louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00205400: Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
Official title: Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anticoagulation
Thromboembolism
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 192
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: Hypothesis: Does the time spent within the target INR range differ when patients are managed by AMD or IT models of anticoagulation care?

Experimental Design: The 36-month trial enrolled 192 eligible patients currently receiving chronic warfarin therapy at the William S. Middleton Memorial VA Hospital. Consenting patients are enrolled and randomized to 1 of 2 groups: usual clinic care with face-to-face visits every 4 weeks (AMS model) or clinic visits every 3 months with interim laboratory visits and telephone follow-up every 4 weeks (IT model). At study conclusion, the amount of time the INR is within target range will be compared between the two groups. Thromboembolic and bleeding event rates, patient knowledge, quality of life and healthcare utilization will also be analyzed.


Eligibility criteria: Inclusion Criteria:

* completion of \>3 months of warfarin
* indefinite warfarin therapy

Exclusion Criteria:

* patients who currently receive \>25% of INR determinations per year from local labs
* extended absences from VA

Primary outcomes:
measure: Percent time in therapeutic range (TTR) using modified version of Rosendaal method
Secondary outcomes:
measure: Event rates for thromboembolism, hemorrhages, hospitalizations, urgent care visits, emergency department visits, triage calls, INRs greater than 6.0 and quality of life
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Christine Sorkness, Pharm D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01342900: Intraoperative Optimisation of Tissue Oxygenation
Official title: Intraoperative Monitoring and Optimisation of Tissue Oxygenation In High-Risk Surgical Patients for Reduction of Postoperative Complications: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Higk Risk Surgery
Keywords: tissue oxygenation
higk risk surgery
high risk patient
postoperative complications
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2011-04-27
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Monitoring and optimizing tissue oxygenation (StO2) in high-risk surgery and/or high-risk surgical patients may decrease the risk of postoperative complications.

Tissue hypoxia occurs frequently during high-risk surgery in high-risk patients. The investigators want to see if an algorithm aimed at optimizing intraoperative tissue oxygenation reduces perioperative complications as well as length of stay in the intensive care unit (ICU LOS), 28-day mortality, and the duration of mechanical ventilation in these patients.


Eligibility criteria: Inclusion Criteria:

. Major elective surgery

* Aged over 65 years with moderate functional limitation of one or more organ systems
* ASA classification III or IV, i.e. severe cardiac, vascular, respiratory or metabolic illness resulting in severe functional limitation
* Routine use of arterial and central venous lines
* Planned postoperative stay on ICU or PACU

Exclusion Criteria:

* Refusal of consent
* acute myocardial ischemia prior to enrolment
* patients receiving palliative treatment only
* disseminated malignancy
* patients unlikely to survive more than 6 hours
* emergency surgery
* transplantations
* neurosurgical patients
* patients undergoing extensive liver surgery requiring low CVP management

Primary outcomes:
measure: incidence of perioperative complications
timeFrame: during operation
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Thomas W.L. Scheeren, Prof.dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Beest PA, Vos JJ, Poterman M, Kalmar AF, Scheeren TW. Tissue oxygenation as a target for goal-directed therapy in high-risk surgery: a pilot study. BMC Anesthesiol. 2014 Dec 16;14:122. doi: 10.1186/1471-2253-14-122. eCollection 2014.
Clinical trial NCT01734200: Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function
Official title: Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function: a 12 Week, Randomized Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cognitive Function
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on improvement of Memory Function. The investigators measured decrement of improvement of Memory Function, including K-MMSE, Rey-Kim Memory Test, BCRS, and PRMQ, and monitored their blood pressure.


Eligibility criteria: Inclusion Criteria:

* Males and females 16-19 years old
* Weight within ±30% of ideal body weight
* Able to give informed consent

Exclusion Criteria:

* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.

Primary outcomes:
measure: Changes in K-MMSE(Korean Mini-Mental State Examination)
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in Rey-Kim Memory Test
timeFrame: 12 weeks
measure: Changes in BCRS(Brief Cognitive Rating Scale)
timeFrame: 12 weeks
measure: Changes in PRMQ(Prospective and retrospective memory questionnaire)
timeFrame: 12 weeks
measure: Changes in STAI(State-trait anxiety inventory)
timeFrame: 12 weeks
measure: Changes in BDNF(Brain derived neurotrophic factor)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT00557700: Study to Investigate the Effect of Inhaled Tiotropium Bromide on Neurokinin-A Induced Bronchoconstriction in Patients With Mild-to-moderate Asthma
Official title: Study to Investigate the Effect of Inhaled Tiotropium Bromide on Neurokinin-A Induced Bronchoconstriction in Patients With Mild-to-moderate Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Mild to moderate asthma
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2007-11-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial compares the outcome of treatment of mild to moderate asthma: inhaled tiotropium bromide versus placebo.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Male or female, at least 18 years old
* Documented medical history of asthma (diagnosis at least 6 months ago)
* Non-smoker or at least stopped for 1 year (in case smoked earlier: maximum of 10 pack-years)
* Able to conduct a technically acceptable spirometry, methacholine and neurokinin-A provocation test.
* At visit 1: PC20 methacholine ≤ 8 mg/ml AND ≤ 3.3x10-7 mol/ml for the neurokinin-A provocation test.
* At visit 1: forced expiratory value in one second \>= 80% of the predicted value.
* Female subjects may not get pregnant and should be using adequate contraception.

Exclusion Criteria:

* Airway infection within 6 weeks prior to first study visit.
* Other respiratory diseases (eg COPD, lung cancer, etc.)
* Participating in another clinical trial.
* Clinically relevant systemic diseases, other than asthma.
* Clinically significant laboratory deviations.
* Alcohol or drug abuse.
* Female subjects who are lactating.

Primary outcomes:
measure: The mean change in the provocative concentration of neurokinin-A (NKA) causing a 20% fall in the forced expiratory volume in one second (PC20NKA), as a measure of indirect airway hyperresponsiveness
timeFrame: After 20 days
Secondary outcomes:
measure: The change in the one-second-value in the forced vital capacity
timeFrame: After 20 days
measure: The mean change in PC20 of methacholine, as a measure of direct airway hyperresponsiveness
timeFrame: After 20 days
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Liège
country: Belgium
facility: CHU Sart Tilman ULG
Study officials:
affiliation: University Hospital, Ghent
name: Guy Joos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04492800: Hair Loss Prevention Study for Pancreatic Cancer
Official title: A Hair Loss Prevention Study for Patients With Advanced Pancreatic Cancer Utilizing Scalp Cooling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alopecia
Lead sponsor: HonorHealth Research Institute
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pilot study intended for hair loss prevention in patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin.

Detailed description: Patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin will experience hair preservation with the use of the Paxman scalp cooling device, at the end of three, 3 week cycles of chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent/assent for the trial
* \>18 years of age on day of signing informed consent
* Diagnosis of pancreatic cancer and scheduled to receive treatment with a regimen containing nab-paclitaxel, gemcitabine and cisplatin

Exclusion Criteria:

* Grade 1 alopecia
* Existing history of scalp metastases or the presence of scalp metastases is suspected
* No history of previous cancers within the past 5 years
* CNS malignancies (either primary or metastatic)
* Cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, cold migraine, cold urticaria, post-traumatic cold dystrophy
* Imminent bone marrow ablation chemotherapy
* Imminent skull radiation
* Previously received or scheduled to undergo skull irradiation
* Severe liver or renal disease from any etiology as patient may not be able to metabolize or clear the metabolites of the chemotherapeutic agent
* Skin cancers including melanoma, squamous cell carcinoma and Merkel cell carcinoma
* Small cell carcinoma of the lung
* Solid tumors that have a high likelihood for metastasis in transit
* Squamous cell carcinoma of the lung

Primary outcomes:
measure: Hair Preservation
timeFrame: 28 to 84 days
Secondary outcomes:
measure: Patient Comfort
timeFrame: 1 to 84 days
measure: Chemotherapy-Induced Alopecia Distress
timeFrame: 1 to 84 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
Study officials:
affiliation: HonorHealth Research Institute - Bisgrove
name: Amy Mirabella, PhD, RN, CHPN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00964600: Bilateral Transversus Abdominis Plane Block and Postoperative Pain Intensity After Elective Cesarean Delivery
Official title: Evaluation of the Effect of Bilateral Transversus Abdominis Plane Block on Postoperative Pain Intensity and Analgesia Consumption After Elective Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: transversus abdominis block
postoperative pain
cesarean
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-08-25
Enrollment: 60
Sex: FEMALE
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 patients planned to go under elective cesarean delivery under general anesthesia are randomly assigned to have either bilateral transversus abdominis plane (TAP) block or usual standard analgesics after cesarean. Pain score (Verbal Analog Scale VAS) and analgesic requirements are recorded. It's supposed that both are significantly reduced in patients undergoing TAP block.


Eligibility criteria: Inclusion Criteria:

1. Elective cesarean delivery
2. Term pregnancies
3. General anesthesia
4. Pfannenstiel incision

Exclusion Criteria:

1. No history of sensitivity to prescribed analgesic (Bupivacaine or related substances)
2. No preeclampsia
3. No history of psychologic disorders

Primary outcomes:
measure: Pain intensity after cesarean section
timeFrame: one year
Secondary outcomes:
measure: Analgesic prescribed measurement
timeFrame: one year
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Sharati hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Laleh Eslamian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03949400: Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis
Official title: Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rehabilitation
Treatment Outcome
Pain
Knee Brace
Outcome Assessment (Health Care)
Recovery of Function
Patient Reported Outcome Measures
Adults
Osteoarthritis, Knee
Lead sponsor: University College of Northern Denmark
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with knee OA and assigned to undergo exercise therapy and education

Brief summary: The primary aim of the study is to investigate the effects of supervised exercise therapy and education on the immediate response to using a soft knee brace in patients with knee osteoarthritis (OA).

Detailed description: Study type: observational Estimated enrollment: 40 participants Observational model: cohort Time perspective: prospective

Inclusion Criteria:

Assigned for exercise and education due to knee osteoarthrosis Age 18 years or older at the time of recruitment Able to read and understand Danish

Exclusion Criteria:

Not mentally able to reply to the questionnaire

Patients are tested with and without the brace before starting the exercise therapy and education program and re-tested with and without the brace after completing the treatment program (6 weeks) and again at 12 weeks.

Eligibility criteria: Inclusion Criteria:

Assigned for exercise and education due to knee osteoarthrosis Age 18 years or older at the time of recruitment Able to read and understand Danish

Exclusion Criteria:

Not mentally able to reply to the questionnaire

Primary outcomes:
measure: Pain - Numerical rating scale (NRS)
timeFrame: 6+12 weeks follow-up
Secondary outcomes:
measure: Y-balance test (YBT)
timeFrame: 6+12 weeks follow-up
measure: Self-perceived knee stability question
timeFrame: 6+12 weeks follow-up
measure: 40-meter walk test
timeFrame: 6+12 weeks follow-up
Other outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) (continous)
timeFrame: 6+12 weeks follow-up
measure: Pain manikin
timeFrame: 6+12 weeks follow up
measure: Likert scale
timeFrame: 6+12 weeks follow-up
measure: Analgetic pain medication intake
timeFrame: 6+12 weeks follow-up
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Municipality, training unit west
state: Nothern
Study officials:
affiliation: Department of Physiotherapy, University College of Northern Denmark
name: Dorte Drachmann
role: STUDY_DIRECTOR
References:
Clinical trial NCT00812500: Dietary Protein Requirement of Elderly Men and Women
Official title: Dietary Protein Requirement of Elderly Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age
Keywords: assess the effect of age on the EAR and RDA for protein
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2008-12-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to assess the effect of age on the estimated average requirement and adequate allowance for dietary protein.


Eligibility criteria: Inclusion Criteria:

* Age: 21-46 years, 63-81 years old
* Not diagnosed with diabetes or metabolic syndrome
* Clinically normal blood laboratory values

Exclusion Criteria:

* Age: 21 years of younger, 47-62 years old, and 82 years and older
* BMI: 20-29 kg/m
* Weight stable: \<2kg change within the last 3 months
* Physical Activity: constant habitual pattern, no deviation \>1x week of 30/minute sessions within the last 3 months

Clinically abnormal values:

* Blood
* Urine

Also, exclude any:

* Using meds that would influence appetite
* Using any anti-inflammatory steroid medications
* Has a joint replacement
* A medical condition that might place them at risk for participating in the study or interfere with successful completion of the study

Primary outcomes:
measure: To determine the dietary protein requirement of older men and women.
timeFrame: 57 days
Secondary outcomes:
measure: What is the lowest amount of protein that a man or women should eat each day to help him or her stay healthy?
timeFrame: 57 days
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References:
Clinical trial NCT00609700: Balanced Volume Replacement Therapy With Ringer's Acetate Solution in Burn Injury
Official title: Balanced Volume Replacement Therapy With Ringer's Acetate Solution in Burn Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Burn Injury
Keywords: burn injury
volume replacement
Ringer's Lactate solution
Ringer's Acetate solution
volume replacement with crystalloids
Lead sponsor: Klinikum St. Georg gGmbH
Sponsor class: OTHER
First posted: 2008-02-07
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: patients within a 24-hours period after severe burn injury

Brief summary: This observational study compares the influence of Ringer's Lactate solution and Ringer's Acetate solution on organ function scores following severe burn injury.

Detailed description: In the early period following severe burn injury volume replacement with high amounts of crystalloids is necessary. In this study we compare the organ function scores of a historical patient group, treated with Ringer's Lactate solution, with an actual patient population, treated with Ringer's Acetate solution.

Eligibility criteria: Inclusion Criteria:

* Age \>=18 years and \<80years
* Burned surface area \>20% and \<70%
* Burn injury \< 24 hours
* Agreement to the study procedures

Exclusion Criteria:

* Burned surface area \> 70%
* Expected survival time \< 24 hours
* Acute or chronic heart failure NYHA III or IV
* Adult respiratory distress syndrome
* Renal failure
* Hepatic failure

Primary outcomes:
measure: Change of SOFA-score from day 3 to day 7 after severe burn injury
timeFrame: day3, day7, day28, day60
Secondary outcomes:
measure: Changes in electrolyte-balance
timeFrame: day3, day7, day28
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Klinikum St Georg
state: Sachsen
Study officials:
affiliation: Klinikum St. Georg Leipzig
name: Armin R Sablotzki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gille J, Klezcewski B, Malcharek M, Raff T, Mogk M, Sablotzki A, Taha H. Safety of resuscitation with Ringer's acetate solution in severe burn (VolTRAB)--an observational trial. Burns. 2014 Aug;40(5):871-80. doi: 10.1016/j.burns.2013.11.021. Epub 2013 Dec 15.