louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00605124: Progressive Exercise After Total Knee Arthroplasty (TKA)
Official title: Progressive Exercise After Total Knee Arthroplasty: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: osteoarthritis
knee
total knee arthroplasty
exercise
Lead sponsor: Jyväskylä Central Hospital
Sponsor class: OTHER
First posted: 2008-01-30
Enrollment: 120
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: Total knee arthroplasty (TKA) is performed more than 7.000 times a year in Finland most often for osteoarthritis (OA). While pain is predictably reduced, function does not typically ever reach that of age-matched, uninjured subjects. Quadriceps weakness has been implicated in the development and progression of knee OA and is a significant problem after TKA. Advance to return to normal daily activities is not sufficient to restore knee function or quadriceps strength after TKA.

The aim of this study is to assess the effectiveness of progressive exercise program restoring knee strength, mobility and improving the functional outcome after primary TKA.

Detailed description: Many studies have shown, that after TKA pain decreased significantly, but muscle strength of the operated knee did not recover and may stay under the preoperative level. To find out the effects of progressive exercise program the investigators will perform, 6 weeks after TKA, a randomized clinical trial of lower extremity strength training using two subgroups of people: traditional exercise group and progressive exercise group.

Eligibility criteria: Inclusion Criteria:

* primary unilateral TKA for knee osteoarthritis

Exclusion Criteria:

* Rheumatoid arthritis
* Fibromyalgia
* Bilateral TKA
* Heart or lung disease, which prevent training
* Unstable serious disease (cancer)
* Reduced cooperation (drug, alcohol abuse, mental illness)

Primary outcomes:
measure: Functional tests, pain
timeFrame: baseline , 6 weeks after operation (start of training), after 12 months training
Secondary outcomes:
measure: Knee muscle strength
timeFrame: baseline, 6 weeks after operation (start of training), after 12 months training
measure: Health related quality of life
timeFrame: baseline and 12 months
measure: gait analysis
timeFrame: baseline, 6 weeks postoperatively, 12 months
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Ceneral Finland Health Care District
Study officials:
affiliation: Central Finland Health Care District
name: Jari Ylinen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Central Finland Health Care District
name: Arja Häkkinen, PhD, Professor
role: STUDY_CHAIR
affiliation: Central Finland Health Care District
name: Petri Salo, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Finland Health Care District
name: Mirja Vuorenmaa, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Finland Health Care District
name: Maija Pesola, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00810524: Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection
Official title: Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Keywords: Chronic hepatitis B
antiviral treatment
long term prognosis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2008-12-18
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Influence of antiviral treatment to the long term prognosis of patients with chronic HBV infection. The aim of antiviral treatment for HBV is to reduce the long term severe complications. In this study, the investigators divided patients with chronic HBV infection into two groups, which start early antiviral treatment and conventional antiviral treatment respectively. All the patients will be followed for ten years. From this study, the investigators want to find out the optimal time for patients with chronic HBV infection to start antiviral treatment.


Eligibility criteria: Inclusion Criteria:

* HBsAg positive for more than 6 months.
* HBeAg positive.
* HBV DNA over 10E5 copies/ml.

Exclusion Criteria:

* Previous antiviral treatment for HBV.
* Co infection of HIV, HCV, HEV, HAV, or HAV.
* Evidence of hepatic carcinoma.
* Evidence of autoimmune disease.
* Evidence of thyroid disease.
* History of mental sickness.

Primary outcomes:
measure: incidence rate of hepatic carcinoma
timeFrame: 10 years after treatment
measure: incidence rate of liver cirrhosis
timeFrame: 10 years after treatment
measure: incidence rate of fulminant hepatitis
timeFrame: 10 years after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital Of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Gao zhiliang, M. D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06535334: Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer
Official title: Intravenous Chemotherapy Versus Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intravenous Chemotherapy Versus Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: woman with recurrent ovarian cancer who was treated with chemotherapy (either intravenous or intraperitoneal)

Brief summary: This study aims to compare intravenous chemotherapy versus intraperitoneal chemotherapy in patients with recurrent ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* women who had recurrent ovarian cancer and was treated with either intravenous or intraperitoneal platinum based chemotherapy

Exclusion Criteria:

* women who did not complete the designated treatment course (exception to those who had to quit due to progressive disease or death of any cause)

Primary outcomes:
measure: RFS
timeFrame: the time interval from the date of surgery or the start of chemotherapy to clinically defined recurrence, disease progression, death from any cause or last follow-up
measure: OS
timeFrame: the time interval from the date of surgery or the start of chemotherapy to the date of death from any cause or last follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT06773234: Evaluation of the Dental Educational Environment Using the DREEM Tool
Official title: Evaluation of the Dental Educational Environment in Upper Egypt Using the DREEM Tool: a Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Educational Problems
Keywords: Educational Environment
DREEM Tool
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 215
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: students registered in the Faculty of Dentistry, Beni-Suef University

Brief summary: This Cross-Sectional Study aims to evaluate the dental educational environment in Upper Egypt using the Dundee Ready Education Environment Measure (DREEM) Questionnaire.

Detailed description: This Cross-Sectional Study aims to evaluate the dental educational environment in Upper Egypt using the Dundee Ready Education Environment Measure (DREEM) Questionnaire. The questionnaire will be sent to students in Faculty of Dentistry, Beni-Suef University to assess their perception of the educational environment.

Eligibility criteria: Inclusion Criteria:

* Students registered in the Faculty of Dentistry, Beni-Suef University

Exclusion Criteria:

- Students registered in any dental school other than the Faculty of Dentistry, Beni-Suef University.

Primary outcomes:
measure: Evaluation of dental students' perception of the educational environment.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Faculty of Dentistry, Beni-Suef University.
Study officials:
affiliation: Lecturer of Pediatric Dentistry and Dental Public Health Faculty of Dentistry, Beni-Suef University.
name: Shereen Mustafa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01943734: The Influence of Health Information in Stretch Break Program Participant's Lifestyle
Official title: The Influence of Health Information in Stretch Break Program Participant's Lifestyle: a Quantitative and Qualitative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Information
Lifestyle
Occupational Health
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 14
Sex: ALL
Minimum age (years): 28
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Objective: To verify the influence of information passed during anthropometric assessment would have in physical exercise (PhE) and eating habits of 14 participants (female=11; 51,07+-8,17 years) from the Stretch Break Program of Federal University of Paraíba (SBP of FUPb). Methods: The research was a descriptive cross-sectional quantitative and qualitative approach. Were applied, between March and May of 2010, anthropometric evaluation and semi-structured interviews. During the evaluation were provided information and guidance on health.


Eligibility criteria: Inclusion Criteria:

* FUPb white collar workers of either gender

Exclusion Criteria:

* Anyone who did not complete anthropometric measurements

Primary outcomes:
measure: Anthropometric evaluation
timeFrame: Up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Paraiba
name: Caroline Martins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00767234: Permission to Collect Blood Over Time for Research
Official title: Predicting DVT Risk in GI Cancer Patients Using Plasma Biomarkers
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pancreatic Cancer
Gastrointestinal Neoplasms
Colon Rectal Cancer Adenocarcinoma
Esophageal Cancer
Gall Bladder Cancer
Gastric (Stomach) Cancer
Gastrooesophageal Cancer
Gastrointestinal Stromal Tumor (GIST)
Hepatobiliary Neoplasm
Liver Carcinoma
Gallbladder Carcinoma
Bile Duct Carcinoma
Carcinoma of the Large Intestine
Anal Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-10-07
Enrollment: 104
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: Active cancers of the GI tract

Brief summary: To determine whether biomarkers assessed in blood samples can be used to detect individuals at risk for developing blood clots or worsening of their underlying disease. The ultimate goal of the study is to identify key biomarkers derived from blood that are most characteristic and informative of individuals who will go on to develop a clotting complication.


Eligibility criteria: Inclusion Criteria:

* Male or female, \>= 18 years old. There are no ethnic restrictions.
* Active cancers of the GI tract (gastroesophageal, colorectal, or pancreatic-biliary) that have completed TNM staging by the American Joint Committee on Cancer; stage III disease if diagnosed within 2 months and all stage IV disease
* Ability to understand and the willingness to sign a written informed consent document.
* Existing staging CT imaging study

Exclusion Criteria:

* Life expectancy \< 6 months
* History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
* Known pregnancy or positive urine pregnancy test in pre-menopausal women
* On anticoagulant therapy (heparin, warfarin, direct thrombin inhibitors)
* No CT imaging studies, or contraindications to undergoing CT imaging
* Existing or anticipated need for a tunneled central venous catheter
* Clinic visitation to Stanford Cancer center for secondary consultation purposes only
* Inability to give informed consent

Primary outcomes:
measure: Identify Biomarkers
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Haruka Itakura
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01010334: Comparison of Standard of Care or Treatment on Protocol
Official title: Randomized Study of Patients (Patient Choice) Who Are Not Eligible for Variations of Standard of Care Protocols When Treated Either on Best Standard of Care Pathways or Per a Protocol Arm That They Failed to Enroll to
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stomach Cancer
Esophageal Cancer
Bladder Cancer
Skin Cancer
Lung Cancer
Uterine Cancer
Ovarian Cancer
Keywords: INST 0813
Standard of Care
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2009-11-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Patient will choose to either receive the standard of care according to National Comprehensive Cancer Network (NCCN) or approved guidelines for their condition or to be treated according to one arm of the protocol that they could not be enrolled on. The selection of the arm will be at physician discretion.

Detailed description: All patients failing to enroll in a specific therapeutic research protocol using FDA approved drugs or CTMS accepted therapies will be screened for this study. Patients will be randomized (Patient own choice) to either standard of care described in the NCCN guidelines and published as peer-reviewed phase II or III studies which show an efficacy or to one of the arms of the protocol they fail to enroll in, as determined by the treating physician.

Eligibility criteria: Inclusion Criteria:

* Patients must have a cancer requiring chemotherapy or radiotherapy

Exclusion Criteria:

* Inability to comply with study and/or follow-up procedures
* Any contraindication per the FDA notice to the selected drugs
* Pregnant (positive pregnancy test) or lactating. No effective means of contraception (men and women) in subjects of child-bearing potential

Primary outcomes:
measure: Number of courses delivered (relative dose intensity for adjuvant studies)
timeFrame: 6 months
Secondary outcomes:
measure: Response rate
timeFrame: 6 months
measure: Progression- or disease-free survival (for metastatic disease)
timeFrame: 6 months
measure: Overall survival
timeFrame: 6 months
measure: Describe all adverse events of grade > 3 and Serious Adverse Events
timeFrame: 6 months
measure: Measure quality of life using a FACT G tool, before and at best response and at the end of the treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico Cancer Center
name: Claire Verschraegen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00962234: Metabolism of Lipids in Advanced Cancer
Official title: Metabolism of Lipids in Advanced Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Neoplasms
Cachexia
Keywords: Lipogenesis
Lipolysis
Phospholipids
Body Composition
Nutritional Status
Lipid Metabolism
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2009-08-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung cancer patients

Brief summary: The causes of failing nutrition status in advanced cancer are not well known. The way fat is moved, stored, burned or changed into other compounds may be affected and will be followed in patients using a tracer and other blood tests. The investigators hypothesize that fat loss and wasting results from low essential fatty acid availability in the body. Changes may occur in the liver that limits distribution and availability of fat to the body as an energy source or for other essential functions.

Detailed description: Weight loss in cancer is the result of breakdown of fat (lipid) and muscle protein reserves. This research will explore how people with cancer use fat in their body through the use of tracers and measures in the blood. A stable isotope of hydrogen called 'deuterium' is used to trace the production of different fats by the liver. Other methods will determine how much and what types of fat are transported around the body. Body composition will be determined by CT scan and related to fat measures.

Eligibility criteria: Inclusion Criteria:

* Low plasma phospholipids OR low plasma ratio of triglycerides to free fatty acids
* Recent weight loss
* Advanced stage lung cancer (Stage 3 or 4)

Exclusion Criteria:

* Having symptoms that may affect measures of fat metabolism (nausea, vomiting, problems swallowing, etc.)
* Taking n-3 fatty acid supplements such as fish oil

Primary outcomes:
measure: Rate of hepatic de novo lipogenesis
timeFrame: 9 months
Secondary outcomes:
measure: Measures of fat transport and availability
timeFrame: 9 months
measure: Resting metabolic rate & fat oxidation
timeFrame: 9 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Vera Mazurak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05122234: Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19
Official title: Effectiveness and Safety Profile of Mesenchymal Stem Cell Secretomes as a Treatment for Severe Cases of COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Keywords: Severe Covid-19
secretome
mesenchymal stem cell
cytokine
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-11-16
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: This study is a multi-centre randomized controlled trial involving severe covid-19 patients. The intervention group will receive mesenchymal stem cell secretomes and standard covid-19 therapy, while the control group receive placebo and standard covid-19 therapy. Clinical presentation, inflamatory marker, laboratory and radiological parameters, RT-PCR conversion, safety profile, and mortality rate will be monitored for a maximum of 14 days after intervention.


Eligibility criteria: Inclusion Criteria:

1. All individuals aged 18 to 65 years
2. It has been confirmed positive for COVID-19 by throat swab / sputum / brochoalveolar lavage (BAL) with real-time reverse transcription polymerase chain reaction (RT-PCR)
3. Categorized as a severe case of COVID-19 patient
4. Agree to participate and sign the informed consent

Exclusion Criteria:

1. History of allergy to penicillin, streptomycin, and amphotericin-B
2. Have any cancer conditions
3. Active in other intervention studies
4. Have had other intervention studies in the last 3 months

Primary outcomes:
measure: Assessment of inflamation marker levels
timeFrame: Day 0 (before intervention), day 7, day 14
Secondary outcomes:
measure: Assessment of clinical outcome
timeFrame: before and after intervention (maximum 14 days after intervention)
measure: Assessment of laboratory routine
timeFrame: before and after intervention (maximum 14 days after intervention)
measure: Assessment of photo thorax
timeFrame: before and after intervention (maximum 14 days after intervention)
measure: Assessment of RT-PCR conversion
timeFrame: before and after intervention (maximum 14 days after intervention)
measure: Mortality rate
timeFrame: maximum 14 days after intervention
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSUPN Dr. Cipto Mangunkusumo
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: RSUP Fatmawati
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: RSUP Persahabatan
state: DKI Jakarta
city: Depok
country: Indonesia
facility: Rumah Sakit Universitas Indonesia
state: Jawa Barat
Study officials:
affiliation: Departemen of Internal Medicine, Faculty of Medicine, University of Indonesia
name: Murdani Abdullah, Prof. M.D., PhD, FACG, FASGE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04048434: Extracorporeal Cytokine Adsorption as Additive Treatment of CAR-T Associated Cytokine Release Syndrome (CRS)
Official title: Effectivity of Extracorporeal Cytokine Adsorption (Cytosorb) as Additive Treatment of CAR-T Cell Associated Cytokine Release (CRS) Syndrome and Encephalopathy Syndrome (CRES)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cytokine Release Syndrome
CAR-T
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: CytoSorbents, Inc
First posted: 2019-08-07
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with severe CAR-T cell associated cytokine release syndrome (CRS) (defined as vasopressor dependent) will be treated with standard of care (SOC) + cytokine adsorption (6hourly for 24 hrs).

Primary endpoint is the change in plasma IL-6 between 0 and 24 hrs.


Eligibility criteria: Inclusion Criteria:

* severe CRS (\> 3) and / or severe CRES (\>3)

AND

- CRS/CRES onset \< 6 hrs

Exclusion Criteria:

* Heparine allergy
* contraindication for anticoagulation

Primary outcomes:
measure: IL-6 change
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich (USZ)
Study officials:
affiliation: Hannover Medical School
name: Sascha David, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stahl K, Schmidt BMW, Hoeper MM, Skripuletz T, Mohn N, Beutel G, Eder M, Welte T, Ganser A, Falk CS, Koenecke C, David S. Extracorporeal cytokine removal in severe CAR-T cell associated cytokine release syndrome. J Crit Care. 2020 Jun;57:124-129. doi: 10.1016/j.jcrc.2020.02.010. Epub 2020 Feb 19.