louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00087932: Socioeconomic Influences on Complementary and Alternative Medicine Use in Cancer Treatment
Official title: Socioeconomic Diversity of CAM Integration in Oncology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Keywords: Complementary Therapies
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-07-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to determine whether differences in the use of complementary and alternative medicine (CAM) are influenced by the socioeconomic status and ethnicity of cancer patients.

Detailed description: The use of CAM is common among patients with cancer. However, there may be differences in participation, treatment preferences, and quality of life that are influenced by socioeconomic factors and ethnicity. This study will compare two distinct socioeconomic groups to determine differences in CAM use.

Participants in this study will complete a questionnaire regarding demographics, socioeconomic status, disease specifics, and facilitators and barriers to CAM use. Participation in an introductory seminar and in various CAM programs will be monitored. Participants will also complete a quality of life scale that will provide insight into the way different populations perceive and use CAM and will identify potential obstacles to integrating CAM into other cancer treatment programs.

Eligibility criteria: Inclusion Criteria:

* Cancer diagnosis
* Able to read and understand English

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Novi
country: United States
facility: Assarian Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: June L. Chan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06944132: CsA vs MMC for Preventing Pterygium Recurrence
Official title: Adjunctive Use of Topical Cyclosporin A Versus Mitomycin C to Prevent Pterygium Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pterygium
Pterygium of the Conjunctiva and Cornea
Keywords: pterygium
Mitimycin C
Cyclosporin A
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: aimed to compare the efficacy and safety of topical cyclosporin A (CsA) versus mitomycin C (MMC) as adjunctive therapies in preventing pterygium recurrence after surgical excision.

Detailed description: A total of 40 eyes from 40 patients undergoing pterygium surgery were randomized into two groups: Group A received topical cyclosporin A, while Group B was treated with topical mitomycin C. Ocular surface inflammation scores, recurrence rates, patient-reported symptoms, and adverse effects were assessed at baseline and during follow-up at 6 months postoperatively.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older.
* Diagnosed with primary pterygium extending at least 1 mm onto the cornea.
* No prior history of pterygium surgery in the affected eye.

Exclusion Criteria:

* History of ocular surface diseases such as dry eye or Sjögren's syndrome.
* Active ocular infection.
* Known hypersensitivity to CsA or MMC.
* Systemic conditions requiring immunosuppressive therapy.

Primary outcomes:
measure: recurrence rate of pterygium
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Change in parameter OSDI (ocular surface disease index) from 0 to 100 points.
timeFrame: 6 months after surgery
measure: Change in clinical parameter Schirmer test (from 0 to 15 mm)
timeFrame: 6 months after surgery
measure: Change in clinical parameter (TBUT)
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ebsar Eye Center
Study officials:
affiliation: Benha University, Ebsar Eye Center
name: Ehab Saad, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00284232: Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes
Official title: Randomized Controlled Trial Studying the Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Keywords: HbA1c
Self-monitoring blood glucose (SMBG)
Diabetes treatment
quality of care
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2006-01-31
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: A randomized controlled trial in patients with type 1 diabetes, assessing the metabolic effects of accurate blood sugar results and education. A systematic approach in self-monitoring blood glucose will improve metabolic control in type 1 diabetes patients. Education in SMBG combined with a high analytical quality instrument for SMBG, introduced in a systematic and thorough way will improve HbA1c by 0,5% and keep it over a period of 9 months.

Detailed description: * Written informed consent 130 patients with type 1 diabetes to be included
* age 18-70
* HbA1c of 8% or higher, variation in HbA1c over the last 18 months sholuld be \<1,5%
* Treated with multiple insulin injections or insulin pumps
* Variation in weight less than 5kg within last year
* Using SMBG on a daily basis
* Mental capacity and stability to participate
* No hypoglycemia unawareness
* No likelihood that patient will drop out or not perform according to protocol
* Continious recruitment from the outpatient clinic at Stavanger University Hospital from October 2004-October 2005
* 9 months follow-up
* Possible 12 month extension after initial
* Intervention group receives new SMBG instrument, education and advice on treatment changes at baseline, 1,2,3,6 and 9 months. Control group continues regular care following national guidelines of Norway. This includes visits usually every 3-6 months at the outpatient clinic and possibly with their GP in addition.

Eligibility criteria: Inclusion Criteria:

* Hba1c 8% or higher, less than 1,5% variation within last year
* Age 18-70
* Multiinjections or insulin pumps
* Stable weight (\<5kg variation last year)
* Mentally stable

Exclusion Criteria:

* Hypoglycemia unawareness
* Mental incapacity

Primary outcomes:
measure: HbA1c %
timeFrame: 9 months
Secondary outcomes:
measure: Hypoclycemic events
timeFrame: 9 months
measure: Measurement quality of blood glucose instrument
timeFrame: 9 months
measure: Frequency of SMBG
timeFrame: 9 months
measure: Satisfaction
timeFrame: 9 months
measure: New learning points for patients
timeFrame: 9 months
measure: Confidence in new instrument quality
timeFrame: 9 months
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Stavanger Health Research
name: Svein Skeie, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01069432: Protocol to Obtain Blood for Discovery of Novel Biomarkers and Potential Therapeutic Targets in Chronic Lymphocytic Leukemia
Official title: Protocol to Obtain Blood for Discovery of Novel Biomarkers and Potential Therapeutic Targets in Chronic Lymphocytic Leukemia
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia
CLL
Normal Volunteers
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2010-02-17
Enrollment: 0
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: Patients at Dartmouth-Hitchcock Medical Center's Norris Cotton Cancer Center

Brief summary: The purpose of this study is to collect a blood sample from patients with Chronic Lymphocytic Leukemia (CLL) and from volunteers without CLL.

Detailed description: The blood sample will be used in the laboratory to perform focused studies on Chronic Lymphocytic Leukemia (CLL).

Eligibility criteria: Inclusion Criteria:

* Patients undergoing routine blood draws as part of their ongoing follow-up care for CLL at the Norris Cotton Cancer Center of DHMC.
* Normal donors who have no history of active or prior hematologic malignancy.

Exclusion Criteria:

* Patients who have received cytotoxic drug, oral or intravenous steroid or targeted antibody therapy for their CLL, other hematologic malignancy or other disease process within the past 2 months are excluded. Use of intravenous immunoglobulin (IVIg) is not a reason for exclusion.
* Normal donors who have a history of steroid use, immunosuppression therapy or autoimmune disease are excluded.

Primary outcomes:
measure: To identify the genes that are differentially expressed at the polysomal RNA and protein levels in human patient CLL cells (compared to normal donor lymphocytes) using high-throughput microarray approaches.
timeFrame: 2 Years
Secondary outcomes:
measure: To determine whether the novel candidate genes from Specific Aim 1 have potential roles in CLL. (Note: Specific Aim 2 does not involve human subjects research).
timeFrame: 2 Years
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Christopher H Lowrey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00932932: Cortisol Activity in Patients With Prader-Willi Syndrome and Healthy Controls
Official title: 11 Beta Hydroxysteroid Dehydrogenase 1 (11-beta HSD 1) Activity in Patients With Prader-Willi Syndrome and in Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prader-Willi Syndrome
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2009-07-07
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Defined population

Brief summary: The purpose of the study is to find out if people with Prader-Willi syndrome have a difference in the protein which changes inactive cortisone to the active stress hormone cortisol.


Eligibility criteria: Inclusion Criteria:

* Prader-Willi syndrome confirmed by molecular testing, ages 6 months to adult
* Controls: Age-matched, sex-matched, developmentally normal, BMI-controlled healthy or obese subjects

Exclusion Criteria:

* PWS subjects without molecular confirmation of the diagnosis
* Subjects receiving glucocorticoid treatment within 3 months of evaluation
* Subjects receiving growth hormone within one year prior to analysis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Wayne Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00584532: Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance.
Official title: Effects of a Genistein Concentrated Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Keywords: Localized
Prostate
Cancer
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 66
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Genistein Combined Polysaccharide (GCP) may play a role as a secondary chemopreventive agent in the treatment of localized prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Participants must be male and have a pathological diagnosis of prostate cancer
* Pathological diagnosis of prostate cancer must be confirmed and on file with CRA prior to study entry.
* No treatment (surgery, radiation, or hormones) prior to study entry.
* PSA between 2.0 and 10.0 ng/ml.
* If PSA is \>10.0, patient must have been on Active Surveillance for 12 months prior to study initiation.
* No known allergy to soy or soy products.
* The patient is not currently taking more than 2 grams of genistein a day in nutritional or diet enhancing supplements (OTC supplements).
* Participant has not been on any previous GCP clinical trial.
* Normal Chemistry values prior to study entry.

Exclusion Criteria:

* No pathological documentation of prostate cancer.
* Prior treatment for prostate cancer.
* PSA \>10.0 ng/ml but not on Active Surveillance for 12 months.
* Allergy to soy or soy products.
* Abnormal chemistry values.

Primary outcomes:
measure: Decrease in PSA levels in men on GCP
timeFrame: 6 Months
Secondary outcomes:
measure: Increased PSA Doubling Time (PSADT)in men on GCP.
timeFrame: 6 Months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Davis - Dept. of Nutrition
name: Robert Hackman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02385032: Comparative Bioavailability Study of UDCA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2015-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate bioavailability of two formulations of ursodiol.


Eligibility criteria: Inclusion Criteria:

* BMI ≥ 19.0 and ≤ 30.0 kg/m2.
* No clinically significant findings in a 12-lead electrocardiogram (ECG)
* Be informed of the nature of the study and give written consent prior to any study procedure

Exclusion Criteria:

* Known history or presence of any clinically significant medical condition
* Participated in a clinical trial which involved administration of an investigational medicinal product within 30 days prior to drug administration, or recently participated in a clinical investigation that, in the opinion of the investigator, would jeopardize subject safety or the integrity of the study results

Primary outcomes:
measure: AUClast
timeFrame: 72 hours
measure: Cmax
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04689932: Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
Official title: Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End Stage Renal Disease
Lead sponsor: Rockwell Medical Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the delivery of Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the pre-dialyzer and post-dialyzer blood lines.

Detailed description: This is a single center, multi dose, open label study assessing the delivery of Triferic AVNU administered intravenously to adult patients (\> or equal to 18 years of age) using the Freedom Pump-20 during hemodialysis into the pre-dialyzer and post-dialyzer blood lines.

Eligibility criteria: Inclusion Criteria:

1. Participant must be 18 years of age inclusive, at the time of signing the informed consent.
2. Receiving chronic hemodialysis for 3-4 hours each session 3x/week.
3. Medically stable according to the investigator opinion
4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

1. Hemodynamically unstable during hemodialysis
2. Evidence of active bleeding from the GI tract.

Primary outcomes:
measure: Time for Complete Infusion of 4.5 mL Triferic AVNU Pre-Dialyzer
timeFrame: On Days 1, 3, and 5, up to 3 hours
measure: Time for Complete Infusion of 4.5 mL Triferic AVNU Post-Dialyzer
timeFrame: On Days 2, 4, and 6, up to 3 hours
Secondary outcomes:
measure: Mean TSAT Max Pre-Dialyzer
timeFrame: up to 3 hours
measure: Mean TSAT Max Post-Dialyzer
timeFrame: up to 3 hours
Other outcomes:
Locations:
city: Webster
country: United States
facility: Luxury Dialysis
state: Texas
Study officials:
affiliation: Rockwell Medical
name: Raymond D Pratt, MD, FACP
role: STUDY_DIRECTOR
References:
Clinical trial NCT02499432: Improving Implementation of Evidence Based PTSD Psychotherapy for Veterans in the Community
Official title: Improving Implementation of Evidence Based PTSD Psychotherapy for Veterans in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: Evidence Based Psychotherapy
Implementation
PTSD
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: The Tug McGraw Foundation
First posted: 2015-07-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To further increase the access of evidence based psychotherapies for Veterans with Posttraumatic Stress Disorder, we propose to offer training and intensive consultation to community-based providers in Cognitive Processing Therapy for Posttraumatic Stress Disorder. However, we believe that many clinicians may not implement Cognitive Processing Therapy or take advantage of consultation after initial training. For this reason, we propose to examine the effectiveness of an enhanced training method, which would add Motivational Interviewing to the standard Cognitive Processing Therapy training. Motivational Interviewing is a form of collaborative discussion for strengthening motivation and commitment to change. We hypothesize that augmenting the standard Cognitive Processing Therapy training with these techniques will reduce providers' reluctance to fully implement the interventions.


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* currently licensed in their mental health discipline or a graduate level trainee in their mental health discipline

Exclusion Criteria:

* Have completed a 2-day training in Cognitive Processing Therapy

Primary outcomes:
measure: Change assessed by Evidence Based Practice Attitudes Scale - 50
timeFrame: immediately pre-intervention/immediately post 2 day intervention/6 month followup
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Veterans Medical Research Foundation
state: California
Study officials:
affiliation: San Diego VA Healthcare System/UCSD/VMRF
name: Carie S Rodgers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01771432: Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria
Official title: Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria. A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asymptomatic Bacteriuria
Pyelonephritis
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective: To determine whether antibiotic treatment of asymptomatic bacteriuria in kidney transplant recipients could be useful to prevent pyelonephritis in these patients.

Detailed description: Design: Randomized prospective study. Setting: University Hospital with an active kidney transplantation program. Patients: Adult kidney transplant recipients. Interventions: Kidney transplant recipients with asymptomatic bacteriuria will be randomly assigned to be treated with antibiotics or to be followed without antibiotic therapy.

Measurements: Urine cultures will be collected weekly during the first month after transplantation, every 2 weeks until three months after transplantation, every month until 6 months after transplantation and every 3 months until 12 months after transplantation. Urine culture will be as well collected if urinary symptoms appeared.

Primary end points: To determine in both groups: the incidence of pyelonephritis.

Secondary end points: To determine outcomes in both groups (renal function, hospitalization, rejection, graft loss, opportunistic infections and mortality) and infection by multiresistant microorganisms.

Eligibility criteria: Inclusion Criteria:

* Patients who receive a transplant allograft during study period

Exclusion Criteria:

* No acceptation of study

Primary outcomes:
measure: To determine the incidence of pyelonephritis in both groups
timeFrame: First year after kidney transplantation
Secondary outcomes:
measure: Renal function
timeFrame: First year after kydney transplantation
measure: Need for hospitalization
timeFrame: First year after kydney transplantation
measure: Incidence of graft loss
timeFrame: First year after kidney transplantation
measure: Mortality
timeFrame: First year after kidney transplantation
Other outcomes:
measure: Infection by multiresistant microorganisms
timeFrame: First year after kydney transplantation
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
affiliation: Hospital Universitari de Bellvitge
name: Núria Sabé Fernàndez
role: PRINCIPAL_INVESTIGATOR
References: