louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01705847: A Phase 1b Study Evaluating GS-9820 in Subjects With Lymphoid Malignancies
Official title: A Phase 1b Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GS-9820 in Subjects With Lymphoid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoid Malignancies
Keywords: chronic lymphocytic leukemia (CLL)
non-Hodgkin lymphoma (NHL)
Hodgkin lymphoma (HL)
indolent non-Hodgkin lymphoma (iNHL)
diffuse large B-cell lymphoma-activated B-cell (DLBCL-ABC)
DLBCL-germinal center B-cell (GCB)
mantle cell lymphoma (MCL)
GS-9820
phosphatidylinositol 3-kinase (PI3K)
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-10-12
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to determine the appropriate dosing regimen of GS-9820 in subjects with lymphoid malignancies. This is a Phase 1b, open-label, dose-escalation and expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of GS-9820.


Eligibility criteria: Inclusion Criteria:

* Previously treated recurrent B-cell iNHL, DLBCL, MCL, HL or CLL
* Measurable lymphadenopathy
* Requires therapy

Exclusion Criteria:

* Recent history of a major non-lymphoid malignancy
* Evidence of ongoing infection
* Concurrent participation in another therapeutic clinical trial

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Overall safety
timeFrame: Up to 5 years
measure: Pharmacokinetic parameters of GS-9820 as measured by Cmax, Tmax, Ctrough, and AUC
timeFrame: Baseline to Day 29
measure: Pharmacodynamics to measure changes in the phosphatidylinositol 3-kinase (P13K) delta pathway activation and changes in plasma concentration of disease-associated chemokines and cytokines
timeFrame: Baseline to Day 29
measure: Tumor control
timeFrame: Up to 5 years
measure: Patient well-being assessed using changes in baseline in HRQL (health related quality of life questionnaire) domain and symptom scores based on the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym)
timeFrame: Up to 5 years
measure: Drug exposure
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU Medical Center (VUmc)
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus MC - Daniel den Hoed Cancer Center
Study officials:
affiliation: Gilead Sciences
name: Henry Adewoye, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02753647: Chidamide Plus R-CHOP in Elderly DLBCL
Official title: A Prospective, Single Arm, Open-label, Phase II Study of Chidamide in Combination With R-CHOP in the Treatment of de Novo, Elderly, High-risk Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 49
Sex: ALL
Minimum age (years): 61
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-arm, open-label phase II study of Chidamide in combination with R-CHOP in the treatment of de novo, elderly, high-risk diffuse large B cell lymphoma patients.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive
* Age 61-75 years
* ECOG 0,1,2
* Life expectancy\>6 months
* Informed consented
* IPI\>1

Exclusion Criteria:

* Chemotherapy before
* Stem cell transplantation before
* History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
* Primary CNS lymphoma
* LVEF≤50%
* Lab at enrollment (Unless caused by lymphoma) Neutrophile\<1.5\*10\^9/L Platelet\<75\*10\^9/L ALT or AST \>2\*ULN,AKP or bilirubin \>1.5\*ULN Creatinine\>1.5\*ULN
* Other uncontrollable medical condition that may that may interfere the participation of the study
* Not able to comply to the protocol for mental or other unknown reasons
* Pregnant or lactation
* HIV infection
* If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.

Primary outcomes:
measure: Complete response rate
timeFrame: 21 days after 6 cycles of treatment (each cycle is 21 days)
Secondary outcomes:
measure: Progression free survival rate
timeFrame: 2 year
measure: Overall survival rate
timeFrame: 2 year
measure: Overall response rate
timeFrame: 21 days after 6 cycles of treatment (each cycle is 21 days)
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Each cycle of treatment and then every 3 months for 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
Study officials:
References:
citation: Zhang MC, Fang Y, Wang L, Cheng S, Fu D, He Y, Zhao Y, Wang CF, Jiang XF, Song Q, Xu PP, Zhao WL. Clinical efficacy and molecular biomarkers in a phase II study of tucidinostat plus R-CHOP in elderly patients with newly diagnosed diffuse large B-cell lymphoma. Clin Epigenetics. 2020 Oct 23;12(1):160. doi: 10.1186/s13148-020-00948-9.
Clinical trial NCT06302647: Assessing Interest in Web/App Platforms for Early Phase Clinical Trial Recruitment
Official title: STUDY TO EVALUATE THE WILLINGNESS OF HEALTHY VOLUNTEERS, PATIENTS, DOCTORS AND PHARMACEUTICAL/BIOTECHNOLOGY INDUSTRY TO USE A PLATFORM (WEB OR APP) TO FACILITATE RECRUITMENT AND ENGAGEMENT IN EARLY PHASE CLINICAL TRIALS AND TO IMPROVE THE KNOWLEDGE OF BOTH HEALTHY VOLUNTEERS AND PATIENTS IN CLINCIAL TRIALS
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Assessing Interest in a Platform for Early Phase Clinical Trial Recruitment
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects above 18 years old willing to fulfill the questionnaire

Brief summary: Study objective:

To assess whether the different stakeholders (volunteers, patients, doctors and industry) involved in early phase trials would be interested in using a platform to facilitate recruitment and engagement in this type of trials. In addition, we will also evaluate the degree of awareness existing in society about clinical trials.

Study subjects: General population, patient, physicians, pharmaceutical-biotechnological industry.

Keywords: healthy volunteer, patient, pharma industry, patient associaiton, questionnaire, clinical trial, platform, recruitment, engagement.


Eligibility criteria: Inclusion Criteria:

* Participant will be over 18 years old.
* Male, female or do not want to specify.
* Participants will be capable to understand spanish language.
* Subjects able to communicate with the investigator and able to read and write and follow all study instructions.

Exclusion Criteria:

* Individuals not willing to complete the eraly phase clinical trial platform Study survey
* Individuals who do not meet eligibility criteria

Primary outcomes:
measure: percentage of each of the three groups that would find the platform useful
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06497647: New Treatment for Nocturnal Enuresis in Children
Official title: Outcome of Treatment of Monosymptomatic Nocturnal Enuresis in Children Using Imipramine Alone Versus Sulbutiamine Alone Versus Imipramine Plus Sulbutiamine : Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nocturnal Enuresis in Children
Keywords: treatment of monosymptomatic nocturnal enuresis in children using sulbutiamine
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 450
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the role of sulbutiamine in treatment of monosymptomatic nocturnal enuresis in children by using it alone or as a combination therapy with tricyclic antidepressants (imipramine+sulbutiamine).


Eligibility criteria: Inclusion Criteria:

* Age : 6 - 18 years old.
* All children diagnosed by Primary monosymptomatic nocturnal enuresis in this age group.

Exclusion Criteria:

* Secondary nocturnal enuresis (child who has been continent for at least 6 months before the onset of bedwetting ).
* congenital anomalies (Posterior urethral valve , ectopic ureter , ectopia vesica ,...)
* history of previous lower urinary tract surgery (Multiple hypospadias surgeries ,..., )
* neurogenic bladder (as underactive bladder ).and urge incontinence.
* presence of post-void residual urine greater than 20% of functional bladder capacity.
* history or evidence of disorders in other organs such as (cardiovascular system disease), liver , psychological problems , evident allergic reaction to both medication.

Primary outcomes:
measure: reduction in the number of wet nights .
timeFrame: the number of wet nights will be measured and compared at the end of each month for 3 months using a calendar fulfilled by the child and his parents.
Secondary outcomes:
measure: determine any side effects of the drugs used in the study
timeFrame: this will be discussed in the follow up that will be done in each month in the outpatient clinic for 3 months.
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Faculty of Medecine
Study officials:
References:
Clinical trial NCT02622347: Spiking-and-Recovery Experiment DOREMI Study
Official title: Spiking-and-Recovery Experiment DOREMI Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: FSH Assay
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bloodserum samples of 30 women with basal FSH concentration varying between 0-14 IU/L.

Brief summary: The purpose of this study is to test the validity of our in-house chemiluminescence assay for measurement of folliclestimulating hormone (FSH) serum levels before and during exogenous recombinant FSH (rFSH) administration.

Detailed description: Study question Does our in-house Beckman-Coulter Unicel DXi800 (Woerden, the Netherlands) chemiluminescence assay completely and consistently recover added known quantities of FSH on top of a known basal serum FSH concentration?

Spiking-recovery experiment The investigators propose a spiking-recovery experiment in which 30 serum samples of different women with basal FSH concentration varying between 0-14 IU/L will be divided into two equal volume parts and spiked with a specific concentration of rFSH (Gonal-F, follitropin alpha; Merck Serono) which will provide a calculated rise in FSH concentration similar to in vivo serum levels.

To perform more reliable testing, the samples will be tested over multiple days.

Basal FSH spiking experiment In the table below an example is given of different basal FSH levels spiked with rFSH diluted 2000 times and the theoretical rise in serum that should be established.

Gonal F concentration is 600 U/L but this concentration unit cannot directly be compared to the units used for the for the routine serum FSH measurement (IU/L). From a pilot experiment the investigators know that on average 60% of rFSH is picked up by the Beckman-Coulter assay.

Buffer spiking In order to determine whether recovery is also influenced by properties of blood serum, the investigators will conduct another spiking experiment in which different concentrations of rFSH will be added to an amount of buffer, with no basal \[FSH\]; 0,1 M phosphate buffer, pH 7.4 with 1-2% of bovine serum albumin (BSA). A calibration line will be constructed with 6 concentrations of recF: range 0-40 U/L.

Eligibility criteria: Inclusion Criteria:

* Female
* Basal FSH concentration varying between 0-14 IU/L

Exclusion Criteria:

* None

Primary outcomes:
measure: Recovery rate
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Broekmans
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02102347: Effect of Phototherapy Incorporated Into an Exercise Program on Osteoarthritis of the Knee
Official title: Effect of Phototherapy Incorporated Into an Exercise Program on Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Keywords: Physical Therapy Modalities
osteoarthritis
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the proposed study is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program on pain, functional capacity, range of motion, muscle strength in individuals with osteoarthritis of the knees. The participants will be allocated to different groups through a randomization process using opaque envelopes containing cards stipulating one of the three following groups: Group A (exercise protocol); Group B (exercise protocol + phototherapy protocol); and Group C (exercise protocol + placebo phototherapy protocol). Phototherapy will be performed on the knees diagnosed with osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of osteoarthritis of the knee (unilateral) according to criteria of the American College of Rheumatology
* age between 40 and 80 years
* either gender
* knee pain and functional disability for at least six months confirmed by historical medical.

Exclusion Criteria:

* Dementia
* neurological disorder (sensory or motor)
* cancer
* diabetes
* acute adverse health condition
* symptoms of osteoarthritis of the hip
* cardiopulmonary disease that impedes walking
* need for wheelchair or gait-assistance device
* and having received steroids through intra-articular injection or orally in the previous six months

Primary outcomes:
measure: physical function
timeFrame: 9 months
Secondary outcomes:
measure: Maximum voluntary isometric contraction
timeFrame: 9 months
Other outcomes:
measure: lower limb functionality
timeFrame: 9 months
measure: pain
timeFrame: 9 months
measure: level of pressure pain
timeFrame: 9 months
measure: Timed up-and-go test
timeFrame: 9 months
measure: trunk stability
timeFrame: 9 months
Locations:
city: São Paulo
country: Brazil
facility: University of Nove de Julho
Study officials:
References:
citation: Coelho Cde F, Leal-Junior EC, Biasotto-Gonzalez DA, Bley AS, de Carvalho Pde T, Politti F, Gonzalez Tde O, de Oliveira AR, Frigero M, Garcia MB, Dibai-Filho AV, Gomes CA. Effectiveness of phototherapy incorporated into an exercise program for osteoarthritis of the knee: study protocol for a randomized controlled trial. Trials. 2014 Jun 11;15:221. doi: 10.1186/1745-6215-15-221.
Clinical trial NCT03135847: Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees
Official title: Physiologically Relevant Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Prosthesis User
Amputation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Louis Stokes VA Medical Center
name: University of Alberta
name: HDT Robotics
name: United States Department of Defense
name: Congressionally Directed Medical Research Programs
First posted: 2017-05-01
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To assess the functional characteristics and utility of upper and lower limb prosthetic devices (advanced bionic and current clinical standard-of-care) that incorporate physiologically relevant touch and/or movement feedback.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria are adults (18 years or over) with major limb amputation (at or above wrist or ankle).

-

Exclusion Criteria:

Exclusion criteria are any skin or pain conditions that would preclude ability to withstand pressures on their limb or to wear a prosthetic socket, or cognitive barriers precluding providing informed consent.

-

Primary outcomes:
measure: Skin or tendon location
timeFrame: 36 months
Secondary outcomes:
measure: Sorting Task
timeFrame: 36 months
measure: Sense of Agency Questionnaire
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Paul Marasco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00388947: Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products
Official title: The Prolapse Registry: An Observational Collection of Short- and Long-Term Patient Outcomes Following Use of AMS Surgical Devices for the Repair of Female Genital Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Prolapse
Keywords: vaginal prolapse
cystocele
rectocele
enterocele
apical prolapse
vaginal vault prolapse
Lead sponsor: ASTORA Women's Health
Sponsor class: INDUSTRY
First posted: 2006-10-17
Enrollment: 1543
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female subjects greater than or equal to 21 years of age with genital prolapse who undergo surgical reconstruction of the pelvic floor using an AMS Prolapse Repair device.

Brief summary: This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry). Data collection focused on the surgical outcomes of AMS prolapse products.

Detailed description: The Prolapse Registry was an observational study of patients who were implanted with AMS devices for the surgical repair of female pelvic prolapse. The registry followed patients post-operatively for up to 2 years and collected demographic, clinical, surgical, safety, and patient outcomes data.

The registry was a web-based system in which surgeons entered patient information with regard to their prolapse surgery. All information entered was de-identified (no names, no date of birth, no date of surgery, etc).

Eligibility criteria: Inclusion Criteria:

* Female at least 21 years old
* Has pelvic organ prolapse requiring surgical repair
* Receives at least one of the AMS Prolapse Repair devices in the treatment of their pelvic organ prolapse

Exclusion Criteria:

* Is contraindicated for an AMS Prolapse Repair per the product's Instruction for Use.

Primary outcomes:
measure: Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device
timeFrame: up to 2-years post-implant
Secondary outcomes:
measure: Prolapse Efficacy Success Rate
timeFrame: 24 months
Other outcomes:
Locations:
city: Whitinsville
country: United States
facility: Samuel Zylstra, MD
state: Massachusetts
Study officials:
affiliation: Whitinsville Medical Center
name: Samuel Zylstra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06995547: Digital Workflow Versus Functional Pick-up Techniques of Two- Implant Retained Mandibular Overdentures
Official title: Digital Workflow Versus Functional Pick-up Techniques of Two- Implant Retained Mandibular Overdentures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occlusal Analysis
Keywords: CAD-CAM, implant, locator attachment, occlusense.
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial\] is to learn if digital pick up can affect occlusal forces on teeth in completely edentulous patients restored with digital complete overdenturs. The main question it aims to answer is:

Researchers will compare digital vs functional pick-up techniques to see if it affects occlusal force.

Participants will be asked to bite on digital articulating paper (occlusense).


Eligibility criteria: Inclusion Criteria:

* completely edentulous, healthy firm mucosa without any remaining roots or jaw cysts. Maxillomandibular Angel's class I relationship with sufficient restorative space (minimum of 8.5 mm measured by using putty index). Sufficient residual alveolar bone quantity and quality class 1-3

Exclusion Criteria:

* Patients with systemic issues such as recent myocardial infarction, hepatic patients, bleeding disorders, autoimmune diseases like rheumatoid arthritis, hyperparathyroidism, uncontrolled diabetes mellitus, severe osteoporosis or cancer were excluded from the study. Also, patients with recent organ transplants, long-term corticosteroid use, radiotherapy, uncooperative patients with psychiatric disorders, heavy smokers, poor oral hygiene, and parafunctional habits were excluded

Primary outcomes:
measure: occlusal force analysis
timeFrame: twelve months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
affiliation: Mansoura University
name: Abdallah mohamed Ibrahim, assistant professor
role: STUDY_CHAIR
References: