louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01423032: Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
Official title: Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Lymphocytic Leukemia
Keywords: relapsed
Lead sponsor: WiSP Wissenschaftlicher Service Pharma GmbH
Sponsor class: OTHER
Collaborators: name: Klinikum Leverkusen gGmbH
name: ribosepharm GmbH
name: Mundipharma Research GmbH & Co KG
First posted: 2011-08-25
Enrollment: 96
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: Bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to its unique mechanism of action distinct from standard alkylating agents. This study assesses its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in comparison to fludarabine.

Patients with relapsed chronic lymphocytic leukemia requiring treatment after one previous systemic regimen (usually chlorambucil-based) are randomized to either receive bendamustine 100 mg/m² on days 1 and 2 of a 4-week cycle, or standard fludarabine treatment consisting of 25 mg/m² on days 1 to 5 every four weeks. The primary objective was to achieve non-inferior progression-free survival with bendamustine.


Eligibility criteria: Inclusion Criteria:

* histologically or immunologically confirmed chronic B-cell leukemia
* refractory (i.e. no response or progression during initial chemotherapy) or relapsed situation after first-line treatment regimen
* disease stage II-IV according to Rai or B/C according to Binet staging system, respectively
* Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better
* negative pregnancy test/ adequate method of contraception

Exclusion Criteria:

* T-CLL, PLL (prolymphocytic leukemia)
* presence of Richter's transformation
* first-line treatment containing either fludarabine or bendamustine
* acute infections or distinctly reduced organ function precluding the application of chemotherapy, as for pulmonary, heart, liver (total bilirubin \> 5mg/dl), renal system (creatinine \> 2 mg/dl), or metabolic disorders
* secondary malignancy (except for curative treated basal cell carcinoma or cervical cancer)

Primary outcomes:
measure: progression-free survival
timeFrame: the patients were followed on average for 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leverkusen
country: Germany
facility: Prof. Dr. Norbert Niederle
state: NRW
Study officials:
affiliation: Med. Klinik III, Klinikum Leverkusen gGmbH, Germany
name: Norbert Niederle, Prof, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01620632: Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatome
Official title: Prospective Evaluation of the Clinical Utility of Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Disease
Pancreas Disease
Keywords: laparoscopy assisted ERCP
altered gastric anatomy
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those patients who have altered gastric anatomy that require a laparoscopy assisted ERCP

Brief summary: The purpose of this research study is to collect data on the technical aspects of Lasparoscopy-assisted ERCP and patient outcomes to help guide future medical care of patients with Roux-en-Y gastric bypass surgery.

Detailed description: Patients would have had a Roux-en-Y gastric bypass in the past that had altered their gastric anatomy. Now they have developed bilary and/or pancreatic problems that require and ERCP. With their altered gastric anatomy a standard ERCP would not be possible. Thus they are scheduled for a Laparoscopy-assisted ERCP.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Altered gastric anatomy
* Scheduled to undergo laparoscopy-assisted ERCP

Exclusion Criteria:

* Any contraindications to performing endoscopy
* Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
* The subject is unable/unwilling to give informed consent

Primary outcomes:
measure: patients with altered gastric anatomy who need an ERCP
timeFrame: approximately one week
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Peter V Draganov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00277732: Pharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial
Official title: Pharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2006-01-16
Enrollment: 288
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for diabetes type 2 patients. Patients will be randomly allocated to the control group ( = no input from pharmacist) or intervention group ( = with pharmaceutical care at baseline and follow-up visits over 6 months).


Eligibility criteria: Inclusion Criteria:

* 45-75 years
* Body Mass Index \>= 25
* Diabetes treatment for at least 12 months
* Regular visitors of the participating community pharmacy

Exclusion Criteria:

* Patients taking only insulin (no oral antidiabetic drugs)

Primary outcomes:
measure: The difference between the study groups in the change of blood glucose and HbA1c
timeFrame: baseline and after 6 months
Secondary outcomes:
measure: Knowledge about diabetes and treatment
timeFrame: after 6 months
measure: Therapy adherence
measure: Body Mass Index
timeFrame: after 6 months
measure: Periods of severe hypoglycemia
measure: GP visits, emergency room visits and hospitalisations
measure: Work days lost
measure: Frequency of eye and foot examination
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Mimi Giri, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02563132: Carbon Dioxide Insufflation Colonoscopy in IBD Patients
Official title: Carbon Dioxide Insufflation Colonoscopy in Inflammatory Bowel Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Carbon Dioxide
Inflammatory Bowel Disease
Keywords: colonoscopy
carbon dioxide
inflammatory bowel disease
Lead sponsor: Vitkovice Hospital
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) after the procedure. So far, it has not been studied in inflammatory bowel disease patients. The study was designed to evaluate discomfort after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.

Detailed description: Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) during up to 24 hours after the procedure. So far, it has not been studied in inflammatory bowel disease patients who represent specific patient population indicated for colonoscopy. They are characterized by younger age, structural changes of the colon including intestinal resections and need for repeated and frequently difficult procedures.The study was designed to evaluate discomfort during 24 hours after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.

Eligibility criteria: Inclusion Criteria:

* known diagnosis of Crohn´s disease and ulcerative colitis
* indication for diagnostic colonoscopy
* informed consent
* unsedated or minimally sedated procedure (\< 3 mg of midazolam)

Exclusion Criteria:

* planned incomplete or therapeutic procedure
* deep sedation or general anesthesia
* intestinal resection longer than ileocecal resection
* isolated gastroduodenal or jejunal location of Crohn´s disease (L4)
* ulcerative proctitis (E1)

Primary outcomes:
measure: Bloating score 1 hour after the colonoscopy
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
facility: Digestive Diseases Center - Vitkovice Hospital
Study officials:
References:
Clinical trial NCT03859232: Effectiveness of Cotton vs. Waterproof Cast Padding
Official title: Effectiveness of Cotton vs. Waterproof Cast Padding After Application of Hip Spica: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Developmental Dysplasia of the Hip
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 0
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to: 1) investigate the effectiveness of waterproof spica cast using Delta-Dry® Pantaloon and cast padding (BSN medical, USA) versus standard gortex pantaloon with cotton cast padding in maintaining the femur fracture and developmental dysplasia of the hip reduction after application of hip spica; 2) evaluate the overall quality ratings of both cast paddings from the perspectives of the patient and the clinicians; and 3) determine the cost difference between the both cast paddings.


Eligibility criteria: Inclusion Criteria:

* Paediatric patients (\<6 years old) diagnosed with developmental dysplasia of the hip or femur fracture who present to Texas Children's Hospital and plan to be treated with a spica cast.

Exclusion Criteria:

* Patients with thigh diameter more than 13.4 inches will be excluded because of the size limitation of the Delta-Dry Pantaloon
* Patients with femur fracture who present for treatment more than 2 weeks from the date of injury, comminuted fracture, non-displaced fracture, or with other surgical comorbidity

Primary outcomes:
measure: Effectiveness as a measure of change in ratings at different time points
timeFrame: Baseline, 2, 6 and 12 weeks post-application
Secondary outcomes:
measure: Quality
timeFrame: Baseline, 2, 6 and 12 weeks post-application
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
References:
Clinical trial NCT01725932: Randomized Controlled Trial of Cognitive Therapy Based Self Help Manual for Depression
Official title: A Multicentre Randomised Controlled Trial of Culturally Adapted CBT Based Self Help Manual for Depression in Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: culture, depression, cognitive therapy, behaviour therapy,
Lead sponsor: Pakistan Association of Cognitive Therapists
Sponsor class: OTHER
First posted: 2012-11-14
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: While CBT (Cognitive Behaviour Therapy)has been found to be effective in treating depression in West, only limited amount of research has been conducted to find assess its effectiveness in low and middle income countries. We have developed culturally sensitive CBT during the last few years in Pakistan. Pakistan has high rates of depression. And there is currently a need to develop and test evidence based treatments which are culturally sensitive and cost effective. IN this project we will be assessing the effectiveness of a culturally sensitive CBT based self help intervention for depression in Pakistan against care as usual, using a randomized controlled design.


Eligibility criteria: Inclusion Criteria:

* All those who fulfil the diagnosis of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4 ) using ICD10 RDC (International Classification of Diseases, Research Diagnostic Criteria), scored 8 or more on HADS (Hospital Anxiety and Depression Scale) Depression Sub-scale, are between the ages of 18-60 and either patient or the carer has at least 5 years of education.

Exclusion Criteria:

* The exclusion criteria include; excessive use of alcohol or drugs (using ICD 10 RDC for alcohol or drug abuse or dependence) significant cognitive impairment (for example learning disability or dementia) and active psychosis.

Primary outcomes:
measure: Hospital Anxiety and depression Rating Scale- Depression subscale
timeFrame: Participants will be assessed at baseline and then end of therapy at 12 weeks
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale, Anxiety subscale
timeFrame: Participants will be assessed at baseline and then end of therapy at 12 weeks
measure: Bradford Somatic Inventory
timeFrame: Participants will be assessed at baseline and then end of therapy at 12 weeks
measure: Brief disability questionnaire
timeFrame: Participants will be assessed at baseline and then end of therapy at 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: PACT
name: Mehwish Khalid, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT04143932: Multiple Myeloma Turkish Prospective Patient Registry
Official title: Multiple Myeloma Patient Registry - Prospective National Multi Center Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Relapse Multiple Myeloma
Keywords: multiple myeloma
MM
Registry
Turkey
Lead sponsor: Turkish Hematology Association
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients diagnosed as multiple myeloma received maximum 2 lines of therapy will be included to this prospective registry.

Brief summary: This is a non-interventional, national, multi center, prospective multiple myeloma registry in Turkey

Detailed description: In this study, approximately from 40 centers 1000 patients will be recruited. All patients will be followed-up till the study end.

All the laboratory results, treatment protocols and responses will be recorded and assessed with EORTC Multiple Myeloma Specific Quality of Life Multiple Myeloma Specific (MY-20) and EORTC Quality of Life-C30 questionnaires.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as multiple myeloma
* Patients signed informed consent form
* Patients received no more then 2 lines of therapy

Exclusion Criteria:

* Patients below 18 years old

Primary outcomes:
measure: Overall Survival
timeFrame: [Time Frame: 5 Years]
measure: Progression Free Survival
timeFrame: [Time Frame: 5 Years]
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol University
Study officials:
affiliation: Medipol University Hospital
name: Omur Gokmen Sevindik, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06425432: Higher Order Aberration and Relationship With Soft Contact Lens Modulus
Official title: Higher Order Aberration and Relationship With Soft Contact Lens Modulus
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Corneal Wavefront Aberration
Keywords: Contact Lens
Higher order aberration
Modulus
Lead sponsor: Southern College of Optometry
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (\>18 years old) who are wearing single-vision soft contact lenses will be recruited.

Brief summary: Higher order aberrations are imperfects in the eye that affect the quality of image projected onto the retina. Soft contact lenses are made of different materials with different stiffness. This study looks to see if the soft contact lens material affects the amount of higher order aberrations in an eye.


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide informed consent
* Adults \> 18 years old regardless of gender, race, or ethnicity
* Habitual single vision soft CL wearer for at least 1 week in any modality.

Exclusion Criteria:

* Multifocal soft CL wear
* GP or ortho K wear in the last 3 months.
* Active eye infections and inflammations.
* Current use of ocular medication.

Primary outcomes:
measure: Mean change in HOA with and without contact lenses
timeFrame: Within the same study visit, measurements will be taken 15 minutes apart to allow for tear film to return to homeostasis after contact lens insertion/removal.
Secondary outcomes:
measure: Correlation between contact lens modulus and changes in HOA with and without contact lenses
timeFrame: Within the same study visit, measurements will be taken 15 minutes apart to allow for tear film to return to homeostasis after contact lens insertion/removal.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02912832: Prospective Assessment of TBDx Feasibility
Official title: TBDx Feasibility Study: Prospective Study to Determine the Feasibility of Automated Smear Microscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Tuberculosis
Keywords: Diagnosis
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 572
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study will be to determine the performance characteristics of TBDx with culture as a gold standard. In addition, the investigators will assess the laboratory technicians' appraisal and technical suitability of the TBDx system.

Detailed description: This will be a blinded, prospective study to determine the performance of the TBDx system for detection of pulmonary TB in comparison to LED microscopy and culture as a gold standard. The study will involve recruitment of 300 TB suspects per site with a high workload and experienced technicians. Participants will be recruited under the FIND TB Reference Materials project and leftover sputum samples used for the assessment of the TBDx.

Eligibility criteria: Inclusion Criteria:

* Persistent cough (\>2 weeks) and at least one other typical symptom of pulmonary TB (fever, night sweats, malaise, recent weight loss, contact with active case, hemoptysis, chest pain, loss of appetite)
* Provision of informed consent (FIND TB Reference Materials)
* Provision of sputum for adequate testing

Exclusion Criteria:

* Patients receiving any anti-TB medication, in the 60 days prior to testing.
* Patients with only extra-pulmonary disease

Primary outcomes:
measure: Performance of TBDx compared to culture
timeFrame: 6 months
Secondary outcomes:
measure: Training needs through questionnaire assessment
timeFrame: 6 months
measure: Comparison of performance of TBDx on direct vs concentrated smear
timeFrame: 6 months
measure: Performance of TBDx in combination with Xpert MTB/RIF through analysis of two different algorithms
timeFrame: 6 months
measure: User appraisal regarding ease of use, hands-on-time and perceived benefit through appraisal questionnaire
timeFrame: 6 months
measure: Identify potential difficulties for implementation through observation and user appraisal
timeFrame: 6 months
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Instituto de Medicina Tropical Alexander von Humboldt - Universidad Peruana Cayetano Heredia
city: Ho Chi Minh City
country: Vietnam
facility: Pham Ngoc Thach Hospital
Study officials:
affiliation: Find
name: Claudia M Denkinger, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04409132: Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.
Official title: A Randomized 4 Period Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: End Stage Renal Disease
Keywords: Pharmacokinetics
Lead sponsor: Rockwell Medical Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-01
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will investigate the administration of Triferic AVNU intravenously by three different administration schedules compared to continuous infusion over 3 hours

Detailed description: An open-label, randomized, four period sequential study of Triferic AVNU administered intravenously by three different administration schedules compared to continuous infusion over 3 hours

Eligibility criteria: Inclusion Criteria:

* Adult hemodialysis patients ≥18 years of age.
* Signed informed consent to participate in the study.
* Stable on hemodialysis prescription for ≥3 months.
* Able to sustain hemodialysis 3x/week for 3 to 4 hours.
* Hemoglobin concentration \>9.5 g/dL.
* Serum TSAT ≥20%.
* Receiving hemodialysis via AV fistula or graft.
* Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.
* Able to receive intermittent heparin administration for anticoagulation of the dialysis circuit.
* Serum TIBC ≥ 150 µg/dL.

Exclusion Criteria:

* Active bleeding disorder (GI, skin, nasal...)
* Receiving hemodialysis via catheter.
* Receiving IV iron within 10 days of the first on-study hemodialysis treatment.
* Receiving oral iron within 10 days of the first on-study hemodialysis treatment.
* Any other condition, that in the opinion of the investigator would not allow completion of the 4 hemodialysis treatments in the study.

Primary outcomes:
measure: Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D
timeFrame: 8 hours
measure: Area under plasma transferrin bound plasma iron concentration- time curve (AUC0-last FeTBI) for all Treatments A,B,C and D
timeFrame: 8 hours
Secondary outcomes:
measure: Maximum observed plasma iron concentration (Cmax pFetotal) for all Treatments A,B,C and D
timeFrame: 8 hours
measure: Maximum observed transferrin bound plasma iron concentration (Cmax FeTBI) for all Treatments A,B,C and D
timeFrame: 8 hours
measure: Maximum observed serum iron concentration (Cmax sFetotal) for all Treatments A,B,C and D
timeFrame: 8 hours
measure: Area under serum Fe concentration-time curve (AUC0-last sFetotal) for all Treatments A,B,C and D
timeFrame: 8 hours
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
affiliation: Rockwell Medical
name: Raymond D Pratt, MD, FACP
role: STUDY_DIRECTOR
References: