louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02417870: Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation
Official title: Safety and Efficacy of Treatment With Ultra-low Dose Subcutaneous IL-2 to Promote Regulatory T Cells Post Renal Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Kidney Transplantation
Keywords: Transplantation
interleukin-2
IL-2
Kidney
Renal
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the safety and tolerability of treatment with low dose rIL-2 in renal transplant recipients. To assess the immunologic impact of low dose rIL-2 in renal transplant recipients. To assess the efficacy of low dose rIL-2 in renal transplant recipients.


Eligibility criteria: Inclusion Criteria:

* Kidney transplant recipients
* \>18 years and \<75 years of age
* \>6 months post Tx
* on stable dose of immunosuppression
* Transplant biopsy showing interstitial fibrosis and tubular atrophy of grade II or greater, with some evidence of lymphocytic infiltration (biopsy is NOT a study procedure, it would be performed as part of the patient's SOC)
* Ability to give informed consent

Exclusion Criteria:

* Biopsy proven acute cellular rejection; greater than grade 1A
* Baseline creatinine \>3.5mg/dL
* Patients with active infection, including Hepatitis B and C, HIV
* Current or prior invasive malignancy
* Patients who are pregnant or breastfeeding
* Patients who are unable to give consent
* Prior intolerance of/allergy to IL2
* Inability to comply with treatment
* History of thrombotic angiopathy including hemolytic uremic syndrome and thrombotic thrombocytopenic purpura
* Symptomatic congestive cardiac failure or uncontrolled cardiac angina
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
* WOCBP and male subjects with reproductive potential must agree to use a highly effective method of birth control \[defined in protocol \& ICF\] during study treatment, and for 6 months after completion of treatment.

Primary outcomes:
measure: Increase in Treg Count
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Anil Chandraker
state: Massachusetts
Study officials:
References:
Clinical trial NCT02606370: Effects of Unstable Shoes on Trunk Muscle Activity, Lumbar Spine Kinematics and Pain in Patients With Low Back Pain
Official title: Effects of Unstable Shoes on Trunk Muscle Activity, Lumbar Spine Kinematics and Pain in Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Unstable Shoes;Trunk muscles;Lumbar lordosis;Low Back Pain
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait using an unstable shoe (Intervention group) and a conventional stable control shoe (Control Group).

Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients with Low Back Pain.

Detailed description: Background: An unstable shoe was developed as a walking device to strengthen the lower extremity muscles and reduce joint loading. A large number of studies have reported increased electromyographic (EMG) activity throughout the gait cycle in most of the lower limb muscles, and significant kinematic changes in the lower extremity. However, no studies have investigated the effects of wearing (1 month) unstable shoes on 1) spine kinematics, 2) trunk muscle activity and 3) Low Back Pain (LBP) during gait in Patients with chronic LBP.

Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait using an unstable shoe (Intervention group) and a conventional stable control shoe (Control Group).

Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients with Low Back Pain.

Eligibility criteria: Inclusion Criteria:

* Patients with Chronic LBP
* BMI \< 30

Exclusion Criteria:

* Hernia
* Lower limb pathologies
* Previous experience with unstable shoes

Primary outcomes:
measure: Disability (assessed by Roland Morris Questionaire)
timeFrame: At 1 month
Secondary outcomes:
measure: EMG activity of trunk muscles
timeFrame: At baseline and at 1 month follow-up
measure: Lumbar spine range of movement (sagittal plane)
timeFrame: At baseline and at 1 month follow-up
Other outcomes:
Locations:
city: Moncada
country: Spain
facility: University CEU Cardenal Herrera
state: Valencia
Study officials:
affiliation: Cardenal Herrera University
name: JF Lisón, Dr.
role: STUDY_DIRECTOR
affiliation: Cardenal Herrera University
name: Pablo Salvador-Coloma
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lison JF, Perez-Soriano P, Llana-Belloch S, Sanchez-Zuriaga D, Salvador-Coloma P. Effects of unstable shoes on trunk muscle activity and lumbar spine kinematics. Eur J Phys Rehabil Med. 2016 Aug;52(4):440-6. Epub 2015 Apr 9.
Clinical trial NCT00937170: Study Comparing Traditional and Gender-specific Total Knee Replacement Designs
Official title: A Prospective, Randomized, Control Trial Comparing Total Knee Arthroplasty With Traditional and Gender-Specific Designs
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Total Knee Replacement
Gender Specific Design
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Stryker Orthopaedics
First posted: 2009-07-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 85
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 results obtained with gender-specific and traditional knee replacement systems design among women undergoing total knee replacement surgery. Women who qualify and agree to participate will be randomly assigned to receive either a traditional or gender-specific knee replacement. During surgery, measurements of bone resection and bone-to-implant relationships will be recorded. At selected time intervals, participants will be asked to fill out questionnaires regarding pain and function, will be examined by their surgeon and routinely obtained xrays will be evaluated. In addition, a subset of participants will be randomly selected to undergo gait analysis to evaluate knee motion and muscle function.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of end-stage degenerative joint disease of the knee
* must be deemed appropriate for total knee replacement surgery

Exclusion Criteria:

* severe flexion deformity of the knee
* greater than 20deg varus or valgus malalignment
* osteomyelitis, septicemia, prior infection of the knee joint
* presence of infections or highly communicable diseases
* significant neurological or musculoskeletal disorders that affect gait or ability to bear weight on lower extremity
* metastatic disease
* congenital, developmental, bone disease or previous knee surgery that may interfere with the total knee prosthesis survival or success
* previous total knee replacement in affected knee
* arthrodesis of the affected knee

Primary outcomes:
measure: Evidence of improved pain relief and function
timeFrame: Pre-op, 4 weeks, 4 months, 1 year, 2 years
Secondary outcomes:
measure: Evidence of improved patellofemoral biomechanics
timeFrame: Pre-op, 4 months, 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University of Connecticut Health Center, Farmington CT, United States
name: R. Michael Meneghini, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05834270: Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe LUTS Due to BPH
Official title: Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Prostate Disease
Prostate Obstruction
Prostate Hypertrophy
Keywords: Tamsulosin
Prostate
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Single dose versus double dose tamsulosin in Management of Moderate and severe lower urinary tract symptoms due to benign prostatic hyperplasia


Eligibility criteria: Inclusion Criteria:

* age more than 50 years
* moderate to severe lower urinary tract symptoms

Exclusion Criteria:

* prostatic cancer
* urethral stricture
* prostate surgery
* Neurogenic bladder

Primary outcomes:
measure: Change in the lower urinary tract symptoms
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Medicine
state: Menofia
Study officials:
References:
Clinical trial NCT04549870: Efficacy of Roflumilast in the Treatment of Psoriasis
Official title: Efficacy of Roflumilast in the Treatment of Psoriasis - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Roflumilast (Daxas®), a selective, long-acting inhibitor of the enzyme phosphodiesterase-4 (PDE4), is used for severe chronic obstructive pulmonary disease. Recent research suggest roflumilast is effective in treating psoriasis. The aim of this investigator-initiated trial is to study the efficacy of oral roflumilast in patients with plaque psoriasis. This has not previously been done.

Detailed description: Aim: To investigate the efficacy of roflumilast in the treatment of psoriasis.

Design: Multicentre, double-blinded, randomised, placebo-controlled, clinical trial.

Participants: Patients ≥18 years with plaque psoriasis.

Method: Twelve weeks treatment with either roflumilast or placebo tablets. Both groups continue for an additional 12 weeks open-label treatment.

Primary endpoint: Proportion of patients achieving at least 75% reduction from baseline psoriasis area and severity index (PASI75) at week 12.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Chronic stable plaque psoriasis (min duration 6 months)
* PASI \>8
* Body mass index (BMI) \> 20 kg/m2
* Candidate for systemic treatment of psoriasis
* Negative pregnancy test (only women)
* Safe anticonception during entire study and at least 1 week after end of treatment (\~5 times plasma half-life of roflumilast) (only applying for fertile women)

Exclusion Criteria:

* Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis
* Current tuberculosis
* Current viral hepatitis
* Heart failure (NYHA III-IV)
* Moderate or severe liver failure (Child-Pugh B-C)
* Current or former malignancy (basal cell carcinoma excluded)
* Current or former depression with suicidal ideation
* Topical therapy for psoriasis during within 2 of randomization or during study
* Systemic therapy for psoriasis or psoriatic arthritis within 4 weeks of randomization or during study
* Treatment with theophylline, phenobarbital, carbamazepine, or phenytoin
* Confirmed pregnancy
* Planned pregnancy within 6 months
* Breast feeding
* Blood donation during study
* Inability to complete study

Primary outcomes:
measure: PASI75
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Alexander Egeberg, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01397370: Multiple Ascending Dose Study of GLPG0492 in Healthy Subjects
Official title: Double Blind, Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of GLPG0492 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2011-07-19
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0492 given to healthy subjects for 14 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after multiple oral administrations.


Eligibility criteria: Inclusion Criteria:

* healthy male, age 18-50 years
* body mass index (BMI) between 18-29.9 kg/m², inclusive.
* normal values of testosterone (2.49-8.36 ng/mL) and LH (1.7-8.6 U/L)

Exclusion Criteria:

* smoking
* drug or alcohol abuse
* hypersensitivity to any of the ingredients of the study drug

Primary outcomes:
measure: To evaluate the safety and tolerability of GLPG0492 in terms of adverse events, vital signs, ECG and abnormal lab tests in comparison with placebo
timeFrame: Up to 2 weeks after last treatment
Secondary outcomes:
measure: To determine the pharmacokinetic profile and metabolism after single and multiple doses of GLPG0492
timeFrame: Up to 2h hours after last treatment
measure: To assess whether GLPG0492 induces CYP450, a pharmacodynamic marker by measuring the ratio of β-OH-cortisol /cortisol in urine
timeFrame: Up to 24 hours after last treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel Early Phase Clinical Unit
Study officials:
affiliation: Galapagos NV
name: Frédéric Vanhoutte, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04737070: Study of High Risk Non Invasive Prenatal Test Population
Official title: Study of High Risk Non Invasive Prenatal Test Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trisomy 21
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: High risk population for prenatal screening of Trisomy 21

Brief summary: The investigator want to study the population of high risk (over 1/50) of Trisomy 21.

According to french guidelines, these patients needs to have a invasive test (such as amniocentesis) but some patients prefer to have a Non Invasive Prenatal Test, with a potential lack of information.


Eligibility criteria: Inclusion Criteria:

* Prenatal screening of Trisomy 21 \> 1/50 (high risk population)

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: number of genetics anomalies
timeFrame: through study completion, an average of 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05424770: The Effect of the Crossword Used in Nursing Education on Learning Success
Official title: The Effect of Crossword Used as an Active Learning Tool in Nursing Education on Learning Achievement: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Nursing
Crossword
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The research was planned as a randomized controlled study to evaluate the effect of crossword, which are an active learning tool, on the success of learning information about pain control in nursing education. Research data is planned to be collected in Hatay Mustafa Kemal University Faculty of Health Sciences. The universe of the research will be the students who take the 3-credit pain control course in the aforementioned faculty in the fall semester. The sample of the research will consist of 72 students who meet the inclusion criteria and agree to participate in the research verbally and in writing. The data of the research will be collected by using the Personal information form prepared in line with the literature, and Success Tests (3 tests) prepared separately for each stage. SPSS program will be used in the analysis of the data.


Eligibility criteria: Inclusion Criteria:

* To be registered in the pain course,
* Taking the pain course for the first time,
* Absence of any psychiatric disorder that will reduce the ability to comprehend and understand,
* Agreeing to participate in the research.

Exclusion Criteria:

-Willingness to leave the research

Primary outcomes:
measure: The effect of crossword on learning achievement in nursing education
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Hatay Mustafa Kemal University Institute of Health Sciences
Study officials:
References:
Clinical trial NCT05861570: Is Combined Steroid and Sodium Hyaluronate Hydrodilatation More Effective Than Isolated Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis
Official title: Steroid and Sodium Hyaluronate Hydrodilatation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adhesive Capsulitis
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2023-05-17
Enrollment: 84
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to compare the efficacy of hydrodilatation with steroid with hyaluronic acid and steroid for treating adhesive capsulitis.

Detailed description: Design: a prospective, double-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (hydrodilatation with steroid ) and group 2 (hydrodilatation with hyaluronic acid and steroid). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Shoulder Pain And Disability Index

Eligibility criteria: Inclusion Criteria:

1. age 35-65 years
2. onset of shoulder stiffness since over a month
3. limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation.

Exclusion Criteria:

1. ultrasound findings of rotator cuff tears,
2. plain radiography findings of significant glenohumeral joint arthritis,
3. accompanying cervical radiculopathy,
4. systemic inflammatory joint disease,
5. intraarticular injection into the glenohumeral joint within the past 3 months
6. history of surgery on the affected shoulders,
7. regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids,
8. allergy to corticosteroid or lidocaine.

Primary outcomes:
measure: change in pain intensity
timeFrame: 0, 6, 12weeks
Secondary outcomes:
measure: change in Shoulder Pain And disability index
timeFrame: 0, 6, 12 weeks
measure: change in glenohumeral joint range of motion
timeFrame: 0, 6, 12weeks
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References:
Clinical trial NCT06949670: Alpha-Synuclein PET/CT in Various α-Syn-Related Disease
Official title: Alpha-Synuclein PET/CT in Various α-Syn-Related Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alpha Synuclein Pathology
Alpha-Synuclein
Parkinson Disease
Keywords: PET/CT
MRI
Alpha-Synuclein
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University General Hospital
First posted: 2025-04-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated PD (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled α-Syn PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Brief summary: To evaluate the potential usefulness of 18F-FIAT-2, 18F-C05-05, 18F-SPAL-T-06 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various α-Syn-related disease patients.

Detailed description: Subjects with various α-Syn-related disease patients underwent 18F-FIAT-2, 18F-C05-05, 18F-SPAL-T-06 PET/CT either for an initial assessment or for recurrence detection.

Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FIAT-2, 18F-C05-05, 18F-SPAL-T-06 PET/CT were calculated.

Eligibility criteria: Inclusion Criteria:

* (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated PD (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled α-Syn PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) patients with none PD syndrome; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References: