louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002317: A Study of Trimetrexate Plus Leucovorin in Children With Pneumocystis Carinii Pneumonia
Official title: A Study of Neutrexin (Trimetrexate Glucuronate) With Leucovorin Protection for Pediatric Patients (Ages 2-12) With Pneumocystis Carinii Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Pneumocystis Carinii
HIV Infections
Keywords: Trimetrexate
Pneumonia, Pneumocystis carinii
Leucovorin
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in pediatric patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or parenteral pentamidine).

Detailed description: Patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. Leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate. Patients are followed for 1 month.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Pneumocystis carinii pneumonia (PCP) confirmed within 15 days prior to study entry.
* Serious intolerance and/or resistance to standard therapies (such as trimethoprim/sulfamethoxazole and parenteral pentamidine) during the course of therapy for the current episode of PCP, OR a documented history of such intolerance during a prior episode.

Exclusion Criteria

Patients with the following prior conditions are excluded:

History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions due to trimetrexate glucuronate.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: West Conshohocken
country: United States
facility: United States Bioscience Inc
state: Pennsylvania
Study officials:
name: Feinberg J
role: STUDY_CHAIR
References:
Clinical trial NCT03177317: Reduced Dose of Prophylactic Dexamethasone for Elderly Patients Receiving Moderate Emetogenic Chemotherapy
Official title: A Feasibility Study of Reduced Dose of Prophylactic Dexamethasone for Elderly Patients Receiving Moderate Emetogenic Chemotherapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Neoplasms
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Feasibility study to evaluate the efficacy of reduced prophylactic dose of dexamethasone in elderly patients receiving moderate emetogenic chemotherapy

Detailed description: The purpose of this trial is to determine if the dose of dexamethasone used as an antiemetic drug in patients with advanced cancer could be safely reduced.

Eligibility criteria: Inclusion Criteria:

* Histopathologically confirmed colorectal cancer patients with curative resection
* ECOG performance status 0-2
* Provision of signed, written and dated informed consent prior to any study specific procedures
* Receiving adjuvant chemotherapy with FOLFOX (5-FU, leucovorin, oxaliplatin) regimen

Exclusion Criteria:

* Having contraindication to dexamethasone
* Having nausea or vomiting before the start of adjuvant chemotherapy

Primary outcomes:
measure: Complete response (CR)
timeFrame: 2 weeks
Secondary outcomes:
measure: Complete control (CC)
timeFrame: 2 weeks
measure: Complete protection (CP)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jin Won Kim, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04916717: Effect Of Counselıng
Official title: Effect Of Counselıng on Qualıty of Lıfe and Self-Care Agency for Patıents Who Are Scheduled for Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement
Quality of Life
Nursing Caries
Keywords: total knee replacement
nursing counseling
counseling
quality of life
self care agency
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: This is a quantitative study and has a quasi-experimental design with a control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to determine the effect of counseling on quality of life and self-care agency for patients who are scheduled for TKR.

Detailed description: This is a quantitative study and has a quasi-experimental design with a control group. The sample of the study consisted of 79 patients including intervention (n=39) and control (n=40). The data are collected by the face-to-face interview method using Patient Identification Form, Quality of Life Scale, and Self-Care Agency Scale before surgery, and 6-8th weeks after discharge. Face-to-face and telephone counseling were applied to individuals in the intervention group. The x2, t-test, one-factor variance analysis, and two-factor variance analysis were used in the analysis of the data.

Eligibility criteria: Inclusion Criteria:

* undergoing TKA for the first time, being scheduled to have unilateral TKA, having surgery for osteoarthritis, having no postoperative complications, fulfilment of discharge criteria after surgery, being aged 18 years or older, being conscious, orientation to place and time, having no hearing or speech problems, ability to understand and speak Turkish, being at least literate, not being diagnosed with any psychiatric diseases and not having a history of cancer.

Exclusion Criteria:

* diagnoses of neurological (e.g. Alzheimer's disease) and psychiatric disorders (e.g. schizophrenia) likely to affect cognitive functions, first accepting to participate in the study and then dropping out of the study, development of complications during follow-up (e.g. infection), unavailability when called and lost to follow-up.

Primary outcomes:
measure: Quality of life (SF-36)
timeFrame: up to 16 weeks
measure: Self Care Agency
timeFrame: up to16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Uşak
country: Turkey
facility: Usak University Education and Research Hospital
state: Merkez
Study officials:
References:
Clinical trial NCT06575517: A Multifaceted Intervention to Improve Bleeding Management Among Patients Using Oral Anticoagulants (IMPACT-BLEEDING)
Official title: A Multifaceted Intervention to Improve Bleeding Management Among Patients Using Oral Anticoagulants (IMPACT-BLEEDING): a Cluster-randomized Trial
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bleeding
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-08-28
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic use of oral anticoagulant (OAC) suffering a major bleeding event while on OAC.

Brief summary: Prospective, cluster randomized trial including expected 168 patients with chronic use of oral anticoagulation (OAC) suffering major bleeding. Randomization will be performed stratified by geographic region (Southern/Southeastern Brazil versus other Brazilian regions).

Detailed description: The Group 1 in this trial will consist of a multifaceted bundle of instructions to sites about optimal management of bleeding, including transfusion thresholds and when indicated; laboratory assessment of coagulation when indicated; reversal agents when indicated, and tailored approach to restarting of oral anticoagulation and dosing adjustments among patients after bleeding episode. This bundle will be based on a society guideline on bleeding management from the American College of Cardiology. The Group 2 will be randomized to the standard of care. Standard of care will be left to the discretion of the sites (clusters) participating in the study. All sites, including those from the control group, will be encouraged to follow local policies of blood product utilization and bleeding management.

Eligibility criteria: Inclusion criteria

* Age ≥ 18 years;
* Patients using chronic OAC (that is, for 30 or more consecutive days) due to AF/flutter, VTE or other clinical indication and presenting with a major bleeding episode according to the definition of the International Society of Thrombosis and Hemostasis (ISTH). Exclusion criteria
* Patients with limitation to follow-up;
* Patients with do not resuscitate order at time of enrolment.

Primary outcomes:
measure: Proportion of patients adherent to a predefined checklist for optimal bleeding management strategies
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03134417: Magnesium and Vitamin D Supplementation and Cardiometabolic Outcomes
Official title: Parathyroid Hormone and Cardiometabolic Outcomes in Obesity: Role of Magnesium and Vitamin D Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Vitamin D Deficiency
Magnesium Deficiency
Cardiovascular Risk Factor
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2017-05-01
Enrollment: 109
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the effects of a combined vitamin D and magnesium supplementation on parathyroid hormone and cardiometabolic health in persons living with obesity.

Detailed description: Individuals living with obesity are at a higher risk of cardiometabolic abnormalities and high circulating parathyroid hormone. There is evidence suggesting that vitamin D may play a role in cardiovascular health outcomes; however, the research is currently inconclusive. Magnesium is a cofactor of vitamin D metabolism, and the prevalence of concurrent vitamin D and magnesium deficiency is high. This study aims to investigate the effect of vitamin D and magnesium supplements in individuals who are overweight and obese on parathyroid hormone and cardiometabolic health.

Eligibility criteria: Inclusion Criteria:

* BMI range 25-40 kg/m2
* 30-70 years of age

Exclusion Criteria:

* Presence of any acute illness in the past month
* Pre-existing chronic medical conditions or medications know to influence energy, vitamin D, magnesium and calcium metabolism, levels of blood glucose, lipids and blood pressure
* Individuals taking vitamin D and magnesium supplement greater than the Recommended Daily allowance
* Participants taking any medications or have disease known to influence calcium or bone metabolism

Primary outcomes:
measure: Serum parathyroid hormone
timeFrame: 12 weeks
Secondary outcomes:
measure: Inflammatory cytokines
timeFrame: 12 weeks
measure: Lipid profile
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Serum osteocalcin
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University Nutrition Sciences Research Lab
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00912717: Pancreatic Adenocarcinoma Gene Environment Risk Study
Official title: The Pancreatic Adenocarcinoma Gene Environment Risk Study -A Prospective Cohort Study of Patients at Risk or Having Pancreatic Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are diagnosed with pancreatic cancer, who are undergoing a procedure to evaluate their pancreas, and who have a family history of pancreatic cancer are recruited during appointments at the University of Pittsburgh Medical Center (e.g. Pancreas Specialty Care Center, GI laboratory, Hereditary GI Program)

Brief summary: After informed consent, participants will be asked to complete a medical/family history questionnaire and provide a blood sample. Some participants may also be asked to provide a urine sample. Individuals undergoing procedures that require collection of biological samples for clinical purposes may have these samples saved for research purposes. Participants will also be asked for their permission for study investigators to access medical records and/or recontact them for updates to their medical and family histories. Data and biospecimens will be stored for potential future research projects.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed or CT confirmed diagnosis of pancreatic adenocarcinoma
* Subjects with abnormal imaging study (CT, MRI, MRCP, EUS)
* Control subjects with a clinical diagnosis of a pancreas, liver, or intestinal condition
* Control subject with acute pancreatitis
* Control subject with chronic pancreatitis
* Control subject with biliary obstruction
* Control subject with pancreatic cyst
* Member of a high risk family (≥ 1 close relative with pancreatic cancer)
* Healthy control (without any of the above conditions)

Exclusion Criteria:

* Under the age of 18 years
* Unable to give informed consent
* Inability to travel to Pittsburgh for in-person enrollment

Primary outcomes:
measure: The data will be used in cohort association studies. Endpoints will depend on the number of patients in the study and the number of markers that are being evaluated.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Randall E Brand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06978517: Effect of Postural Stability System Comparison to Nintendo Wii Fit Balance Training on Fall Risk and Postural Stability in Elderly
Official title: Effect of Postural Stability System Comparison to Nintendo Wii Fit Balance Training on Fall Risk and Postural Stability in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall Risk
Postural Stability
Balance
Elderly
Keywords: Fall risk
postural stability
Biodex balance system
Nintendo Wii fit
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Human balance is a complex multidimensional concept related to postural control, and it refers essentially to the ability to maintain a posture (e.g., sitting or standing), move between postures, and not fall when reacting to an external disturbance. One-third to one-half of the population over age 65 reports some difficulty with balance or ambulation .Because of the high incidence of balance and mobility disorders in older adults, interventions are necessary that optimize the performance of balance- and mobility-related activities older adults .

The aim of the current study will benefit clinicians and physiotherapists as it provide an insight to the benefits of balance training. The practical application of balance training will provide neurological advantages tothe geriatric population to allow lesser fall risk and postural instability.

The study will be a non-blinded randomized control trial, consisting of two groups. Study will be conducted over 1 year. Subjects will be selected via a non-probability purposive sampling technique using a coin toss method, followed by randomization into two groups (A and B). Ethical approval will be obtained from the ERC FUMC. One group will receive Nintendo Wii Fit balance training while the second group will receive postural stability system training over 8 weeks. Baseline tests will be performed before and after the intervention for balance, postural stability, and sensory integration. Data will be entered and analyzed on SPSS version 22.


Eligibility criteria: Inclusion Criteria:

* Age 55years and above
* Males and females both
* Berg balance scale score 21-40
* TUG in less than 20 sec

Exclusion Criteria:

* Use of a wheelchair or walker.
* Any diagnosed neurological condition.
* Any severe musculoskeletal condition.

Primary outcomes:
measure: Balance
timeFrame: 8 weeks
measure: Fall risk
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University College of Physical Therapy
Study officials:
References:
Clinical trial NCT01380717: Renal and Systemic Vascular Resistance in Chronic Kidney Disease (CKD)
Official title: The Role of Renal and Peripheral Vascular Resistance in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Insufficiency
Hypertension
Vasodilation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 83
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: TREATMENT

Brief summary: Patients with reduced kidney function have a higher risk of heart disease and death. Studies have shown that blood vessels in patients with hypertension change with a decrease of lumen size and growth of the vessel wall. By treating patients with antihypertensive certain medication vessel lumen and walls normalize. Treating hypertension in patients with chronic kidney disease slows the progression of kidney function loss.

The aim is to compare different degrees of antihypertensive medication in patients with chronic kidney disease and hypertension will slow the progression of kidney loss.


Eligibility criteria: Inclusion Criteria:

* eGFR 15-60 ml/min for at least 3 months
* Blood pressure \> 130 mmHg systolic og \>80 mmHg diastolic (patients without antihypertensive treatment or in treatment with Beta-blockers, ACEi, ARBs or CCB not in maximum dosi).
* Blood pressure \< 130 mmHg systolic og \< 80 mmHg diastolic (patients receiving Beta-blockers, ACEi, ARBs og CCB).
* Fertile women using safe contraceptives

Exclusion Criteria:

* Ultrasound verified Polycystic Kidney Disease (ADPKD)
* Claustrophobia (MRi scan).
* Contraindications to MRi.
* Pregnancy or wish to become pregnant in the study period.
* Nephrotic syndrome with gross edema.
* Known allergy to any study medication.
* Blood pressure \< 130 mmHg systolic or \< 80 mmHg diastolic without antihypertensive treatment.
* Blood pressure \> 130 mmHg systolic or \> 80 mmHg diastolic and in maximum dosages of all three Beta-blockers, ACEi (ARBs) and CCB.

Primary outcomes:
measure: Change in glomerular filtration rate between the two treatment arms.
timeFrame: Measured at baseline and after 18 months of treatment
Secondary outcomes:
measure: Changes in glomerular filtration rate stratified after changes in pulse wave velocity, renal vascular resistance and forearm minimal resistance at baseline and after 18 months of treatment.
timeFrame: 18 months
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Renal Medicine, Aarhus University Hospital, Skejby
Study officials:
affiliation: Department og Renal Medicine, Aarhus University Hospital, Skejby
name: Niels Henrik Buus, DrMedSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03810417: Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI
Official title: Single System Double Blinded Trial to Evaluate the Effect of Pre-operative Treatment With DigiFab to Prevent Post-operative Acute Kidney Injury (AKI) in Patients at High Risk for AKI Undergoing Cardiac Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Kidney Injury
Keywords: coronary artery bypass surgery
ouabain
acute kidney injury
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients undergoing coronary artery bypass surgery
Primary purpose: PREVENTION

Brief summary: Acute kidney injury (AKI) occurs in up to 30% of patients undergoing coronary artery bypass graft (CABG) surgery, and often requires patients to go on dialysis. In patients needing dialysis, the risk of dying is very high.There are no known therapies to reduce the chance of developing kidney damage after heart surgery. There is evidence that patients with high levels of a substance called ouabain have an increased risk of developing kidney damage. This study is testing the hypothesis that giving a medication called DigiFab to lower the ouabain levels will reduce the risk of developing kidney damage after heart surgery.

Detailed description: This is a randomized double-blinded study investigating the role of DigiFab in patients with elevated risk of acute kidney injury undergoing CABG surgery. University of Maryland Medical Center (UMMC) and University of Maryland St Joseph Medical Center (UMSJMC) patients who are undergoing CABG, meet the inclusion criteria and provide consent will be enrolled in this study and randomized to either DigiFab arm or the placebo (vehicle) arm. The study involves a follow up period of 72 hours post CABG surgery.

Eligibility criteria: Inclusion Criteria:

* Undergoing coronary artery bypass surgery
* glomerular filtration rate \> 15 History of Diabetes Mellitus or GFR \< 60

Exclusion Criteria:

* Allergy to Digifab Contrast dye within 3 days Creatinine \> 25% above baseline

Primary outcomes:
measure: Renal function
timeFrame: 72 hours
Secondary outcomes:
measure: Need for dialysis
timeFrame: 30 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: St Josephs Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland
name: Stephen S Gottlieb
role: PRINCIPAL_INVESTIGATOR
References: