louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05203705: Clinical Study on the Efficacy and Safety of Multiple Oral Administrations of SHR2285 Tablets in Patients Undergoing Elective Total Knee Arthroplasty
Official title: Efficacy and Safety of SHR2285 Tablets Following Multiple Oral Administrations in Patients Undergoing Elective Total Knee Arthroplasty: a Multicenter, Randomized, Positive-controlled Phase II Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prevention of Venous Thrombosis After TKA
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-24
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR2285 tablets compared with Enoxaparin
Primary purpose: TREATMENT

Brief summary: This study is a multi-center, randomized, open-label, double-blind, positive-controlled phase II clinical study evaluating the efficacy and safety of different doses of SHR2285 tablets vs. enoxaparin for the prevention of postoperative venous thromboembolism in patients undergoing elective unilateral total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

1. Understand the study procedures and methods, voluntarily participate in the study, and sign the written informed consent form (ICF);
2. Scheduled to undergo elective unilateral total knee arthroplasty;
3. Males or females aged 40-75 years.

Exclusion Criteria:

1. Weighing less than 40 kg or greater than 135 kg;
2. Allergic to contrast agents rendering the patient unable to undergo venous angiography of the lower extremities; allergic to enoxaparin or any of the ingredients listed in the package insert thereof; allergic to the investigational product or any of the ingredients thereof;
3. With malignant tumors that still require medical intervention; except for radically treated non-melanoma skin cancer, basal cell carcinoma or squamous cell skin cancer, or cervical carcinoma in situ;
4. With a history of major liver disease within 1 year;
5. With myocardial infarction, transient ischemic attack, or ischemic stroke within 6 months.

Primary outcomes:
measure: Number of patients with confirmed composite endpoint
timeFrame: Day 12
measure: Number of patients with composite bleeding
timeFrame: Day 12
Secondary outcomes:
measure: Number of patients with composite venous thromboembolic events (VTE)
timeFrame: Day 1 to Day 12
measure: Number of patients with composite venous thromboembolic events (VTE)
timeFrame: Day 1 to Day 42
Other outcomes:
Locations:
city: Beijing
country: China
facility: Perking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01672905: PSA Antibody Levels in Samples From Patients With Prostate Cancer Treated on Protocol ECOG-E9802
Official title: Evaluation of PSA Antibody on E9802: Confirmation and Concordance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: recurrent prostate cancer
stage I prostate cancer
stage IIA prostate cancer
stage IIB prostate cancer
stage III prostate cancer
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-08-27
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients who participated in E9802 and provided samples for research

Brief summary: RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This clinical trial studies prostate-specific antigen (PSA) antibody levels in samples from patients treated for prostate cancer on trial ECOG-E9802.

Detailed description: OBJECTIVES:

Primary

* To evaluate changes in prostate-specific antigen (PSA) antibody levels over time among patients treated on ECOG-E9802.

Secondary

* To characterize the concordance of PSA antibody assessment between the ECOG Immunology Laboratory and the NCI Immunology Laboratory.

OUTLINE: Previously tested samples are evaluated for changes in PSA antibody levels over time (from baseline to follow-up at 12 and 24 weeks) at the ECOG Immunology Laboratory and the NCI Immunology Laboratory. Results are compared between the laboratories.

Eligibility criteria: DISEASE CHARACTERISTICS: Samples collected on ECOG-E9802 (A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox/TRICOM with GM-CSF in Patients with PSA Progression after Local Therapy for Prostate Cancer)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: PSA antibody levels are compared between baseline and follow-up at 12 weeks, as well as 24 weeks, using Wilcoxon signed-rank test
timeFrame: 12 weeks
Secondary outcomes:
measure: Concordance of PSA antibody assessment between the ECOG Immunology Laboratory and the NCI Immunology Laboratory; concordance correlation coefficient will be computed
timeFrame: 12 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Robert S. DiPaola, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00857298: Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome
Official title: Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV (Human Immunodeficiency Virus)
Metabolic Syndrome
HIV Infections
Keywords: HIV
Metabolic Syndrome
Obesity
Treatment Experienced
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2009-03-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Obese HIV-positive women with Metabolic Syndrome (HIV-MS) and obese HIV-negative women with Metabolic Syndrome will be studied before and after achieving moderate (6%-8%) diet-induced weight loss. The investigators hypothesize that health markers will improve in both groups but that the improvement will be blunted in the women with HIV-MS.


Eligibility criteria: Inclusion Criteria:

* Sedentary
* Obese
* Have either dyslipidemia (HDL \< 50 or triglycerides \> 150), waist circumference \> 88cm, and impaired glucose tolerance or homeostasis model assessment value of \> 3
* Subjects with HIV-MS must have been receiving HAART for \> 6 months

Exclusion Criteria:

* Medication changes in the last 3 months
* Diabetes mellitus
* Medical problems that in the opinion of the principal investigator may interfere with patient safety
* Substance abuse

Primary outcomes:
measure: Effect of weight loss on body composition
timeFrame: three months
measure: Effect of weight loss on insulin action
timeFrame: three months
Secondary outcomes:
measure: Effect of weight loss on body fat mass
timeFrame: three months
measure: Effect of weight loss on adipose tissue distribution
timeFrame: three months
measure: Effect of weight loss intrahepatic triglyceride content
timeFrame: three months
measure: Effect of weight loss on insulin action adipose tissue
timeFrame: three months
measure: Effect of weight loss on insulin action in liver
timeFrame: three months
measure: Effect of weight loss on insulin action in skeletal muscle
timeFrame: three months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Dominic Reeds, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reeds DN, Pietka TA, Yarasheski KE, Cade WT, Patterson BW, Okunade A, Abumrad NA, Klein S. HIV infection does not prevent the metabolic benefits of diet-induced weight loss in women with obesity. Obesity (Silver Spring). 2017 Apr;25(4):682-688. doi: 10.1002/oby.21793. Epub 2017 Feb 28.
Clinical trial NCT00683098: Long-term Results After Endoscopic Total Extraperitoneal Repair of Recurrent Inguinal Hernia
Official title: Long-term Results After Endoscopic Total Extraperitoneal Repair of Recurrent Inguinal Hernia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia
Keywords: recurrent hernia
endoscopic total extraperitoneal repair
inguinal pain
questionnaire
Lead sponsor: St. Claraspital AG
Sponsor class: OTHER
First posted: 2008-05-23
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients, who had endoscopic total extraperitoneal repair of recurrent inguinal hernia at our institution between 1995 and 2008

Brief summary: Evaluation of long-term results for chronic pain and impairment of daily activities after endoscopic total extraperitoneal repair of recurrent inguinal hernia with inguinal pain questionnaire (IPQ).

Detailed description: Evaluation of long-term results for chronic pain and impairment of daily activities after endoscopic total extraperitoneal repair of recurrent inguinal hernia with inguinal pain questionnaire (IPQ).

All patients, who had a endoscopic preperitoneal mesh repair of a recurrent inguinal hernia between 1995 and 2008 were prospectively recorded and will be sent the IPQ via mail.

Eligibility criteria: Inclusion Criteria:

* patients, who had endoscopic total extraperitoneal repair of recurrent inguinal hernia at our institution between 1995 and 2008

Exclusion Criteria:

* none

Primary outcomes:
measure: Pain according to Inguinal Pain Questionnaire Activity according to Inguinal Pain Questionnaire
timeFrame: up to 10 years
Secondary outcomes:
measure: Recurrence, Reoperation
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: St. Claraspital
Study officials:
affiliation: Department of Surgery
name: Urs Pfefferkorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Staarink M, van Veen RN, Hop WC, Weidema WF. A 10-year follow-up study on endoscopic total extraperitoneal repair of primary and recurrent inguinal hernia. Surg Endosc. 2008 Aug;22(8):1803-6. doi: 10.1007/s00464-008-9917-9. Epub 2008 Apr 29.
citation: Hallen M, Bergenfelz A, Westerdahl J. Laparoscopic extraperitoneal inguinal hernia repair versus open mesh repair: long-term follow-up of a randomized controlled trial. Surgery. 2008 Mar;143(3):313-7. doi: 10.1016/j.surg.2007.09.028. Epub 2008 Jan 14.
citation: Franneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyren O, Sandblom G. Validation of an Inguinal Pain Questionnaire for assessment of chronic pain after groin hernia repair. Br J Surg. 2008 Apr;95(4):488-93. doi: 10.1002/bjs.6014.
Clinical trial NCT03414398: Assessing Cirrhosis Quality of Care While Accounting for Cost
Official title: Assessing Cirrhosis Quality of Care While Accounting for Cost: Is the Patient and/or Caregiver Perspective Associated With Outcomes or Quality Metrics, and What is the Cost of Implementing and Measuring Quality Metrics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Lead sponsor: New York Presbyterian Hospital
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cirrhosis, aged 18-80.

Brief summary: The objective of this study is to determine what influences the patient and caregiver perception of care, and if this perception associates with the percentage of and what quality metrics are being met and outcomes. The investigators also plan to capture the cost of providing quality metrics and the cost of monitoring adherence to quality metrics.

Detailed description: This study will be conducted using mixed-methods. The qualitative part will consist of in person, 1:1, open ended in depth interviews using a standard interview guide with probes. The quantitative part will document subjects meeting or not meeting the quality metrics supported by strong evidence, clinical outcomes, and medical bills.

Eligibility criteria: Inclusion Criteria:

* primary liver cirrhosis
* receiving care at the study cite
* no evidence of hepatic encephalopathy if the subject is providing consent

Exclusion Criteria:

* no documentation of cirrhosis
* unable to confirm diagnosis of cirrhosis by imaging or pathology

Primary outcomes:
measure: Participant perceptions of care
timeFrame: 2 years
measure: Relationship of perceptions of quality of care to recent hospitalizations
timeFrame: 2 years
measure: Relationship of perceptions of quality of care to portal hypertension quality metric adherence
timeFrame: 2 years
Secondary outcomes:
measure: Assess if portal hypertension quality metric adherence equates to less hospitalizations
timeFrame: 2 years
measure: Association of quality metric adherence with survival
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital - Weill Cornell Medicine
state: New York
Study officials:
affiliation: New York Presbyterian Hospital - Weill Cornell
name: Robert S Brown, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01564498: Effects of Purple Vegetables on Cardiovascular Disease (CVD) Risk Factors
Official title: A Pilot Study of the Effects of Replacing Orange Carrots and White Potatoes With Purple Varieties, on Risk Factors for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hypertension
Hypercholesterolemia
Type II Diabetes
Obesity
Inflammation
Keywords: anthocyanins
antioxidant
polyphenols
bioavailability
cholesterol
insulin sensitivity
glucose tolerance
atherosclerosis
metabolic syndrome
Lead sponsor: University of Guelph
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Agriculture, Food and Rural Affairs
First posted: 2012-03-27
Enrollment: 60
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: PREVENTION

Brief summary: The hypothesis is that richly coloured purple vegetables, rich in polyphenolic compounds including anthocyanins will have higher antioxidant and other biological activities, than more lightly coloured versions of these foods. Diets of human subjects will be modified to allow consumption of 200-300 g of raw carrots or cooked potatoes. Participants will be randomized to consume either orange or purple carrots, or white or purple potatoes. They will consume these diets for 12 weeks and bioavailability of polyphenolics will be examined as well as anthropometry and blood biochemistry for changes in risk factors associated with cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* adult men and women 18-65 years of age
* must have a least one of the following risk factors associated with increased risk of type II diabetes and/or cardiovascular disease:

  * borderline high or hypertension or undergoing treatment for such
  * abnormal fasting blood glucose or undergoing treatment for such
  * overweight or obese
  * borderline high or high LDL-cholesterol or undergoing treatment for such
  * borderline low or low HDL-cholesterol
  * borderline high or high triglycerides or undergoing treatment for such

Exclusion Criteria:

* smokers, pregnant or nursing women

Primary outcomes:
measure: Blood cholesterol
timeFrame: 12 weeks
Secondary outcomes:
measure: blood pressure
timeFrame: 12 weeks
measure: body composition
timeFrame: 12 weeks
measure: insulin resistance
timeFrame: 12 weeks
measure: blood and urinary polyphenol metabolites
timeFrame: 12 weeks
measure: circulating biomarkers of cardiovascular disease and type II diabetes risk
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Human Nutraceutical Research Unit
state: Ontario
Study officials:
References:
Clinical trial NCT03929198: Translation of Pritikin Program to the Community
Official title: Population-Based Lifestyle Intervention: Translation of the Pritikin Program to the Community- Pilot Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Obesity
Weight Loss
Hypertension
Hypercholesterolemia
Hypertriglyceridemia
Keywords: metabolic syndrome
obesity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Pritikin Longevity Center
name: Wellmont Health System
First posted: 2019-04-26
Enrollment: 54
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: The broad, long-term aims of this scope of work are to investigate the effects of the Pritikin Program to the general population. The study will test the effects on individuals from the community with dysfunctional lipids, blood pressure and glycemic control. To assess the effectiveness of the Pritikin Program in the community, the effects of Pritikin lifestyle intervention on overall health will be investigated.


Eligibility criteria: Inclusion Criteria:

* Dysfunctional lipids, blood pressure and glycemic control determined at a screening visit:

  * Triglycerides \> 150 mg/dL OR HDL \<50 in females, \<40 mg/dL in males
  * Systolic blood pressure ≥130 mmHg OR diastolic blood pressure ≥80 mmHg (or on hypertension medication)
  * HbA1c ≥5.7% or higher
* No diagnosis or treatment for cancer in the past year
* No diagnosis of mild cognitive impairment or dementia in the past year
* Ability to perform daily exercise, including aerobic activity and resistance exercise
* Non-smoker in the past year

Exclusion Criteria:

* Positive exercise stress test

Primary outcomes:
measure: Body Weight
timeFrame: 6 weeks
measure: Blood Pressure
timeFrame: 6 weeks
measure: Cholesterol
timeFrame: 6 weeks
measure: Triglycerides
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
References:
Clinical trial NCT00000898: The Effects of Staggered Dosing on Interactions Between Paired Combinations of Nelfinavir, Ritonavir, and Saquinavir
Official title: A Prototype Study to Test the Effect of Staggered Dosing on the Pharmacokinetic Interactions Between Paired Combinations of Nelfinavir (NFV), Ritonavir (RTV), and Soft Gelatin Capsule of Saquinavir (SQVsgc)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Drug Interactions
Drug Therapy, Combination
Saquinavir
HIV Protease Inhibitors
Ritonavir
Nelfinavir
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if staggering doses of nelfinavir, ritonavir, and saquinavir has any effect on the interactions between these drugs.


Eligibility criteria: Inclusion Criteria

Patients must have:

* Absence of HIV-1 infection as documented by any licensed ELISA test kit within 14 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Any medical condition that, in the opinion of the investigator, would interfere with the patient's ability to participate in this protocol.

Patients with the following prior conditions and symptoms are excluded:

* History of chronic illness such as hypertension, coronary artery disease, arthritis, diabetes, or any chronic gastrointestinal conditions that might interfere with drug absorption.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Gen Hosp
state: California
city: San Francisco
country: United States
facility: Univ of California/ San Francisco / Dept of Medicine
state: California
city: Stanford
country: United States
facility: Stanford Univ Med Ctr
state: California
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
Study officials:
name: Blaschke T
role: STUDY_CHAIR
name: Flexner C
role: STUDY_CHAIR
name: Sheiner L
role: STUDY_CHAIR
References:
citation: Washington CB, Flexner C, Sheiner LB, Rosenkranz SL, Segal Y, Aberg JA, Blaschke TF; AIDS Clinical Trials Group Protocol (ACTG 378) Study Team. Effect of simultaneous versus staggered dosing on pharmacokinetic interactions of protease inhibitors. Clin Pharmacol Ther. 2003 May;73(5):406-16. doi: 10.1016/s0009-9236(03)00006-7.
Clinical trial NCT06767098: Efficacy of New Ergonomic Device in Non-Specific Neck Pain.
Official title: The Effect of Mobile Holder in Treatment of Patients with Non-Specific Neck Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: neck pain
text neck
smartphone
ergonomics
posture
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if smartphone holder works to treat neck pain in adults. It will also learn about the usability of smartphone holders. The main questions it aims to answer are:

* Does the smartphone holder decrease pain level and improve function in case of neck pain?
* How likely will the participants recommend the holder for their friends?

Researchers will compare adding the holder to the commonly used exercises for neck pain to a group which will receive the common exercise only. To see if the holder can modify neck pain.

Participants will:

* Do the exercise with or without using the holder
* Visit the clinic 3 times per week for a month for receiving exercise
* Keep a diary of their usage for the holder


Eligibility criteria: Inclusion Criteria:

* • Subject's age ranges from 18-45

  * Having neck discomfort symptoms that were triggered by certain neck positions and by palpating the cervical musculature for at least three months
  * Smartphones addiction \>6hours per day

Exclusion Criteria:

* • Pregnancy.

  * Neck pain associated with whiplash injuries or trauma
  * medical red flag history (such as tumour, fracture, metabolic diseases, rheumatoid arthritis and osteoporosis)
  * Neck pain with cervical radiculopathy or neck pain associated with externalized cervical disc herniation.
  * If the patient had previous surgery in the neck area (irrespective of the reason for the operation)

Primary outcomes:
measure: neck pain intensity
timeFrame: "From enrollment to the end of treatment at 4 weeks"
measure: pain pressure threshold
timeFrame: "From enrollment to the end of treatment at 4 weeks"
Secondary outcomes:
Other outcomes:
Locations:
city: Benha
country: Egypt
facility: Outpatient's clinics of the faculty of physical therapy, Benha university
city: Benha
country: Egypt
facility: Faculty of Physical Therapy, Benha University
Study officials:
References: