to week 12,52
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Korea University Ansan Hospital
name: DR Cha, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05218044: Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
Official title: Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ductal Carcinoma in Situ
Keywords: DCIS
Lead sponsor: Glendale Adventist Medical Center d/b/a Adventist Health Glendale
Sponsor class: OTHER
Collaborators: name: Helen Rey Breast Cancer Research Foundation
name: California Oncology Research Institute
name: Doterra Healing Hands Foundation
First posted: 2022-02-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cryoablation or tumor freezing is a percutaneous, office-based procedure that is emerging as a minimally invasive, cost-effective alternative to surgery that is currently being evaluated in clinical trials for the management of for early-stage invasive breast cancer. The investigator will also evaluate the potential of cryoablation as a minimally invasive alternative to surgery for small areas of DCIS by examining its ability to achieve complete ablation of DCIS within the targeted cryoablation zone of necrosis.


Eligibility criteria: Inclusion Criteria:

* DCIS spanning 2 cm or less based on its radiographic appearance by mammography and/or breast contrast-enhanced MRI
* Diagnosis of DCIS by minimally invasive needle biopsy
* No prior history of DCIS or invasive breast cancer in the same breast
* No history of surgical biopsy and/or lumpectomy for diagnosis/treatment in the same breast
* Adequate breast volume and skin clearance to permit cryoablation as assessed by Dr. Holmes. This excludes male and females with breasts too small to allow safe cryoablation
* Non-pregnant, non-lactating, and no history of pregnancy within the preceding 6 months
* No history of breast radiation in the same breast

Primary outcomes:
measure: Ability of cryoablation to achieve complete ablation of DCIS
timeFrame: 6 months
Secondary outcomes:
measure: Recurrence rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Office of Dennis R. Holmes, M.D., F.A.C.S.
state: California
Study officials:
References:
Clinical trial NCT02272244: Increasing Colorectal Cancer (CRC) Screening Among Hispanic Primary Care Patients
Official title: Increasing Colorectal Cancer (CRC) Screening Among Hispanic Primary Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Cancer Screening
Decision Support
Navigation
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Lehigh Valley Hospital
name: Fox Chase Cancer Center
name: Patient-Centered Outcomes Research Institute
First posted: 2014-10-22
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to test a standard mailed intervention (SI) versus a novel decision support and navigation intervention (DSNI). Working with patients and stakeholders, this randomized trial will include 400 Hispanic men and women who are 50 to 75 years of age, patients in community based primary care practices, and are eligible for CRC screening. We will consent, survey, and randomize participants either to the SI Group (n=200) or the DSNI Group (n=200). Study specific aims are to: (1) Assess intervention (DSNI versus SI) impact on overall CRC screening adherence; (2)Assess intervention (DNSI versus SI) impact on CRC screening decision stage; (3) Assess intervention (DNSI versus SI) impact on test-specific CRC screening adherence; and (4) Assess intervention (DNSI versus SI) impact on CRC and knowledge and perceptions.


Eligibility criteria: Inclusion Criteria:

* Male or Female
* Self-identifies as being Hispanic or Latino
* 50 to 75 years of age

Exclusion Criteria:

* Previous diagnosis of CRC
* Up to date with CRC screening guidelines.
* Personal history of inflammatory bowel disease
* Personal history of polyps
* Family history of CRC diagnosed before the age of 60 years

Primary outcomes:
measure: Overall Screening Adherence
timeFrame: 12 months
Secondary outcomes:
measure: Change in Screening Decision Stage
timeFrame: 6 months
measure: Test Specific Screening Adherence
timeFrame: 12 Months
measure: Screening Knowledge and Perceptions
timeFrame: 6 months
Other outcomes:
Locations:
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Ronald E Myers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Myers RE, Stello B, Daskalakis C, Sifri R, Gonzalez ET, DiCarlo M, Johnson MB, Hegarty SE, Shaak K, Rivera A, Gordils-Molina L, Petrich A, Careyva B, de-Ortiz R, Diaz L. Decision Support and Navigation to Increase Colorectal Cancer Screening Among Hispanic Patients. Cancer Epidemiol Biomarkers Prev. 2019 Feb;28(2):384-391. doi: 10.1158/1055-9965.EPI-18-0260. Epub 2018 Oct 17.
Clinical trial NCT01669044: Comparison the Hemodynamics Effects Between Dexmedetomidine and Propofol in Major Abdominal Surgical Patients
Official title: Comparison the Hemodynamics Effects Between Dexmedetomidine and Propofol in Major Abdominal Surgical Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Tumor
Intestinal Obstruction
Cirrhosis
Intestinal Fistula
Aneurism
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Postoperative patients of major abdominal surgery

Brief summary: The alpha2 agonist dexmedetomidine is a new sedative agent combined with the analgesic qualities and lack of respiratory depression. Patients sedated with dexmedetomidine could be easily roused, these advances shows dexmedetomidine may be a effective and safe sedative agent. But some studies showed some adversely effects of dexmedetomidine on haemodynamics (such as bradycardia, hypotension), the investigators want to further research the effects of dexmedetomidine on haemodynamics, such as Cardiac Output (CO), Systemic Venous Resistance Index(SVRI), and so on. Propofol is widely used sedative agent in ICU, it also has adversely effects like bradycardia and hypotension, so the investigators want to compare the effect of dexmedetomidine with propofol on haemodynamics after major abdominal surgery. Expect to further research the mechanism of haemodynamics of dexmedetomidine.

Detailed description: When the patients can be roused, they will first receive analgesia with bolus of fentanyl 0.03mg, followed by a continuous infusion at a ﬁxed dose of 0.3μg/kg/h during study period. Then patients will be randomly divided into two groups (Dexmedetomidine and Propofol). All of them will receive hemodynamic monitoring through "Vigileo"(Edwards Lifesciences) and cardiogram monitor. The study will continue for 6-24 hours.

Eligibility criteria: Inclusion Criteria:

1. Postoperative patients of major abdominal surgery
2. Age ≧ 18

Exclusion Criteria:

1. heart rate ≤ 50 bpm
2. allergy with dexmedetomidine or propofol
3. pregnancy

Primary outcomes:
measure: Cardiac output
timeFrame: the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours
Secondary outcomes:
measure: Stroke Volume
timeFrame: the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours
Other outcomes:
measure: Systemic Venous Resistance Index
timeFrame: the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours
Locations:
city: Guangzhou
country: China
facility: First affiliated hostipal,Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: study principal investigator
name: minying chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05635240: Chronic Anterior Shoulder Instability in the Military
Official title: Chronic Anterior Shoulder Instability in the Military
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Shoulder Dislocation
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 120
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 will be composed of French military member with a first episode of true anterior glenohumeral shoulder dislocation.

Brief summary: Anterior shoulder instability is a chronic condition that occurs after an anteromedial dislocation. Its prevalence is high in athletes but has been little studied in the armed forces. In general, patients with a first episode of dislocation have a 1 in 2 chance of experiencing at least one recurrence. The more recurrences there are, the more damage there is to the joint and the greater the disability for the patient. The decree determining the medical aptitude of military personnel emphasizes the need to have recourse to a specialized consultation to determine the classification of the soldier after a first episode of dislocation. In the absence of data collected specifically in the military population, classification is based on the surgeon's experience and extrapolation of results obtained in the general population.


Eligibility criteria: Inclusion Criteria:

* Military member with a first episode of true anterior glenohumeral shoulder dislocation,
* Male or female,
* Major,
* Having a sufficient level of reading/writing of the French language,
* Did not object to participating in the study.

Exclusion Criteria:

* Patient with a history of homolateral shoulder dislocation or surgery on the affected shoulder,
* Collagen disease confirmed by genetic testing,
* Inflammatory arthropathy,
* History of rotator cuff injury,
* Insufficient French reading/writing skills,
* Under legal protection,
* Objection to participating in the study.

Primary outcomes:
measure: Percentage of patients with a new episode of true anterior glenohumeral shoulder dislocation or subluxation 1 year after the initial dislocation.
timeFrame: Through study completion (72 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées Percy
city: Tours
country: France
facility: Direction Médicale des Forces
Study officials:
References:
Clinical trial NCT03093740: Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant
Official title: Use of Direct-acting Antiviral Therapy to Prevent Spread of HCV Infection for Patients Receiving a HCV Positive Kidney Transplant as a HCV Negative Recipient
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Renal Failure Chronic
Hepatitis C
Keywords: hemodialysis
renal failure
kidney transplant
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Based on the genotype and viral resistance testing of the donor, that will be determined within the first week, we will initiate a genotype specific regimen for HCV treatment as available by prescription
Primary purpose: PREVENTION

Brief summary: Open label single center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.

Detailed description: The study objective is to determine if the administration of direct acting antivirals for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment.

Eligibility criteria: Inclusion Criteria:

* Donor meets MGH transplant center criteria and already listed for isolated kidney transplant
* No available living kidney donor
* Recipient has ≤ 730 days of accrued transplant waiting time
* Recipient chronic hemodialysis or peritoneal dialysis
* Recipient must agree to birth control.

  °.Weigh ≥ 50kg
* Serum ALT within normal limits
* Subject's Insurance company approves payment for DAA therapy post-kidney transplant

Exclusion Criteria:

* AB Blood type
* HCV genotype 1
* BMI \> 35
* Any liver disease in recipient
* Pregnant or nursing (lactating) women
* Known allergy or intolerance to tacrolimus that would require administration of cyclosporine
* Albumin \< 3g/dl or
* Platelet count \< 75 x 103/mL
* Positive crossmatch or positive donor specific antibodies
* HCV RNA positive
* Hepatitis B surface antigen positive
* Patients with primary focal segmental glomerulosclerosis (FSGS)
* Any contra-indication to kidney transplantation per our center protocol

Primary outcomes:
measure: Undetectable HCV RNA
timeFrame: 12 weeks post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Raymond Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06450340: A Trial of Tai Chi Intervention for Youngsters with Visual Impairments
Official title: Effects of Tai Chi on Health Fitness and Quality of Life in Youngsters with Visual Impairments: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Impairment and Blindness (Excl Colour Blindness)
Keywords: Tai Chi
physical fitness
sleep quality
quality of life
Lead sponsor: Guangzhou University of Chinese Medicine
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 44
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigators conducted a single-blind, randomized trial of Taijiquan exercise as compared with a control intervention consisting of wellness education and jogging for youngsters with visual impairments. Sessions lasted 60 minutes each and took place three times a week for 12 weeks for each of the study groups. The primary end point was a change in the Brockport Physical Fitness Test (BPFT) at the end of 12 weeks. Secondary end points included summary scores of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and Pittsburgh Sleep Quality Index (PSQI)at the end of 12 weeks.

Detailed description: * Brockport Physical Fitness Test (BPFT) for youngsters with visual impairments, including 20-meter lap scores, Body mass index (BMI), Dominant Grip Strength, Curl-Up, Trunk lift, Back-Saver Sit-and-Reach and Shoulder Stretch.
* Basic information about visually impaired youth, including age, gender, height, weight.
* summary scores of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
* summary scores of of the Medical Outcomes Study Pittsburgh Sleep Quality Index (PSQI)

Eligibility criteria: Inclusion Criteria:

* The age ranges from 10 to 17 years old, regardless of sex.
* had no previous experience as an athlete.
* could follow simple instructions.
* could walk without assistance.
* could maintain a regular lifestyle during the experiment.
* provided informed consent.

Exclusion Criteria:

* The exclusion criterion applied to those who suffered any severe illness or ailment which hinders mobility.

Primary outcomes:
measure: Brockport Physical Fitness Test (BPFT)
timeFrame: One measurement was made from the day of random grouping, and another measurement was made within one week after 12 weeks of exercise intervention.
Secondary outcomes:
measure: 36-Item Short-Form Health Survey
timeFrame: One measurement was made from the day of random grouping, and another measurement was made within one week after 12 weeks of exercise intervention.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: One measurement was made from the day of random grouping, and another measurement was made within one week after 12 weeks of exercise intervention.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou School For The Visually Impaired
state: Guangdong
Study officials:
affiliation: Master Instructor
name: Jian Zheng, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT02112240: Feasibility Study to Develop Sentinel Lymph Node Mapping in Rectal Cancer Patients
Official title: Novel Sentinel Lymph Node Mapping Technique in Early Stage Rectal Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rectal Cancer
Keywords: sentinel lymph node
lymphatic mapping
rectal tumor
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2014-04-11
Enrollment: 0
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: The purpose of this study is to see if investigators can develop a technique to identify sentinel lymph nodes in the rectum for rectal cancer patients with the use of a radiotracer (Tc-sulfur colloid), a dye (Spot), and imaging, both pre- and intraoperatively. Eligible patients are those with stage I-III rectal cancer undergoing standard low anterior resection or abdominoperineal resection.

Investigators hypothesize that use of a unique intraoperative lymphatic mapping technique using a mobile gamma camera will identify the sentinel lymph node in patients with rectal cancer with greater than 80% sensitivity.

Subjects will receive injections of the tracer and dye prior to surgery, have preoperative SPECT/CT imaging to be used as a guide to the rectal lymphatic system and then proceed to their scheduled surgery. During surgery, images of the rectum will be taken with a unique mobile gamma camera prior to removal and upon resection.

If surgeons are able to identify the sentinel lymph nodes surrounding the rectal tumor, the hope is to combine this technique with a less invasive surgery called transanal endoscopic microsurgery (TEM) for early stage rectal cancer patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients with stage I,II, or III rectal cancer undergoing standard trans- abdominal low anterior resection or abdominoperineal resection surgery at the University of Virginia
* Willing and able to give written informed consent

Exclusion Criteria:

* Patients less than 18 years of age
* Women who are pregnant and/or breastfeeding
* Prisoners
* Unable to give written informed consent
* Participants with medical contradictions or have potential problems complying with the requirements of the protocol, in the opinion of the investigator

Primary outcomes:
measure: Evaluating the sensitivity of identifying the sentinel lymph node using a unique mobile gamma camera intraoperatively.
timeFrame: At the time of surgery and the time of pathological review, an expected average of 7 days.
Secondary outcomes:
measure: Feasibility
timeFrame: From the time of tracer and dye injections to 30 day postoperative visit
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Traci L Hedrick, MD
role: PRINCIPAL_INVESTIGATOR
References: