louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00584766: Intensive Combo Chemo With Autologous BM Rescue for Metastatic Breast Cancer
Official title: Intensive Combination Chemotherapy With Autologous Bone Marrow Rescue for Metastatic Breast Cancer After Intitial Cytoreduction With Standard Agents: A Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the therapeutic efficacy of high-dose cyclophosphamide and BCNU with autologous bone marrow transplantation after initial tumor cytoreduction for patients with receptor-negative metastatic breast carcinoma and to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast carcinoma


Eligibility criteria: Inclusion Criteria:

* breast carcinoma at first clinical evidence of metastatic disease
* must have measurable disease by physical exam, x-ray, or scan
* Age \< or equal to 55
* performance status 0-2

Exclusion Criteria:

* can't have had more than one prior chemotherapy regimen
* can't have had concurrent hormonal therapy
* no brain metastases
* no previous pelvic radiation
* no history of another malignancy

Primary outcomes:
measure: Quality of maximal response; time to initial disease progression; and overall survival
timeFrame: undetermined
Secondary outcomes:
measure: to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast cancer
timeFrame: undetermined
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: George Selby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02086266: The Efficacy of Pilates in the Recovery of Post-prostatectomy Urinary Incontinence
Official title: The Efficacy of Pilates Compared to Pelvic Floor Muscle Training Associated With Electrical Stimulation in the Recovery of Post-prostatectomy Urinary Incontinence: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Urinary Incontinence
Keywords: Prostatectomy
Urinary Continence
Physical Therapy Modalities
Pelvic Floor
Randomized Trial.
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 54
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy between a Pilates exercise program and a Pelvic Floor Muscle Training (PFMT) protocol combined with anal electrical stimulation (AES) in the recovery of urinary continence (UI) after radical prostatectomy.

There are no studies that evaluate Pilates mat exercises for incontinence in men although it can be assured that this method has the pelvic floor contractions as a principle for practice. If this new therapeutic approach proves to be as effective as described treatment in improving urinary complaints, it will be an option for patients who prefer a non-invasive treatment.

Detailed description: This randomized clinical trial includes 69 individuals with urinary incontinence one month after radical prostatectomy. One physiotherapist, with experience in urogynecology, was responsible for all the assessments. Urinary frequency, nocturia, 24-hour pad test, number of pads used per day, and the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) were the variables evaluated.

The subjects were allocated in one of two treatment groups (G1: Pilates; G2: anal electrical stimulation combined with pelvic floor muscle training). Volunteers participated of 10 sessions of the corresponding treatment and were reassessed objectively by the number of pads used per day, and subjectively with the score of quality of life.

Eligibility criteria: Inclusion Criteria:

* Volunteers between 50 and 75 years old;
* Submitted to radical prostatectomy;
* With complaints of urinary incontinence;
* That completed one month of surgery;

Exclusion Criteria:

* History of incontinence;
* Transurethral resection of the prostate;
* Diagnosis of neurological or cognitive impairment;
* Subjects who were unable to attend treatment sessions, due to distance or physical limitations.

Primary outcomes:
measure: Change in the number of pads used per day at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Change in the 24 hours Pad Test at 3 months
timeFrame: 3 months
measure: Change in the International Consultation of Urinary Incontinence- Short Form at 3 months
timeFrame: 3 months
measure: Change in the episodes of nocturia at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05743426: Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies
Official title: Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcoma
Gastrointestinal Cancer
Keywords: toxicity
survey
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 180
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: Subjects with gastrointestinal malignancy or sarcoma receiving treatment at study center.

Brief summary: This prospective, single-institution, observational study explores disease outcomes and toxicities in subjects with gastrointestinal malignancies and sarcoma (bone and soft tissue) who are being treated with standard-of-care therapies including radiotherapy.

Recent advances in treatment approaches affected disease outcomes and toxicities. Prospective monitoring of disease outcomes and toxicities using standardized assessments will provide information about recent changes in the standard of care and further refine treatment approaches and prospective clinical trial design.


Eligibility criteria: Inclusion Criteria

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

1. Subject is willing and able to provide written informed consent to participate in the study and HIPAA authorization for the release of personal health information. Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designer.
2. Age ≥ 18 years at the time of consent.
3. Histological, cytological, or radiographic evidence/confirmation of a gastrointestinal malignancy or sarcoma.
4. Females with childbearing potential and male subjects with fathering potential are allowed to participate in this study.

Exclusion Criteria

All subjects meeting any exclusion criteria at baseline will be excluded from study participation.

1. Inability or unwillingness to provide informed consent
2. Patients who state they do not expect to be available or willing to follow up at expected intervals post-treatment

Primary outcomes:
measure: Disease-free survival
timeFrame: Up to 10 years
Secondary outcomes:
measure: Local Control
timeFrame: Up to 10 years
measure: Adverse Events
timeFrame: Up to 10 years
measure: Quality of life PRO-CTCAE
timeFrame: Up to 10 years
measure: Quality of life EQ-5D-5L
timeFrame: Up to 10 years
measure: Quality of life Toronto Extremity Salvage Score (TESS)
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, Department of Radiation Oncology
state: North Carolina
Study officials:
affiliation: Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill
name: Theodore K Yanagihara
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06882226: Evaluation of the Emotional Burden of the Nurse
Official title: Evaluation of the Emotional Burden of the Nurse in Onco-hematology
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Burnout, Professional
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nurse attached to uoc 1E hematology and TCSE and uoc 5E geriatric hematology and rare diseases.

Brief summary: Asses the emotional burden on nursing staff and how much they are at risk for burnout.

Detailed description: The study involves the administration of a questionnaire paper questionnaire (maslach burnout scale) in the presence.

Eligibility criteria: Inclusion Criteria:

* Nursing personnel afferent to the OU of hematology and stem cell transplantation hematopoietic and the uoc geriatric hematology and rare hemapathies with more than 2 years of experience in the above departments.
* Signature of informed consent.
* Ability to understand and complete.

Exclusion Criteria:

* Nursing staff not belonging to the departments of hematology
* Failure to sign informed consent

Primary outcomes:
measure: Assessment of emotional burden on nursing staff
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: FPG
name: Fabio Lamberti
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00367926: The Effect of American Ginseng Root and Its Components on Glycemia in Healthy Individuals
Official title: Effect of American Ginseng Root and Derived Polysaccharides on Postprandial Glycemia in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperglycemia
Keywords: ginseng
polysaccharides
postprandial glycemia
area under the glucose curve
peak incremental glucose
Lead sponsor: Risk Factor Modification Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Ontario Ginseng Growers Association
First posted: 2006-08-23
Enrollment: 12
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the effect of polysaccharides from American ginseng root on postprandial glycemia in healthy individuals.

Detailed description: Glycemia-lowering effects of American ginseng root have been repeatedly observed in healthy individuals and in type 2 diabetes. It is unclear which components trigger these effects. Pre-clinical evidence suggests that, aside from ginseng saponins, ginseng polysaccharides may reduce glycemia. This assumption has not been investigated so far in humans.

We therefore undertook a double-blind randomized controlled clinical trial to determine the effect of American ginseng root polysaccharides, at escalating doses, on postprandial glycemia, in comparison to the American ginseng root and control in healthy individuals. We hypothesized that polysaccharides will reduce glycemia comparably to a dose of ginseng root that contains polysaccharides at an equivalent amount to the average polysaccharide dose. We therefore tested polysaccharide doses equivalent to 9, 12 and 15 g of rot, 12 go of ginseng root and a wheat bran control. Each subject received each treatment in random sequence, after a 12-hour overnight fast and 40 minutes prior to a 25-g oral glucose tolerance test. Capillary blood samples were collected at baseline, prior to glucose ingestion and at 15, 30, 45, 60, 90, 120 minutes after the start of glucose intake. Capillary blood glucose was measured.

Eligibility criteria: Inclusion Criteria:

* 16-65 years old
* normal renal and hepatic function
* fasting plasma glucose: 4-6 mmol/l
* clinically euthyroid
* normotensive

Exclusion Criteria:

* pregnant
* taking herbs, supplements or medication that affect glycemia
* major illnesses/ disease
* heavy alcohol use (\> 3 drinks/ day)
* heavy smoking (\> 10 cigarettes/ day)

Primary outcomes:
measure: incremental area under the postprandial glucose curve
measure: incremental peak postprandial glucose
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Risk Factor Modification Centre
state: Ontario
Study officials:
affiliation: St. Michael's Hospital/ University of Toronto
name: Vladimir Vuksan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000426: Treatment of Calcium Deficiency in Young Women
Official title: Treatment of Calcium Deficiency in Young Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Keywords: Calcium deficiency
Dietary calcium
Dietary protein
Osteoporosis
Calcium supplement
Bone density
Bone mass
Bone mass accumulation
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 1999-11-04
Enrollment: 150
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study looks at the effects of calcium supplementation on bone density in women in their third decade of life. We placed women aged 19-27 who take in low amounts of calcium in their diets in one of two groups. We will give women in one group a placebo (inactive pill) and women in the other group 1500 milligrams of calcium per day (as calcium carbonate). We will monitor the results by looking at the change in bone mineral density measured at the hip, total body, forearm, and spine. Treatment will last 3 years.

Detailed description: This is a randomized, controlled trial of calcium carbonate supplementation (1500 milligrams per day) in third-decade women with low calcium-to-protein intakes. We accept women aged 19-27 on the basis of good health and the 7-day food diary demonstrating a dietary calcium-to-protein ratio (in milligrams:grams) that does not exceed 13. The outcome variable is the change in BMD at hip, total body, forearm, and spine. Treatment lasts for 3 years. We expect that bone mass will increase in both groups but will increase to a greater extent in the calcium-supplemented group than in the nonsupplemented group.

Eligibility criteria: Inclusion Criteria:

* Women in good health
* Dietary calcium-to-protein ratio (in mg:g, as assessed by 7-day food diary) does not exceed 13

Exclusion Criteria:

* Smoking
* Pregnancy
* Lactation
* Endocrine disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Robert P. Heaney, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heaney RP. Phosphorus nutrition and the treatment of osteoporosis. Mayo Clin Proc. 2004 Jan;79(1):91-7. doi: 10.4065/79.1.91.
Clinical trial NCT01608126: Medial Cervical Block for Carotid Endarterectomy Comparison With Standard Method
Official title: A Comparison of Medial Cervical Plexus Block Versus Combined (Superficial and Deep) Cervical Plexus Block for Carotid Endarterectomy: A Prospective, Randomized Single Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Plexus Block Comparison
Keywords: Ultrasound
Cervical Plexus
Anesthesia, Conduction
Surgical Procedures, Elective
Atherectomy
Lead sponsor: Masaryk Hospital Krajská zdravotní a.s.
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to compare efficacy, complications and safety of the standard method of Combined (superficial and deep) cervical plexus block (SDCPB) with Ultrasound guided Medial Cervical plexus block technique (MCPB).

Hypothesis: Ultrasound assisted MCPB is safer than SDCPB with similar efficacy.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing Elective Carotid Endarterectomy

Exclusion Criteria:

* Denied consent to block performance, Emergency procedure

Primary outcomes:
measure: number of additional applications of short-acting local anaesthetic
timeFrame: intraoperatively
measure: patient satisfaction
timeFrame: 24 h after operation
measure: Complications
timeFrame: perioperative
Secondary outcomes:
Other outcomes:
Locations:
city: Ústí nad Labem
country: Czech Republic
facility: Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.
Study officials:
affiliation: Masaryk Hospital
name: Daniel Nalos, MUDr.
role: STUDY_CHAIR
affiliation: Purkynje University Ústí nad Labem
name: Jiří Cihlář, Prof Ing
role: PRINCIPAL_INVESTIGATOR
affiliation: Masaryk Hospital
name: Luděk Vašátko, MUDr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Masaryk Hospital
name: David Bejšovec, MUDr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pandit JJ, Satya-Krishna R, Gration P. Superficial or deep cervical plexus block for carotid endarterectomy: a systematic review of complications. Br J Anaesth. 2007 Aug;99(2):159-69. doi: 10.1093/bja/aem160. Epub 2007 Jun 18.
citation: Hakl M, Michalek P, Sevcik P, Pavlikova J, Stern M. Regional anaesthesia for carotid endarterectomy: an audit over 10 years. Br J Anaesth. 2007 Sep;99(3):415-20. doi: 10.1093/bja/aem171. Epub 2007 Jul 9.
citation: Ramachandran SK, Picton P, Shanks A, Dorje P, Pandit JJ. Comparison of intermediate vs subcutaneous cervical plexus block for carotid endarterectomy. Br J Anaesth. 2011 Aug;107(2):157-63. doi: 10.1093/bja/aer118. Epub 2011 May 24.
Clinical trial NCT00166426: Exisulind Versus Placebo After Surgical Removal of the Prostate
Official title: Prospective, Randomized, Double-Blind Trial of Adjuvant Exisulind Versus Placebo for Patients at Risk for Prostate Cancer Recurrence After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: OSI Pharmaceuticals
First posted: 2005-09-14
Enrollment: 240
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a study in which patients with prostate cancer treated by surgical removal of the prostate and considered to be at risk for prostate cancer recurrence will receive Exisulind 250 mg twice a day or placebo twice a day for two years.


Eligibility criteria: Males 18 years of age or older with prostate cancer treated primarily by radical prostatectomy and randomized within 45 days after surgery may be eligible for enrollment into this protocol. Participants cannot have had hormonal therapy, cryotherapy, thermotherapy, or radiotherapy prior to entering the study.

Primary outcomes:
measure: Assess efficacy of drug vs placebo regarding overall rate of biochemical progression
measure: Assess the efficacy of drug vs placebo regarding time to biochemical progression
measure: Assess efficacy of drug vs placebo regarding overall rate of clinical progression
measure: Assess efficacy of drug vs placebo regarding time to clinical progression
measure: Assess efficacy of drug vs placebo regarding cancer specific survival
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Bradley C. Leibovich, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00323726: Trends in Incidence and Survivals for Ovarian Germ Cell Tumors: A 27-Year Population-Based Study
Official title: Trends in Incidence and Survivals for Ovarian Germ Cell Tumors: A 27-Year Population-Based Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ovarian Cancer
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2006-05-09
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ovarian germ cell tumors

Brief summary: Trends in Incidence and Survivals for Ovarian Germ Cell Tumors: A 27-Year Population-Based Study

Detailed description: This is a chart review.

Eligibility criteria: Inclusion Criteria:

* Patients with Ovarian Germ Cell Tumors in the last 27 years.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Harriet Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01224626: Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)
Official title: Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)(Regulatory Post Marketing Commitment Plan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vancomycin Resistance Enterococcus Faecium
Keywords: VRE
Japanese
Post Marketing Surveillance
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-10-20
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who are prescribed to Zyvox (linezolid).

Brief summary: To collect the efficacy and safety information in subjects who have been treated with Zyvox (linezolid) for vancomycin resistance Enterococcus faecium infection for their appropriate use in daily practice.


Eligibility criteria: Inclusion Criteria:

* Subject to whom Zyvox (linezolid) was administered.
* Infected subject with Vancomycin resistance Enterococcus faecium.

Exclusion Criteria:

* Infected subject with MRSA and other organism.

Primary outcomes:
measure: Number of Participants With Adverse Drug Reactions.
timeFrame: Baseline to 8 weeks
measure: Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment.
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Adverse Drug Reactions Unlisted in Japanese Package Insert.
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: